CEFADROXIL SUMMARY
CEFADROXIL TABLETS, USP AND CEFADROXIL CAPSULES, USP
Rx only
Cefadroxil , USP (hemihydrate) is a semisynthetic cephalosporin antibiotic intended for oral administration. It is white to off-white crystalline powder. It is slightly soluble in water and it is acid-stable.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxil Tablets and Cefadroxil Capsules and other antibacterial drugs, Cefadroxil Tablets and 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.
Cefadroxil is 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.
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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
Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding [Completed]
The objective of the study was to test the hypothesis that acupuncture treatment hastens
recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers with
210 cases of breast inflammation (commonly called "mastitis") during breastfeeding were
randomly assigned to one of three treatment groups. There were two groups where acupuncture
was used and one without acupuncture. The mothers symptoms were recorded at the onset of
health care contact and daily until recovery. All care interventions given, including
antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk
sample to test for bacterial growth. It was found that acupuncture did not shorten the
women's contacts with health care services but did improve their symptoms on contact days 3
and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which
was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New
Zealand where up to 100% are given antibiotics. Seven women (3. 3% of those in the study)
developed a breast boil and this is a similar number to a study in Australia where many more
were treated by antibiotics. This could mean that many women throughout the world are given
antibiotics when in fact they may recover without them. This is an important finding in
relation to the fight against antibiotic resistant bacteria.
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Page last updated: 2008-06-22
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