Ketof
Generic Name
Ketotifen Fumarate
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ketof 1 mg syrup | ৳ 66.00 | N/A |
Description
Overview of the medicine
Ketof 1 mg Syrup contains Ketotifen fumarate, which is an anti-allergic agent primarily used for the prophylactic treatment of bronchial asthma, allergic conjunctivitis, allergic rhinitis, and other allergic conditions. It acts as both a mast cell stabilizer and an H1-antihistamine.
Uses & Indications
Dosage
Adults
1 mg (5 ml syrup) twice daily, with meals. If drowsiness occurs, gradually increase dose over the first week, starting with 0.5 mg (2.5 ml syrup) twice daily.
Elderly
No specific dose adjustment is generally required, but caution is advised in patients with impaired renal or hepatic function.
Renal_impairment
No specific dose adjustment guidelines, but caution is advised. Monitor for adverse effects.
How to Take
Administer orally, preferably with meals to minimize gastrointestinal discomfort. Do not stop treatment abruptly.
Mechanism of Action
Ketotifen works by stabilizing mast cells, thereby inhibiting the release of inflammatory mediators like histamine, leukotrienes, and prostaglandins. It also blocks H1 histamine receptors, providing antihistaminic effects. Additionally, it inhibits the accumulation of eosinophils and reduces bronchial hyperreactivity.
Pharmacokinetics
Onset
Antihistaminic effects occur within hours, but the prophylactic effect for asthma may take several weeks (2-12 weeks) to become maximal.
Excretion
Approximately 60-70% of a dose is excreted via urine, mainly as metabolites, within 48 hours. Fecal excretion accounts for 25-30%.
Half life
Biphasic elimination. Initial half-life approximately 3-5 hours; terminal half-life about 21 hours.
Absorption
Rapidly absorbed orally, but bioavailability is about 50% due to first-pass metabolism. Peak plasma concentrations reached within 2-4 hours.
Metabolism
Extensively metabolized in the liver, primarily by 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.
- Patients with epilepsy or a history of seizures (use with caution).
Drug Interactions
CNS Depressants
Concomitant use with other sedatives, hypnotics, antihistamines, or alcohol may enhance CNS depression. Avoid concurrent use or use with extreme caution.
Oral Antidiabetics
Ketotifen may cause a reversible fall in platelet count when co-administered with oral antidiabetics. Platelet counts should be monitored.
Anticholinergic Agents
May increase the risk of anticholinergic side effects.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms of overdose include drowsiness, confusion, disorientation, tachycardia, hypotension, and possibly coma. Management involves symptomatic and supportive care. Gastric lavage may be considered if ingestion is recent. Monitor vital signs and maintain airway.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Ketotifen is excreted in breast milk; therefore, use is not recommended during lactation or breastfeeding should be discontinued.
Side Effects
Contraindications
- Hypersensitivity to Ketotifen or any component of the formulation.
- Patients with epilepsy or a history of seizures (use with caution).
Drug Interactions
CNS Depressants
Concomitant use with other sedatives, hypnotics, antihistamines, or alcohol may enhance CNS depression. Avoid concurrent use or use with extreme caution.
Oral Antidiabetics
Ketotifen may cause a reversible fall in platelet count when co-administered with oral antidiabetics. Platelet counts should be monitored.
Anticholinergic Agents
May increase the risk of anticholinergic side effects.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms of overdose include drowsiness, confusion, disorientation, tachycardia, hypotension, and possibly coma. Management involves symptomatic and supportive care. Gastric lavage may be considered if ingestion is recent. Monitor vital signs and maintain airway.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Ketotifen is excreted in breast milk; therefore, use is not recommended during lactation or breastfeeding should be discontinued.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date when stored unopened.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies
Patent Status
Off-patent
Clinical Trials
Ketotifen has been evaluated in numerous clinical trials for its efficacy in asthma prophylaxis, allergic rhinitis, and allergic conjunctivitis, showing significant reduction in symptoms and improved quality of life for patients.
Lab Monitoring
- Platelet count monitoring if co-administered with oral antidiabetics.
- Liver function tests may be considered in rare cases of suspected hepatic impairment.
Doctor Notes
- Emphasize that Ketof is for prophylaxis, not for acute asthma relief.
- Advise patients on the potential for drowsiness and its implications for driving/operating machinery.
- Counsel on the importance of adherence, as full therapeutic effect may take weeks.
- Caution about potential interaction with oral antidiabetics and CNS depressants.
Patient Guidelines
- Do not stop taking Ketof syrup suddenly, as asthma symptoms may recur.
- It may take several weeks for the full prophylactic effect to become apparent.
- Ketof syrup may cause drowsiness; avoid driving or operating machinery until you know how it affects you.
- Avoid alcohol consumption during treatment.
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 to catch up.
Driving Precautions
Ketof syrup may cause drowsiness, dizziness, or blurred vision. Patients should be warned not to drive or operate machinery if they experience these effects.
Lifestyle Advice
- Avoid known allergens that trigger your asthma or allergies.
- Maintain a healthy lifestyle with regular exercise and a balanced diet.
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