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Karbinal ER

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Karbinal ER

CLINICAL PHARMACOLOGY

Mechanism of Action

Carbinoxamine is an H1 receptor antagonist (antihistamine) that exhibits anticholinergic (drying) and sedative properties.

Antihistamines compete with histamine for receptor sites on effector cells.

Pharmacokinetics

Karbinal ER after single-dose administration of 16 mg was bioequivalent to the reference carbinoxamine immediate-release oral solution after the administration of two doses of 8 mg six hours apart under fasting conditions. The carbinoxamine mean (SD) peak plasma concentration (Cmax) was 28.7 (5.3) ng/mL at 6.7 hours after Karbinal ER administration. The plasma half-life of carbinoxamine was 17.0 hours. There was no effect of food on the pharmacokinetic parameters.

Karbinal ER after multiple-dose administration of 16 mg every 12 hours for 8 days was bioequivalent to the reference carbinoxamine immediate-release oral solution after multiple-dose administration of 8 mg every 6 hours. The mean (SD) steady-state Cmax was 72.9 (24.4) ng/mL at 5.6 hours after Karbinal ER administration. Carbinoxamine mean (SD) minimum plasma concentration at steady-state was 51.8 (20.3) ng/mL.

Nonclincal Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to determine the possible effects of carbinoxamine on carcinogenesis, mutagenesis, and fertility.

Clinical Studies

The efficacy and safety of Karbinal ER is based on demonstration of bioequivalence to the immediaterelease reference product [see Pharmacokinetics].

Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.

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