Ketotifen 1 mg/5 ml Syrup
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Ketotifen has anti-allergic properties and has been used similarly to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing asthmatic attacks. Ketotifen exerts a sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity, and duration, and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.
- Adults: 1 mg twice daily with food. If necessary, the dose may be increased to 2 mg twice daily in severe cases.
- Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
- Use in elderly: Same as adult dose or as advised by the physician.
Stafen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents, and it has been suggested that Stafen should therefore be avoided.
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agents, and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breastfeeding cannot be given.
Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the b,eginning of treatment but usually disappear spontaneously after a few days.
Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.
It is important to continue the previous treatment for a minimum of two weeks after starting Stafen to avoid the possibility of exacerbation of asthma. This applies especiallyent patient. If an intercurrent infection occurs, Stafen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Stafen, reactions may be impaired, and patients should be warned not to take charge of a vehicle or machinery until the effect of Stafen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Stafen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.
Store in a cool and dry place, protect from light. Keep out of the reach of children.
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