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.

Disturbed sleep, headache, skin rash, urticaria, weight gain, abdominal pain, increased appetite, nfluenza, eyelid edema, respiratory tract infection, epistaxis.

1 mg PO BID. Administer without regards to meals.

Infants and Children 6 months to 3 years: Initial: 0.05 mg/kg once daily or in 2 divided doses for 5 days; Maintenance: 0.05 mg/kg/dose twice daily (maximum dose: 1 mg twice daily) Children >3 years and Adolescents: Initial: 1 mg once daily or in 2 divided doses for 5 days; Maintenance: 1 mg twice daily

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

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