Ethifen

Ketotifen Fumarate
Antihistamine

Ethifen

Description

Composition:

Ethifen Tablet:  Each film coated tablet contains Ketotifen Fumarate BP equivalent to Ketotifen 1 mg. Ethifen Syrup:  Each 5 ml syrup contains Ketotifen Fumarate BP equivalent to Ketotifen 1 mg.

Pharmacology:

Ethifen 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. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attack. 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 establishing attacks of asthma.

Indications:

Prophylactic treatment of bronchial asthma. Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

Dosage & Administration:

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases. Children above 3 years: 5 ml twice daily with food. Patients known to be easily sedated should begin treatment with 2.5 to 5 ml 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.

Contraindications:

Concomitant therapy of Ketotifen and oral antidiabetics should be avoided.

Warning & Precautions:

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 especially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If intercurrent 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 vehicles or machinery until the effect of Ketotifen treatment of the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Side effects:

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.

Pregnancy & Lactation:

Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding cannot be given.

Drug interaction:

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.

Overdose:

The reporting features of overdose include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise general supportive treatment shall be instituted.

Storage:

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Packing:

Ethifen Tablet: Each box contains 10×10’s tablet in blister pack.

Ethifen Syrup: Each bottle contains 100 ml syrup.