Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
STAT Rx USA LLC
CEFUROXIME AXETIL
CEFUROXIME 500 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
CEFUROXIME AXETIL - CEFUROXIME AXETIL TABLET, FILM COATED STAT RX USA LLC ---------- 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 Læs hele dokumentet