Tomart
Ketotifen 1mg
Tomart
Ketotifen 1mg
Presentation
Tomart Tablet: Each tablet contains Ketotifen Fumarate BP 1.38 mg equivalent to Ketotifen 1 mg.
Description
Ketotifen is a non-bronchodilator anti-asthmatic drug that inhibits the effect of certain endogenous substances known to be inflammatory mediators. In addition, Ketotifen is a potent anti-allergic substance possessing a powerful and sustained noncompetitive histamine (H1) receptor-blocking property.
Ketotifen is a type of asthma medication that, when taken every day and used along with other anti-asthmatic medications, may reduce the frequency, severity and duration of asthma symptoms or attacks in patients. It may also lead to a reduction in daily requirements of other anti-asthmatic medications such as theophyllines and β2-agonists, without the deterioration in pulmonary functions (FEV1, FVC and PEFR). The prophylactic activity of ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.
- AVAILABILITY: AVAILABLE
Indications
Ketotifen is indicated in long-term prevention of
- Bronchial asthma
- Allergic Bronchitis.
- Asthmatic symptoms associated with hay fever.
Prevention and treatment of allergic diseases, including: acute and chronic urticaria, atopic dermatitis and allergic rhinitis.
Dosage & administration
Ketotifen Fumarate is to be administered orally, with or without food.
Adults: 1 mg of Ketotifen twice daily. In severe cases the dose may be doubled. 0.5 to 1 mg at night may be preferable for the first few days of treatment if drowsiness is likely to be problem.
Children above 3 years: same as adult dose or as advised by the physician.
Children (6 months to 3 years): 0.05 mg per kg body weight given twice daily or as advised by the physician.
Contraindication
It is contraindicated for patients hypersensitive to Ketotifen.
Use in pregnancy, lactation & childhood
Pregnancy category C. There are no adequate and well controlled studies in pregnant woman. It is not known whether ketotifen is excreted in human milk. Caution should be exercised when this medicine is administered to a nursing woman.
Side-effects
During the first several days of the treatment with ketotifen following adverse effects may appear: somnolence, xerostomia, mild dizziness and fatigue, which are usually reversible with the treatment. In some patient body weight enhancement is seen, due to appetite increasing.
Precaution
Treatment with existing anti-histaminic treatment should be continued for at least 2 weeks after initiation of ketotifen treatment due to the risk of exacerbation of asthma. For the same reason, ketotifen should be gradually over a period of 2 to 4 weeks.
Drowsiness may occur, particularly during the first days of treatment patients should be warned not to drive or operate machinery until the effect of treatment on the individual is known. Ketotifen may also potentiate the effects of sedatives, hypnotics, antihistamines and alcohol. For this reason patients should be advised to avoid alcoholic drinks.
Overdosage
The reported features of overdosage include confusion, drowsiness, disorientation, headache, bradycardia and respiratory depression. Elimination of the drug with gastric lavage or emesis is recommended. Otherwise general supportive treatment is all that is required shall be instituted.
Drug interactions
Concomitant treatment with oral antidiabetic preparation enhances the risk of reversible thrombocytopenia. Ketotifen may potentiate the effect of the sedative, hypnotic and antihistamine medicines as well as alcohol.
Pharmaceutical precaution
Store in a cool, dry place and protect from light. Keep out of reach of children.
Packing
Tomart Tablet : Box containing 3x10/5 x10/10x10 tablets in blister pack.