Состав:
Применение:
Применяется при лечении:
Артралгия,Болезненная менструация,Боли в спине,Боль,Боль в горле,Боль в ухе,Головная боль,Грипп,Зубная боль,Лихорадка,Мигрень,Мышечные Боли,Напряженная головная боль,Невралгия,Простуда,Синдром Прорезывания Зубов
Страница осмотрена фармацевтом Федорченко Ольгой Валерьевной Последнее обновление 2022-04-06
Внимание!
Информация на странице предназначена только для медицинских работников!
Информация собрана в открытых источниках и может содержать значимые ошибки!
Будьте внимательны и перепроверяйте всю информацию с этой страницы!
Топ 20 лекарств с такими-же компонентами:
Топ 20 лекарств с таким-же применением:
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Depon
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Acetaminophen
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Суспензия для приема внутрь
Таблетки
У детей с 3 мес (от 1 до 3 мес применение Deponа по всем показаниям возможно только по назначению врача) до 6 лет в качестве жаропонижающего средства (ОРВИ, грипп, детские инфекции, поствакцинальные реакции и другие состояния, сопровождающиеся повышенной температурой тела) и болеутоляющего средства (болевой синдром слабой и умеренной интенсивности, в т.ч. головная и зубная боль, боль в мышцах, невралгия, боль при травмах и ожогах).
Болевой синдром слабой или умеренной интенсивности (головная боль, невралгия, миалгия, артралгия, альгодисменорея, зубная боль), понижение повышенной температуры тела при инфекционно-воспалительных заболеваниях (в т.ч. простудных).
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Драже; Суспензия для приема внутрь для детей
Суспензия для приема внутрь
Таблетки
Внутрь. Взрослым по 500 мг до 4 раз в сутки, максимальная разовая доза — 1 г, суточная — 4 г. Курс не более 5 дней. Детям по 10–15 мг/кг каждые 6 ч, курс 3–5 дней.
Внутрь, запивая большим количеством жидкости, через 1–2 ч после приема пищи 3–4 раза в сутки с интервалом не менее 4 ч.
Суспензию Depon для детей не следует разводить. Для удобства и точности дозирования используют мерную ложку, отмеряющую 2,5 и 5 мл суспензии.
Рекомендуемые дозы для детей от 3 мес до 6 лет
| Возраст | Разовые дозы |
| 3 мес — 1 год | 60–120 мг парацетамола (2,5–5 мл) |
| От 1 года до 6 лет | 120–240 мг парацетамола (5–10 мл) |
Продолжительность лечения: 3 дня в качестве жаропонижающего и до 5 дней в качестве болеутоляющего средства. При необходимости продолжения приема препарата требуется консультация врача.
Внутрь, предпочтительнее между приемами пищи, шипучую таблетку полностью растворяют в стакане воды, а полученный раствор сразу выпивают. Если врачом не даны другие указания, то при применении препарата следует соблюдать следующие дозировки:
взрослые: по 500–1000 мг (1–2 шипучие таблетки) 3–4 раза в сутки, максимальная доза — 4 г/сут.
дети: дозировка по массе тела ребенка подразумевает прием дозы 10–15 мг/кг. Удобная схема дозировок приведена в таблице.
| Возраст | Масса тела, кг | Разовая доза, мг | Максимальная суточная доза, г |
| 6–9 лет | 22–30 | 250 (0,5 табл.) | 1–1,5 (2–3 табл.) |
| 9–12 лет | до 40 | 500 (1 табл.) | 2 (4 табл.) |
| старше 12 лет | >40 | 500–1000 (1–2 шипучих табл.) | 2–4 (4–8 табл.) |
Рекомендуемый интервал между приемами — 6–8 ч (не менее 4 ч). Максимальная продолжительность лечения для детей — 3 дня, для взрослых — не более 5 дней при назначении в качестве обезболивающего средства и не более 3 дней при назначении в качестве жаропонижающего средства. После 5 дней лечения проводят анализ периферической крови.
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Суспензия для приема внутрь
Таблетки
Гиперчувствительность, тяжелые нарушения функции печени, почек, заболевания крови, дефицит глюкозо-6-фосфатдегидрогеназы, грудной возраст до 1 мес.
Повышенная чувствительность к компонентам препарата, почечная и печеночная недостаточность, дефицит глюкозо−6-фосфатдегидрогеназы, беременность, кормление грудью, детский возраст до 6 лет.
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Суспензия для приема внутрь
Таблетки
Тошнота, рвота, боли в животе, аллергические реакции (кожная сыпь, зуд, крапивница, отек Квинке); редко — тромбоцитопения, агранулоцитоз, лейкопения, анемия; при длительном применении в больших дозах — гепатотоксическое и нефротоксическое действие, панцитопения, метгемоглобинемия.
Аллергические реакции — кожная сыпь, зуд, крапивница, отек Квинке; тошнота, боль в эпигастрии; анемия, тромбоцитопения. При длительном применении в больших дозах — гепатотоксическое действие, нефротоксическое действие (почечная колика, асептическая пиурия, интерстициальный нефрит, папиллярный некроз), гемолитическая анемия, апластическая анемия, метгемоглобинемия, панцитопения, агранулоцитоз. Очень редко — понижение АД, гипогликемия, диспноэ, васкулит.
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Суспензия для приема внутрь
Таблетки
Симптомы: бледность, потливость, боль в желудке, тошнота и рвота, через 1–2 сут — признаки поражения печени (болезненность в области печени, повышение активности печеночных ферментов в крови, увеличение протромбинового времени). В тяжелых случаях — печеночная недостаточность, гепатонекроз, энцефалопатия, коматозное состояние.
Лечение: прекращение приема препарата, промывание желудка, назначение энтеросорбентов (активированный уголь, полифепан), в/в введение антидота — N-ацетилцистеина или назначение внутрь метионина.
Симптомы: бледность кожных покровов, анорексия, тошнота, рвота; гепатонекроз (выраженность некроза вследствие интоксикации прямо зависит от степени передозировки).
Лечение: промывание желудка, назначение активированного угля.
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Обладает чрезвычайно малым влиянием на синтез ПГ в периферических тканях, не изменяет водно-солевой обмен (задержка натрия и воды) и не повреждает слизистую ЖКТ.
Предоставленная в разделе Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Суспензия для приема внутрь
Таблетки
Cmax в плазме достигается через 30–90 мин после приема внутрь. Величина соотношения объема распределения и биодоступности у детей и новорожденных подобна таковым у взрослых. T1/2 — 1,5–2,5 ч. Метаболизируется в печени. У новорожденных и детей до 10 лет основным метаболитом является сульфат парацетамола, у детей 12 лет и старше — конъюгированный глюкуронид. При недостатке глутатиона эти метаболиты могут блокировать ферментные системы гепатоцитов и вызывать их некроз. Примерно 85–95% дозы выводится с мочой за 24 ч (менее 4% препарата — в неизмененном виде).
Абсорбция высокая, связывание с белками плазмы — 15%. Cmax в плазме достигается через 0,5–2 ч. Проходит через ГЭБ, проникает в грудное молоко (менее 1% от принятой дозы). Эффективная терапевтическая концентрация в плазме достигается при назначении в дозе 10–15 мг/кг.
Метаболизируется в печени: 80% конъюгирует с глюкуроновой кислотой и сульфатами с образованием неактивных метаболитов, 17% гидроксилируется с образованием активных метаболитов, которые конъюгируют с глутатионом и образуют неактивные метаболиты. При недостатке глутатиона эти метаболиты могут блокировать ферментные системы гепатоцитов и вызывать их некроз. Т1/2 — 2–3 ч, у пожилых пациентов клиренс препарата снижается и увеличивается период полувыведения. Выводится почками — 3% в неизмененном виде.
Фармокологическая группа
Предоставленная в разделе Фармокологическая группа Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу Фармокологическая группа
в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
- Анилиды
Взаимодействие
Предоставленная в разделе Взаимодействие Deponинформация составлена на основе данных о другом лекарстве с точно таким же составом как лекарство Depon. Будьте
внимательны и обязательно уточняйте информацию по разделу Взаимодействие
в инструкции к лекарству Depon непосредственно из упаковки или у фармацевта в аптеке.
more…
Суспензия для приема внутрь
Таблетки
Алкоголь, барбитураты, трициклические антидепрессанты, противосудорожные препараты, фенилбутазон, рифампицин усиливают гепатотоксичность, салицилаты — нефротоксическое действие.
Парацетамол усиливает действие непрямых антикоагулянтов, снижает эффективность урикозурических препаратов, повышает токсичность хлорамфеникола.
Стимуляторы микросомального окисления в печени (фенитоин, этанол, барбитураты, рифампицин, фенилбутазон, трициклические антидепрессанты, эстрогенсодержащие контрацептивы) увеличивают продукцию гидроксилированных активных метаболитов, что обусловливает возможность развития тяжелых интоксикаций при небольших передозировках. Этанол способствует развитию острого панкреатита. Ингибиторы микросомального окисления (циметидин) снижают риск гепатотоксического действия. Снижает эффективность урикозурических препаратов. Усиливает действие препаратов, угнетающих ЦНС, этанола. При замедлении опорожнения желудка (пропантелин) может иметь место замедленное наступление действия парацетамола, а при ускорении (метоклопрамид) — препарат начинает действовать быстрее. Усиливается токсичность хлорамфеникола. Следует соблюдать осторожность при продолжительном применении парацетамола и одновременной терапии пероральными препаратами, тормозящими свертывание крови.
Depon цена
У нас нет точных данных по стоимости лекарства.
Однако мы предоставим данные по каждому действующему веществу
Средняя стоимость Acetaminophen 500 mg за единицу в онлайн аптеках от 0.16$ до 0.31$, за упаковку от 21$ до 31$.
Средняя стоимость Acetaminophen 120 mg за единицу в онлайн аптеках от 2.05$ до 2.05$, за упаковку от 25$ до 25$.
Средняя стоимость Acetaminophen 325 mg за единицу в онлайн аптеках от 0.21$ до 0.21$, за упаковку от 21$ до 21$.
Средняя стоимость Acetaminophen 650 mg за единицу в онлайн аптеках от 2.3$ до 2.3$, за упаковку от 28$ до 28$.
Источники:
- https://www.drugs.com/search.php?searchterm=depon
- https://pubmed.ncbi.nlm.nih.gov/?term=depon
Доступно в странах
Найти в стране:
А
Б
В
Г
Д
Е
З
И
Й
К
Л
М
Н
О
П
Р
С
Т
У
Ф
Х
Ч
Ш
Э
Ю
Я
Top 20 medicines with the same components:
Top 20 medicines with the same treatments:
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Depon
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Acetaminophen
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.
Depon ActiFast is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu.
Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds and influenza, aches and pains and post-immunisation fever.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Adults, the elderly and young persons 16 years and over:
2 tablets every 4 hours to a maximum of 8 tablets in 24 hours.
Children 6 — 9 years:
½ tablet every 4 hours to a maximum of 4 doses in 24 hours.
Children 10 — 11 years:
1 tablet every 4 hours to a maximum of 4 doses in 24 hours
Adolescents 12 — 15 years:
1 to 1 ½ tablets every 4 hours to a maximum of 4 doses in 24 hours
Do not give to children aged under 6 years of age.
For oral administration.
Adults, including the elderly and children 16 years and over:
Two tablets to be taken with half a tumbler of water (100 ml).
To ensure fast onset of pain relief no less than two tablets must be taken with 100 ml of water. For maximum speed of action this should be on an empty stomach.
Two tablets up to four times daily as required. The dose should not be repeated more frequently than every four hours nor should more than four doses be taken in any 24 hour period.
Children aged 12-15 years:
One tablet to be taken with half a tumbler of water (100ml), up to four times daily as required. The dose should not be repeated more frequently than every four hours nor should more than 4 doses be given in any 24 hour period.
Children under 12 years of age:
Depon ActiFast is not recommended for children under 12 years of age.
For the relief of fever after vaccinations at 2, 3 and 4 months
2.5ml. This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
|
Age : 2 — 3 months |
Dose |
|
Pain and other causes of fever — if your baby weighs over 4 kg and was born after 37 weeks |
2.5 ml If necessary, after 4-6 hours, give a second 2.5 ml dose |
|
— Do not give to babies less than 2 months of age. — Leave at least 4 hours between doses. — Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. |
Children aged 3 months — 6 years:
|
Child’s Age |
How Much |
How often (in 24 hours) |
|
3 — 6 months |
2.5 ml |
4 times |
|
6 — 24 months |
5 ml |
4 times |
|
2 — 4 years |
7.5 ml (5 ml + 2.5 ml) |
4 times |
|
4 — 6 years |
10 ml (5 ml + 5 ml) |
4 times |
|
— Do not give more than 4 doses in any 24 hour period — Leave at least 4 hours between doses — Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist |
It is important to shake the bottle for at least 10 seconds before use.
The Elderly:
In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Hypersensitivity to Depon or any of the constituents.
Hypersensitivity to paracetamol or any of the other constituents.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Care is advised in the administration of Depon to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
Contains Depon.
Do not take anything else containing Depon while taking this medicine.
Talk to your doctor at once if you take too much of this medicine, even if you feel well. This is because too much Depon can cause delayed, serious liver damage.
Patients should be advised that Depon may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing products concurrently.
Each Depon ActiFast tablet contains 173 mg of sodium and should not be taken by patients on a low sodium diet.
Patients should be advised to consult their doctor if their headaches become persistent.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products.
Patient Information Leaflet:
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension should be used with caution in severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Concomitant use of other paracetamol-containing products should be avoided.
Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.
Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).
Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
The label contains the following statements:
Contains paracetamol.
Do not give anything else containing paracetamol while giving this medicine.
Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.
For oral use only.
Always use the syringe supplied with the pack.
Do not give to babies less than 2 months of age.
For infants 2-3 months no more than 2 doses should be given.
Do not give more than 4 doses in any 24 hour period.
Leave at least 4 hours between doses.
Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.
As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.
Keep out of the sight and reach of children.
Do not store above 25°C. Keep bottle in the outer carton.
It is important to shake the bottle for at least 10 seconds before use.
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.
The leaflet contains the following statements:
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.
Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars.
The sorbitol liquid (E420) and maltitol liquid (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose.
Very rare cases of serious skin reactions have been reported. Symptoms may include:
— Skin reddening
— Blisters
— Rash
If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
None.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Adverse effects of Depon are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causality related to Depon.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis |
|
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Adverse effects of paracetamol are rare but hypersensitivity/anaphylactic reactions including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
Most reports of adverse reactions to paracetamol relate to overdose with the drug.
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.
Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.
Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Liver damage is possible in adults who have taken 10g or more of Depon. Ingestion of 5g or more of Depon may lead to liver damage if the patient has risk factors (see below).
Risk Factors
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b) Regularly consumes ethanol in excess of recommended amounts.
Or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of Depon overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of Depon overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Depon concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).
Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Depon however, the maximum protective effect is obtained up to 8 hours post ingestion.
If required the patient should be given intravenous-N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.
Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below)
Risk Factors:
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes
OR
b) Regularly consumes ethanol in excess of recommended amounts
OR
c) Is likely to be glutathione deplete e.g, eating disorders, cystic fibrosis, HIV infection, starvation, cachexia
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, hyperhidrosis, malaise, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. This may include hepatomegaly, liver tenderness, jaundice, acute hepatic failure and hepatic necrosis. Abnormalities of glucose metabolism and metabolic acidosis may occur. Blood bilirubin, hepatic enzymes, INR, prothrombin time, blood phosphate and blood lactate may be increased. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patient who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Mechanisms of Action/Effect
Analgesic — the mechanism of analgesic action has not been fully determined. Depon may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation.
The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Antipyretic — Depon probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
ATC Code N02B E01
Paracetamol has analgesic and antipyretic actions. The mechanism of action is based on the inhibition of prostaglandin biosynthesis.
Paracetamol is poorly absorbed in the stomach but well absorbed in the small intestine due to the greater surface area and hence adsorptive capacity.
Sodium bicarbonate is an excipient in the formulation which has a role in increasing the rates of gastric emptying and of paracetamol dissolution and hence the speed of absorption of paracetamol to provide faster onset of relief.
The amount of sodium bicarbonate contained in 2 tablets of Depon ActiFast are required per dose to have such effects. Sodium bicarbonate influences the rate of gastric emptying in a concentration dependant manner with the maximal effect achieved at near isotonic concentrations (150 mmol/litre)(i.e. 150 millimolar) — equivalent to 2 Depon ActiFast tablets in 100 ml water.
Hypertonic solutions (500-1,000 mmol/litre)(i.e. 500 to 1,000 millimolar — equivalent to the amount of sodium bicarbonate in 6-12 Depon ActiFast tablets given with 100 ml water) appear to inhibit gastric emptying. The therapeutic application of enhanced gastric emptying has previously been demonstrated with significantly faster rate of absorption of paracetamol and significantly faster onset of pain relief from soluble tablets containing sodium bicarbonate compared to conventional tablets. Depon ActiFast has been formulated with 630 mg sodium bicarbonate per tablet that results in near isotonicity at a 2-tablet dose in gastric fluid.
The role of the dissolution rate of Depon ActiFast Tablets in vivo at gastric pH is unknown. Therefore the role of tablet dissolution in the speed of action of Depon ActiFast Tablets is unclear.
It is likely that no single mode of action is responsible for the pharmacokinetic profile observed with Depon ActiFast. The relative contributions of the different factors will vary depending on the circumstances under which the product is taken.
Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides)
ATC Code: N02 BE01
Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Absorption and Fate
Depon is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged Depon. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following Depon overdosage and cause liver damage.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as the glucuronide and sulphate conjugates, — less than 5% is excreted unchanged in the urine as unmodified paracetamol. Binding to plasma proteins is minimal.
The mean elimination half-life of paracetamol following administration of Depon ActiFast is 2 to 3 hours and is similar to that achieved following administration of standard paracetamol tablets in fasted and fed states.
Following administration of Depon ActiFast, paracetamol has a median time to peak plasma concentrations (tmax) of 25 minutes in fasted subjects and 45 minutes in the fed subjects. Maximum plasma concentrations were reached at least twice as fast for Depon ActiFast as for standard paracetamol tablets in both the fed and fasted state (p= 0.0002). Following administration of Depon ActiFast, paracetamol is generally measurable in plasma within 10 minutes in both the fed and fasted state.
Two tablets of Depon ActiFast are required to be taken with 100 ml of water to obtain this fast rate of absorption of paracetamol. The maximum rate of absorption is obtained on an empty stomach. When one tablet is taken the rate of absorption of paracetamol for Depon ActiFast is the same as for standard paracetamol tablets. This is thought to be due to insufficient sodium bicarbonate present in the single tablet dose to increase the rate of paracetamol absorption. In addition, tablets taken with insufficient (<100 mls) water are unlikely to have increased speed of action. (See 5.1 Pharmacodynamic properties).
The extent of absorption of paracetamol from Depon ActiFast tablets is equivalent to that of standard paracetamol tablets as shown by AUC in both fed and fasted states.
Absorption
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses.
Distribution
Drug is widely distributed throughout most body fluids.
Biotransformation
Metabolism occurs almost entirely via hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected.
Children have less capacity for glucuronidation of the drug than do adults.
In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.
Elimination
Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours.
Pharmacotherapeutic group
The information provided in Pharmacotherapeutic group of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Other Analgesics and Antipyretics (Anilides)
Preclinical safety data
The information provided in Preclinical safety data of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
None stated
Preclinical safety data on paracetamol in the literature have not revealed any findings which are of relevance to the recommended dosage and use of the product and which have not been mentioned in other sections of the SmPC.
Mutagenicity
There are no studies relating to the mutagenic potential of Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.
In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.
Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10 mM for 2h).
Carcinogenicity
There are no studies to the carcinogenic potential of Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.
There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract, or paracetamol and renal cell carcinoma.
There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500 mg/kg/day paracetamol.
Teratogenicity
There is no information relating to the teratogenic potential of Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.
Paracetamol has been found to be foetotoxic to cultured rat embryo.
Fertility
A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.
Incompatibilities
The information provided in Incompatibilities of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
None known
Special precautions for disposal and other handling
The information provided in Special precautions for disposal and other handling of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
No special requirements for disposal.
Depon price
We have no data on the cost of the drug.
However, we will provide data for each active ingredient
The approximate cost of Acetaminophen 500 mg per unit in online pharmacies is from 0.16$ to 0.31$, per package is from 21$ to 31$.
The approximate cost of Acetaminophen 120 mg per unit in online pharmacies is from 2.05$ to 2.05$, per package is from 25$ to 25$.
The approximate cost of Acetaminophen 325 mg per unit in online pharmacies is from 0.21$ to 0.21$, per package is from 21$ to 21$.
The approximate cost of Acetaminophen 650 mg per unit in online pharmacies is from 2.3$ to 2.3$, per package is from 28$ to 28$.
Available in countries
Find in a country:
| Trade Name | Depon |
| Availability | Rx and/or OTC |
| Generic | Acetaminophen |
| Acetaminophen Other Names | Acenol, Acetaminofén, Acetaminophen, Acétaminophène, APAP, Paracetamol, Paracétamol, Paracetamolum |
| Related Drugs | Buprenex, aspirin, ibuprofen, tramadol, cyclobenzaprine, Paracetamol, naproxen, diclofenac, Tylenol, oxycodone |
| Type | |
| Formula | C8H9NO2 |
| Weight | Average: 151.1626 Monoisotopic: 151.063328537 |
| Protein binding |
The binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%), when given at therapeutic doses. |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | Cyprus, Greece |
| Last Updated: | September 19, 2023 at 7:00 am |
Depon
Depon (paracetamol), also commonly known as Tylenol, is the most commonly taken analgesic worldwide and is recommended as first-line therapy in pain conditions by the World Health Organization (WHO). It is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a variety of forms including syrup form, regular tablets, effervescent tablets, injection, suppository, and other forms.
Depon is often found combined with other drugs in more than 600 over the counter (OTC) allergy medications, cold medications, sleep medications, pain relievers, and other products. Confusion about dosing of this drug may be caused by the availability of different formulas, strengths, and dosage instructions for children of different ages. Due to the possibility of fatal overdose and liver failure associated with the incorrect use of acetaminophen, it is important to follow current and available national and manufacturer dosing guidelines while this drug is taken or prescribed.
Animal and clinical studies have determined that acetaminophen has both antipyretic and analgesic effects. This drug has been shown to lack anti-inflammatory effects. As opposed to the salicylate drug class, acetaminophen does not disrupt tubular secretion of uric acid and does not affect acid-base balance if taken at the recommended doses. Depon does not disrupt hemostasis and does not have inhibitory activities against platelet aggregation. Allergic reactions are rare occurrences following acetaminophen use.
Uses
Depon is an analgesic drug used alone or in combination with opioids for pain management, and as an antipyretic agent.
In general, acetaminophen is used for the treatment of mild to moderate pain and reduction of fever. It is available over the counter in various forms, the most common being oral forms.
Depon injection is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
Because of its low risk of causing allergic reactions, this drug can be administered in patients who are intolerant to salicylates and those with allergic tendencies, including bronchial asthmatics. Specific dosing guidelines should be followed when administering acetaminophen to children.
Depon is also used to associated treatment for these conditions:
Acute Gouty Arthritis, Acute Musculoskeletal Pain, Allergies, Ankylosing Spondylitis (AS), Arthritis, Chills, Cold, Cold Symptoms, Common Cold, Common Cold/Flu, Cough, Cough caused by Common Cold, Coughing caused by Flu caused by Influenza, Dyskinesia of the Biliary Tract, Dyskinesia of the Urinary Tract, Febrile Convulsions, Febrile Illness Acute, Fever, Fibromyalgia Syndrome, Flu caused by Influenza, Headache, Joint dislocations, Menstrual Distress (Dysmenorrhea), Mild pain, Muscle Inflammation, Muscle Injuries, Muscle Spasms, Musculoskeletal Pain, Nasal Congestion, Neuralgia, Osteoarthritis (OA), Pain, Pollen Allergy, Postoperative pain, Premenstrual cramps, Rheumatoid Arthritis, Rhinopharyngitis, Rhinorrhoea, Severe Pain, Sinusitis, Soreness, Muscle, Spasms, Spastic Pain of the Gastrointestinal Tract, Sprains, Tension Headache, Toothache, Upper Respiratory Tract Infection, Whiplash Syndrome, Acute Torticollis, Mild to moderate pain, Minor aches and pains, Minor pain, Moderate Pain, Airway secretion clearance therapy, Antispasmodic, Bronchodilation
How Depon works
According to its FDA labeling, acetaminophen’s exact mechanism of action has not been fully established — despite this, it is often categorized alongside NSAIDs (nonsteroidal anti-inflammatory drugs) due to its ability to inhibit the cyclooxygenase (COX) pathways. It is thought to exert central actions which ultimately lead to the alleviation of pain symptoms.
One theory is that acetaminophen increases the pain threshold by inhibiting two isoforms of cyclooxygenase, COX-1 and COX-2, which are involved in prostaglandin (PG) synthesis. Prostaglandins are responsible for eliciting pain sensations. Depon does not inhibit cyclooxygenase in peripheral tissues and, therefore, has no peripheral anti-inflammatory effects. Though acetylsalicylic acid (aspirin) is an irreversible inhibitor of COX and directly blocks the active site of this enzyme, studies have shown that acetaminophen (paracetamol) blocks COX indirectly. Studies also suggest that acetaminophen selectively blocks a variant type of the COX enzyme that is unique from the known variants COX-1 and COX-2. This enzyme has been referred to as COX-3. The antipyretic actions of acetaminophen are likely attributed to direct action on heat-regulating centers in the brain, resulting in peripheral vasodilation, sweating, and loss of body heat. The exact mechanism of action of this drug is not fully understood at this time, but future research may contribute to deeper knowledge.
Depon
Table Of contents
- Depon
- Uses
- Dosage
- Side Effect
- Precautions
- Interactions
- Uses during Pregnancy
- Uses during Breastfeeding
- Accute Overdose
- Food Interaction
- Half Life
- Volume of Distribution
- Clearance
- Interaction With other Medicine
- Contradiction
- Storage
Toxicity
LD50 = 338 mg/kg (oral, mouse); LD50 = 1944 mg/kg (oral, rat)
Overdose and liver toxicity
Depon overdose may be manifested by renal tubular necrosis, hypoglycemic coma, and thrombocytopenia. Sometimes, liver necrosis can occur as well as liver failure. Death and the requirement of a liver transplant may also occur. Metabolism by the CYP2E1 pathway releases a toxic acetaminophen metabolite known as N-acetyl-p-benzoquinoneimine(NAPQI). The toxic effects caused by this drug are attributed to NAPQI, not acetaminophen alone.
Carcinogenesis
Long-term studies in mice and rats have been completed by the National Toxicology Program to study the carcinogenic risk of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice consumed a diet containing acetaminophen up to 6,000 ppm. Female rats showed evidence of carcinogenic activity demonstrated by a higher incidence of mononuclear cell leukemia at doses 0.8 times the maximum human daily dose (MHDD). No evidence of carcinogenesis in male rats (0.7 times) or mice (1.2 to 1.4 times the MHDD) was noted. The clinical relevance of this finding in humans is unknown.
Mutagenesis
Depon was not found to be mutagenic in the bacterial reverse mutation assay (Ames test). Despite this finding, acetaminophen tested positive in the in vitro mouse lymphoma assay as well as the in vitro chromosomal aberration assay using human lymphocytes. In published studies, acetaminophen has been reported to be clastogenic (disrupting chromosomes) when given a high dose of 1,500 mg/kg/day to the rat model (3.6 times the MHDD). No clastogenicity was observed at a dose of 750 mg/kg/day (1.8 times the MHDD), indicating that this drug has a threshold before it may cause mutagenesis. The clinical relevance of this finding in humans is unknown.
Impairment of Fertility
In studies conducted by the National Toxicology Program, fertility assessments have been performed in Swiss mice in a continuous breeding study. No effects on fertility were seen.
Use in pregnancy and nursing
The FDA label for acetaminophen considers it a pregnancy category C drug, meaning this drug has demonstrated adverse effects in animal studies. No human clinical studies in pregnancy have been done to this date for intravenous acetaminophen. Use acetaminophen only when necessary during pregnancy. Epidemiological data on oral acetaminophen use in pregnant women demonstrate no increase in the risk of major congenital malformations. While prospective clinical studies examining the results of nursing with acetaminophen use have not been conducted, acetaminophen is found secreted in human milk at low concentrations after oral administration. Data from more than 15 nursing mothers taking acetaminophen was obtained, and the calculated daily dose of acetaminophen that reaches the infant is about 1 to 2% of the maternal dose. Caution should be observed when acetaminophen is taken by a nursing woman.
Food Interaction
- Avoid alcohol. Alcohol may increase the risk of hepatotoxicity.
- Take with or without food. The absorption is unaffected by food.
Depon Alcohol interaction
[Major] GENERALLY AVOID:
Chronic, excessive consumption of alcohol may increase the risk of acetaminophen-induced hepatotoxicity, which has included rare cases of fatal hepatitis and frank hepatic failure requiring liver transplantation.
The proposed mechanism is induction of hepatic microsomal enzymes during chronic alcohol use, which may result in accelerated metabolism of acetaminophen and increased production of potentially hepatotoxic metabolites.
In general, chronic alcoholics should avoid regular or excessive use of acetaminophen.
Alternative analgesic/antipyretic therapy may be appropriate in patients who consume three or more alcoholic drinks per day.
However, if acetaminophen is used, these patients should be cautioned not to exceed the recommended dosage (maximum 4 g/day in adults and children 12 years of age or older).
Depon Drug Interaction
Unknown: aspirin, aspirin, diphenhydramine, diphenhydramine, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, fluticasone nasal, fluticasone nasal, metoprolol, metoprolol, polyethylene glycol 3350, polyethylene glycol 3350, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, cetirizine, cetirizine
Volume of Distribution
Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Depon appears to be widely distributed throughout most body tissues except in fat.
Elimination Route
Depon has 88% oral bioavailability and reaches its highest plasma concentration 90 minutes after ingestion.
Peak blood levels of free acetaminophen are not reached until 3 hours after rectal administration of the suppository form of acetaminophen and the peak blood concentration is approximately 50% of the observed concentration after the ingestion of an equivalent oral dose (10-20 mcg/mL).
The percentage of a systemically absorbed rectal dose of acetaminophen is inconsistent, demonstrated by major differences in the bioavailability of acetaminophen after a dose administered rectally. Higher rectal doses or an increased frequency of administration may be used to attain blood concentrations of acetaminophen similar to those attained after oral acetaminophen administration.
Half Life
The half-life for adults is 2.5 h after an intravenous dose of 15 mg/kg. After an overdose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen.
Clearance
Adults: 0.27 L/h/kg following a 15 mg/kg intravenous (IV) dose.
Children: 0.34 L/h/kg following a 15 mg/kg intravenous (IV dose).
Elimination Route
Depon metabolites are mainly excreted in the urine. Less than 5% is excreted in the urine as free (unconjugated) acetaminophen and at least 90% of the administered dose is excreted within 24 hours.
Innovators Monograph
You find simplified version here Depon
FAQ
What is Depon used for?
Depon is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever.
How safe is Depon?
When used as directed, taking Depon is generally safe and effective.
How does Depon work?
Depon relieves pain by elevating the pain threshold, that is, by requiring a greater amount of pain to develop before a person feels it. It reduces fever through its action on the heat-regulating center of the brain.
What are the common side effects of Depon?
Common side effects of Depon are include;
- nausea,
- stomach pain,
- loss of appetite,
- itching,
- rash,
- headache,
- dark urine,
- clay-colored stools,
- or jaundice (yellowing of skin or eyes).
Is Depon safe during pregnancy?
Depon as one of the only safe pain relievers for pregnant individuals during pregnancy.
Is Depon safe during breastfeeding?
Depon are safe to use when breastfeeding.
Can I drink alcohol with Depon?
Mixing Depon and alcohol can potentially lead to liver damage. Rarely, liver damage can be severe or even life-threatening.
Can I drive after taking Depon?
You should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you. you should know that Depon and codeine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position.
How often can I take Depon?
Take every 4 to 6 hours, as needed, up to 4 times in a 24-hour period.
How do I take Depon?
Take Depon exactly as directed on the prescription or package label.
How much Depon can I take daily?
The usual dose is 325 mg to 650 mg. Take every 4 to 6 hours, as needed, up to 4 times in a 24-hour period. The maximum dose may vary from 3,000 mg to 4,000 mg, but do not take more than 4,000 mg in a 24-hour period.
How long does Depon take to work?
It usually takes about 45 minutes for oral, liquid, or tablet Depon to start working. The oral disintegrating tablets start to work in about 20 minutes.
What is the half life of Depon?
The Depon half-life was 5.4 hours (range, 0.8-119.7 hours).
How long can I take Depon?
Don’t take Depon for more than 10 days in a row unless you’ve been instructed to do so by your doctor.
Who should not take Depon?
You should not take Depon if you are allergic to it, or if you take other medications that contain acetaminophen. Ask a doctor or pharmacist if this medicine is safe to use if you’ve ever had cirrhosis of the liver, or if you drink alcohol daily.
What happens if I miss a dose?
Since Depon is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention. An overdose of acetaminophen can be fatal. The first signs of an Depon overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Should I stop taking Depon?
It is suggested that you stop taking Depon and talk with your doctor if: You still feel pain after 10 days (adult) or 5 days (children) You still have a fever after 3 days. Your symptoms get worse, or you feel new symptoms.
Can Depon affects my heart ?
It is not known to increase risks of heart attack, heart failure, or stroke.
Can Depon affect my kidneys?
Depon broken down/metabolized almost completely by the liver, so the kidneys hardly do any of the work and are not affected by it. Depon is safe for the kidneys.
Can Depon affects my liver?
Depon toxicity can quickly lead to liver damage. Liver damage associated with Depon use sends thousand of Americans to the hospital each year.
DEPON 500MG TABLETS
Country: Cyprus
Language: Greek
Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Active ingredient:
PARACETAMOL
ATC code:
N02BE01
INN (International Name):
PARACETAMOL
Dosage:
500MG
Pharmaceutical form:
TABLETS
Composition:
PARACETAMOL (0000103902) 500MG
Administration route:
ORAL USE
Prescription type:
Παράλληλη εισαγωγή
Therapeutic area:
PARACETAMOL
Product summary:
Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή; PACK WITH 20 TABS IN BLISTER(S) (PI3001201) 20 TABLET — Εγκεκριμένο — Χωρίς Ιατρική Συνταγή
Patient Information leaflet
23/03/20
P.C
09/04/20
P.C
DEPON 500 MG
ΔΙΣΚΊΟ
DEPON 500 MG
ΑΝΑΒΡΆΖΟΝ ΔΙΣΚΊΟ
DEPON 200 MG
ΥΠΌΘΕΤΟ
DEPON 600 MG
ΥΠΌΘΕΤΟ
DEPON 120 MG/5 ML
ΣΙΡΌΠΙ
DEPON MAXIMUM 1 G
ΑΝΑΒΡΆΖΟΝ ΔΙΣΚΊΟ
DEPON ODIS 500 MG
ΔΙΑΣΠΕΙΡΌΜΕΝΟ ΣΤΟ ΣΤΌΜΑ ΔΙΣΚΊΟ
Παρακεταμόλη ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ
ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ
ΦΆΡΜΑΚΟ, ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ
ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ.
Πρέπει πάντοτε να παίρνετε αυτό το
φάρμακο ακριβώς όπως περιγράφεται στο
παρόν φύλλο
οδηγιών χρήσης ή σύμφωνα με τις
οδηγίες του γιατρού ή του
φαρμακοποιού σας.
• Φυλάξτε αυτό το φύλλο οδηγιών
χρήσης. Ίσως χρειαστεί να το διαβάσετε
ξανά.
• Απευθυνθείτε
στον
φαρμακοποιό
σας,
εάν
χρειαστείτε
περισσότερες
πληροφορίες
ή
συμβουλές.
• Εάν παρατηρήσετε κάποια
ανεπιθύμητη ενέργεια, ενημερώστε τον
γιατρό ή τον φαρμακοποιό
σας. Αυτό ισχύει και για κάθε πιθανή
ανεπιθύμητη ενέργεια που δεν
αναφέρεται στο παρόν
φύλλο οδηγιών χρήσης. Βλέπε παράγραφο
4.
• Πρέπει να απευθυνθείτε σε γιατρό
εάν δεν αισθάνεστε καλύτερα ή εάν
αισθάνεστε χειρότερα.
ΤΙ ΠΕΡΙΈΧΕΙ ΤΟ ΠΑΡΌΝ ΦΎΛΛΟ ΟΔΗΓΙΏΝ:
1. Τι είναι το DEPON και ποια είναι η χρήση
του
2. Τι πρέπει να γνωρίζετε πριν πάρετε
το DEPON
3. Πώς να πάρετε το DEPON
4. Πιθα�
Read the complete document
Similar products
Search alerts related to this product
View documents history
Depon Drug Information [ Bristol-Myers Squibb ]
Table of content
Depon category:
- Human
- Analgetics Acetaminophen Salicylates Codeine
- Miscellaneous Analgesics and Antipyretics
Active ingredients:
- Acetaminophen
Depon companies and manufacturers:
-
Bristol-Myers Squibb
General Information
Depon forms, composition and dosages:
- N / A
Indications, usages and classification codes:
- N02BE01 — Acetaminophen (Paracetamol)
There is an additional general information about this medication active ingredient paracetamol (acetaminophen):
Pharmacological action
Analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis, the predominant influence on the thermoregulation center in the hypothalamus, enhances heat transfer.
Why is Depon prescribed?
Pain weak and moderate intensity of different genesis (including headache, migraine, toothache, neuralgia, myalgia, algomenorrhea; pain in trauma, burns). Fever in infectious and inflammatory diseases.
Paracetamol dosage and administration
Oral or rectally adults and adolescents with a body weight over 60 kg is used in a single dose of 500 mg, the multiplicity of admission — up to 4 times / Maximum duration of treatment — 5-7 days.
Maximum dose: single — 1 g, daily — 4 g.
Single dose for oral administration for children aged 6-12 years — 250-500 mg, 1-5 years — 120-250 mg, from 3 months to 1 year — 60-120 mg, up to 3 months — 10 mg / kg. Single dose rectal in children aged 6-12 years — 250-500 mg, 1-5 years — 125-250 mg.
Multiplicity — 4 at intervals of not less than 4 h. The maximum duration of treatment — 3 days.
Maximum dose: 4 single dose per day.
Depon Side Effects
Digestive system: rarely — dyspepsia; long-term use at high doses — hepatotoxic effects, methemoglobinemia, renal dysfunction and liver, hypochromic anemia.
Hemopoietic system: rarely — thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis.
Allergic reactions: rarely — skin rash, itching, hives.
Contraindications
Chronic active alcoholism, increased sensitivity to paracetamol, marked disturbances of liver function and / or kidney disease, anemia, pregnancy (I term).
Using during pregnancy and breastfeeding
Paracetamol crosses the placental barrier. So far, no observed adverse effects of paracetamol on the fetus in humans.
Paracetamol is excreted in breast milk: the content in milk was 0.04-0.23% of the dose adopted mother.
If necessary, use of paracetamol during pregnancy and lactation (breastfeeding) should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus or child.
In experimental studies found no embryotoxic, teratogenic and mutagenic action of paracetamol.
Special Instructions
With caution used in patients with disorders of the liver and kidneys, with benign hyperbilirubinemia, as well as in elderly patients.
With prolonged use of paracetamol is necessary to monitor patterns of peripheral blood and functional state of the liver.
Used for treatment of premenstrual tension syndrome in combination with pamabrom (diuretic, a derivative of xanthine) and mepyramine (Histamine H1-receptors blocker).
Depon Drug Interactions
With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of paracetamol.
With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.
With the simultaneous use of anticholinergics may decrease absorption of paracetamol.
With the simultaneous use of oral contraceptives accelerated excretion of paracetamol from the body and may reduce its analgesic action.
With the simultaneous use with urological means reduced their effectiveness.
With the simultaneous use of activated charcoal reduced bioavailability of paracetamol.
When applied simultaneously with diazepam may decrease excretion of diazepam.
There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with paracetamol. A case of severe toxic liver injury.
Described cases of toxic effects of paracetamol, while the use of isoniazid.
When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of paracetamol, which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of paracetamol and phenobarbital.
In applying cholestyramine a period of less than 1 h after administration of paracetamol may decrease of its absorption.
At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.
With the simultaneous use of metoclopramide may increase absorption of paracetamol and its increased concentration in blood plasma.
When applied simultaneously with probenecid may decrease clearance of paracetamol, with rifampicin, sulfinpyrazone — may increase clearance of paracetamol due to increasing its metabolism in the liver.
At simultaneous application with ethinylestradiol increases absorption of paracetamol from the gut.
Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce — rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).
Depon in case of emergency / overdose
At a reception in toxic doses (10-15 g in adults) may develop liver necrosis.
Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in the upper right part of the stomach, yellowing of the skin or eyes, flu-like symptoms
Storage Conditions
In a dry, protected from light place, temperature 15-25 °C.
Expiration date for paracetamol: 3 years.
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
- Depon analogs
- Depon similar
Прозрачный, маслянистый раствор желтоватого цвета, практически свободный от частиц.
1 мл раствора (1 ампула) содержит 25 мг флуфеназина деканоата.
Вспомогательные вещества: бензиловый спирт, масло сезамовое (кунжутное).
Антипсихотические средства (производные фенотиазина с пиперазиновой структурой).
Код ATX: N05AB02.
Фармакологические свойства
Фармакодинамика
Флуфеназина деканоат является эфиром флуфеназина — мощного антипсихотического препарата — производным фенотиазина пиперазинового типа. Препарат медленно абсорбируется из места инъекции и гидролизуется в плазме до терапевтически активной формы — флуфеназина.
Модитен депо не оказывает выраженный седативный и гипотензивный эффект.
Фармакокинетика
Период полувыведения флуфеназина после внутримышечной инъекции составляет от 2,5 до 16 недель, что подтверждает важность индивидуального подбора доз и интервалов приема для каждого пациента. Стабильный уровень препарата в плазме достигается в течение 2-4 недель.
Показания для применения
Лечение и профилактика рецидивов различных форм шизофрении и параноидальных психозов.
Эффективность препарата Модитен депо показана не только при лечении острых состояний, но и в качестве поддерживающей терапии у пациентов с хроническими заболеваниями, которые часто принимают лекарства нерегулярно или имеют трудности с усвоением фенотиазина при пероральном приеме.
Способ применения и дозировка
Взрослые
Рекомендовано стабилизировать состояние пациента в госпитальных условиях.
Пациенты, которые ранее не получали препараты флуфеназина.
Начальная доза составляет 0,5 мл, т.е. 12,5 мг (0,25 мл, т.е. 6,25 мг для пациентов старше 60 лет). Препарат вводят внутримышечно, глубоко в ягодичную область.
Начало действия развивается в интервале 24-72 часа после приема, эффект с точки зрения влияния на психотические симптомы становится существенным в интервале 48-96 часов. Последующие дозы и интервалы приема определяют индивидуально. При назначении препарата в качестве поддерживающей терапии однократная доза может быть эффективна для контроля симптомов шизофрении до четырех недель или более.
Для достижения наилучшего терапевтического эффекта с наименьшим количеством побочных реакций дозу препарата и частоту приема следует подбирать индивидуально; для большинства пациентов оптимальной является дозировка от 0,5 мл (12,5 мг) до 4,0 мл (100 мг) с интервалом приема 2-5 недель.
Пациенты, которые ранее получали флуфеназин перорально.
Невозможно прогнозировать эквивалентную дозу препарата пролонгированного действия (депо) в виду вариабельности индивидуальных реакций.
Пациенты, которые ранее получали препараты флуфеназина пролонгированного действия.
Пациенты, перенесшие рецидив после прекращения приема флуфеназина пролонгированного действия, могут возобновить лечение с той же дозировки; при необходимости допускается увеличить частоту приема в первые недели лечения до достижения удовлетворительного контроля состояния пациента.
Пациенты пожилого возраста
Лица пожилого возраста могут быть особенно чувствительны в отношении экстрапирамидных реакций, седативного и гипотензивного эффектов. Для предотвращения указанных явлений рекомендованы более низкие поддерживающая и первоначальная дозы препарата.
Дети
Препарат не рекомендован.
Примечание
При повышении дозировки следует принимать во внимание вариабельность индивидуальных реакций и наблюдать за состоянием пациента.
Препарат обладает пролонгированным действием: при прекращении терапии рецидив симптомов может не наблюдаться в течение нескольких недель или месяцев.
Путь введения: внутримышечно.
Если врач сочтет дозу препарата Модитен депо слишком низкой, то лечение может быть дополнено таблетированной формой (Модитен таблетки, покрытые оболочкой).
Раствор для инъекций Модитен депо нельзя смешивать с другими растворами для инъекций.
Острые дистонические реакции возникают нечасто и, как правило, в течение первых 24-48 часов; возможны реакции замедленного типа. У восприимчивых пациентов указанные явления могут появиться уже после приема малых доз и включать окулогирный криз и опистотонус. Для облегчения состояния вводят внутривенно противопаркинсонический препарат — проциклидин.
Паркинсоноподобные состояния могут появиться в период между вторым и пятым днями после инъекции, и, как правило, уменьшаются при последующем введении препарата. Вероятность проявления реакций подобного типа может быть снижена путем назначения меньших доз препарата при повышении частоты приема или путем сопутствующего применения противопаркинсонических средств (тригексифенидил, бензатропин или проциклидин). Указанные препараты не следует назначать регулярно вследствие риска обострения антихолинергических побочных явлений, провоцирования состояний спутанности сознания или нарушения терапевтической эффективности Модитен депо.
При тщательном подборе доз число пациентов, которым показан прием противопаркинсонических препаратов, может быть минимизировано.
Поздняя дискинезия возможна у некоторых пациентов при длительной терапии антипсихотическими препаратами или уже после прекращения лечения. Повышение риска отмечено у лиц пожилого возраста, особенно у женщин, при назначении высоких доз. Симптомы носят персистирующий характер и в некоторых случаях необратимы. Поздняя дискинезия проявляется в виде ритмичных непроизвольных движений языка, мышц лица или шеи (высовывание языка, надувание щек, гримасничанье, жевательные движения), в некоторых случаях возможны непроизвольные движения конечностей. Эффективного лечения поздней дискинезии не существует. В случае возникновения указанных симптомов прием антипсихотического препарата рекомендовано прекратить. При возобновлении лечения, повышении дозы препарата или замене одного антипсихотического средства другим возможно «маскирование» симптомов. Также отмечено, что «червеобразные» движения языка являются ранним признаком заболевания, которое не развивается при прекращении лечения на этом этапе.
Другие нежелательные явления
При приеме препаратов фенотиазина иногда наблюдаются сонливость, вялость, нечеткость зрения, сухость во рту, запор, затрудненное или непроизвольное мочеиспускание, незначительное снижение артериального давления, нарушение интеллектуальных способностей, эпилептические припадки.
Также в ходе лечения фенотиазином наблюдались головная боль, заложенность носа, рвота, эмоциональное возбуждение, бессонница и гипонатриемия.
Получены редкие сообщения о патологических изменениях крови при применении производных фенотиазина. Если у пациента развиваются признаки устойчивой инфекции, то следует провести анализ крови. Сообщалось о транзиторной лейкопении и тромбоцитопении; в редких случаях — о появлении антинуклеарных антител и СКВ.
Имеются редкие сообщения о желтухе. При этом транзиторные отклонения от нормы тестов оценки функции печени могут быть получены и при отсутствии данного синдрома.
Получены сообщения о редких случаях преходящего повышения уровня холестерина в сыворотке крови у пациентов при приеме флуфеназина перорально.
Пигментация кожи и помутнение хрусталика иногда наблюдались после длительного приема высоких доз препаратов данного класса.
Известно, что фенотиазин вызывает реакции фоточувствительности, но для флуфеназина таких сообщений получено не было. Иногда возможны реакции гиперчувствительности (анафилактические реакции).
Пожилые пациенты могут быть более чувствительны в отношении седативного и гипотензивного эффектов.
Воздействие фенотиазина на сердце зависит от дозы. Изменения на ЭКГ с удлинением интервала QT и изменением зубца Т возможны при применении умеренных и высоких доз препарата; пациенты сообщали о предшествующей сильной аритмии, включая пароксизмальную желудочковую тахикардию и фибрилляцию желудочков. Известны случаи внезапной смерти у госпитализированных пациентов, получавших фенотиазин.
Известны случаи венозной тромбоэмболии, в том числе легочной эмболии и тромбоза глубоких вен, связанные с приемом антипсихотических препаратов — частота неизвестна.
Препараты фенотиазина могут нарушать регуляцию температуры тела. Пожилые люди или пациенты с гипотиреозом могут быть особенно чувствительны к гипотермии. При жаркой и влажной погоде или вследствие приема препаратов, нарушающих потоотделение (например, противопаркинсонические средства) может быть повышена угроза гипертермия.
В редких случаях у пациентов, находившихся на терапии антипсихотическими препаратами, был установлен злокачественный нейролептический синдром (ЗНС), характеризующийся гипертермией, а также некоторыми из далее перечисленных или всей совокупностью симптомов: мышечная ригидность, расстройство вегетативной нервной системы (лабильное артериальное давление, тахикардия, потоотделение), акинезия и измененное состояние сознания, иногда развивающееся до помрачения сознания или комы. Лейкоцитоз, повышение КФК, нарушения функции печени и острая почечная недостаточность также возможны. В указанных случаях следует немедленно прекратить прием антипсихотических препаратов и обеспечить интенсивную симптоматическую терапию.
Гормональные эффекты фенотиазина включают в себя гиперпролактинемию, галакторею, гинекомастию, олигоменорею или аменорею. Может быть нарушена половая функция, возможен ложный результат при проведении теста на беременность. Также известны случаи нарушения секреции антидиуретического гормона.
Получены сообщения о возникновении отеков при приеме фенотиазина.
Повышенная чувствительность к активному веществу препарата, вспомогательным веществам или другим фенотиазинам
Коматозное состояние
Церебральный атеросклероз тяжелой степени
Феохромоцитома
Почечная недостаточность
Печеночная недостаточность
Тяжелая сердечная недостаточность
Тяжелые депрессивные состояния
Патологические изменения крови
Детский возраст до 18 лет
Лечение симптоматическое.
В случае экстрапирамидных нарушений эффективны пероральные и парентеральные антипаркинсонические препараты, такие как проциклидин или бензатропин, при тяжелой форме гипотензии рекомендовано контролировать состояние пациента во избежание развития циркуляторного шока (например, с помощью вазоконстрикторов или инфузионных растворов внутривенно). Из вазоконстрикторов назначают метараминол или норадреналин, так как адреналин еще в большей степени может понизить давление вследствие взаимодействия с фенотиазином.
В следующих случаях применяют с осторожностью:
Заболевание печени
Почечная недостаточность
Нарушение сердечного ритма, заболевание сердца
Тиреотоксикоз
Острое респираторное заболевание
Эпилепсия, состояния провоцирующие эпилепсию (например, алкогольный абстинентный синдром или повреждение мозга)
Болезнь Паркинсона
Пациенты, у которых выявлена гиперчувствительность к другим фенотиазинам
Закрытоугольная глаукома в персональном или семейном анамнезе
Жаркая погода
Пожилой возраст, особенно ослабленные пациенты или лица с риском гипотермии
Гипотиреоз
Миастения гравис
Гипертрофия предстательной железы
У пациентов с сердечно-сосудистыми заболеваниями в анамнезе (в том числе наследственными) перед началом лечения флуфеназином следует провести ЭКГ обследование, мониторинг и коррекцию нарушений электролитного баланса.
При приеме антипсихотических средств известны случаи развития венозной тромбоэмболии (ВТЭ). У пациентов, проходящих терапию данными препаратами, часто присутствуют приобретенные факторы риска возникновения ВТЭ, которые следует оценить до и во время лечения флуфеназином и при необходимости предпринять превентивные меры.
После резкой отмены антипсихотических препаратов возможен острый абстинентный синдром, проявляющийся в виде тошноты, рвоты, повышенного потоотделения и бессонницы. Возможно повторное проявление психических симптомов, известны случаи возникновения нарушений, характеризующихся непроизвольными движениями (например, акатизия, дистония, дискинезия). Следовательно, завершение терапии целесообразно проводить постепенно.
Психически больные пациенты, принимающие большие дозы фенотиазинов, перенесшие операцию, должны находиться под строгим контролем на предмет наличия гипотонии. Может возникнуть необходимость в сниженном количестве болеутоляющих средств или средств, успокаивающих центральную нервную систему.
Флуфеназин должен использоваться с осторожностью у пациентов, подверженных воздействию инсектицидов на основе органических соединений фосфора.
Нейролептические средства повышают уровень пролактина, а у грызунов было обнаружено увеличение количества новообразований молочной железы после длительного применения. Однако на сегодняшний день исследования не показали связи между длительным применением этих лекарств и опухолей молочной железы человека.
Как и в случае с любым препаратом фенотиазина, лечащий врач должен не упускать из виду вероятности “скрытой пневмонии” у пациентов, длительно получающих флуфеназин.
Повышенная смертность у пациентов пожилого возраста с деменцией
Результаты двух крупных обсервационных исследований показали, что пожилые пациенты с деменцией, получающие лечение антипсихотическими препаратами, имеют небольшой повышенный риск смертности, по сравнению с теми, кто данное лечение не получает. Данных для однозначной оценки этого явления недостаточно, причина повышенного риска не ясна. Флуфеназин не показан для лечения нарушений поведения, связанных с возрастной деменцией.
Беременность и лактация
Период беременности
Безопасность применения во время беременности не установлена. Препарат назначают в случаях, когда положительный эффект для матери превышает потенциальный риск для плода.
Младенцы, матери которых принимали антипсихотический препарат в течение третьего триместра беременности, находятся в группе риска возникновения нежелательных реакций, включающих экстрапирамидные и/или абстинентные симптомы. В таком случае новорожденные должны находиться под медицинским наблюдением.
Период лактации
Флуфеназин выделяется с грудным молоком, поэтому кормление грудью во время лечения препаратом не рекомендовано.
Влияние на способность управлять автомобилем или другими механизмами
Препарат может оказывать воздействие на умственные и физические способности пациента, необходимые для вождения автомобиля или управления другими механизмами.
Следует учитывать вероятность того, что препараты фенотиазина могут:
Усиливать угнетающее действие на ЦНС таких средств, как этиловый спирт, анестезирующие средства общего действия, снотворные, седативные средства или сильные анальгетики.
Антагонизировать действие адреналина и других симпатомиметиков и снижать антигипертензивный эффект альфа-адреноблокаторов, таких как гуанетидин и клонидин.
Ослаблять/ухудшать: антипаркинсонический эффект леводопы; действие антисудорожных препаратов; метаболизм трициклических антидепрессантов; контроль диабета.
Потенцировать действие антикоагулянтов и антидепрессантов.
Взаимодействовать с литием.
Антихолинергический эффект может быть улучшен при помощи противопаркинсонических или других антихолинергических препаратов.
Фенотиазины могут улучшать абсорбцию кортикостероидов, дигоксина, миорелаксантов.
Флуфеназин метаболизируется через систему цитохрома Р450 2D6 и сам является ингибитором фермента, метаболизирующего препарат. Следовательно, концентрация в плазме и эффект флуфеназина могут быть увеличены и пролонгированы с помощью препаратов, являющихся либо субстратами, либо ингибиторами изоформы Р450 (например, антиаритмические препараты, некоторые антидепрессанты, в том числе селективные ингибиторы обратного захвата серотонина и трициклические антидепрессанты, некоторые антипсихотические средства, |3-блокаторы, ингибиторы протеазы, опиаты, циметидин и МДМА), что вероятно может привести к тяжелой гипотензии, сердечной аритмии, побочным явлениям со стороны ЦНС.
Одновременное применение барбитуратов и фенотиазина может привести к снижению концентраций в плазме крови обоих препаратов и усилению эффекта в случае отмены одного из них.
Влияние флуфеназина на интервал QT вероятно усиливается при одновременном применении других препаратов, удлиняющих этот интервал. Следовательно, сопутствующий прием этих средств противопоказан. Например, антиаритмические препараты класса IА (хинидин, дизопирамид, и прокаинамид) и класса III (амиодарон и соталол), трициклические антидепрессанты (амитриптилин), определенные тетрациклические антидепрессанты (мапротилин), некоторые антипсихотические препараты (фенотиазин и пимозид), некоторые антигистаминные препараты (терфенадин), литий, хинин, пентамидин, спарфлоксацин и другие.
Поскольку нарушение электролитного баланса, особенно гипокалиемия, сильно увеличивает риск удлинения интервала QT, то сопутствующего приема препаратов, вызывающих такие нарушения, следует избегать.
Сопутствующий прием ингибиторов МАО может усиливать седативный эффект, констипацию, ксеростомию и гипотензию.
Благодаря адренолитическому действию фенотиазины могут уменьшать прессорный эффект адренергических вазоконстрикторов (эфедрин, фенилэфрин).
Сообщалось, что фенилпропаноламин взаимодействует с фенотиазином и вызывает желудочковую экстрасистолию.
Одновременное применение фенотиазина и ингибиторов АПФ или антагонистов ангиотензина II может привести к тяжелой постуральной артериальной гипотензии.
Сопутствующий прием тиазидных диуретиков может вызвать гипотензию. Спровоцированная приемом диуретиков гипокалиемия может потенцировать фенотиазин-индуцированную кардиотоксичность.
Клонидин может уменьшать нейролептическое действие фенотиазина.
Метилдопа повышает риск проявления экстрапирамидных побочных эффектов, связанных с приемом препаратов фенотиазина.
Гипотензивное действие блокаторов кальциевых каналов усиливается при одновременном приеме антипсихотических препаратов.
Метризамид может вызывать судорожные припадки при одновременном применении с препаратами фенотиазина.
Одновременное применение фенотиазина и амфетаминовых/анорексических средств может вызвать антагонистические фармакологические эффекты.
Одновременное применение фенотиазина и кокаина может повысить риск развития острой дистонии.
При сопутствующем приеме селективных ингибиторов обратного захвата серотонина в редких случаях был диагностирован острый паркинсонизм.
Фенотиазины могут нарушать действие противосудорожных препаратов. Уровень фенитоина в плазме может быть повышен или понижен.
Фенотиазины ингибируют усвоение глюкозы и тем самым могут оказывать влияние на интерпретацию результатов ПЭТ исследований с использованием маркированной глюкозы.
Условия и срок хранения
Хранить при температуре от 8 °C до 25 °C.
Хранить в оригинальной упаковке с целью защиты от света.
Хранить в недоступном от детей месте.
2 года.
Не использовать позднее даты, указанной на упаковке.
5 ампул по 1 мл в блистере в картонной коробке с инструкцией. На ампулы, изготовленные из темного стекла в соответствии с ЕФ, нанесена белая точка, выше точки нанесено кольцо голубого/синего цвета.
Информация о производителе
КРКА, д.д., Ново место, Шмарьешка цеста, 6, 8501 Ново место, Словения.
Таблетки, покрытые пленочной оболочкой
Одна таблетка содержит
активные вещества: сухие водные экстракты:
Пикрориза курроа (Picrorhiza kurroa Benth.) 80.00
Андрографис метельчатого (Andrographis paniculata Nees.) 40.00
Эклипта белая (Eclipta alba Hassk.) 40.00
Филлантус нирури (Phyllanthus niruri L.) 40.00
Паслен черный (Solanum nigrum L.) 30.00
Тиноспора сердцелистная (Tinospora cordifolia Miers.) 30.00
Иссоп водный (Bacopa monnieri L.) 10.00
Берхавия раскидистая (Boerhavia diffusa L.) 10.00
Имбирь лекарственный (Zingiber officinale Roscoe) 10.00
Перец длинный (Piper longum L.) 8.00
вспомогательные вещества: крахмал кукурузный высушенный*, целлюлоза микрокристаллическая, тальк, магния стеарат, карбоксиметилкрахмал натрия, натрия кросскармеллоза, натрия лаурилсульфат, натрия метилгидроксибензоат, натрия пропилгидроксибензоат, натрия бензоат, бронопол, вода очищенная**.
состав оболочки: «Опадрай II белый» («Opadry II white 85G568918»):
лецитин (соя), титана диоксид Е171, полиэтиленгликоль/макрогол, тальк, спирт поливиниловый. «Опадрай II зелёный» («Opadry II Green 85G51606»):
полиэтиленгликоль, FD&C синий №1 лак алюминиевый, лецитин, спирт поливиниловый, титана диоксид Е171, тальк, хинолиновый жёлтый Е104 лак алюминиевый.
* — кукурузный крахмал предварительно высушивают при 105 ºC, до достижения содержание влаги не более 4.0 %
*- испаряется во время процесса нанесения покрытия
Продолговатые, двояковыпуклые, с закругленными концами таблетки, покрытые пленочной оболочкой светло-зеленого цвета со специфическим запахом
Препараты для лечения заболеваний печени
Код АТС А05ВА
Дипана® обладает гепатопротекторным, желчегонным и иммуномодулирующим действием.
Комплекс биологически активных веществ растительного происхождения, входящих в состав препарата Дипана®, предохраняет печень от воздействия токсичных веществ (алкоголь, лекарственные препараты и т. д.), стимулирует регенерацию клеток печени; оказывает желчегонное действие; нормализует белковосинтетическую функцию печени; способствует улучшению процесса пищеварения; обладает иммуномодулирующей активностью, воздействуя на клеточный и гуморальный звенья иммунитета.
Дипана® содержит сухие водные экстракты растений, обладающие следующим действием:
Экстракты корневищ Пикроризы курроа, листьев и цветов Андрографиса метельчатого обладают гепатопротекторным действием, предотвращая поражение печени токсическими веществами и лекарственными препаратами.
Экстракт листьев и плодов Паслена черного активизирует детоксикационную функцию печени, оказывая стимулирующее влияние на ферментные системы митохондрий гепатоцитов.
Экстракт листьев Иссопа водного, корней и листьев Эклипты белой обладают антиоксидантной активностью.
Экстракт корней Бурхавии раскидистой улучшает отток желчи.
Экстракты корней и листьев Филлантуса нирури и стеблей Тиноспоры сердцелистной обладают антивирусным, желчегонным, гепатопротекторным действием.
Экстракт корневищ Имбиря лекарственного – уменьшает диспепсические расстройства, нормализует перистальтику кишечника и желчевыводящих протоков. Экстракт плодов Перца длинного – предотвращает развитие фиброза печени, потенцирует терапевтическое действие компонентов, входящих в состав остальных экстрактов.
В комплексной терапии:
— острых и хронических заболеваний печени различной этиологии (инфекционные, токсические, лекарственные)
— алкогольной болезни печени
— жировой дистрофии печени
— дискинезии желчевыводящих путей
— при хронических интоксикациях (в т. ч. при длительном употреблении
алкоголя)
Взрослым таблетки Дипана® принимать внутрь до приема пищи или жидкости, запивая достаточным количеством воды.
|
Показание |
|
|
|
|
При лечении алкогольной болезни печени, жировой дегенерации, токсических поражений печени |
2-3 таблетки, в зависимости от тяжести патологии |
2 раза в день или согласно рекомендации врача |
8-12 недель в зависимости от тяжести заболевания |
|
В составе комплексной терапии гепатитов, при токсических и лекарственных поражениях печени |
2 таблетки |
3 раза в день |
4-8 недель |
|
Для профилактики поражений печени при хронических интоксикациях |
1-2 таблетки |
3 раза в день |
4-8 недель |
|
При дискинезиях желчевыводящих путей |
1 таблетка |
2 раза в день или согласно рекомендации врача |
3-6 недель |
— аллергические реакции
— сухость во рту, тошнота
— кишечные спазмы, диарея
— нарушение сна
— головные боли
— усиление диуреза
— повышенная чувствительность к компонентам препарата
— активный гепатит (с повышенными АЛТ, АСТ)
— желчнокаменная болезнь
— детский возраст до 18 лет
— беременность и период лактации
При одновременном приеме Дипаны® с другими лекарственными средствами случаи несовместимости не известны
Особенности влияния лекарственного средства на способность управлять транспортным средством или потенциально опасными механизмами
Препарат не оказывает влияния на снижение скорости психомоторных реакций.
Случаи передозировки препарата не известны.
По 12 таблеток помещают в контурную ячейковую упаковку.
По 4 контурные ячейковые упаковки помещают в картонную пачку вместе с инструкцией по медицинскому применению на государственном и русском языках.
Хранить в сухом, защищенном от света месте при температуре не выше 25°С.
Хранить в недоступном для детей месте!
3 года
Не применять по истечении срока годности
СЕНТИСС ФАРМА Пвт. Лтд.
212/Д-1, Грин Парк, Нью Дели, Индия
Top 20 medicines with the same components:
Top 20 medicines with the same treatments:
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Depon
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Acetaminophen
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.
Depon ActiFast is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu.
Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds and influenza, aches and pains and post-immunisation fever.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Adults, the elderly and young persons 16 years and over:
2 tablets every 4 hours to a maximum of 8 tablets in 24 hours.
Children 6 — 9 years:
½ tablet every 4 hours to a maximum of 4 doses in 24 hours.
Children 10 — 11 years:
1 tablet every 4 hours to a maximum of 4 doses in 24 hours
Adolescents 12 — 15 years:
1 to 1 ½ tablets every 4 hours to a maximum of 4 doses in 24 hours
Do not give to children aged under 6 years of age.
For oral administration.
Adults, including the elderly and children 16 years and over:
Two tablets to be taken with half a tumbler of water (100 ml).
To ensure fast onset of pain relief no less than two tablets must be taken with 100 ml of water. For maximum speed of action this should be on an empty stomach.
Two tablets up to four times daily as required. The dose should not be repeated more frequently than every four hours nor should more than four doses be taken in any 24 hour period.
Children aged 12-15 years:
One tablet to be taken with half a tumbler of water (100ml), up to four times daily as required. The dose should not be repeated more frequently than every four hours nor should more than 4 doses be given in any 24 hour period.
Children under 12 years of age:
Depon ActiFast is not recommended for children under 12 years of age.
For the relief of fever after vaccinations at 2, 3 and 4 months
2.5ml. This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
|
Age : 2 — 3 months |
Dose |
|
Pain and other causes of fever — if your baby weighs over 4 kg and was born after 37 weeks |
2.5 ml If necessary, after 4-6 hours, give a second 2.5 ml dose |
|
— Do not give to babies less than 2 months of age. — Leave at least 4 hours between doses. — Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. |
Children aged 3 months — 6 years:
|
Child’s Age |
How Much |
How often (in 24 hours) |
|
3 — 6 months |
2.5 ml |
4 times |
|
6 — 24 months |
5 ml |
4 times |
|
2 — 4 years |
7.5 ml (5 ml + 2.5 ml) |
4 times |
|
4 — 6 years |
10 ml (5 ml + 5 ml) |
4 times |
|
— Do not give more than 4 doses in any 24 hour period — Leave at least 4 hours between doses — Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist |
It is important to shake the bottle for at least 10 seconds before use.
The Elderly:
In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Hypersensitivity to Depon or any of the constituents.
Hypersensitivity to paracetamol or any of the other constituents.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Care is advised in the administration of Depon to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
Contains Depon.
Do not take anything else containing Depon while taking this medicine.
Talk to your doctor at once if you take too much of this medicine, even if you feel well. This is because too much Depon can cause delayed, serious liver damage.
Patients should be advised that Depon may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing products concurrently.
Each Depon ActiFast tablet contains 173 mg of sodium and should not be taken by patients on a low sodium diet.
Patients should be advised to consult their doctor if their headaches become persistent.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products.
Patient Information Leaflet:
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension should be used with caution in severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Concomitant use of other paracetamol-containing products should be avoided.
Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.
Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).
Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
The label contains the following statements:
Contains paracetamol.
Do not give anything else containing paracetamol while giving this medicine.
Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.
For oral use only.
Always use the syringe supplied with the pack.
Do not give to babies less than 2 months of age.
For infants 2-3 months no more than 2 doses should be given.
Do not give more than 4 doses in any 24 hour period.
Leave at least 4 hours between doses.
Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.
As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.
Keep out of the sight and reach of children.
Do not store above 25°C. Keep bottle in the outer carton.
It is important to shake the bottle for at least 10 seconds before use.
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.
The leaflet contains the following statements:
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.
Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars.
The sorbitol liquid (E420) and maltitol liquid (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose.
Very rare cases of serious skin reactions have been reported. Symptoms may include:
— Skin reddening
— Blisters
— Rash
If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
None.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Adverse effects of Depon are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causality related to Depon.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis |
|
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Adverse effects of paracetamol are rare but hypersensitivity/anaphylactic reactions including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
Most reports of adverse reactions to paracetamol relate to overdose with the drug.
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.
Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.
Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Liver damage is possible in adults who have taken 10g or more of Depon. Ingestion of 5g or more of Depon may lead to liver damage if the patient has risk factors (see below).
Risk Factors
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b) Regularly consumes ethanol in excess of recommended amounts.
Or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of Depon overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of Depon overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Depon concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).
Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Depon however, the maximum protective effect is obtained up to 8 hours post ingestion.
If required the patient should be given intravenous-N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.
Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below)
Risk Factors:
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes
OR
b) Regularly consumes ethanol in excess of recommended amounts
OR
c) Is likely to be glutathione deplete e.g, eating disorders, cystic fibrosis, HIV infection, starvation, cachexia
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, hyperhidrosis, malaise, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. This may include hepatomegaly, liver tenderness, jaundice, acute hepatic failure and hepatic necrosis. Abnormalities of glucose metabolism and metabolic acidosis may occur. Blood bilirubin, hepatic enzymes, INR, prothrombin time, blood phosphate and blood lactate may be increased. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patient who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Mechanisms of Action/Effect
Analgesic — the mechanism of analgesic action has not been fully determined. Depon may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation.
The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.
Antipyretic — Depon probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.
ATC Code N02B E01
Paracetamol has analgesic and antipyretic actions. The mechanism of action is based on the inhibition of prostaglandin biosynthesis.
Paracetamol is poorly absorbed in the stomach but well absorbed in the small intestine due to the greater surface area and hence adsorptive capacity.
Sodium bicarbonate is an excipient in the formulation which has a role in increasing the rates of gastric emptying and of paracetamol dissolution and hence the speed of absorption of paracetamol to provide faster onset of relief.
The amount of sodium bicarbonate contained in 2 tablets of Depon ActiFast are required per dose to have such effects. Sodium bicarbonate influences the rate of gastric emptying in a concentration dependant manner with the maximal effect achieved at near isotonic concentrations (150 mmol/litre)(i.e. 150 millimolar) — equivalent to 2 Depon ActiFast tablets in 100 ml water.
Hypertonic solutions (500-1,000 mmol/litre)(i.e. 500 to 1,000 millimolar — equivalent to the amount of sodium bicarbonate in 6-12 Depon ActiFast tablets given with 100 ml water) appear to inhibit gastric emptying. The therapeutic application of enhanced gastric emptying has previously been demonstrated with significantly faster rate of absorption of paracetamol and significantly faster onset of pain relief from soluble tablets containing sodium bicarbonate compared to conventional tablets. Depon ActiFast has been formulated with 630 mg sodium bicarbonate per tablet that results in near isotonicity at a 2-tablet dose in gastric fluid.
The role of the dissolution rate of Depon ActiFast Tablets in vivo at gastric pH is unknown. Therefore the role of tablet dissolution in the speed of action of Depon ActiFast Tablets is unclear.
It is likely that no single mode of action is responsible for the pharmacokinetic profile observed with Depon ActiFast. The relative contributions of the different factors will vary depending on the circumstances under which the product is taken.
Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides)
ATC Code: N02 BE01
Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.
The information provided in of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
Absorption and Fate
Depon is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged Depon. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following Depon overdosage and cause liver damage.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as the glucuronide and sulphate conjugates, — less than 5% is excreted unchanged in the urine as unmodified paracetamol. Binding to plasma proteins is minimal.
The mean elimination half-life of paracetamol following administration of Depon ActiFast is 2 to 3 hours and is similar to that achieved following administration of standard paracetamol tablets in fasted and fed states.
Following administration of Depon ActiFast, paracetamol has a median time to peak plasma concentrations (tmax) of 25 minutes in fasted subjects and 45 minutes in the fed subjects. Maximum plasma concentrations were reached at least twice as fast for Depon ActiFast as for standard paracetamol tablets in both the fed and fasted state (p= 0.0002). Following administration of Depon ActiFast, paracetamol is generally measurable in plasma within 10 minutes in both the fed and fasted state.
Two tablets of Depon ActiFast are required to be taken with 100 ml of water to obtain this fast rate of absorption of paracetamol. The maximum rate of absorption is obtained on an empty stomach. When one tablet is taken the rate of absorption of paracetamol for Depon ActiFast is the same as for standard paracetamol tablets. This is thought to be due to insufficient sodium bicarbonate present in the single tablet dose to increase the rate of paracetamol absorption. In addition, tablets taken with insufficient (<100 mls) water are unlikely to have increased speed of action. (See 5.1 Pharmacodynamic properties).
The extent of absorption of paracetamol from Depon ActiFast tablets is equivalent to that of standard paracetamol tablets as shown by AUC in both fed and fasted states.
Absorption
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses.
Distribution
Drug is widely distributed throughout most body fluids.
Biotransformation
Metabolism occurs almost entirely via hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected.
Children have less capacity for glucuronidation of the drug than do adults.
In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.
Elimination
Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours.
Pharmacotherapeutic group
The information provided in Pharmacotherapeutic group of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Other Analgesics and Antipyretics (Anilides)
Preclinical safety data
The information provided in Preclinical safety data of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
Pills; Rectal suppositories; Rectal suppositories for children; Solution for infusion; Substance; Substance-powder; Syrup; Tablets, effervescent
Bolus; Coated tablet; Effervescent tablet; Film-coated tablet; Tablets, soluble
Suspension for ingestion for children
None stated
Preclinical safety data on paracetamol in the literature have not revealed any findings which are of relevance to the recommended dosage and use of the product and which have not been mentioned in other sections of the SmPC.
Mutagenicity
There are no studies relating to the mutagenic potential of Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.
In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.
Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10 mM for 2h).
Carcinogenicity
There are no studies to the carcinogenic potential of Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension.
There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract, or paracetamol and renal cell carcinoma.
There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500 mg/kg/day paracetamol.
Teratogenicity
There is no information relating to the teratogenic potential of Depon Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.
Paracetamol has been found to be foetotoxic to cultured rat embryo.
Fertility
A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.
Incompatibilities
The information provided in Incompatibilities of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
None known
Special precautions for disposal and other handling
The information provided in Special precautions for disposal and other handling of Depon
is based on data of another medicine with exactly the same composition as the Depon.
. Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Depon directly from the package or from the pharmacist at the pharmacy.
more…
No special requirements for disposal.
Depon price
We have no data on the cost of the drug.
However, we will provide data for each active ingredient
The approximate cost of Acetaminophen 500 mg per unit in online pharmacies is from 0.16$ to 0.31$, per package is from 21$ to 31$.
The approximate cost of Acetaminophen 120 mg per unit in online pharmacies is from 2.05$ to 2.05$, per package is from 25$ to 25$.
The approximate cost of Acetaminophen 325 mg per unit in online pharmacies is from 0.21$ to 0.21$, per package is from 21$ to 21$.
The approximate cost of Acetaminophen 650 mg per unit in online pharmacies is from 2.3$ to 2.3$, per package is from 28$ to 28$.