ALLEGRA-D 24 HOUR- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

STAT RX USA LLC

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). 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 co

Product summary:

ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47), with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink. Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. December 2009 sanofi-aventis U.S. LLC Bridgewater, NJ 08807 ©2009 sanofi-aventis U.S. LLC

Authorization status:

New Drug Application

Summary of Product characteristics

ALLEGRA-D 24 HOUR - FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE
HYDROCHLORIDE TABLET, FILM COATED
STAT RX USA LLC
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DESCRIPTION
ALLEGRA-D 24 HOUR (fexofenadine hydrochloride and pseudoephedrine
hydrochloride)
Extended-Release Tablets for oral administration contain 180 mg
fexofenadine hydrochloride for
immediate release and 240 mg pseudoephedrine hydrochloride for
extended release. Tablets also
contain as excipients: microcrystalline cellulose, sodium chloride,
cellulose acetate, polyethylene
glycol, opadry white, povidone, talc, hypromellose, croscarmellose
sodium, copovidone, titanium
dioxide, magnesium stearate, colloidal silicon dioxide, brilliant blue
aluminum lake, acetone, isopropyl
alcohol, methyl alcohol, methylene chloride, water, and black ink.
Fexofenadine hydrochloride, one of the active ingredients of ALLEGRA-D
24 HOUR, is a histamine
H -receptor antagonist with the chemical name
(±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-
piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid hydrochloride
and the following chemical
structure:
Fexofenadine Hydrochloride
Structure Image
The molecular weight is 538.13 and the empirical formula is C
H NO •HCl. Fexofenadine
hydrochloride is a white to off-white crystalline powder. It is freely
soluble in methanol and ethanol,
slightly soluble in chloroform and water, and insoluble in hexane.
Fexofenadine hydrochloride is a
racemate and exists as a zwitterion in aqueous media at physiological
pH.
Pseudoephedrine hydrochloride, the other active ingredient of
ALLEGRA-D 24 HOUR, is an
adrenergic (vasoconstrictor) agent with the chemical name
[S-(R*,R*)]-α-[1-(methylamino)ethyl]-
benzenemethanol hydrochloride and the following chemical structure:
Pseudoephedrine Hydrochloride Structure Image
The molecular weight is 201.70 and the molecular formula is C
H NO•HCl. Pseudoephedrine
hydrochloride occurs as fine, white to off-white crystals or powder,
having a faint characteristic odor.
It is very soluble in water, freely soluble in alcohol, and sparingly
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