CEFADROXIL SUMMARY
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.
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 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 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.
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NEWS HIGHLIGHTS
Published Studies Related to Cefadroxil
Bioequivalence study of two oral formulations of cefadroxil in healthy volunteers. [2008] Two different cefadroxil (CAS 50370-12-2) formulations were evaluated for their relative bioavailability in 24 healthy volunteers who received a single 500 mg oral dose of each preparation. An open, randomized clinical trial designed as a two-period crossover study with a 7-day washout period between doses was employed.
Comparative bioavailability of two cefadroxil products using serum and urine data in healthy human volunteers. [2004.07] 1. The aim of the present study was to assess the bioequivalence of two cefadroxil products, namely Ultracef (a reference product) in the form of a 500 mg capsule (produced by Bristol-Myers Squibb Laboratories, Princeton, NJ, USA) and Roxil (a test product) in the form of a 500 mg capsule (produced by Tabuk Pharmaceutical Manufacturing, Tabuk, Saudi Arabia)...
Comparison of azithromycin and cefadroxil for the treatment of uncomplicated skin and skin structure infections. [2003.09] In this multicenter, investigator-blind trial, we compared the efficacy and safety of azithromycin and cefadroxil for the treatment of uncomplicated skin and skin structure infections (SSSIs). A total of 296 patients were randomized to receive either azithromycin (500 mg on day 1, followed by 250 mg once a day on days 2 to 5) or cefadroxil (500 mg twice a day for 10 days)...
Linezolid versus cefadroxil in the treatment of skin and skin structure infections in children. [2003.04] BACKGROUND: Skin and skin structure infections are common reasons for visits to pediatricians, accounting for up to 18%. Staphylococcus aureus and Streptococcus pyogenes are the most frequently isolated Gram-positive pathogens in uncomplicated skin infections. Increasingly outpatient infections involve antibiotic-resistant Gram-positive pathogens including methicillin-resistant S. aureus... CONCLUSIONS: Linezolid is well-tolerated and as effective as cefadroxil in treating uncomplicated skin infections in pediatric patients. Linezolid effectively treated infections caused by S. aureus, methicillin-resistant S. aureus and S. pyogenes.
Randomized, double-blind, multicenter comparison of oral cefditoren 200 or 400 mg BID with either cefuroxime 250 mg BID or cefadroxil 500 mg BID for the treatment of uncomplicated skin and skin-structure infections. [2002.07] BACKGROUND: Uncomplicated skin and skin-structure infections are commonly observed in medical practice. Because these infections typically are confined to the superficial layers and seldom lead to the destruction of skin structures and resultant systemic dissemination, in general they can be treated with an oral antibiotic with potent microbiologic activity against gram-positive pathogens. OBJECTIVE: This paper compares the efficacy and tolerability of 3 beta-lactam antibiotics in patients with uncomplicated skin and skin-structure infections... CONCLUSION: In this population of patients with uncomplicated skin and skin-structure infections, including those due to Staphylococcus aureus or Streptococcus pyogenes, the clinical cure rate and tolerability of cefditoren were comparable to those of cefuroxime and cefadroxil.
Clinical Trials Related to Cefadroxil
To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers [Completed]
A Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma) [Completed]
Comparative randomized, single dose, two-way crossover open-label study to determine the
bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham
Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets
(Kahira Pharm &Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration
of each to healthy adults under fasting conditions.
Cefadroxil 500 mg Capsules Under Fasting Conditions [Completed]
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg
capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules
(manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal
healthy non-smoking male and female subjects under fasting conditions.
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects. [Completed]
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg
capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules
(manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal
healthy non-smoking male and female subjects under fed conditions.
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction [Completed]
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction
(TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are
also used routinely in immediate breast reconstruction to prevent fluid accumulation and
seroma formation at the surgical sites. Antibiotics are most often prescribed as a
precaution since drains can be a source for infection by creating open channels to outside
contaminants. Plastic surgery patients without closed suction drainage devices are usually
not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic
prophylaxis is recommended for up to 24 hours only. These recommendations do not take into
account the increased risk of indwelling closed suction drains. A recent survey of plastic
surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are
divided as to extended outpatient administration following TE breast reconstruction.
The study plans to prospectively enroll patients who will undergo immediate breast
reconstruction with TE or AF based breast reconstruction. Using the above data and the
current protocol, the investigators will investigate the optimal antibiotic discontinuation
period for these patients. The investigators hypothesize that the use of 24-hour
perioperative antibiotics in TE or AF based immediate breast reconstruction with closed
suction drainage, does not result in an increased infection rate compared to prolonged
postoperative antibiotic administration.
Reports of Suspected Cefadroxil Side Effects
Toxic Epidermal Necrolysis (8),
Trismus (5),
Paraesthesia (5),
Urticaria (2),
Strabismus (2),
Bronchospasm (2),
Dyspnoea (2),
Chest Discomfort (2),
Angioedema (2),
Drug Hypersensitivity (2), more >>
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Page last updated: 2008-06-22
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