Generic

Ketotifen Fumarate

Indications

• Ketotifen is prescribed for the treatment of bronchial asthma as a preventative measure.
• Allergic disorders such as rhinitis and conjunctivitis are treated symptomatically.
• It’s used to treat the itching, discomfort, and tenderness that come with neurofibroma.
• Allergy symptoms such as hay fever and urticaria are treated symptomatically.

Pharmacology

Ketotifen has anti-allergic properties and has been used similarly, to sodium cromoglycate 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.

Dosage & Administration

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

For 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 alcohol 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 is avoided.

Contraindications

A reversible drop in platelet count has been noted in a few patients taking Ketotifen with oral antidiabetic medication, leading to the recommendation that this combination is 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

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.

Therapeutic Class

Cromoglycate & related drugs

Storage Conditions

Store in a cool and dry place, and protect from light. Keep out of the reach of children.

Pharmaceutical Name

UniMed UniHealth Pharmaceuticals Limited