Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
DIRECT RX
ORAL
PRESCRIPTION DRUG
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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. NOTE: CEFUROXIME AXETIL TABLETS USP 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 USP: Cefuroxime axetil tablets USP 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: - Pharyngitis/Tonsillitis cause
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. 20 Tablets/Bottle NDC 65862-698-20 60 Tablets/Bottle NDC 65862-698-60 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. 20 Tablets/Bottle NDC 65862-699-20 60 Tablets/Bottle NDC 65862-699-60 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. 20 Tablets/Bottle NDC 65862-700-20 60 Tablets/Bottle NDC 65862-700-60 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.
Abbreviated New Drug Application
CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET DIRECT RX ---------- CEFUROXIME AXETIL DESCRIPTION SECTION 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)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene- 2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, 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 USP are film-coated and contain the equivalent of 125 mg, 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Cefuroxime axetil tablets USP contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. CLINICAL PHARMACOLOGY SECTION 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. TABLE 1. POSTPRANDIAL PHARMACOKINETICS OF CEFUROXIME ADMINISTERED AS CEFUROXIME AXETIL TABLETS TO ADULTSA aMean values of 12 healthy adult volunteers. b Drug administered immediately after a meal. Doseb (Cefuroxime Equivalent) Peak Plasma Concentration (mcg/mL) Time of Peak Plasma Concentration (hr) Mean Elimination Half-Life (hr) AUC (mcg-hr mL) 125 mg 2.1 2.2 1.2 6.7 250 mg 4.1 2.5 1.2 12.9 500 mg 7 3 1 Прочетете целия документ