Tofen
Generic Name
Ketotifen Fumarate
Manufacturer
Radiant Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tofen 1 mg tablet | ৳ 4.00 | ৳ 60.00 |
Description
Overview of the medicine
Tofen 1 mg Tablet contains Ketotifen Fumarate, an antihistamine and mast cell stabilizer. It is used for the long-term prophylaxis of bronchial asthma, allergic rhinitis, and allergic conjunctivitis. It is not effective for the treatment of acute asthma attacks.
Uses & Indications
Dosage
Adults
1 mg twice daily, with food. In severe cases, dosage may be increased to 2 mg twice daily.
Elderly
Same as adults. Caution is advised in patients with impaired renal or hepatic function.
Renal_impairment
No specific dosage adjustment is generally required, but close monitoring is advisable.
How to Take
Take the tablet orally with food, preferably in the morning and evening.
Mechanism of Action
Ketotifen stabilizes mast cells, thereby inhibiting the release of inflammatory mediators such as histamine and leukotrienes. It also acts as a non-competitive H1-antihistamine, blocking histamine receptors to reduce allergic symptoms.
Pharmacokinetics
Onset
Antiasthmatic effect develops slowly over several weeks (2-12 weeks). Antihistaminic effects may be observed earlier.
Excretion
Approximately 70% of the dose is excreted renally, mostly as metabolites, and about 1% as unchanged drug within 48 hours.
Half life
Approximately 12 hours (biphasic elimination with initial half-life of 3-5 hours and terminal half-life of about 21 hours for metabolites).
Absorption
Well absorbed from the gastrointestinal tract; however, bioavailability is approximately 60% due to significant first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily via N-glucuronidation. The main metabolite is ketotifen-N-glucuronide, which is pharmacologically inactive.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
- Patients with epilepsy or a history of seizures (as it may lower seizure threshold).
Drug Interactions
Oral antidiabetics
There have been rare reports of a reversible decrease in platelet count in patients receiving ketotifen concomitantly with oral antidiabetic agents. Monitor platelet count if co-administered.
Other antihistamines
Additive anticholinergic and sedative effects may occur.
CNS depressants (e.g., alcohol, sedatives, hypnotics)
May enhance central nervous system depressant effects, leading to increased drowsiness or sedation.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, confusion, disorientation, nystagmus, headache, tachycardia, hypotension, and in severe cases, convulsions and coma. Management involves gastric lavage, activated charcoal, and symptomatic and supportive treatment. Benzodiazepines may be used for convulsions.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ketotifen is excreted in breast milk in animals; therefore, it should be used with caution in breastfeeding mothers.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
- Patients with epilepsy or a history of seizures (as it may lower seizure threshold).
Drug Interactions
Oral antidiabetics
There have been rare reports of a reversible decrease in platelet count in patients receiving ketotifen concomitantly with oral antidiabetic agents. Monitor platelet count if co-administered.
Other antihistamines
Additive anticholinergic and sedative effects may occur.
CNS depressants (e.g., alcohol, sedatives, hypnotics)
May enhance central nervous system depressant effects, leading to increased drowsiness or sedation.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, confusion, disorientation, nystagmus, headache, tachycardia, hypotension, and in severe cases, convulsions and coma. Management involves gastric lavage, activated charcoal, and symptomatic and supportive treatment. Benzodiazepines may be used for convulsions.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ketotifen is excreted in breast milk in animals; therefore, it should be used with caution in breastfeeding mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Available in pharmacies, hospitals
Approval Status
Approved (internationally and in Bangladesh for many years)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketotifen has been subject to numerous clinical trials since its introduction, demonstrating its efficacy and safety profile in the prophylaxis of asthma and allergic conditions. Most data are from older, established trials.
Lab Monitoring
- Monitor platelet count if co-administered with oral antidiabetics.
- Liver function tests in case of suspected hepatotoxicity.
Doctor Notes
- Emphasize the prophylactic nature of ketotifen; it is not a rescue medication.
- Advise patients on the slow onset of therapeutic effect and the importance of continuous therapy.
- Caution about potential drowsiness and interactions with CNS depressants.
Patient Guidelines
- This medicine is for long-term prevention, not for immediate relief of asthma attacks.
- Do not stop taking the medicine abruptly, especially if you are also taking corticosteroids for asthma.
- It may take several weeks to achieve the full therapeutic effect.
- Avoid alcohol while taking this medicine as it may increase drowsiness.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Tofen may cause drowsiness, dizziness, or impaired concentration. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Identify and avoid known allergens that trigger your asthma or allergic symptoms.
- Maintain a healthy lifestyle with regular exercise and a balanced diet.
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