国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Cefuroxime axetil (UNII: Z49QDT0J8Z) (Cefuroxime - UNII:O1R9FJ93ED)
Ranbaxy Pharmaceuticals Inc.
Cefuroxime axetil
TABLET
125 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. There are
Cefuroxime axetil tablets, USP, 125 mg, 250 mg and 500 mg containing cefuroxime (as cefuroxime axetil, USP amorphous), are blue colored, uncoated caplets (capsule-shaped tablets) debossed with “RX831, RX832 and RX833 ” on one side and plain on the other side, respectively. They are supplied as follows: The 125 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX831” NDC 63304-831-30 Bottles of 30 NDC 63304-831-04 Bottles of 250 NDC 63304-831-77 Blister unit-dose pack of 100 The 250 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX832” NDC 63304-832-20 Bottles of 20 NDC 63304-832-05 Bottles of 500 NDC 63304-832-77 Blister unit-dose pack of 100 The 500 mg Cefuroxime axetil tablet is a blue colored, uncoated caplet (capsule-shaped tablet) debossed with “RX833” NDC 63304-833-20 Bottles of 20 NDC 63304-833-60 Bottles of 60 NDC 63304-833-05 Bottles of 500 NDC 63304-833-77 Blister unit-dose pack of 100 Store at 20 - 25°C (68 - 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.
CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET RANBAXY PHARMACEUTICALS INC. ---------- RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs, cefuroxime axetil tablets 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, USP (amorphous). 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 (6_R_,7_R_)-7-[2-(2-furyl)glyoxyl-amido]-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 are blue colored, uncoated caplets (capsule-shaped tablets) and contain the equivalent of 125, 250, or 500 mg of cefuroxime as cefuroxime axetil (amorphous). Cefuroxime axetil tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 1 aluminum lake, microcrystalline cellulose, sodium lauryl sulfate, and stearic acid. 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 are shown in Table 1. 2 20 22 4 10 TABLE 1: POSTPRANDIALPHARMACOKINETICS OF CEFUROXIME ADMINISTERED AS CEFUROXIMEAXETIL TABLETS TO ADULTS D 完全なドキュメントを読む