Zadifen
Generic Name
Ketotifen Fumarate 1 mg Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zadifen 1 mg tablet | ৳ 2.00 | ৳ 20.00 |
Description
Overview of the medicine
Ketotifen fumarate is an H1-antihistamine and mast cell stabilizer. It is used for the long-term prophylaxis of bronchial asthma, allergic rhinitis, and allergic conjunctivitis. It prevents the release of inflammatory mediators from mast cells and reduces allergic reactions, but is not effective for acute asthma attacks.
Uses & Indications
Dosage
Adults
1 mg orally twice daily with food (morning and evening). If necessary, dosage can be increased to 2 mg twice daily.
Elderly
Similar to adult dosage. Use with caution in patients with hepatic or renal impairment.
Renal_impairment
No specific dose adjustment is generally required, but caution is advised in severe impairment. Monitor for increased side effects.
Hepatic_impairment
Use with caution. Dose adjustment may be necessary in severe hepatic dysfunction. Monitor liver function tests.
How to Take
Take orally with food to reduce gastrointestinal discomfort and to improve absorption. Do not crush or chew the tablet; swallow whole with water.
Mechanism of Action
Ketotifen acts as a non-competitive H1-receptor antagonist and stabilizes mast cells, preventing the release of histamine and other inflammatory mediators (e.g., leukotrienes). It also inhibits calcium influx into mast cells and may inhibit phosphodiesterase.
Pharmacokinetics
Onset
Therapeutic effects for asthma prophylaxis may take several weeks (2-12 weeks) to become fully apparent.
Excretion
Approximately 1% of an oral dose is excreted unchanged in urine within 48 hours. The remainder is excreted as metabolites, mainly via urine (about 60-70%) and feces (about 20-30%).
Half life
Biphasic elimination. Initial half-life for parent compound is approximately 3-5 hours; terminal half-life for metabolites is about 21 hours.
Absorption
Well absorbed orally (about 60-70%). Peak plasma concentrations are reached within 2-4 hours. Bioavailability is about 50% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily via N-demethylation and glucuronidation. Main metabolite is ketotifen-N-glucuronide.
Side Effects
Contraindications
- •Hypersensitivity to Ketotifen or any component of the formulation
- •Patients with epilepsy or history of convulsions (may lower seizure threshold)
Drug Interactions
Oral Antidiabetics
Reversible fall in platelet count has been reported in a few isolated cases; therefore, concomitant use should be avoided.
CNS Depressants (e.g., alcohol, sedatives, hypnotics)
May potentiate the sedative effects.
Storage
Store in a cool, dry place, below 25°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms include drowsiness, confusion, disorientation, tachycardia, hypotension, and possibly convulsions (especially in children). Treatment is symptomatic and supportive; gastric lavage may be considered if recent ingestion. Monitor vital signs.
Pregnancy & Lactation
Pregnancy Category C. Should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as Ketotifen may pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Available in pharmacies
Approval Status
Approved by DGDA
Patent Status
Patent expired, generic available
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Global Brand Names
International brand names for this medicine
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