ALLEGRA D-12 HOUR- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, extended release

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:

Physicians Total Care, Inc.

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ALLEGRA-D 12 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 12 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 12 HOUR is contraindicated in patients with known hypersensitivity to any of its ingredients. Due to its pseudoephedrine component, ALLEGRA-D 12 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 arter

Product summary:

ALLEGRA-D 12 HOUR Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 12 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) of: ALLEGRA-D 12 HOUR is a two-layer tablet, one white layer and one tan layer with a clear film coating on the tablet. The tablets are engraved with "06/012D" on the white layer. Store ALLEGRA-D 12 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.)

Authorization status:

New Drug Application

Summary of Product characteristics

ALLEGRA D-12 HOUR - FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE
HYDROCHLORIDE TABLET,
EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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ALLEGRA-D 12 HOUR
(FEXOFENADINE HCL 60 MG AND PSEUDOEPHEDRINE HCL 120 MG)
EXTENDED-RELEASE TABLETS
DESCRIPTION
ALLEGRA-D 12 HOUR (fexofenadine hydrochloride and pseudoephedrine
hydrochloride)
Extended-Release Tablets for oral administration contain 60 mg
fexofenadine hydrochloride for
immediate release and 120 mg pseudoephedrine hydrochloride for
extended release. Tablets also
contain as excipients: microcrystalline cellulose, pregelatinized
starch, croscarmellose sodium,
magnesium stearate, carnauba wax, stearic acid, silicon dioxide,
hypromellose and polyethylene glycol.
Fexofenadine hydrochloride, one of the active ingredients of ALLEGRA-D
12 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:
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 12 HOUR, is an
adrenergic (vasoconstrictor) agent with the chemical name
[S-(R*,R*)]-α-[1-(methylamino)ethyl]-
benzenemethanol hydrochloride and the following chemical structure:
The molecular weight is 201.70. 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.
®
®
1
32
39
4
10
15
It is very soluble in water, freely soluble in alcohol, and sparingly
soluble in chloroform.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Fexofenadine hydrochloride, the major active metabolite of
t