Ketosma
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 |
|---|---|---|
| ketosma 1 mg syrup | ৳ 45.00 | N/A |
Description
Overview of the medicine
Ketosma 1 mg Syrup contains Ketotifen Fumarate, an antihistamine and mast cell stabilizer, used for the prophylactic treatment of bronchial asthma, allergic conjunctivitis, and allergic rhinitis.
Uses & Indications
Dosage
Adults
1 mg (5 ml) twice daily with food. If necessary, the dose may be increased to 2 mg (10 ml) twice daily.
Elderly
No specific dose adjustment is generally required, but caution is advised due to potential for increased sensitivity.
Renal_impairment
No specific dose adjustment for mild to moderate renal impairment. Use with caution in severe impairment, as metabolites are excreted renally.
How to Take
Administer orally with food to reduce GI upset and improve tolerance. For asthma prophylaxis, treatment should be maintained for at least 2-3 months.
Mechanism of Action
Ketotifen acts as a non-competitive H1-antihistamine and a mast cell stabilizer. It inhibits the release of inflammatory mediators like histamine and leukotrienes from mast cells, thereby reducing allergic reactions. It also blocks calcium channels, further stabilizing mast cells.
Pharmacokinetics
Onset
Antihistaminic effects within hours; full mast cell stabilizing effects may take several weeks (2-4 weeks) for asthma prophylaxis.
Excretion
Excreted mainly in urine (about 60-70% as metabolites) and feces.
Half life
Approximately 12 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract; bioavailability is approximately 50% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily via glucuronidation.
Side Effects
Contraindications
- Hypersensitivity to Ketotifen or any component of the syrup
- Concomitant use with oral antidiabetics (risk of reversible thrombocytopenia)
Drug Interactions
Antihistamines
Increased risk of drowsiness and other CNS depressant effects.
Oral Antidiabetics
Concomitant use may increase the risk of reversible thrombocytopenia. Avoid combination.
CNS Depressants (e.g., alcohol, hypnotics, sedatives)
May potentiate the sedative effects of Ketotifen.
Storage
Store in a cool, dry place, below 30°C. Protect from light. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, disorientation, tachycardia, CNS stimulation (especially in children), and convulsions. Treatment is symptomatic and supportive; gastric lavage may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. Small amounts may pass into breast milk; use with caution or consider alternatives during lactation.
Side Effects
Contraindications
- Hypersensitivity to Ketotifen or any component of the syrup
- Concomitant use with oral antidiabetics (risk of reversible thrombocytopenia)
Drug Interactions
Antihistamines
Increased risk of drowsiness and other CNS depressant effects.
Oral Antidiabetics
Concomitant use may increase the risk of reversible thrombocytopenia. Avoid combination.
CNS Depressants (e.g., alcohol, hypnotics, sedatives)
May potentiate the sedative effects of Ketotifen.
Storage
Store in a cool, dry place, below 30°C. Protect from light. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, disorientation, tachycardia, CNS stimulation (especially in children), and convulsions. Treatment is symptomatic and supportive; gastric lavage may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. Small amounts may pass into breast milk; use with caution or consider alternatives during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture when stored properly.
Availability
Pharmacies nationwide
Approval Status
Approved and widely available
Patent Status
Patent Expired
Clinical Trials
Ketotifen has undergone extensive clinical trials demonstrating its efficacy in the prophylaxis of asthma and treatment of various allergic conditions.
Lab Monitoring
- Complete Blood Count (CBC) if used concomitantly with oral antidiabetics (due to thrombocytopenia risk).
Doctor Notes
- Advise patients that full therapeutic effects for asthma may take several weeks.
- Monitor for drowsiness, especially at the start of treatment.
- Caution patients about potential interactions with oral antidiabetics.
Patient Guidelines
- Do not use for acute asthma attacks.
- Take with food to minimize stomach upset.
- Be aware of potential drowsiness and avoid driving or operating heavy machinery until you know how the medicine affects you.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not double the dose to catch up.
Driving Precautions
May cause drowsiness or dizziness. Patients should avoid driving or operating machinery until they are certain the medication does not impair their ability to perform such activities safely.
Lifestyle Advice
- Avoid alcohol while taking this medicine.
- Maintain a healthy diet to manage potential weight gain.
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