Stafen Tablet: Each tablet contains Ketotifen Fumarate BP equivalent to Ketotifen 1 mg.
Stafen Syrup: Each 5 ml syrup contains Ketotifen Fumarate BP equivalent to Ketotifen 1 mg.
Ketotifen is a potent antihistamine, which exhibits strong H1 receptor-blocking activity. Also, it has been shown to possess anti anaphylactic properties and is effective in preventing asthmatic attacks.
Stafen is indicated in the prophylactic treatment of bronchial asthma and also for the prevention and treatment of allergic conditions such as rhinitis, allergic bronchitis, acute and chronic urticaria, atopic dermatitis and conjunctivitis.
The drug is particularly of value in patients who suffer from more than one atopic disease, e.g. asthma and rhinitis, when one formulation benefits both conditions.
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetics and it has been suggested that this combination should therefore be avoided. Since Ketotifen has the properties of the antihistamines, it may potentiate the effects of other CNS depressant drugs such as alcohol, antihistamines, hypnotics and sedatives.
Concomitant therapy of Ketotifen and oral antidiabetics should be avoided.
The symptomatic side effects of Ketotifen are few and relatively minor. The common side effects are drowsiness, dry mouth and slight dizziness. The incidence of drowsiness appears to decline during extended period of treatment. Also, there have been occasional reports of CNS stimulation and weight gain. Fewer side effects are reported in children.
Pregnancy: Pregnancy category C.
Nursing Mother: It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Stafen is administered to a nursing woman.
Paediatric Use: Safety & effectiveness in paediatric patients below the age of 3 years have not been established.
Treatment with existing antiasthmatic drugs should be continued for at least 2 weeks after initiation of Ketotifen treatment owing to the risk of exacerbation of asthma. For the same reason, Ketotifen should be discontinued gradually over a period of 2 to 4 weeks. Drowsiness may occur, particularly during the 1st day of treatment, so patients taking Ketotifen should be warned not to drive or operate machinery until the effect of treatment on the individual is known.
Store below 30 C, keep in dry place & protect from light. Keep out of the reach of children.