Allegra D - Warnings & Precautions

Fexofenadine/Pseudoephedrine

WARNINGS

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy (see CONTRAINDICATIONS). Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

PRECAUTIONS

General

Due to its pseudoephedrine component, ALLEGRA-D should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy (see WARNINGS and CONTRAINDICATIONS). Patients with decreased renal function should be given a lower initial dose (one tablet per day) because they have reduced elimination of fexofenadine and pseudoephedrine (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).



Information for Patients

Patients taking ALLEGRA-D tablets should receive the following information: ALLEGRA-D tablets are prescribed for the relief of symptoms of seasonal allergic rhinitis. Patients should be instructed to take ALLEGRA-D tablets only as prescribed. Do not exceed the recommended dose. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult the doctor. Patients should also be advised against the concurrent use of ALLEGRA-D tablets with over-the-counter antihistamines and decongestants.

The product should not be used by patients who are hypersensitive to it or to any of its ingredients. Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of MAO inhibitor. It also should not be used by patients with severe hypertension or severe coronary artery disease.

Patients should be told that this product should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant. Patients should be cautioned not to break or chew the tablet. Patients should be directed to swallow the tablet whole. Patients should be instructed not to take the tablet with food. Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children.


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