CEFUROXIME AXETIL tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Lake Erie Medical DBA Quality Care Products LLC

INN (Mezinárodní Name):

CEFUROXIME AXETIL

Složení:

CEFUROXIME 500 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Cefuroxime Axetil Tablets USP, 125 mg of cefuroxime (as cefuroxime axetil), are  white to off-white, film-coated, capsule shaped tablets with ‘A32’ debossed on one side and plain on the other side. 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. 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. 55700-436-20 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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 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)
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 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
DUR