Prescribing Details
Description
Prosma ® is a non-bronchodilator anti-asthmatic drug with marked anti-anaphylactic and special antihistamine properties. In addition, Prosma ® exerts a powerful and sustained H1 receptor blocking activity which can be clearly dissociated from its anti-anaphylactic properties.
Uses
No Data
Indications
Prosma ® is a non-bronchodilator anti-asthmatic drug with marked anti-anaphylactic and special antihistamine properties. In addition, Prosma ® exerts a powerful and sustained H 1 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: 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 0.5mg (1/2 tablet) twice daily or 1 mg at night.
Children over 3 years of age may be given 1 mg twice daily with meal. Children aged 6 months to 3 years 0.05 mg (0.25 ml syrup) per kg of body weight twice daily (in the morning and evening.
Use in pregnancy & lactation
It should not be used in pregnancy and during breast feeding, although there is no evidence of teratogenic effect.
Geriatric use
Precautions
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 infections 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.
Contraindications
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.
Drug interactions
No Data
Overdose
No Data
Preparation
No Data
Pharmaceutical precautions
Store in a cool place (Below 30°C), protected from light & moisture.
