FEXOFENADINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 180 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 6 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 of age and older . Fexofenadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of fexofenadine hydrochloride. Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported. Teratogenic Effects: 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 c

Product summary:

Fexofenadine hydrochloride tablets, 180 mg are pink colored, oval, beveled edged, biconvex tablets debossed “194” on one side and “R” on the other side, and are supplied in bottles of 10 (NDC 21695-462-10); bottles of 30 (NDC 21695-462-30) and bottles of 60 (NDC 21695-462-60). Store Fexofenadine hydrochloride tablets at controlled room temperature 20° to 25°C (68°-77°F) (See USP Controlled Room Temperature). Foil-backed blister packs containing fexofenadine hydrochloride tablets should be protected from excessive moisture.  

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FEXOFENADINE HYDROCHLORIDE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FEXOFENADINE
HYDROCHLORIDE.
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Fexofenadine hydrochloride is an H1-receptor antagonist indicated for:
• Relief of symptoms associated with seasonal allergic rhinitis in
patients 6 years of age and older (1.1)
• Treatment of uncomplicated skin manifestations of chronic
idiopathic urticaria in patients 6 years of age and older (1.2)
DOSAGE AND ADMINISTRATION
Patient Population
Fexofenadine hydrochloride tablets (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
starting dose in patients with decrease renal function should be the
recommended dose indicated above but administered
once daily
dose not for use in patients with decreased renal function
• Fexofenadine hydrochloride tablets: take with water (2.1)
DOSAGE FORMS AND STRENGTHS
• Fexofenadine hydrochloride tablets: 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)
WARNINGS AND PRECAUTIONS
Fexofenadine hydrochloride tablets do not contain phenylalanine. (5)
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 REAC