Tofen
Generic Name
Ketotifen
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tofen 1 mg syrup | ৳ 75.00 | N/A |
Description
Overview of the medicine
Ketotifen is a mast cell stabilizer with antihistaminic properties, primarily used for the long-term prophylactic treatment of bronchial asthma, allergic rhinitis, and allergic conjunctivitis. It helps to prevent allergic reactions.
Uses & Indications
Dosage
Adults
Adults and children over 3 years: 1 mg (5 ml syrup) twice daily, with food. If drowsiness occurs, start with 0.5 mg at night and gradually increase to 1 mg twice daily.
Elderly
No specific dosage adjustment is generally required, but caution should be exercised, and patients monitored for adverse effects.
Renal_impairment
No specific dosage adjustment is generally considered necessary, but use with caution in severe renal impairment.
How to Take
Take orally, preferably with food, twice daily (morning and evening). For optimal effect in asthma, it may take several weeks.
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, leukotrienes, and platelet-activating factor from mast cells. It also reduces eosinophil chemotaxis and activation, thereby preventing the development of allergic reactions.
Pharmacokinetics
Onset
Antihistaminic effects may be seen within hours. For asthma prophylaxis, full therapeutic effect usually takes several weeks (2-3 weeks).
Excretion
Approximately 60-70% of a dose is excreted renally within 48 hours, mainly as metabolites. About 1% is excreted unchanged in urine.
Half life
Plasma elimination half-life is biphasic, with an initial half-life of 3-5 hours and a terminal half-life of 12-23 hours.
Absorption
Well absorbed from the gastrointestinal tract (about 60%), with peak plasma concentrations reached within 2-4 hours. Bioavailability is about 50% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily by N-demethylation and glucuronidation. The major metabolite is ketotifen-N-glucuronide.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
- Patients with epilepsy or a history of seizures (as ketotifen may lower the seizure threshold).
Drug Interactions
Antihistamines
Concurrent use with other antihistamines may increase the risk of sedation.
Oral antidiabetics
There have been rare, reversible reports of a decrease in platelet count in patients concurrently taking ketotifen and oral antidiabetic drugs. This combination should be avoided.
CNS depressants (e.g., alcohol, sedatives, hypnotics)
May potentiate the sedative effects of these drugs. Concurrent use should be approached with caution.
Storage
Store below 30°C, in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, confusion, disorientation, tachycardia, hypotension, and possibly coma. Management is symptomatic and supportive. Gastric lavage may be considered if recent ingestion. Monitor vital signs and provide supportive care.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Lactation: Ketotifen is excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
- Patients with epilepsy or a history of seizures (as ketotifen may lower the seizure threshold).
Drug Interactions
Antihistamines
Concurrent use with other antihistamines may increase the risk of sedation.
Oral antidiabetics
There have been rare, reversible reports of a decrease in platelet count in patients concurrently taking ketotifen and oral antidiabetic drugs. This combination should be avoided.
CNS depressants (e.g., alcohol, sedatives, hypnotics)
May potentiate the sedative effects of these drugs. Concurrent use should be approached with caution.
Storage
Store below 30°C, in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, confusion, disorientation, tachycardia, hypotension, and possibly coma. Management is symptomatic and supportive. Gastric lavage may be considered if recent ingestion. Monitor vital signs and provide supportive care.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Lactation: Ketotifen is excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Refer to the product packaging for specific expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Globally approved, widely available
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketotifen has undergone extensive clinical trials demonstrating its efficacy and safety in the prophylactic treatment of asthma and various allergic conditions. It has been used clinically for many decades.
Lab Monitoring
- Periodically monitor liver function tests if elevated levels are suspected or in prolonged use.
- Monitor platelet count if co-administered with oral antidiabetics (this combination is generally avoided).
Doctor Notes
- Emphasize the prophylactic nature of Ketotifen; it is not for acute symptom relief.
- Advise patients that full asthma benefit may not be seen for several weeks.
- Caution about potential drowsiness and advise against operating machinery or driving until effects are known.
- Monitor for potential weight gain, especially in children.
Patient Guidelines
- This medicine is for prophylactic (preventive) treatment, not for acute asthma attacks. Always carry your rescue inhaler if you have asthma.
- It may take several weeks for the full beneficial effect to become apparent, especially for asthma.
- Do not stop taking the medication abruptly, especially if you have asthma, without consulting your doctor.
- Avoid alcohol while taking this medicine, as it can increase drowsiness.
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 continue with your regular dosing schedule. Do not double the dose.
Driving Precautions
Ketotifen may cause drowsiness or dizziness. Patients should be warned about engaging in activities requiring mental alertness, such as driving or operating machinery, until they know how the medicine affects them.
Lifestyle Advice
- Identify and avoid known triggers for your asthma or allergies (e.g., dust, pollen, pet dander).
- Maintain a healthy lifestyle with regular exercise and a balanced diet.
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