Zaditen (Discontinued)

Brand and Other Names:Ketotifen Systemic
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Dosing & Uses

AdultPediatric

Systemic formulation not commercially available in the United States

Not for adults

Other Indications & Uses

Adjunct treatment of mild atopic asthma in children

Systemic formulation not commercially available in the United States

Atopic Asthma

>3 years old: 1 mg PO BID

6 months old-3 years old: 0.05 mg/kg PO BID

Start with 1/2 dose, increase to full dose within 5 days

Not for acute attacks

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Adverse Effects

1-10%

Weight gain (5.3%)

Rash (4%)

Respiratory infection (4%)

Abdominal pain (1.3%)

Increased appetite (1.3%)

Epistaxis (1.3%)

Puffy eyelid (1.3%)

Sleep disturbance (1.3%)

Other ADRs are equal to or less than placebo

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Warnings

Contraindications

Hypersensitivity

Sensitivity to benzoate compounds

Cautions

Do not reduce immediately symptomatic & prophylactic antiasthmatic drugs (xanthine derivatives, 2-agonists, sodium cromoglycate, corticosteroids) when starting treatment with ketotifen

History of epilepsy

Perform thrombocyte counts in pts taking oral antidiabetic agents concomitantly

May potentiate the effects of sedatives, hypnotics, antihistamines & alcohol

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Pregnancy & Lactation

Pregnancy Category: safety not established; weigh risk/benefit

Lactation: secreted into breast milk, do not use if breastfeeding

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Half-life: 1 hour

Bioavailbility: 50%

Protein Bound: 75%

Absorption: rapid; 60%

Metabolites: inactive ketotifen-N-glucuronide

Excretion: urine: 1% unchanged drug, 60-70% as metabolites

Mechanism of Action

Nonbronchodilator which inhibits effects of certain inflammatory mediators & exerts antiallergic activity

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