FEXOFENADINE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (Mezinárodní Name):

FEXOFENADINE HYDROCHLORIDE

Složení:

FEXOFENADINE HYDROCHLORIDE 60 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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 repo