Prosma

Prosma

Prosma® Tablets: White, diamond shaped, scored tablets having P at one side and A on another side of breakline; each
tablet contains Kelotifen fumarate BP equivalent to 1mg Ketotifen.

Prosma® Syrup: Yellow coloured, lemon flavoured syrup; each 5ml contains Ketotifen fumarate BP equivalent to 1 mg Ketotifen.

Uses
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.

It is indicated in long-term prevention of
- Bronchial asthma (all forms including mixed)
- Allergic bronchitis
- Asthmatic symptoms associated with hay fever Prevention and treatment of
- Multi-system allergies
- Allergic rhinitis
- Skin and food allergy

Dosage and administration
Adults: 1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily in severe cases. Initial treatment in readily sedated patients is 0.5mg (1/2 tablet) twice
daily or 1mg at night.
Children over 2 years of age may be given 1 mg twice daily with meal. Children aged 6 months to 2 years 0.5mg (1/2 tablet or 2.5ml syrup) twice daily.




Contra-indications, warnings, etc.
Contra-indications:A reversible fall in the platelet count has been observed in few patients receiving Ketotifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
Use in pregnancy and lactation: It should not be used in pregnancy and during breast feeding, although there is no evidence of teratogenic effect.

Precaution: 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 upto one year. If intercurrent infection occurs the treatment must supplemented with specific antimicrobial therapy.

Side-effects: 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.

Pharmaceutical precautions
Store in a cool place (below 30°C), protected from light and moisture.

Package quantities
Prosma® Tablet: Cartons of 100 tablets in strips.
Prosma® Syrup: Bottles of 100ml.

ACI Limited