Stafen
Generic Name
Ketotifen Fumarate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| stafen 1 mg syrup | ৳ 75.00 | N/A |
Description
Overview of the medicine
Ketotifen is an antihistamine and mast cell stabilizer used for the prophylactic treatment of bronchial asthma, allergic conjunctivitis, and allergic rhinitis. It helps prevent allergic reactions by stabilizing mast cells and blocking histamine.
Uses & Indications
Dosage
Adults
1 mg twice daily (morning and evening) with food. May be increased to 2 mg twice daily in severe cases. Children 6 months to 3 years: 0.05 mg/kg body weight twice daily. Children >3 years: 1 mg twice daily.
Elderly
Similar to adult dose, but may require lower initial dose if renal/hepatic impairment is present.
Renal_impairment
No specific dose adjustment generally required, but monitor for increased side effects.
How to Take
Oral. Can be taken with food to minimize gastrointestinal upset. Do not discontinue abruptly in asthma.
Mechanism of Action
Ketotifen acts as an H1-antihistamine, blocking histamine receptors. Additionally, it stabilizes mast cells, preventing the release of inflammatory mediators like histamine and leukotrienes, which are involved in allergic and asthmatic reactions. It also inhibits calcium influx into mast cells.
Pharmacokinetics
Onset
Antihistaminic effects within hours. Prophylactic anti-asthmatic effect may take several weeks.
Excretion
Primarily excreted via urine (approx. 60-70%) and feces (approx. 30-40%) as metabolites within 48 hours.
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 (approx. 60-80%). Bioavailability is about 50% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily by N-demethylation and glucuronidation.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
- Not indicated for acute asthma attacks.
Drug Interactions
Other antihistamines
Additive sedative effects.
Oral antidiabetic agents
Reversible decrease in platelet count reported in a few cases (rare). Close monitoring is advised.
CNS Depressants (e.g., sedatives, hypnotics, alcohol)
Enhanced sedative effects.
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms include drowsiness, confusion, disorientation, tachycardia, hypotension, dizziness, and headache. In children, excitation and convulsions may occur. Treatment is symptomatic and supportive, including gastric lavage or activated charcoal if recent ingestion, and monitoring vital signs.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Excreted in breast milk, so caution is advised; discontinue nursing or the drug.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
- Not indicated for acute asthma attacks.
Drug Interactions
Other antihistamines
Additive sedative effects.
Oral antidiabetic agents
Reversible decrease in platelet count reported in a few cases (rare). Close monitoring is advised.
CNS Depressants (e.g., sedatives, hypnotics, alcohol)
Enhanced sedative effects.
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms include drowsiness, confusion, disorientation, tachycardia, hypotension, dizziness, and headache. In children, excitation and convulsions may occur. Treatment is symptomatic and supportive, including gastric lavage or activated charcoal if recent ingestion, and monitoring vital signs.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Excreted in breast milk, so caution is advised; discontinue nursing or the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months when unopened. Refer to the specific product's packaging for exact duration.
Availability
Pharmacies, Hospitals
Approval Status
Widely approved in many countries including Bangladesh
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have established Ketotifen's efficacy and safety in the prophylaxis of asthma and treatment of allergic conditions since its introduction.
Lab Monitoring
- Generally not required. Monitor platelet count if co-administered with oral antidiabetic agents.
Doctor Notes
- Advise patients that Stafen is not a bronchodilator and should not be used for acute asthma attacks.
- Inform patients that several weeks of treatment may be required for optimal anti-asthmatic effect.
- Counsel patients about potential drowsiness and interactions with CNS depressants.
Patient Guidelines
- May cause drowsiness; avoid driving or operating heavy machinery until you know how it affects you.
- Do not stop taking the medicine suddenly, especially if used for asthma prophylaxis.
- Take with food to minimize stomach upset.
- Full therapeutic effect for asthma may take several weeks.
Missed Dose Advice
Take the missed dose as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause drowsiness, dizziness, and impaired judgment. Patients should be advised to exercise caution when driving or operating machinery.
Lifestyle Advice
- Identify and avoid allergens and asthma triggers.
- Maintain a healthy lifestyle.
- Do not use for acute asthma attacks; always have your rescue inhaler ready.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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