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(Generic versions may still be available.)
Astemizole tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria. Astemizole should not be used as a p r n product for immediate relief of symptoms. Patients should be advised not to increase the dose in an attempt to accelerate the onset of action.
Clinical studies have not been conducted to evaluate the effectiveness of Astemizole in the common cold.
DOSAGE AND ADMINISTRATION
The recommended dosage for adults and children 12 years of age and older is 10 mg (1 tablet) once daily.
Patients should be advised not to increase the dose of Astemizole in an attempt to accelerate the onset of action. (See WARNINGS.)
Studies evaluating the need for dosage adjustments for patients with hepatic or renal dysfunction have not been performed. Since astemizole is extensively metabolized by the liver, use of Astemizole in patients with significant hepatic dysfunction should generally be avoided.
Astemizole should be taken in an empty stomach, e.g., at least two hours after a meal. There should be no additional food intake for at least one hour post-dosing.
Astemizole is available as white, scored tablets containing 10 mg of astemizole debossed "JANSSEN" and on the reverse side debossed "AST/10."
Storage: Store tablets at room temperature (59°-86°) (15°- 30°C). Protect from moisture.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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