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:

STAT Rx USA LLC

INN (International Name):

CEFUROXIME AXETIL

Composition:

CEFUROXIME 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY). Cefuroxime Axetil Tablets: Cefuroxime Axetil Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1.   Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.      NOTE : The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefuroxime Axetil Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. Th

Product summary:

Cefuroxime Axetil Tablets - 500 mg are white film coated capsule-shaped, biconvex unscored, embossed with W922 on one side and the other side plain. They are available in bottles of 20 - NDC # 16590-215-20 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501 Store at 20° - 25°C (68° - 77°F). Replace cap securely after each opening.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFUROXIME AXETIL - CEFUROXIME AXETIL TABLET, FILM COATED
STAT RX USA LLC
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PRODUCT INFORMATION
CEFUROXIME AXETIL TABLETS, USP
Rx Only
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.
DESCRIPTION
Cefuroxime Axetil Tablets, USP contain cefuroxime as cefuroxime
axetil. Cefuroxime Axetil is a
semisynthetic, broad-spectrum cephalosporin antibiotic for oral
administration.
Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of
cefuroxime, is (_RS_)-1-hydroxyethyl
(_6R,7R_)-7-[2-(2-furyl)
glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo
[4.2.0]oct-2-ene-2-
carboxylate,7 -(_Z_)-(_O_-methyl-oxime),1-acetate 3-carbamate. Its
molecular formula is C
H N O S,
and it has a molecular weight of 510.48.
Cefuroxime axetil is in the amorphous form and has the following
structural formula:
Cefuroxime Axetil Tablets are film-coated and contain the equivalent
of 125, 250, or 500 mg of
cefuroxime as cefuroxime axetil. Cefuroxime Axetil Tablets contain the
inactive ingredients colloidal
silicon dioxide, prosolv SMCC 50, sodium lauryl sulfate,
croscarmellose sodium, hydrogenated castor
oil, hypromellose, propylene glycol, titanium dioxide, dewaxed shellac
powder, dibutyl sebacate and
polysorbate 80.
CLINICAL PHARMACOLOGY
ABSORPTION AND METABOLISM
After oral administration, cefuroxime axetil is absorbed from the
gastrointestinal tract and rapidly
hydrolyzed by nonspecific esterases in the intestinal mucosa and blood
to cefuroxime. Cefuroxime is
subsequently distributed throughout the extracellular fluids. The
axetil moiety is metabolized to
acetaldehyde and acetic acid.
PHARMACOKINETICS
Approximately 50% of serum cefuroxime is bound to protein. Serum
pharmacokinetic parameters for
Cefuroxime Axetil Tablets is shown in Table 1.
2
20
22
4
10
TABLE 1. POSTPRANDIAL PHARMACO