Stafen
Generic Name
Ketotifen
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| stafen 1 mg tablet | ৳ 4.00 | ৳ 40.00 |
Description
Overview of the medicine
Stafen 1 mg Tablet contains Ketotifen, an antihistamine and mast cell stabilizer used for the long-term prophylactic treatment of bronchial asthma, allergic conjunctivitis, and allergic rhinitis.
Uses & Indications
Dosage
Adults
Adults: 1 mg twice daily (morning and evening) with food. May be increased to 2 mg twice daily if necessary.
Elderly
Elderly: No special dosage adjustment is required unless there is renal or hepatic impairment.
Renal_impairment
Renal impairment: Caution advised, dosage reduction may be necessary in severe cases. Consult a physician.
How to Take
Take orally with food. For prophylactic treatment of asthma, a minimum of 2-3 months of treatment is required.
Mechanism of Action
Ketotifen exerts its action by stabilizing mast cells and inhibiting the release of inflammatory mediators like histamine. It also possesses H1-antihistamine properties and may inhibit calcium influx in mast cells.
Pharmacokinetics
Onset
Antihistaminic effects within hours, prophylactic effects for asthma may take several weeks.
Excretion
Mainly excreted in urine (approximately 60-70%) as metabolites, with a smaller amount in feces.
Half life
Biphasic elimination with a short initial half-life (3-5 hours) and a longer terminal half-life (21 hours).
Absorption
Well absorbed from the gastrointestinal tract, though bioavailability is about 50% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily by N-glucuronidation.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation
- Concomitant use with oral antidiabetics (risk of reversible thrombocytopenia)
Drug Interactions
CNS Depressants
May potentiate the effects of sedatives, hypnotics, other antihistamines, and alcohol.
Oral Antidiabetics
Concomitant use may lead to a reversible decrease in platelet count (thrombocytopenia). Avoid co-administration.
Anticholinergic Drugs
May increase anticholinergic side effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, confusion, disorientation, tachycardia, hypotension, and convulsions. Treatment is symptomatic and supportive. Gastric lavage may be considered.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as ketotifen is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation
- Concomitant use with oral antidiabetics (risk of reversible thrombocytopenia)
Drug Interactions
CNS Depressants
May potentiate the effects of sedatives, hypnotics, other antihistamines, and alcohol.
Oral Antidiabetics
Concomitant use may lead to a reversible decrease in platelet count (thrombocytopenia). Avoid co-administration.
Anticholinergic Drugs
May increase anticholinergic side effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, confusion, disorientation, tachycardia, hypotension, and convulsions. Treatment is symptomatic and supportive. Gastric lavage may be considered.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as ketotifen is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the date of manufacture.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Generic available
Clinical Trials
Ketotifen has been evaluated in numerous clinical trials for its efficacy in asthma prophylaxis and allergic conditions, showing positive outcomes in reducing symptom frequency and severity.
Lab Monitoring
- Complete Blood Count (CBC) with platelet count (especially if co-administered with oral antidiabetics)
- Liver function tests (if signs of hepatic impairment appear)
Doctor Notes
- Monitor for signs of drowsiness or sedation, especially during initiation of therapy.
- Advise patients on the importance of regular, long-term use for asthma prophylaxis.
- Be aware of potential drug interactions with oral antidiabetics and CNS depressants.
Patient Guidelines
- Take this medicine regularly, even if you feel well, to get the full prophylactic benefit.
- Avoid alcohol and other CNS depressants.
- May cause drowsiness, so exercise caution when driving or operating machinery.
- Do not stop taking this medicine suddenly, especially if you are taking it for asthma.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause drowsiness or dizziness. Patients should be warned not to drive or operate machinery until they know how Ketotifen affects them.
Lifestyle Advice
- Identify and avoid known allergens.
- Maintain a healthy lifestyle with regular exercise and a balanced diet.
- Discuss any concerns about drowsiness with your doctor.
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Global Brand Names
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