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:

LUPIN LIMITED

INN (International Name):

CEFUROXIME AXETIL

Composition:

CEFUROXIME 250 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 - 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 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 m

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. 20s Bottle NDC 68180-302-20 60s Bottle NDC 68180-302-60 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. 20s Bottle NDC 68180-303-20 60s Bottle NDC 68180-303-60 Store the tablets at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET
LUPIN LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFUROXIME AXETIL TABLETS USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFUROXIME
AXETIL TABLETS USP.
CEFUROXIME AXETIL TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Cefuroxime axetil tablets USP 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 and secondary
bacterial infections of acute 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 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
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 USP 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 USP
INFECTION
DOSAGE
DURATION (DAYS)
ADUL