CEFUROXIME AXETIL tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Cefuroxime axetil (UNII: Z49QDT0J8Z) (Cefuroxime - UNII:O1R9FJ93ED)

Dostępny od:

Ascend Laboratories, LLC

INN (International Nazwa):

Cefuroxime axetil

Skład:

Cefuroxime 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes . Limitations of Use - The efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials. -  The efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials. Cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes . Cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute ba

Podsumowanie produktu:

Cefuroxime axetil tablets, USP 250 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with ''204 debossed on one side and plain on the other side as follows: 20 Tablets/Bottle                      NDC 67877-215-20 60 Tablets/Bottle                      NDC 67877-215-60 100 Tablets/Bottle                    NDC 67877-215-01 30 Tablets (3x10 Unit-dose Tablets)   NDC  67877-215-84 Cefuroxime Axetil Tablets, USP 500 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with 203'' debossed on one side and plain on the other side as follows: 20 Tablets/Bottle                      NDC 67877-216-20 60 Tablets/Bottle                      NDC 67877-216-60 100 Tablets/Bottle                    NDC 67877-216-01   30 Tablets (3x10 Unit-dose Tablets)   NDC  67877-216-84 Store at 20° to 25°C (68° to 77°F).  [See USP Controlled Room Temperature]. Replace cap securely after each opening. 

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CEFUROXIME AXETIL - CEFUROXIME AXETIL TABLET, FILM COATED
ASCEND LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFUROXIME AXETIL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEFUROXIME AXETIL
TABLETS.
CEFUROXIME AXETIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Cefuroxime axetil tablet is a cephalosporin antibacterial drug
indicated for the treatment of the following
infections due to susceptible bacteria: (1)
Pharyngitis/tonsillitis (adults and pediatric patients) (1.1)
Acute bacterial otitis media (pediatric patients) (1.2)
Acute bacterial maxillary sinusitis (adults and pediatric patients)
(1.3)
Acute bacterial exacerbations of chronic bronchitis (adults and
pediatric patients 13 years and older)
(1.4)
Uncomplicated skin and skin-structure infections (adults and pediatric
patients 13 years and older)
(1.5)
Uncomplicated urinary tract infections (adults and pediatric patients
13 years and older) (1.6)
Uncomplicated gonorrhea (adults and pediatric patients 13 years and
older) (1.7)
Early Lyme disease (adults and pediatric patients 13 years and older)
(1.8)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefuroxime axetil
and other antibacterial drugs, cefuroxime axetil should be used only
to treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DOSAGE AND ADMINISTRATION
Tablets and oral suspension are not bioequivalent and are therefore
not substitutable on a milligram-
per-milligram basis. (2.1)
Administer tablets with or without food. (2.2)
Administer cefuroxime axetil tablets as described in the dosage
guidelines. (2.2)
Dosage adjustment is required for patients with impaired renal
function. (2.5)
ADULT PATIENTS AND PEDIATRIC PATIENTS DOSAGE GUIDELINES FOR CEFUROXIME
AXETIL TABLETS
INFECTION
DOSAGE
DURATION
(DAYS)
ADULTS AND ADOLESCENTS (13 YEARS AND OLDER)
Pharyngitis/tonsillitis (mild to modera