Alercina comprimidos инструкция на русском

Alercina Plus (cetirizine, pseudoephedrine) Tablets

In two double-blind, placebo-controlled trials (n = 2094) in which 701 patients with seasonal allergic rhinitis were treated with Alercina Plus (cetirizine, pseudoephedrine) Tablets (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) twice daily for two weeks, the percent of patients who withdrew prematurely due to adverse events was 2.0% in the Alercina Plus (cetirizine, pseudoephedrine) group, compared with 1.1% in the placebo group. All adverse events that were reported by greater than 1% of patients in the Alercina Plus (cetirizine, pseudoephedrine) group are listed in Table 1.

TABLE 1. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN SEASONAL ALLERGIC RHINITIS TRIALS OF Alercina Plus (cetirizine, pseudoephedrine) TABLETS AT RATES OF 1% OR GREATER (PERCENT INCIDENCE)

ZYRTEC Tablets

Controlled and uncontrolled clinical trials of cetirizine conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving cetirizine at doses of 5 to 20 mg per day. The duration of treatment ranged from 1 week to 6 months, with a mean exposure of 30 days.

Most adverse reactions reported during therapy with cetirizine were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving cetirizine 5 mg or 10 mg was not significantly different from placebo (2.9% vs. 2.4%, respectively).

The most common adverse reaction in patients aged 12 years and older that occurred more frequently on cetirizine than placebo was somnolence. The incidence of somnolence associated with cetirizine was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for cetirizine were uncommon (1.0% on cetirizine vs. 0.6% on placebo). Fatigue and dry mouth also appeared to be treatment-related adverse reactions. There were no differences by age, race, gender or by body weight with regard to the incidence of adverse reactions.

Table 2 lists adverse experiences in patients aged 12 years and older that were reported for cetirizine 5 and 10 mg in controlled clinical trials in the United States and were more common with cetirizine than placebo.

TABLE 2. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN PLACEBO-CONTROLLED UNITED STATES CETIRIZINE TRIALS (MAXIMUM DOSE OF 10 MG) AT RATES OF 2% OR GREATER (PERCENT INCIDENCE)

In addition, headache and nausea occurred in more than 2% of the patients, but were more common in placebo patients.

The following events were observed infrequently (less than 2%), in 3982 adults and children 12 years and older or in 659 pediatric (6 to 11 years) patients who received cetirizine in U.S. trials, including an open study of six months duration. A causal relationship of these infrequent events with cetirizine administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of cetirizine has been reported.

In foreign marketing experience or experience in the post market period, the following additional rare, but potentially severe adverse events have been reported: anaphylaxis, cholestasis, glomerulonephritis, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, thrombocytopenia, aggressive reaction and convulsions.

Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride may cause mild CNS stimulation in hypersensitive patients.

Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, nausea, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.

Allercina (10 Mg 7 Coated Tablets)

cetirizine dihydrochloride

ACTION AND MECHANISM

— Antiallergic. Cetirizine is a long-acting piperazine derivative that competitively and reversibly blocks H1 receptors, decreasing the systemic effects of histamine. It results in vasoconstriction and decreased vascular permeability, reducing redness and edema associated with allergy. Partially mitigates symptoms associated with allergic processes such as eye redness or nasal congestion. It also produces a slight bronchodilator effect and a decrease in dermal pruritus.

Cetirizine is the polar metabolite of hydroxyzine, a sedative piperazine antihistamine. However, its greater polarity compared to hydroxyzine, causes it to barely cross the blood-brain barrier and results in sedation to a much lesser extent than other first-generation antihistamines, although more than piperidine derivatives. Its anticholinergic effects are also very insignificant, due to greater selectivity for H1 receptors. It lacks the cardiac effects of some second-generation antihistamines.

PHARMACKINETICS

Orally:

— Absorption: After oral administration, cetirizine is rapidly absorbed, reaching Cmax in one hour. Its bioavailability is around 70%. Its effects are longer than those of other first-generation antihistamines, reaching 24 hours.

Effects of food : When administering cetirizine together with food, a delay in absorption may occur, with increases in Tmax of 1.7 hours, but the amount absorbed is not significantly modified.

— Distribution: Cetirizine binds strongly to plasma proteins (93%). Cetirizine does not appear to cross the placental barrier significantly, but it has been detected in milk.

— Metabolism: It is partially metabolized in the liver, through oxidation reactions and O-dealkylation through cytochrome P450. The metabolites formed are inactive.

— Elimination: Cetirizine is excreted primarily by renal elimination (90%), mainly in unchanged form, although sometimes up to 50% of the dose can be eliminated in the form of metabolites. Only a small amount is excreted with feces. Its elimination half-life in adults is about 6 hours.

Pharmacokinetics in special situations :

— Renal impairment: In patients with renal insufficiency the clearance of cetirizine is decreased, so that in patients with severe renal impairment (CLcr less than 10 ml / minute) undergoing hemodialysis, the half-life may be as long as 20 hours , with a clearance of 0.3 ml / minute / kg.

— Children: Cetirizine is eliminated more rapidly in children, with plasma half-life values ​​of 6 hours for children between 6-12 years, 5 hours for children 2-6 years and 3 hours for children under 2 years.

— Elderly: A decrease in clearance has been observed, probably related to a physiological reduction of renal functionality. The elimination half-life is about 12 hours, and the clearance is 0.55 ml / minute / kg.

INDICATIONS

— Treatment of nasal and ocular symptoms of [SEASONAL ALLERGIC RHINITIS] and [PERENNE ALLERGIC RHINITIS].

POSOLOGY

«Dosage tablets»

— Adults: 10 mg / 24 h.

— Children and adolescents <18 years:

* Adolescents> 12 years: 10 mg / 24 h.

* Children 6-12 years: 5 mg / 12 h.

* Children <6 years: this medicine is not intended for these patients.

— Elderly: no dose adjustment required.

Missed dose : do not double the next dose.

POSOLOGY IN RENAL INSUFFICIENCY

— Mild renal impairment (CLcr 50-79 ml / min): no dose adjustment is required.

— Moderate renal insufficiency (CLcr 30-49 ml / min): 5 mg / 24 h.

— Severe renal impairment (CLcr 10-30 ml / min): 5 mg every other day.

— End-stage renal impairment (CLcr <10 ml / min): contraindicated.

The dose should be adjusted individually in children with renal impairment based on age, weight and degree of renal functionality.

POSOLOGY IN HEPATIC INSUFFICIENCY

It does not require dosage adjustment.

RULES FOR THE CORRECT ADMINISTRATION

— Tablets: ingest with a glass of liquid. The tablets can be split in half with the aim of obtaining the 5 mg dose.

Administration with food : can be taken with or without food.

CONTRAINDICATIONS

— Hypersensitivity to any component of the medication. There may be cross reactions with other antihistamines, so it is not recommended to use any H1 antihistamine in patients who have presented hypersensitivity to any compound in the group.

— [PORPHYRIA]. H1 antihistamines have been associated with the appearance of porphyric outbreaks, so they are not considered safe in these patients.

— Severe renal impairment (CLcr <10 ml / minute). The safety and efficacy of cetirizine in patients with severe or severe renal impairment have not been evaluated.

PRECAUTIONS

— [RENAL INSUFFICIENCY]. Adjust the dosage according to the degree of insufficiency. Not recommended in patients with severe renal impairment (CLcr less than 10 ml / minute) (see Contraindications).

— [LIVER FAILURE]. Patients with chronic liver disease (hepatocellular, cholestatic and biliary cirrhosis) who were given 10 or 20 mg of cetirizine in a single dose had a 50% increase in half-life with a 40% decrease in clearance compared Like healthy volunteers.

Dose adjustment is only necessary in patients with impaired liver function if they have concomitant kidney damage.

— [EPILEPSY]. Caution should be exercised in epileptic patients, since antihistamines have occasionally been associated with paradoxical reactions of hyperexcitability, even at therapeutic doses, which could reduce the seizure threshold.

— Photosensitivity. Cetirizine could lead to photosensitivity phenomena, so it is recommended not to sunbathe during treatment, and protect yourself by sunscreens.

PRECAUTIONS RELATING TO EXCIPIENTS

— This medicine contains lactose. Patients with hereditary or galactose [INTOLERANCE TO LACTOSE], Lapp lactase insufficiency or glucose or galactose malabsorption should not take this medicine.

— This medicine contains lactose. The intake of amounts greater than 5 g daily should be taken into account in patients with [DIABETES] and with intolerance to certain sugars.

PATIENT ADVICE

— Very rarely it could cause drowsiness, so it is recommended to be cautious when driving, and not combine it with drugs or other sedative substances such as alcohol.

— It is advisable to administer in a single dose. If adverse reactions occur or in young children it is recommended to fragment the dose.

— It is advised not to sunbathe during treatment.

SPECIAL WARNINGS

— Due to the antiallergic effects of this medicine, it could give false negatives in dermal tests of hypersensitivity to antigen extracts. It is recommended to suspend the administration of this medicine at least 72 hours before the test.

INTERACTIONS

Cetirizine does not exert very significant sedative effects, but it is recommended that extreme precautions be taken in the case of administering sedative drugs or alcohol, as potentiation of the central depressant action could occur. Cetirizine could potentiate the photosensitizing effects of other active substances that give rise to photosensitivity reactions. In addition, drug interactions with the following active ingredients have been described:

— Oral anticoagulants (acenocoumarol). The co-administration of acenocoumarol and cetirizine has led to some cases of potentiation of the anticoagulant effect, probably due to a shift in protein binding. This interaction seems to be especially important in patients with renal impairment, while in the case of normal renal functionality it does not appear to be very significant. However, it is recommended to monitor the patient, and readjust the dose of the anticoagulant if necessary.

— Theophylline. After administering a dose of 400 mg of theophylline, a 16% decrease in the clearance of cetirizine has been observed. It may be necessary to monitor the patient.

PREGNANCY

FDA Category B.

Safety in animals : in studies conducted with mice, rats and rabbits, using doses 40, 180 and 220 times higher than human therapeutics, no teratogenic effects have been recorded.

Safety in humans : there are no adequate and well-controlled studies in humans. There are reports of a possible association between the use of antihistamines in general during the last 2 weeks of pregnancy and an increased risk of retrolental fibroplasia in premature children. The use of this medicine is only accepted in the absence of safer therapeutic alternatives.

LACTATION

Cetirizine is excreted with breast milk. In studies with beagle dogs, quantities of 3% of the administered dose have been found. Due to the risk of adverse reactions in children it is recommended to stop breastfeeding or avoid the administration of this medicine.

CHILDREN

Cetirizine can be used in children from 2 years old, selecting the appropriate pharmaceutical form. Although their anticholinergic effects are not important, young children may be more susceptible to them, with a paradoxical reaction of excitement and tendency to seizures.

Safety and efficacy in children <2 years have not been evaluated.

ELDERLY

In patients> 65 years of age, a reduction in the elimination of cetirizine has been observed, probably due to the decrease in renal functionality, rather than at the age itself. It is not necessary to adjust the dosage in these patients if renal function is normal. If the functionality is reduced, the dose should be adjusted similarly to the settings in patients with renal impairment ( see Dosage in Renal impairment ).

In addition, it should be borne in mind that the elderly may be more sensitive to the adverse effects of antihistamines, such as dizziness, sedation, confusion, hypotension and hyperexcitability. Although cetirizine does not usually cause severe drowsiness, and its anticholinergic effects are less than other antihistamines, it is advised to use with caution. If persistent or serious side effects appear, it may be advisable to discontinue treatment.

EFFECTS ON DRIVING

Cetirizine does not usually cause drowsiness as often as first-generation antihistamines, but it cannot be ruled out. Therefore, it is recommended to exercise caution when driving or operating dangerous machinery, until they are reasonably certain that the drug treatment does not adversely affect them.

ADVERSE REACTIONS

The side effects of cetirizine are usually mild and transient, being more frequent during the first days of treatment. Cetirizine produces less sedation than other H1 antihistamines and its anticholinergic effects are practically nil, although it cannot be ruled out that they appear. There is great interindividual variability with respect to the frequency and intensity of the symptoms, especially affecting young children and the elderly. The most common adverse reactions are:

— Digestive Cases of gastrointestinal discomfort have been described as [NAUSEAS], [VOMITOS], [CONDENSATION], [DIARRHEA], [EPIGASTRIC PAIN], [ANOREXIA] or [MOUTH DROUGHT].

— Neurological / psychological. Some cases of [SOMNOLENCE], [CEFALEA], [ASTENIA], [MAREO] and [EXCITABILITY] have been described with [AGITATION], especially in children.

— Allergic / dermatological. [HYPERSENSITIVITY REACTIONS] may appear with [ANGIOEDEMA] after systemic administration of antihistamines and occasionally [PHOTOSENSITIVITY REACTIONS] after intense exposure to sunlight, with [DERMATITIS], [PRURITE], [EXANTEMATIC ERUPTIONS] and [ERITEMA ].

In case these symptoms appear, it is recommended to divide the dose. If they persist or worsen, it is recommended to discontinue treatment.

OVERDOSE

Symptoms : Cetirizine hardly presents sedative and anticholinergic effects. In case of overdose, sedation is expected and sometimes, especially in children and the elderly, hyperexcitability phenomena.

Treatment : Cetirizine is rapidly absorbed in the intestine, so in case of overdose the stomach wash is ineffective, unless it is done before 30 minutes after ingestion. There is no known antidote. Symptomatic treatment will be followed.

Allercina Leaflet (10 Mg 7 Coated Tablets)

Аналоги (синонимы) препарата Алпизарин^®

Аналоги по действующему веществу не найдены.

Название препарата	Цена за упак., руб.	Аптеки
Алпизарин®, мазь для местного и наружного применения, 2%, туба алюминиевая 10 г — пачка картонная Производитель: Фармцентр ВИЛАР АО (Россия)
84.00
89.00
107.00
Алпизарин®, мазь для местного и наружного применения, 5%, туба алюминиевая 10 г — пачка картонная Производитель: Фармцентр ВИЛАР АО (Россия)
94.00
103.00
120.00
Алпизарин®, таблетки, 100 мг, №20 — 20 шт. — упаковка контурная ячейковая — пачка картонная Производитель: Фармцентр ВИЛАР ЗАО (Россия)
212.00
219.00
Алпизарин®, таблетки, 100 мг, №20 — 10 шт. — упаковка контурная ячейковая (2) — пачка картонная Производитель: Фармцентр ВИЛАР ЗАО (Россия)
248.00
Алпизарин®, таблетки, 100 мг, №20 — 10 шт. — упаковка контурная ячейковая (2) — пачка картонная Производитель: Фармцентр ВИЛАР АО (Россия)
257.00

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Информация предназначена исключительно для сравнения цен в стационарных аптеках, осуществляющих деятельность в
соответствии со статьей 55 Федерального закона «Об обращении лекарственных средств» от 12.04.2010 № 61-ФЗ.