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Asumalife
Ketotifen exerts potent
antianaphylactic and antihistaminic
effects. Its powerful and sustained H1-receptor blocking
activity can be clearly dissociated from its antianaphylactic
properties. Ketotifen has been used in the prophylactic
treatment of asthma.
Ingredient(s)
Each tablet contains:
Ketotifen Fumarate 1.38mg
(eg. to Ketotifen 1 mg)
Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics)
1. Ketotifen is a potent antihistamine which exhibits strong
H1-receptors blocking activity. In addition it has been
shown to possesses antianaphylactic properties and is
effective in preventing asthmatic attacks.
2. Laboratory experiments suggest that the activity of the
drug may be mainly due to the inhibition of release of
chemical mediators from tissue mast cells and basophils,
in particular histamine and the leukotriene, and to calcium
antagonistic properties.
3. Ketotifen is extremely effective in protecting patients
against histamine-induced bronchospasm both in single
and when administered long term.
4. Gastrointestinal absorption of Ketotifen following oral
administration is rapid, with an absorption half-life of less
than one hour. Peak plasma concentrations are achieved
at 2 hours after dosing. 30 ~ 50% of the drug is excreted
in the urine and the remainder in the feces. The
elimination half-life is 22 hours.
Indication(s)
Prophylactic treatment of bronchial asthma and symptomatic
treatment of allergic rhinitis, dermatitis, urticaria and pruritus.
Dosage and Administration
Adults and Children over 2 years of age : 1 mg twice daily with
morning and evening meals.
Children under 2 years of age : No clear evidence of efficacy
and safety has been established.
To minimize the initial sedation with ketotifen, a progressive
regimen is recommended during the first week of treatment
commencing with one half the daily recommended dosage
given in 2 divided doses or in a single dose given in the
evening, followed within 5 days, by an increase to the full
therapeutic dose.
Concomitant therapy : A progressive reduction in dosage of
other asthma drugs, where clinically indicated, should be
attempted only after 6 to 12 weeks of ketotifen, therapy.
To be dispensed on physician's prescription.
Contraindications
Contraindicated in patients with known hypersensitivity to
ketotifen.
Precaution(s) / Warning(s)
1. The dose should be reduced gradually over a period of
one week upon withdrawal to prevent the recurrence of
the symptoms of asthma.
2. Care should be exercised when
driving a vehicle or
operating machinery because ketotifen may cause
sedation.
3. Although there is no evidence of teratogenic effects,
ketotifen fumarate should be given to pregnant women
only if the potential benefit justifies the potential risk to
the fetus.
4. It is not known whether Ketotifen Fumarate is excreted in
breast milk. Asumalife should therefore be given to
nursing mothers only if absolutely essential.
Drug Interactions
1. Ketotifen may potentiate the effects of sedatives,
hypnotic, antihistamines and alcohol.
2. Concomitant use of ketotifen with oral antidiabetic agent
should be avoided as a reversible fall in the platelet count
has been observed.
Side Effect(s) / Adverse Reaction(s)
There is a relatively low incidence of adverse reactions
reported. Sedation, dry mouth, dizziness, increased appetite
and weight gain may occur occasionally.
CNS stimulation including excitability and agitation in children
has been reported.
Symptoms and Treatment for Overdosage, and
Antidote(s)
Overdosages with up to 120 mg ketotifen have been reported.
The main symptoms of acute overdosage include: drowsiness
to severe sedation; confusion and disorientation; tachycardia
and hypotension; convulsion, especially in children;
hyperexcitability in children; reversible coma. Treatment
should be symptomatic. If ingestion is recent, the stomach
should be emptied. If necessary, specific or symptomatic
treatment should be instituted.
Shelf-Life
2 years from the date of manufacture.
Storage Condition(s)
Keep in a tight container. Store at temperature below 30°C.
Protect from light and moisture.
Product Description and Packing(s)
A white tablet, one side with a score and the other side
impressed with the mark "YS".
Plastic bottle of 60's.
Plastic bottle of 500's and 1000's (for export only).
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