CEFUROXIME AXETIL- cefuroxime axetil tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticali Inc.

INN (International Name):

CEFUROXIME AXETIL

Composition:

CEFUROXIME 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefuroxime axetil tablets USP 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 USP 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 USP 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 tablets USP for sinus infections caused by β-la

Product summary:

Cefuroxime Axetil Tablets USP, 500 mg of cefuroxime (as cefuroxime axetil), are  white to off-white, film-coated, capsule shaped tablets with ‘A34’ debossed on one side and plain on the other side. Bottle of 20 - 68788-9914-2 Bottle of 30 - 68788-9914-3 Bottle of 60 - 68788-9914-6 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, FILM COATED
PREFERRED PHARMACEUTICALI 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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Cefuroxime axetil tablets USP is 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 USP and
other antibacterial drugs, cefuroxime axetil tablets USP 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 mg or 500 mg every 12 hours
10
Secondary bacterial infections of acute
bronchitis
250 mg or 500 mg every 12 hours
5 to 10
Uncomplicated skin and skin-structure
infe ctions
250 mg 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
10
Acute bacterial maxillary sinusitis
250 mg every 12 hours
10
DOSAGE FORMS AND STRENGTHS
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Pharyngitis/tonsillitis (adults and pediatric patients) (1.1)
Acute bacterial otitis media (pediatric patients) (1.2)
Acute bacterial maxillary