Quibron t sr инструкция по применению

General Considerations:

Quibron®-T/SR has not been adequately studied for its bioavailability when administered with food (see PRECAUTIONS, Drug-Food Interactions).

The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400-1600 mg/day in adults <60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady-state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments (See Table V). Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION, Table VI). Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage (see WARNINGS).

If the patient’s symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (see WARNINGS and PRECAUTIONS), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline concentrations should be monitored at frequent intervals, e.g., every 24 hours.

Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.

Table V contains theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum theophylline concentration.

Each tablet contains: Theophylline 300 mg in a patented controlled release system.

Pharmaceutical form

Controlled release tablets.

Pharmacological action

The exact mechanism of action of theophylline is unknown. Theophylline directly relaxes the smooth muscles of the bronchi and pulmonary blood vessels.

Theophylline increases the force of contraction of diaphragmatic muscles and may be capable of reducing fatigability and thereby improves contractility in patients with chronic obstructive airways disease.

Pharmacokinetics

Theophylline is rapidly and completely absorbed after oral administration, maximum plasma concentration is reached in 2 hrs. distributes freely into fat-free tissues & approximately 40% is bound to plasma protein and 90% of the dose metabolized in the liver, excreted by the kidneys (15% of the drug is excreted unchanged) .

It has also been demonstrated that twice- daily dosing produces minimal peak to trough variation and plasma theophylline levels can be maintained within the therapeutic range of 10-20 mcg/ml throughout the 12 hours dosing interval.

Indications

For the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.

Dosage and administration

Adults: The usual maintenance dose is 300 or 400 mg 12-hourly following an initial week of therapy on 200 mg 12 hourly.

The Elderly:Initial week 200 mg/12 hours then the dose should be adjusted following the response to the initial week of therapy.

It may be appropriate to administer a large evening or morning dose in some patients, in order to achieve optimum therapeutic effect when symptoms are most severe e.g. at the time of the morning dip in lung function.

For patients not presently receiving theophylline whose night time or day time symptoms persist despite other therapy, a single evening or morning dose of Quibron tablets may be added to their treatment regimen.

Children : 9 mg/kg twice daily some children with chronic asthma require and tolerate much higher dose (10-16 mg/kg twice daily).

Dose titration: Patients vary in their response to xanthines and it may be necessary to titrate dosages individually. Steady state of theophylline levels are generally attained 3 – 4 days after dose adjustment. If a satisfactory clinical response is not achieved, serum theophylline should be measured 6-8 hours after the last dose.

Based on serum theophylline assay results, dosage should be titrated as follows:

It is advisable to re- check serum theophylline concentration after dose adjustment, when steady state is attained.

Side effects

The risk of side effects,usually associated with theophylline and xanthine derivatives such as nausea, gastric irritation, headache and CNS stimulation is significantly reduced when Quibron tablet preparations are given.

Pregnancy and lactation

Theophylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Theophylline is excreted into breast milk and may cause irritability to the infants.

Precautions and warnings

Theophylline should be used with extreme caution in patients with active peptic ulcer disease, seizure disorders, cardiac arrhythmias.

Quibron – FAQs

What is the drug Quibron used for?

Quibron  indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. It is also  indicated for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.

What class of drugs is Quibron?

Quibron contains Theophylline, which belong to a drug class known as ” Xanthines ” used for OBSTRUCTIVE AIRWAY DISEASES.

What is Quibron a steroid?

Quibron is not a steroid, it belongs to a group of medicines called (Xanthine). It works by relaxing the smooth muscles of the bronchi and pulmonary blood vessels.

Why is Quibron no longer used?

Due to its side effects that come with the higher doses, Quibron is no longer widely prescribed.

What are the side effects of Quibron?

Quibron may cause the following side effects, and you should tell your doctor if any of these symptoms are aggravated or persist for a long time:

• upset stomach – stomachache.
• headache
• Insomnia, difficulty sleeping.
• Feeling uncomfortable and nervous.

Quibron may cause serious side effects, and you should contact your doctor immediately if you experience any of the following symptoms:

• Vomiting
• Increased or rapid heart rate
• Arrhythmia
• convulsions
• Skin rash.

Do doctors still prescribe Quibron?

Nowadays, Quibron is not widely prescribed , cause of its serious side effects, and its narrow therapeutic index

Who should not use Quibron?

The patient should be alerted to refer to the doctor if you feel nausea, vomiting, persistent headache, insomnia, difficulty sleeping or lack of sleep, rapid heartbeat, diarrhea, or an increase in diuresis during treatment with Quibron, even if another cause is suspected. All the aforementioned symptoms indicate an increase in theophylline concentration in the blood and are considered signs of the onset of theophylline poisoning.

The patient must be informed of the need to contact the doctor if a new symptom occurs, especially persistent fever (unexplained high body temperature), or if  the patient feels a deterioration in respiratory functions, or if the patient begins to smoke cigarettes or begins to quit.

How long should I used  Quibron?

The duration of treatment varies according to the targeted condition, and usually extends from two weeks to a month .

Does Quibron affect heart rate?

Yes Quibron affects the heart rate. It causes rapid  heart rate

How quickly does Quibron work?

The effect of Quibron begins within 20 minutes, the maximum effect is reached within two hours, and the effect of the pills lasts for a period ranging from 6 to 12 hours

Does Quibron raise blood pressure?

Quibron Affects heart rate, and in theory this effect can increase blood pressure.

List of Theophylline Controlled Released Tablets Products – MENA

1. Uniphyllin Continus Tablets 300 or 400 mg- Mundi Pharma
2. Theophylline 200 mg S.R. Tablets – Amriyia
3. Quibron T/SR Tablets – 300 mg – BMS
4. Minophylline 200 mg S.R. Tablets – Alexandria.
5. Riaphyllin SR Tablets – 300 mg – Riyahd Pharma

Quibron – AR information

• كيبرون أقراص ممتدة المفعول قابلة للتقسيم – 300 ميليجرام ثيوفيللين
• كيبرون تى إس آر ۳۰۰ مجم أقراص قابلة للتقسيم المتعدد – موسع للشُعب الهوائية

Product reference code: R03DA04. Check product images on google.

Dosage and Administration

General Considerations:

Quibron^®-T/SR has not been adequately studied for its bioavailability when administered with food (see PRECAUTIONS, Drug-Food Interactions).

The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400-1600 mg/day in adults <60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady-state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments (See Table V). Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION, Table VI). Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage (see WARNINGS).

If the patient’s symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (see WARNINGS and PRECAUTIONS), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline concentrations should be monitored at frequent intervals, e.g., every 24 hours.

Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.

Table V contains theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum theophylline concentration.

How Supplied

Quibron^®-T/SR Tablets: Bottles of 100 and 500, white, in the ACCUDOSE^® Tablet design with “M 019” debossed on one side, containing 300 mg of anhydrous theophylline.

NDC 61570-019-01. .. .. .. .. .. .. .. Bottles of 100

NDC 61570-019-05. .. .. .. .. .. .. .. Bottles of 500

Store from 15°-25°C (59°-77°F)

Rx Only.

Rev. 8/99

Manufactured for Monarch Pharmaceuticals^®, Inc., Bristol, TN 37620

Manufactured by Bristol-Myers Squibb, Princeton, NJ 0854

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