Zaditen (Ketotifen) 15 mg 30 tabs, Novartis

Manufacturer: Novartis
Pharmaceutical name: Ketotifen
Pack: 30 tabs (1mg/tab)

As an add-on medication in the chronic treatment of mild atopic asthmatic children. Zaditen is a prophylactic agent to be used on a continuous basis and is not effective in the acute prevention or treatment of acute asthma attacks. Continuous use of Zaditen may reduce the frequency, severity and duration of asthmatic symptoms or attacks, and lead to a reduction in daily requirements of concomitant antiasthmatic medication, like theophyllines and b2-agonists.

Several weeks of Zaditen therapy may be necessary before the therapeutic effect becomes clinically evident. Full clinical effectiveness is generally reached after 10 weeks of treatment. Zaditen may have an anti-inflammatory effect in the lungs and the time of onset of clinical efficacy may reflect the recovery period of the lungs from inflammation. It is therefore recommended that for patients not adequately responding within a few weeks, treatment with ketotifen should be maintained for a minimum of 2 to 3 months. If it is necessary to withdraw ketotifen, this should be done progressively over a period of 2 to 4 weeks. Symptoms of asthma may recur.

Hypersensitivity to Zaditen or any other components of the formulations. Patients sensitive to benzoate compounds should not take ketotifen syrup.

Symptomatic and prophylactic antiasthmatic drugs (xanthine derivatives, b2-agonists, sodium cromoglycate, corticosteroids) already in use should not be reduced immediately when treatment with Zaditen is initiated. This applies especially to systemic corticosteroids and ACTH injections because of the possible existence of adrenocortical insufficiency in steroid-dependent patients; in such cases recovery of a normal pituitary-adrenal response to stress may take up to one year.

Since drowsiness may occur in the early stages of therapy, patients engaging in activities requiring rapid and precise responses should be cautioned.

A reversible fall in the thrombocyte count in patients receiving Zaditen concomitantly with oral antidiabetic agents has been observed in rare cases. Thrombocyte counts should therefore be carried out in patients taking oral antidiabetic agents concomitantly.

Zaditen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol. Zaditen syrup should not be administered to patients sensitive to benzoate compounds. Zaditen tablets are benzoate-free and can be administered alternatively to such patients. In diabetic patients, the carbohydrate content of the syrup (5 mL: 4 g carbohydrate) should be taken into consideration.