International generic name
Drug form and composition
Tablets. One tablet contains 1 mg Ketotifen equivalent. Syrup. 1 ml syrup contains
0.2 mg Ketotifen equivalent.
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
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.
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.
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.
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.
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.
30 tablets of 1 mg. Vials, containing 125 ml syrup.
Tablets - 4 years. Syrup - 3 years