Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
CEFADROXIL (UNII: 280111G160) (CEFADROXIL ANHYDROUS - UNII:Q525PA8JJB)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Cefadroxil Capsules USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not available. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintai
Product: 63629-1358 NDC: 63629-1358-1 10 CAPSULE in a BOTTLE NDC: 63629-1358-2 20 CAPSULE in a BOTTLE NDC: 63629-1358-3 28 CAPSULE in a BOTTLE NDC: 63629-1358-4 30 CAPSULE in a BOTTLE NDC: 63629-1358-5 60 CAPSULE in a BOTTLE NDC: 63629-1358-6 4 CAPSULE in a BOTTLE NDC: 63629-1358-7 14 CAPSULE in a BOTTLE NDC: 63629-1358-8 40 CAPSULE in a BOTTLE NDC: 63629-1358-9 5 CAPSULE in a BOTTLE
Abbreviated New Drug Application
CEFADROXIL- CEFADROXIL CAPSULE BRYANT RANCH PREPACK ---------- CEFADROXIL CAPSULES USP 500 MG Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil capsules and other antibacterial drugs, cefadroxil capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefadroxil monohydrate is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4- hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate, [6R-[6α,7β(R*)]]-. It has the formula C H N O S•H O and the molecular weight of 381.40. It has the following structural formula: Each capsule contains cefadroxil monohydrate USP equivalent to 500 mg of cefadroxil. In addition, each capsule also contains the following inactive ingredients: crospovidone, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide. CLINICAL PHARMACOLOGY Cefadroxil monohydrate is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 mcg/mL, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 mcg/mL during the period following a single 500-mg oral dose. Increases in dosage generally produce a proportionate increase in cefadroxil monohydrate urinary concentration. The urine antibiotic concentration, following a 1-g dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours. MICROBIOLOGY _In vitro _tests demonstrate that the cephalosporins are bact Leggi il documento completo