CEFADROXIL- cefadroxil capsule
Sandoz Inc
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil and other antibacterial drugs, cefadroxil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Cefadroxil, USP 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 (6R ,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 formula C16 H17 N3 O5 S�H2 O and the molecular weight of 381.40. It has the following structural formula:
Cefadroxil Chemical Structure
(click image for full-size original)
Each capsule, for oral administration, contains cefadroxil monohydrate equivalent to 500 mg cefadroxil. In addition, each capsule contains the following inactive ingredients: magnesium stearate, FD&C Blue #1, FD&C Yellow #6, FD&C Red #40, titanium dioxide and gelatin.
CLINICAL PHARMACOLOGY
Cefadroxil is rapidly absorbed after oral administration. Following single doses of 500 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 inhibitions 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):
Beta-hemolytic streptococci
Staphylococci, including penicillinase-producing strains
Streptococcus (Diplococcus) pneumoniae
Escherichia coli
Proteus mirabilis
Klebsiella species
Moraxella (Branhamella) catarrhalis
Note: Most strains of Enterococcus faecalis (formerly Streptococcus faecalis) and Enterococcus faecium (formerly Streptococcus faecium) are resistant to cefadroxil. It is not active against most strains of Enterobacter species, Morganella morganii (formerly Proteus morganii), and P. vulgaris. It has no activity against Pseudomonas species and Acinetobacter calcoaceticus (formerly Mima and Herellea species).
Susceptibility tests
