Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
Ranbaxy Pharmaceuticals Inc
CEFUROXIME AXETIL
CEFUROXIME 125 mg in 5 mL
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 for oral suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of cefuroxime axetil for oral suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well-controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen. - 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 for oral suspensio
Cefuroxime Axetil For Oral Suspension USP: When reconstituted as directed, cefuroxime axetil for oral suspension USP provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. It is supplied as follows: The 125 mg/5 mL: is a white to cream colored granular powder forming white to cream colored suspension on constitution with water. The resulting suspension has a fruity flavor. NDC 63304-963-03 50 mL bottles NDC 63304-963-04 100 mL bottles The 250 mg/5 mL: is a white to cream colored granular powder forming white to cream colored suspension on constitution with water. The resulting suspension has a fruity flavor. NDC 63304-964-03 50 mL bottles NDC 63304-964-04 100 mL bottles Before reconstitution, store dry powder between 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature) After reconstitution, immediately store suspension between 2 - 8 ° C (36 - 46 ° F), in a refrigerator. DISCARD AFTER 10 DAYS.
Abbreviated New Drug Application
CEFUROXIME AXETIL FOR ORAL SUSPENSION- CEFUROXIME AXETIL SUSPENSION RANBAXY PHARMACEUTICALS INC ---------- CEFUROXIME AXETIL FOR ORAL SUSPENSION,USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil for oral suspension and other antibacterial drugs, cefuroxime axetil for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefuroxime axetil for oral suspension, USP contains cefuroxime as cefuroxime axetil. Cefuroxime axetil USP 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)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 crystalline form and has the following structural formula: Cefuroxime axetil for oral suspension USP, when reconstituted with water, provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. Cefuroxime axetil USP for oral suspension contains the following inactive ingredients: aspartame, hypromellose phthalate, mannitol, methacrylic acid copolymer, monosodium citrate, peppermint flavor, silicon dioxide, sodium benzoate, sodium chloride, sucrose, tutti frutti flavor, xanthan gum. 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 pharmacoki Läs hela dokumentet