Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE 60 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HYDROCHLORIDE TABLET LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- 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 Lesen Sie das vollständige Dokument