Atopic asthma: Adjunctive therapy in the chronic treatment of mild, atopic asthma in children Limitations of use: Not indicated for acute prevention or treatment of acute asthma attacks.

Histamine H1 Antagonist

Absorption: Rapid, ≥60%
1. Bioavailability: ~50%
2. Time to peak, plasma: 2 to 4 hours
Distribution
1. Protein binding: 75%
Metabolism
Metabolism: Hepatic via N-glucuronidation to inactive metabolite ketotifen-N-glucoronide; N-demethylation to active metabolite nor-ketotifen; and keto-reduction to hydroxyl derivative
Excretion
Urine (>60% as metabolites, 1% as unchanged drug)
Pharmakodynamics
1. Clearance: Increased in children >3 years; decreased in children ≤3 years
2. Half-life elimination: Biphasic: Distribution: 3 to 5 hours; Elimination: 21 hours

Hypersensitivity to ketotifen or any component of the formulation; use of ketotifen syrup in patients sensitive to benzoate compounds

Adverse events have been observed in some animal studies.

Breast-feeding is not recommended by the manufacturer.

>3 years old: 5mL BID
6 months to 3 years old: 0.25mL/kg
Patients who are more sensitive to sedation effect can take half the recommended dose during the first week (BID or QN) and increase to the full recommended dose within five days.
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There are no dosage adjustments provided in the manufacturer's labeling.

There are no dosage adjustments provided in the manufacturer's labeling.