For the treatment of allergic conditions including allergic rhinitis†, atopic dermatitis†, and acute or chronic urticaria†. 1 mg PO every 12 hours. Ketotifen is also available in a sustained release oral formulation that allows for once daily dosing.
Antihistamine; Antiallergy
Ketotifen 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. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. 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.
OPHTHALMIC Allergic conjunctivitis: Adult: As 0.025% solution: Instill 1 drop into the affected eye(s) bid. Child: 3 yr: As 0.025% solution: Instill 1 drop into the affected eye(s) bid.
Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
Acute asthma attack. May impair tasks requring mental alertness e.g. driving or operating machinery. History of epilepsy. Pregnancy & lactation. Children <3 yr.
Sedation, drowsiness, dizziness, dry mouth, wt gain, increased appetite, CNS stimulation. Rarely, cystitis. Conjunctival injection, headaches & rhinitis (ophthalmic).
Caution is recommended; this drug should be used during pregnancy only if the benefit to the mother outweighs the risk to the fetus. Animal studies have revealed excretion of this drug into maternal milk following oral administration, however, it is unknown whether topical ophthalmic administration results in excretion into human breast milk. Use is considered acceptable; caution is recommended.
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.
Store in a cool and dry place, protect from light. Keep out of the reach of children.