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Tifen (Ketotifen BP)

COMPOSITION:

Tifen Tablet : Each tablet contains Ketotifen Fumarate BP 1.38 mg, equivalent to Ketotifen 1 mg.

Tifen Syrup : Each 5 ml syrup contains Ketotifen Fumarate BP 1.38 mg, equivalent to Ketotifen 1 mg.

INDICATION:

Tifen is indicated for the following conditions-

1. For the prophylactic treatment of bronchial asthma.

2. Symptomatic treatment of allergic conditions including rhinitis and

3. For alleviating the complications of itching, pain and tenderness  associated with neurofibroma.

4. Symptomatic treatment of allergy such as hayfever, urticaria.

DOSAGE AND ADMINISTRATION:

Adult: 1 mg twice daiIy with food. The dose may be increased to 2 mg twice daily in severe cases, if necessary.

Children above 2 years: 1 mg twice daily with food.

Use in the elderly: same as adult dose.

N.B. Patients known to be easily sedated should begin treatment with 0.5 mg to 1 mg at night for the first few days.

CONTRAINDICATION:

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


SIDE EFFECT:

Drowsiness, dry mouth and slight dizziness may occur at the beginning of treatment, but usually disappear spontaneously after a few days.

PRECAUTION:

It is important to continue the previous treatment for a minimum of two weeks after starting Tifen 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 intercurrent infection occurs, Tifen treatment must be supplemented by specific antimicrobial therapy. During the first days of treatment with Tifen, reactions may be impaired and patient should be warned not to take charge of vehicle or machinery until the effect of Tifen treatment on the individual is known. Patient should be advised to avoid alcoholic drinks.

DRUG INTERACTION:

Tifen 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.

OVERDOSE:

The reported feature of over doses include confusion, drowsiness, nystagmus, headache and disorientation. Bradycardia and respiratory depression should be watched for. Elimination of the drug with gastric lavage or emesis is recommended. Otherwise, general supportive treatment that is required should be instituted.

STORAGE:

· Store in cool & dry place, protected from light.

· Keep out of reach of children.

PACKAGING:

Tifen Tablet: Each box contains 10x10 tablets in blister pack.

Tifen Syrup: 100 ml syrup in amber glass bottle.

 

 

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