Country: United States
Language: English
Source: NLM (National Library of Medicine)
CEFADROXIL (UNII: 280111G160) (CEFADROXIL ANHYDROUS - UNII:Q525PA8JJB)
Hikma Pharmaceuticals USA Inc.
CEFADROXIL
CEFADROXIL ANHYDROUS 500 mg
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 is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil 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 maintain the effectiveness of C
Cefadroxil Capsules USP, 500 mg are available as opaque chocolate brown and white hard gelatin capsules, imprinted with "WEST-WARD 947" in bottles of 20, 50 and 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP using a child-resistant closure. Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 - USA Manufactured by: Jazeera Pharmaceutical Industries (JPI) Al- Kharj Road P. O. Box 106229 Riyadh 11666 Saudi Arabia An Affiliate of: Hikma Pharmaceuticals LLC P.O. Box 182400 Amman 11118 Jordan Revised February 2020
Abbreviated New Drug Application
CEFADROXIL- CEFADROXIL CAPSULE HIKMA PHARMACEUTICALS USA INC. ---------- CEFADROXIL CAPSULES- MFD BY JAZEERA CEFADROXIL CAPSULES, USP Rev. 02/2020 Rx Only To reduce the development of drug resistant bacteria and maintain the effectiveness of cefadroxil capsule and other antibacterial drugs, cefadroxil capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefadroxil is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is chemically designated as (6 R,7R)- 7-[(R)-2-amino-2-(p- hydroxyphenyl) acetamido]-3-methyl-8-oxo-5-thia- 1-azabicyclo[4.2.0]oct-2-ene-2- carboxylic acid monohydrate. It has the following structural formula: C H N O S•H O M.W. 381.40 Cefadroxil Capsules, USP contain the following inactive ingredients: black iron oxide,colloidal silicon dioxide, croscarmellose sodium, gelatin,lactose monohydrate, magnesium stearate, red iron oxide, and titanium dioxide. CLINICAL PHARMACOLOGY Cefadroxil 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 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 bactericidal because of their inhibition of cell-wall synthesis. Cefadroxil has been shown to be active against the following organisms both _in vitro _and in clinical infections (see INDICATIONS AND USAGE): 16 17 3 5 2 Beta-hemolyt Read the complete document