International generic name

Ketotifen

Drug form and composition

Tablets. One tablet contains 1 mg Ketotifen equivalent. Syrup. 1 ml syrup contains 0.2 mg Ketotifen equivalent.

Indications

Long-term prevention of all forms of the bronchial asthma, allergic bronchitis, and asthma manifestations in allergic rhinitis. Prevention and treatment of allergic diseases, including: acute and chronic urticaria, atopic dermatitis, allergic rhinitis and conjunctivitis.

Dosage and administration

The tablets and the syrup are taken orally with meal. In adults - 1 mg, 2 times daily, in the morning and in the evening. In case of insufficient effect after 4-week treatment the dose could be increased up to 2 mg, 2 times daily. In children aged 6 months- to 3 years - 0.5 mg (2.5 ml syrup), 2 times daily; in children older than 3 years - 1 mg, 2 times daily (in the morning and in the evening). The treatment with Ketotifen should be discontinued gradually, with graduate reduction of the dose within 2-4 weeks, in order to avoid the risk of asthma symptoms recidivating. It is advisable the treatment to continue 2-3 months.

Contraindications

The preparation should not be used in hypersensitivity and during the first trimester of the pregnancy.

Special warnings and precautions

In patents, sensitive to the sedative effect of the preparation, initial dose should be half of the usual, which could be gradually increased. In order to avoid suprarenal insufficiency, in patients, treated regularly with corticosteroids, Ketotifen should be started after gradually reducing of the corticosteroid dose, or elongation of the interdosage intervals. In case of intercurrent infections Ketotifen should not be discontinued. In pregnant and nursing women Ketotifen is used only after precise consideration of the mother and the fetus risk/benefit ratio. At the beginning of the treatment Ketotifen may cause patient reaction disorders, which requires enhanced attention in drivers and machinery operating persons.

Drug interactions

Concomitant treatment with oral antidiabetic preparations enhances the risk of reversible thrombocytopenia. Ketotifen potentiates the effect of the sedative, hypnotic, and antihistamine medicines, as well as alcohol. The preparation could be combined with antiseptic and antibacterial medicines.

Adverse reactions

During the first several days of the treatment with Ketotifen following adverse effects may appear: somnolence, xerostomia, mild dizziness, and fatigue, which are usually reversible with the treatment. In some patients body weight enhancement is seen, due to appetite increasing. Hypersensitivity is very rare side effect, seen in immunocompromized patients.

Pharmacological mechanisms

Ketotifen is an antihistamine preparation with prolonged preventive effect on the frequency and intensity of the asthma attacks. Its mechanism of action ultimately is associated with reduction of histamine, serotonine and other mast cell mediators release, and simultaneous selective blocking of the H1-receptors. As a result of the latter effects the level of the cell cAMP in enhanced and eosinophilic infiltration is inhibited. Although the preparation influences favorably expectoration, it does not cope the asthmatic attacks, but only prevents their appearance.

Supplied

30 tablets of 1 mg. Vials, containing 125 ml syrup.

Expiry

Tablets - 4 years. Syrup - 3 years