
| KETOTIFEN FUMARATE-HAKIM |
| :: Asthma prophylactic (Systemic), Antiallergic (Systemic) :: |
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Syrup 1 mg/5ml (120 ml) |
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Pharmacologic category
Systemic antiallergic ; Systemic asthma prophylactic
Mechanism of action
Ketotifen is a non-bronchodilator antiasthmatic drug which inhibits the effects of certain endogenous substances known to be inflammatory mediators such as histamine leukotrienes C4 and D4 (SRS – A) and platelet activating factor (PAF) , and thereby exerts antiallergic activity . Ketotifen possesses a powerful and sustained non – competitive histamine (H1) blocking property.
Indications
Oral ketotifen is indicated as an add – on medication in the chronic treatment of mild atopic asthmatic children . Ketotifen is a prophylactic agent to be used on a continuous basis and is not effective in the acute prevention or treatment of acute asthma attacks.
Side/Adverse effects
Flu syndrome ; Respiratory infection ; Cystitis ; Erythema multiforme ; Hepatitis ; Seizures ; Weight gain ; Abdominal pain ; CNS stimulation ( excitation , irritability , insomnia , nervousness) – particularly in children ; Dizziness ; Dryness of mouth ; Epistaxis ; Increased appetite ; Sedation ; Skin rash ; Sleep disturbance ; Swelling of eyelids.
Note: Dizziness , dryness of mouth , and sedation may occur at the beginning of ketotifen treatment but usually disappear with continued use .
Contraindications
Hypersensitivity to ketotifen or any other component of the formulation.
Warnings / Precautions
Risk – benefit should be considered when the following medical problems exist : Diabetes mellitus (carbohydrate content of the syrup should be taken into consideration ; use ketotifen with caution if taking an oral antidiabetic agent) ; Epilepsy (ketotifen may lower the seizure threshold).
Pregnancy
FDA pregnancy category C. Adequate and well – controlled studies in humans have not been done.
Breast–Feeding
Ketotifen may be distributed into human breast milk. Women who take this medication should not breast – feed.
Drug Interactions
Concomitant use of oral antidiabetic agent with ketotifen may result in reversible thrombocytopenia ; platelet counts are recommended during concurrent use . Concurrent use of alcohol , antihistamines , hypnotics and sedatives with ketotifen may potentiate the CNS depressant effects of these medications.
Monitoring Parameters
Platelet count (recommended in patients taking oral antidiabetic agent concomitantly ).
Dietary Considerations
Ketotifen may be taken with or without food.
Administration and dosage
- Usual adult and adolescent dose: Atopic asthma (prophylaxis) – Oral , 1 mg (5 ml) twice daily , in the morning and evening.
- Usual pediatric dose: Atopic asthma (prophylaxis) – Infants and children 6 months to 3 years of age : Oral, 0.25 ml (50 mcg or 0.05 mg ) per kg of body weight twice daily , in the morning and evening.
- Children older than 3 years of age: as usual adult and adolescent dose.
How Supplied
Syrup, 1mg/5ml ketotifen (as fumarate)
Storage
Store below 30° C. Protect from light and moisture.
References
- USP DI, 2004
- Up To Date, Vol. 13.1 (2005)
- Martindale, The Complete Drug Reference, 33 rd edition 2002
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