Prosma^®

Prosma is a non-bronchodilator anti-asthmatic drug with marked anti-anaphylactic and special antihistaminic properties. In addition, Prosma exerts a powerful and sustained H₁-receptor blocking activity which can be clearly dissociated from its anti-anaphylactic properties.

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Prosma is indicated in long-term prevention of
- Bronchial asthma (all forms including mixed)
- Allergic bronchitis
- Asthmatic symptoms associated with hay fever

Prosma is also indicated in prevention and treatment of
- Multi-system allergies
- Allergic rhinitis
- Skin and food allergy

Route of administration: Prosma should be taken in oral route.

Adults: The recommended dose of Prosma is 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases. Initial treatment in readily sedated patients is 0.5 mg (1/2 tablet) twice daily or 1 mg at night.

Children:
Children aged 3 years and above: Prosma may be given 1 mg twice daily with meal.
Children aged 6 months to below 3 years: Prosma 0.05 mg (0.25 ml of syrup) per kg of body weight twice daily, (in the morning and evening).

Pregnancy: Its safety in human pregnancy has not been established. Ketotifen should therefore be given to pregnant women only in compelling circumstances.

Lactation: Ketotifen is excreted in breast milk. Therefore mothers receiving ketotifen should not breastfeed.

Previous anti-asthmatic treatment should be continued for a minimum of 2 weeks after initiation of ketotifen treatment. Exacerbation of asthma may occur related to stopping existing treatment. This applies especially to systemic corticosteroid and ACTH 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. If intercurrent infection occurs the treatment must supplemented with specific antimicrobial therapy.

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

Ketotifen is contraindicated in patient with known hypersensitivity to ketotifen or any components of this product.

Drug interaction with medication: A reversible fall in the platelet count has been observed in few patients receiving ketotifen concomitantly with oral anti-diabetic agents and it has been suggested that this combination should therefore be avoided.

Drug interaction with food and others: Not applicable.

Symptoms of overdose of ketotifen are drowsiness, confusion, dyspnoea, bradycardia or tachycardia, disorientation, convulsions, severe hypotension and reversible coma. If overdose occurs, treatment should be symptomatic and supportive.

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Store in a cool place (Below 30°C), protected from light & moisture.

Prosma Tablet: Each tablet contains Ketotifen 1 mg as Fumarate BP.
Prosma Syrup: Each 5 ml contains Ketotifen 1 mg as Fumarate BP.

Storage
Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Packing
Prosma Tablet: Carton of 100 tablets in blister.
Prosma Syrup: Bottle of 100 ml.