Asmafen
Generic Name
Ketotifen
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| asmafen 1 mg syrup | ৳ 55.00 | N/A |
Description
Overview of the medicine
Ketotifen is an antihistamine and mast cell stabilizer used for the long-term prophylactic treatment of bronchial asthma, allergic bronchitis, and other allergic conditions. It is not indicated for the treatment of acute asthma attacks.
Uses & Indications
Dosage
Adults
1 mg (5 ml syrup) twice daily with food. If necessary, the dose may be increased to 2 mg (10 ml syrup) twice daily.
Elderly
No specific dosage adjustment is usually needed for elderly patients, but caution is advised due to potential increased sensitivity to side effects.
Renal_impairment
No specific dosage adjustment guidelines are available for renal impairment. Use with caution.
How to Take
Asmafen syrup is for oral administration. It can be taken with or without food, but taking it with food may reduce gastrointestinal discomfort. Measure the dose accurately using the provided measuring cup or spoon.
Mechanism of Action
Ketotifen acts as a non-competitive H1-antihistamine and a mast cell stabilizer. It inhibits the release of histamine, leukotrienes, and other inflammatory mediators from mast cells. It also reduces the hyper-reactivity of the airways and may have phosphodiesterase inhibitory activity.
Pharmacokinetics
Onset
Antihistaminic effects within hours. Prophylactic anti-asthmatic effect may take several weeks to develop.
Excretion
Approximately 60-70% excreted renally (urine) within 48 hours, with a small portion excreted in feces.
Half life
Biphasic elimination with a short initial half-life (3-5 hours) and a longer terminal half-life (12-24 hours) for the parent compound and active metabolite.
Absorption
Well absorbed orally, but bioavailability is about 50% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver, primarily via N-glucuronidation to an active metabolite.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any of its excipients
- Patients with epilepsy or a history of seizures (as ketotifen may lower the seizure threshold)
- Concomitant use with oral antidiabetics (rare reports of reversible decrease in platelet count)
Drug Interactions
Oral antidiabetics
There have been rare, reversible decreases in platelet count reported in patients receiving ketotifen concomitantly with oral antidiabetics. Concomitant use should be avoided or carefully monitored.
Other antihistamines
May increase sedative effects.
CNS depressants (alcohol, sedatives, hypnotics)
May enhance the sedative effects.
Storage
Store below 30°C in a dry place, protected from light. Keep out of reach of children. Do not freeze.
Overdose
Symptoms of overdose include drowsiness, disorientation, nausea, vomiting, tachycardia, and convulsions (especially in children). Management is symptomatic and supportive. Gastric lavage may be considered soon after ingestion. Benzodiazepines can be used for seizures. Monitor vital signs.
Pregnancy & Lactation
Pregnancy Category C. Ketotifen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother. 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 of its excipients
- Patients with epilepsy or a history of seizures (as ketotifen may lower the seizure threshold)
- Concomitant use with oral antidiabetics (rare reports of reversible decrease in platelet count)
Drug Interactions
Oral antidiabetics
There have been rare, reversible decreases in platelet count reported in patients receiving ketotifen concomitantly with oral antidiabetics. Concomitant use should be avoided or carefully monitored.
Other antihistamines
May increase sedative effects.
CNS depressants (alcohol, sedatives, hypnotics)
May enhance the sedative effects.
Storage
Store below 30°C in a dry place, protected from light. Keep out of reach of children. Do not freeze.
Overdose
Symptoms of overdose include drowsiness, disorientation, nausea, vomiting, tachycardia, and convulsions (especially in children). Management is symptomatic and supportive. Gastric lavage may be considered soon after ingestion. Benzodiazepines can be used for seizures. Monitor vital signs.
Pregnancy & Lactation
Pregnancy Category C. Ketotifen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother. 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
24 months (unopened). Once opened, use within 28 days.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic
Clinical Trials
Ketotifen has undergone extensive clinical trials establishing its efficacy and safety profile for the prophylactic treatment of bronchial asthma and other allergic conditions in both adults and children.
Lab Monitoring
- No routine lab monitoring is generally required. If used concomitantly with oral antidiabetics, platelet count monitoring is advised due to rare reports of thrombocytopenia.
Doctor Notes
- Emphasize to patients that ketotifen is a prophylactic agent and not for acute relief of asthma symptoms.
- Advise patients on the delayed onset of full therapeutic effect (several weeks) and the importance of continued regular dosing.
- Counsel patients regarding potential sedative effects, especially during initial therapy, and precautions for driving/operating machinery.
- Monitor for drug interactions, especially with oral antidiabetics (platelet count) and CNS depressants (enhanced sedation).
Patient Guidelines
- Asmafen is a prophylactic medicine and is not for the treatment of acute asthma attacks. Continue using your reliever inhaler as prescribed.
- The full prophylactic effect may take several weeks to develop. Do not stop treatment abruptly.
- May cause drowsiness, especially at the start of treatment. Avoid driving or operating machinery until you know how the medicine affects you.
- Avoid alcohol consumption while taking this medicine as it may increase drowsiness.
Missed Dose Advice
If a dose is missed, 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
Asmafen may cause drowsiness, dizziness, or sedation, especially at the beginning of treatment. Patients should be warned about driving or operating machinery or engaging in potentially hazardous activities until they know how the medicine affects them.
Lifestyle Advice
- Identify and avoid known asthma and allergy triggers.
- Maintain a healthy lifestyle with balanced diet and regular exercise (if compatible with your condition).
- Ensure a clean, dust-free home environment to minimize exposure to allergens.
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