Generic

Ketotifen Fumarate

Indications

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.

Pharmacology

Ketotifen has anti-allergic characteristics and has been utilized in the preventative treatment of asthma in a similar way to sodium chromoglycate. It has antihistamine characteristics as well. Ketotifen has strong anti-anaphylactic effects and is useful for avoiding asthma attacks. Ketotifen has a long-lasting inhibitory effect on histamine reactions, which is distinct from its anti-anaphylactic effects. Ketotifen is as effective orally as a selective mast cell stabilizer delivered by inhalation in asthmatic individuals, according to research. In such tests, antihistamines were unsuccessful. Long-term clinical trials have been conducted to determine the efficacy of Ketotifen. The number, severity, and length of asthma attacks were reduced, and in some cases, the patients were completely free of attacks. It was also possible to gradually reduce corticosteroids and/or bronchodilators. It may take several weeks for Ketotifen’s prophylactic activity to become fully established. Ketotifen will not stop an asthma episode that has already started.

Dosage & Administration

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.

Interaction

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.

Contraindications

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.

Side Effects

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

To avoid an asthma exacerbation, it is critical to continue the previous medication for at least two weeks after commencing Ketotifen. Because of the possibility of adrenocortical insufficiency in steroid-dependent patients, this is especially true for systemic corticosteroids and ACTH. Ketotifen treatment must be complemented by specialized antibiotic therapy if intercurrent infection occurs. Reactions may be impaired on the first day of Ketotifen medication, and patients should be advised not to drive or operate machinery until the effects of Ketotifen treatment on the person are known. Patients should be encouraged to stay away from alcoholic beverages.

Therapeutic Class

Cromoglycate & related drugs

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Pharmaceutical Name

Ibn Sina Pharmaceuticals Ltd.