FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Major Pharmaceuticals

INN (mednarodno ime):

FEXOFENADINE HYDROCHLORIDE

Sestava:

FEXOFENADINE HYDROCHLORIDE 30 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Fexofenadine hydrochloride tablets, 30 mg are pink colored, oval shaped tablets embossed with “192” on one side and “R” on the other side and are supplied in unit-dose packages of 100 (10 x 10).  Unit dose packages of 100 (10 x 10) 0904-5961-61 Fexofenadine hydrochloride tablets, 60 mg are pink colored, oval shaped tablets embossed with “193” on one side and “R” on the other side and are supplied in unit-dose packages of 100 (10 x 10).  Unit dose packages of 100 (10 x 10) 0904-5962-61 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 unit-dose packages of 100 (10 x 10).  Unit dose packages of 100 (10 x 10)  0904-5963-61 Store Fexofenadine hydrochloride tablets at controlled room temperature 15° to 30°C (59°-86°F) (See USP Controlled Room Temperature). Foil-backed blister packs containing fexofenadine hydrochloride tablets should be protected from excessive moisture. Rx only Manufactured by: Dr. Reddy's Laboratories Limited Bachepalli – 502 325 INDIA Distributed by: MAJOR PHARMACEUTICALS Livonia, MI 48150 Revised: 0509

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HYDROCHLORIDE TABLET, FILM
COATED
MAJOR PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FEXOFENADINE HYDROCHLORIDE SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR FEXOFENADINE HYDROCHLORIDE.
FEXOFENADINE HYDROCHLORIDE TABLETS.
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 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
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 REACTIONS, CONTACT DR. REDDY’S
LABORATORIES, INC. AT 1-888-375-3784 OR
FDA AT 1-800-FDA-1088 OR
DRUG INTERACTIONS
Antacids: Do not take at the same time as alumi