CEFUROXIME AXETIL- cefuroxime axetil tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

CEFUROXIME AXETIL

Composition:

CEFUROXIME 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablets in the prevention of rheumatic fever was not established in clinical trials. - The efficacy of cefuroxime axetil tablets 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-mode

Product summary:

Cefuroxime Axetil Tablets USP, 250 mg of cefuroxime (as cefuroxime axetil), are white to off-white, film-coated, capsule shaped tablets with ‘A33’ debossed on one side and plain on the other side. NDC 68071-3000-2 Botles of 20 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET
NUCARE PHARMACEUTICALS,INC.
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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
RECENT MAJOR CHANGES
Indications and Usage, Acute Bacterial Exacerbations of 11/2016
Chronic Bronchitis and Secondary Bacterial Infections of
Acute Bronchitis: Secondary Bacterial Infections of Acute
Bronchitis ( 1.4)-Removed
Dosage and Administration, Dosage for Cefuroxime Axetil 11/2016
T able ts:
Secondary Bacterial Infections of Acute Bronchitis ( 2.2)-
Removed
INDICATIONS AND USAGE
Cefuroxime axetil tablets are 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 tablets and other
antibacterial drugs, cefuroxime axetil tablets 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