Clarinex

[Desloratadine]

Nursing Mothers

Desloratadine passes into breast milk, therefore a decision should be made whether to dis-continue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.

Pediatric Use

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The safety and effectiveness of CLARINEX Tablets in pediatric patients under 12 years of age have not been established.

Geriatric Use

Clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (see CLINICAL PHARMACOLOGY Ð Special Populations).

Information for Patients:

Patients should be instructed to use CLARINEX Tablets as directed. As there are no food effects on bioavailability, patients can be instructed that CLARINEX Tablets may be taken without regard to meals. Patients should be advised not to increase the dose or dosing frequency as studies have not demon-strated increased effectiveness at higher doses and somnolence may occur. Phenylketonurics: CLARINEX RediTabs Tablets contain phenylalanine 1.75 mg per tablet.

DRUG ABUSE AND DEPENDENCE

There is no information to indicate that abuse or dependency occurs with CLARINEX Tablets.

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