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Basic Drug Info
Drug Name:Allegra--D 24 Hour
Manufacturer:sanofi-aventis U.S. LLC
Other Info:

Rev.

July 2006asanofi-aventis U.S.

LLCBridgewater, NJ 08807©2006 sanofi-aventis U.S.

LLC



Clinical Trials:


Indications and Usage

ALLEGRA-D 24 HOUR Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older.

Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.ALLEGRA-D 24 HOUR should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Hay fever -- seasonal variety of allergic rhinitis, marked by acute conjunctivitis with lacrimation and itching; regarded as an allergic condition triggered by specific allergens.

Sneezing -- The sudden, forceful, involuntary expulsion of air from the NOSE and MOUTH caused by irritation to the MUCOUS MEMBRANES of the upper RESPIRATORY TRACT.

Rhinorrhea --

Excessive tearing --

Bloodshot eye --

Redness of eye -- Lay term applied to any condition with dilation of conjunctival or ciliary blood vessels; innumerable causes, especially irritation and infection.

Contraindications

ALLEGRA-D 24 HOUR is contraindicated in patients with known hypersensitivity to any of its ingredients.Due to its pseudoephedrine component, ALLEGRA-D 24 HOUR is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see Drug Interactions section).

It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures.

Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Angle Closure Glaucoma -- A form of glaucoma in which the intraocular pressure increases because the angle of the anterior chamber is blocked and the aqueous humor cannot drain from the anterior chamber.

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Coronary Artery Disease -- Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Sleeplessness -- Difficulty in going to sleep or getting enough sleep.

Dizziness -- An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness.

Asthenia -- Clinical sign or symptom manifested as debility, or lack or loss of strength and energy.

Weakness --

Tremor -- Cyclical movement of a body part that can represent either a physiologic process or a manifestation of disease. Intention or action tremor, a common manifestation of CEREBELLAR DISEASES, is aggravated by movement. In contrast, resting tremor is maximal when there is no attempt at voluntary movement, and occurs as a relatively frequent manifestation of PARKINSON DISEASE.

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

Warnings

Sympathomimetic amines should be used with caution 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.

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