FEXOFENADINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fexofenadine hydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. Fexofenadine hydrochloride tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. Fexofenadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of fexofenadine hydrochloride tablets. Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported. Pregnancy Category C. There was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine up to 300 mg/kg (which led to fexofenadine exposures that were approximately 4 and 30 times, respectively, the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride based on comparis

Product summary:

Fexofenadine hydrochloride tablets USP are available as follows: 60 mg – peach, round, film-coated tablets debossed with “93” on one side and “7252” on the other side, in blistercards of 30. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HYDROCHLORIDE TABLET, FILM
COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FEXOFENADINE HYDROCHLORIDE TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FEXOFENADINE HYDROCHLORIDE TABLETS USP.
FEXOFENADINE HYDROCHLORIDE TABLETS USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Fexofenadine hydrochloride is an H -receptor antagonist indicated for:
Relief of symptoms associated with seasonal allergic rhinitis in
patients ≥ 2 years of age (1.1)
Treatment of uncomplicated skin manifestations of chronic idiopathic
urticaria in patients ≥ 6 months of age (1.2)
DOSAGE AND ADMINISTRATION
Patient Population
Fexofenadine Hydrochloride Tablets USP (2.1)
*
†
Adults and children ≥ 12 years
60 mg twice daily or 180 mg once daily
Children 6 to 11 years
30 mg twice daily
Children 2 to 5 years
N/A
Children 6 months to less than 2 years
N/A
Fexofenadine hydrochloride tablets USP: take with water (2.1)
DOSAGE FORMS AND STRENGTHS
Fexofenadine hydrochloride tablets USP: 30 mg, 60 mg, and 180 mg (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to fexofenadine and any of the
ingredients of fexofenadine hydrochloride tablets. (4)
ADVERSE REACTIONS
The most common adverse reactions (≥ 2%) in subjects age 12 years
and older were headache, back pain, dizziness,
stomach discomfort, and pain in extremity. In subjects aged 6 to 11
years, cough, upper respiratory tract infection, pyrexia
and otitis media were more frequently reported. In subjects aged 6
months to 5 years, vomiting, diarrhea,
somnolence/fatigue and rhinorrhea were more frequently reported. (6.1)
Other adverse reactions have been reported. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT TEL: [phone]-
2872, X6351 AND [e-mail] OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Antacids: Do not take at