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DOSAGE
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1 Tab PO qD, do not use more than 1 tab within 24 hours
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GENERIC
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fexofenadine hcl 180mg + pseudoephendrine hcl 240mg
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INDICATIONS
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ALLEGRA-D 24 HOUR (fexofenadine hcl 180 and pseudoephendrine hcl 240) 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.
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MECHANISM OF ACTION
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Antihistamine/ Decongestant
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MICROBIOLOGY
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Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine hydrochloride inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. In laboratory animals, no anticholinergic or alpha1-adrenergic-receptor blocking effects were observed. Moreover, no sedative or other central nervous system effects were observed. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier.
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Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.
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CONTRAINDICATIONS & WARNINGS
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Due to the pseudoephedrine component, ALLEGRA-D 24 HOUR (fexofenadine hcl 180 and pseudoephendrine hcl 240) is contraindicated in patients taking monoamine oxidase inhibitors and for 14 days after stopping use of an MAO inhibitor.
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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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PEDIATRIC USE
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Safety and effectiveness in children below the age of 12 years have not been established.
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PREGNANCY
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Category C Teratogenic Effects:. Terfenadine alone was not teratogenic in rats at oral doses up to 300 mg/kg (approximately 3 times the maximum recommended human daily oral dose of ALLEGRA-D 24 HOUR (fexofenadine hcl 180 and pseudoephendrine hcl 240) based on comparison of the AUCs of fexofenadine) and in rabbits at oral doses up to 300 mg/kg (approximately 25 times the maximum recommended human daily oral dose of ALLEGRA-D 24 HOUR (fexofenadine hcl 180 and pseudoephendrine hcl 240) based on comparison of the AUCs of fexofenadine).
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NOTE
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Extended Release, aval in Non-Drowsy
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