SUPRAX cefixime tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)

Доступно од:

LUPIN LIMITED

INN (Међународно име):

CEFIXIME

Састав:

CEFIXIME ANHYDROUS 400 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

SUPRAX- CEFIXIME TABLET
SUPRAX- CEFIXIME CAPSULE
SUPRAX- CEFIXIME TABLET, CHEWABLE
SUPRAX- CEFIXIME POWDER, FOR SUSPENSION
LUPIN LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUPRAX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SUPRAX.
SUPRAX (CEFIXIME) TABLETS USP, 400 MG
SUPRAX (CEFIXIME) CAPSULES, 400 MG
SUPRAX (CEFIXIME) CHEWABLE TABLETS, 100 MG, 150 MG AND 200 MG
SUPRAX (CEFIXIME) FOR ORAL SUSPENSION USP, 100 MG/5 ML
SUPRAX (CEFIXIME) FOR ORAL SUSPENSION USP, 200 MG/5 ML
SUPRAX (CEFIXIME) FOR ORAL SUSPENSION USP, 500 MG/5 ML
FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL:1986
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF SUPRAX AND OTHER
ANTIBACTERIAL DRUGS, SUPRAX SHOULD BE USED ONLY TO TREAT INFECTIONS
THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE
CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Suprax (cefixime) is a cephalosporin antibacterial drug indicated for
Uncomplicated Urinary Tract Infections (1.1)
Otitis Media (1.2)
Pharyngitis and Tonsillitis (1.3)
Acute Exacerbations of Chronic Bronchitis (1.4)
Uncomplicated Gonorrhea (cervical/urethral) (1.5)
DOSAGE AND ADMINISTRATION
Adults: 400 mg daily (2.1)
Children: 8 mg/kg/day (2.2)
DOSAGE FORMS AND STRENGTHS
Film-coated, scored Tablets: 400 mg (3)
Capsules: 400 mg (3)
Chewable Tablets: 100 mg, 150 mg and 200 mg (3)
Oral Suspension: 100 mg/5 mL, 200 mg/5 mL and 500 mg/5 mL (3)
CONTRAINDICATIONS
Contraindicated in patients with known allergy to cefixime or other
cephalosporins. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions including shock and fatalities have been
reported with cefixime. Discontinue use if a
reaction occurs. (5.1)
_Clostridium difficile _associated diarrhea: Evaluate if diarrhea
occurs. (5.2)
ADVERSE REACTIONS
Most common adverse reactions are gastrointestinal such as diarrhea
(16%), nausea (7%), loose stools (6%), abdominal
pain (3%), dyspepsia (3%), and vomiting. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS,