Ketof
Generic Name
Ketotifen
Manufacturer
ACI Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ketof 1 mg tablet | ৳ 2.50 | ৳ 25.00 |
Description
Overview of the medicine
Ketotifen is an anti-allergic medication used to prevent and treat various allergic conditions, primarily allergic conjunctivitis, allergic rhinitis, and for prophylaxis of asthma. It works by stabilizing mast cells, thereby reducing the release of inflammatory mediators like histamine, and also by acting as an H1-antihistamine.
Uses & Indications
Dosage
Adults
1 mg twice daily (morning and evening) with food. If drowsiness occurs, start with 0.5 mg twice daily for the first week.
Elderly
Similar to adult dosage, but caution should be exercised in patients with impaired renal function.
Renal_impairment
No specific dose adjustment guidelines; use with caution and monitor for increased side effects.
How to Take
Take orally, preferably with food, to minimize gastrointestinal discomfort. For asthma prophylaxis, it is essential to continue previous anti-asthmatic treatments for at least 2 weeks after initiating Ketotifen.
Mechanism of Action
Ketotifen acts as a non-competitive H1-antihistamine and a mast cell stabilizer. It inhibits the release of histamine and other inflammatory mediators (e.g., leukotrienes) from mast cells. It also blocks calcium influx into mast cells, thereby preventing their degranulation. Its anti-allergic effects are thought to be primarily due to mast cell stabilization.
Pharmacokinetics
Onset
Symptomatic relief for allergic rhinitis/conjunctivitis typically within hours. Full therapeutic effect for asthma prophylaxis may take several weeks (4-12 weeks).
Excretion
Approximately 60-70% of the dose is excreted renally, mainly as metabolites, within 48 hours. A small portion is excreted via feces.
Half life
Biphasic elimination with a short initial half-life of 3-5 hours and a longer terminal half-life of about 21 hours (due to active metabolites).
Absorption
Well absorbed from the gastrointestinal tract (about 60% bioavailability). Peak plasma concentrations are reached within 2-4 hours after oral administration.
Metabolism
Extensively metabolized in the liver, primarily via N-demethylation and glucuronidation. Main metabolite is ketotifen-N-glucuronide, which is inactive.
Side Effects
Contraindications
- Hypersensitivity to Ketotifen or any component of the formulation.
- Acute asthma attacks (not indicated for acute relief).
- Patients with severe liver impairment.
Drug Interactions
Theophylline
No significant interaction reported, but some studies suggest potential for altered Theophylline levels.
Antihistamines
Concomitant use with other antihistamines may increase sedative effects.
Oral Antidiabetics
Concurrent use may lead to reversible thrombocytopenia; caution and blood count monitoring recommended.
CNS Depressants (e.g., alcohol, hypnotics, sedatives)
May potentiate the sedative effects of Ketotifen.
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, nystagmus, tachycardia, hypotension, and rarely, convulsions. Treatment involves gastric lavage, administration of activated charcoal, and symptomatic supportive care. Monitor vital signs.
Pregnancy & Lactation
Pregnancy Category C. Should only be used if the potential benefit outweighs the potential risk to the fetus. Ketotifen is excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to Ketotifen or any component of the formulation.
- Acute asthma attacks (not indicated for acute relief).
- Patients with severe liver impairment.
Drug Interactions
Theophylline
No significant interaction reported, but some studies suggest potential for altered Theophylline levels.
Antihistamines
Concomitant use with other antihistamines may increase sedative effects.
Oral Antidiabetics
Concurrent use may lead to reversible thrombocytopenia; caution and blood count monitoring recommended.
CNS Depressants (e.g., alcohol, hypnotics, sedatives)
May potentiate the sedative effects of Ketotifen.
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, nystagmus, tachycardia, hypotension, and rarely, convulsions. Treatment involves gastric lavage, administration of activated charcoal, and symptomatic supportive care. Monitor vital signs.
Pregnancy & Lactation
Pregnancy Category C. Should only be used if the potential benefit outweighs the potential risk to the fetus. Ketotifen is excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved (internationally and in Bangladesh)
Patent Status
Off-patent
Clinical Trials
Ketotifen has been extensively studied for its efficacy in asthma prophylaxis, allergic rhinitis, and conjunctivitis. Studies demonstrate its ability to reduce symptoms and medication use in these conditions, though its role in asthma has been somewhat superseded by newer therapies.
Lab Monitoring
- Blood counts (especially platelet count) if co-administered with oral antidiabetic agents.
- Liver function tests if signs of hepatic impairment appear.
Doctor Notes
- Emphasize that Ketotifen is for prophylaxis, not for acute asthma attacks. Patients must continue their rescue inhalers.
- Counsel patients on potential drowsiness and advise against driving or operating machinery until effects are known.
- Monitor blood counts if co-prescribed with oral antidiabetic agents due to rare risk of thrombocytopenia.
Patient Guidelines
- Take Ketotifen regularly as prescribed, even if symptoms improve, especially for asthma prophylaxis.
- Do not stop taking other asthma medications abruptly unless advised by your doctor.
- Be aware of potential drowsiness and avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medicine affects you.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose.
Driving Precautions
Ketotifen may cause drowsiness, dizziness, and impaired alertness, particularly at the beginning of treatment. Patients should be warned not to drive or operate machinery if they experience these side effects.
Lifestyle Advice
- Identify and avoid known allergens that trigger your condition.
- Maintain a clean indoor environment to reduce exposure to dust mites and pet dander.
- Quit smoking and avoid exposure to secondhand smoke.
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