Generic

Ketotifen Fumarate

Indications

• Prophylactic treatment o, bronchial asthma
• Allergic rhinitis
• .Allergic conditions such as hay fever, itchy rash, or reactions to insect bites
• Allergic conjunctivitis

Pharmacology

Ketotifen has anti-allergic characteristics and has been utilized in the preventive treatment of asthma in the same way as sodium cromoglycate has. It also functions as an antihistamine. Ketotifen has strong anti-anaphylactic effects and is useful in avoiding asthma episodes. Ketotifen has a long-lasting inhibitory impact on histamine responses that is distinct from its anti-anaphylactic effects. Ketotifen is as effective orally as an inhaled selective mast cell stabilizer in asthmatic patients, according to experimental research. In such experiments, antihistamines were unsuccessful. Ketotifen’s efficacy has been examined in long-term clinical studies. Asthma episodes were reduced in number, intensity, and length, and patients were totally free of attacks in certain situations. It was also feasible to gradually reduce corticosteroids and/or bronchodilators. Ketotifen’s prophylactic action may take several weeks to become completely established. Ketotifen will not stop existing asthma episodes.

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

A reversible fall in the thrombocyte count in patients receiving Ketotifen concomitantly with oral anti-diabetic agents has been observed in rare cases. So it has been suggested that this combination should therefore be avoided.

Ketotilen may potentiate the effects of sedatives, hypnotics, anti-histamines, and alcohol.

Contraindications

Hypersensitivity to Ketotiren or any other components of the formulation.

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

Pregnancy: its safety in human pregnancy has not been established. Ketotifen should therefore be given to pregnant women only in compelling circumstances. macaroni Ketotifen is excreted in breast milk. Therefore mothers receiving Kelolilen should not breastfeed.

Precautions & Warnings

Symptomatic and prophylactic anti-asthmatic drugs (Xanthine derivatives, P2-agonists, Sodium Cromoglycate, Corticosteroids) already in use should not be reduced immediately when treatment with Ketotifen is initiated. This applies especially to Systemic Corticosteroids and ACTH injections because of the possible existence of adrenocortical insufficiency in steroid-dependent patients. During the first day of treatment with Ketolifen, reactions may be impaired and patients should be warned not to take charge of a vehicle or machinery until the effect of Ketotifen treatment on the individual is known.

Therapeutic Class

Cromoglycate and related medications

Storage Conditions

Keep cool and dry, and keep away from direct sunlight. Keep out of children’s reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd