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:

Preferred 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 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 bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only). Limitations of Use The effectiveness of cefuroxime axetil for sinus infections caused by β-lactamase–producing Haemoph

Product summary:

Cefuroxime axetil tablets USP, 250 mg of cefuroxime (as cefuroxime axetil), are white to off-white, capsule-shaped, film-coated tablets with "LUPIN" debossed on one side and "302" on the other side, supplied in bottles of 20 and 60. Bottle of 20 - 68788-9700-2 Bottle of 30 - 68788-9700-3 Bottle of 60 - 68788-9700-6 Cefuroxime axetil tablets USP, 500 mg of cefuroxime (as cefuroxime axetil), are white to off-white, capsule-shaped, film-coated tablets with "LUPIN" debossed on one side and "303" on the other side, supplied in bottles of 20 and 60. Bottle of 20 - 68788-9701-2 Bottle of 30 - 68788-9701-3 Bottle of 60 - 68788-9701-6 Store the tablets at 20 to 25°C (68 to 77°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
PREFERRED 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 11/2016
of Chronic Bronchitis and Secondary Bacterial Infections
of Acute Bronchitis: Secondary Bacterial Infections of
Acute Bronchitis (1.4)-Removed
Dosage and Administration, Dosage for CEFTIN Tablets: 11/2016
Secondary Bacterial Infections of Acute Bronchitis
(2.2)-Re move d
INDICATIONS AND USAGE
Cefuroxime axetil tablets are a cephalosporin antibacterial drug
indicated for the treatment of the following infections due
to susceptible bacteria: (1)
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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
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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 moderate)
250 mg every 12 hours
10
Acute bacterial maxillary sinusitis (mild to moderate)
250 mg every 12 hours
10
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
250 or 500 mg every 12 hours
10
Uncomplicated skin and skin-structure infections
250 or 500 mg every 12 hours
10
Uncomplicated urinary tract infections
250 mg every 12 hours
7 to 10
Uncomplicated gonorrhea
1,000 mg
single dose
Early Lyme disease
500 mg every 12 hours
20
Pediatric Patients younger than 13 years (who can swallow tablets
whole)
Acute bacterial otitis media
250 mg every 12 hours
Acute bac