Ketotifen Fumarate BP
Tablet: Each tablet contains Ketotifen Fumarate BP 1.38 mg equivalent to 1 mg Ketotifen.
Syrup: Each 5 ml syrup contains Ketotifen Fumarate BP 1.38 mg equivalent to 1 mg Ketotifen.
is a preparation of Ketotifen, which has anti-allergic properties and has been used similarly, to sodium
chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine.
Alarid® (Ketotifen) possesses marked anti-anaphylactic properties and is effective in preventing asthmatic
(Ketotifen) exerts as 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.
Prophylactic treatment of bronchial asthma.
Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
DOSAGE AND ADMINISTRATION:
Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe
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.
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly
with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided.
Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when
breast feeding can not be given.
It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid
the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because
of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection
occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of
treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of
vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be
advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines
The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory
depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is
recommended. Otherwise general supportive treatment is all that is required shall be instituted.
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.
Store in a cool and dry place, protect from light. Keep out of the reach of children.
Tablet : Box containing 100s tablets in blister pack.
Syrup: Each PET bottle100 ml syrup and a measuring cup.
Brand: Square Pharmaceuticals Ltd