FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, 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.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 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. Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY). Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. Due to its pseudoephedrine component, Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are contraindicated in patients with narrow-angle glaucoma or urin

Product summary:

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 10 (NDC 54868-6087-1 ); bottles of 30 (NDC 54868-6087-2 ) and bottles of 60 (NDC 54868-6087-0 ). Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are two-layer tablets, one white layer and one tan layer with a clear film coating on the tablets. The tablets are engraved with "93 T13" on the white layer. Store Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. June 2009 Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 Manufactured for: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 ©2009 sanofi-aventis U.S. LLC 50090574

Authorization status:

New Drug Application

Summary of Product characteristics

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE -
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET,
FILM COATED, EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
DESCRIPTION
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, 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, 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.
It is very soluble in water, freely soluble in alcohol, and sparingly
soluble in chloroform.
1
32
39
4
10
15
CLINICAL PHARMACOLOGY
Mechanism of Action
Fexofenadine hydrochloride, the major active metabolite of
terfenadine, is an antihistamine with
selective peripheral H -receptor antagonist activity. Fexofenadine
hydrochl