Generics: Ketotifen Fumarate.
Ketotifen is indicated in the following conditions-
- For the prophylactic treatment of bronchial asthma.
- Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
- For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
- Symptomatic treatment of allergy such as hayfever, urticaria.
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 an asthmatic attacks. Ketotifen exerts as 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.
Route of administration: Orally.
Sedatives, hypnotics, antihistamines, and alcohols may be amplified by ketotifen. A reversible decrease in platelet count has been documented in a few patients taking Tifen with oral antidiabetic medications, leading to the recommendation that this combination be avoided.
A reversible drop in platelet count has been noted in a few patients taking Ketotifen with an oral antidiabetic medication, leading to the recommendation that this combination be avoided. Despite the lack of evidence of a teratogenic impact, Ketotifen is not recommended during pregnancy or when breastfeeding is not possible.
Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.
Pregnancy & Lactation:
Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.
Precautions & Warnings:
It is important to continue the above treatment for at least two weeks after starting ketotifen to avoid the possibility of your asthma getting worse. This is particularly suitable for systemic corticosteroids and ACTH, because steroid-dependent patients may have adrenal insufficiency. If a concurrent infection occurs, it must be supplemented with a specific antibiotic treatment, treatment with ketotifen. On the first day of ketotifen treatment, the response may be impaired, and patients should be advised not to be responsible for vehicles or machinery until ketotifen treatment affects the individual. Patients should be advised to avoid drinking alcohol. Ketotifen can potentiate the effects of tranquilizers, hypnotics, antihistamines, and alcohol.
Cromoglycate & related drugs.
Store in a cool and dry place, protect from light. Keep out of the reach of children.
Manufactured by: Square Pharmaceuticals Ltd.