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Cefaclor Extended-Release (Cefaclor Extended-Release) - Summary

 
 



To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

 

SUMMARY

Cefaclor, USP, the active ingredient in cefaclor extended-release tablets USP, is a semisynthetic cephalosporin antibiotic for oral administration.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP 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.

The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.)

Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (non--lactamase-producing strains only), Moraxella catarrhalis (including -lactamase-producing strains) or Streptococcus pneumoniae.

NOTE: In view of the insufficient numbers of isolates of -lactamase producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by -lactamase producing H. influenzae.

Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (non--lactamase-producing strains only), Moraxella catarrhalis (including -lactamase-producing strains), or Streptococcus pneumoniae. (See above NOTE.)

Pharyngitis and tonsillitis due to Streptococcus pyogenes.

NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available.

Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible).

NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.


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NEWS HIGHLIGHTS

Published Studies Related to Cefaclor Extended-Release (Cefaclor)

Effects of cefaclor on gastric emptying and cholecystokinin release in healthy humans. [2010.01.08]
BACKGROUND AND AIMS: In rodents, cephalosporin antibiotics can mimic peptones and stimulate release of cholecystokinin (CCK), a hormone that slows gastric emptying. The rate of gastric emptying is a major determinant of postprandial blood glucose and insulin concentrations. We therefore evaluated the effect of orally administered cefaclor on plasma CCK and gastric emptying, as well as postprandial glycemic and insulinemic responses, in healthy humans... CONCLUSION: Cefaclor, when given before a meal in the form of a capsule, does not stimulate CCK release or slow gastric emptying in healthy humans.

[Comparative study on cefdinir and cefaclor in the treatment of patients with mild to moderate bacterial community acquired pneumonia.] [2004.11.17]
OBJECTIVE: To evaluate the efficacy and safety of cefdinir in the treatment of patients with mild to moderate bacterial community acquired pneumonia (CAP)... CONCLUSION: cefdinir is safe and effective, shorten the course of treatment in the treatment of mild to moderate bacterial community acquired pneumonia.

Clarithromycin suspension: bioequivalence studies on two different strengths. [2004.09]
Two studies were performed in different groups of volunteers, with the aim to prove the bioequivalence of test (Klaromin) and reference clarithromycin (CAS 81103-11-9) suspensions containing in 5 mL either 125 mg (study 1) or 250 mg (study 2) of the drug, administered as an oral dose of 10 mL...

Comparative effect of different types of food on the bioavailability of cefaclor extended release tablet. [2004.04]
This randomized, six-treatment, six-period, six sequence, single dose, crossover pharmacokinetic study assessed the effect of different types of food on the bioavailability of 500-mg cefaclor extended release tablet in 23 healthy male volunteers. A single dose of cefaclor extended release 500-mg tablet was administered at six occasions: after overnight fasting, after two vegetarian (high-fat and low-fat), two non-vegetarian (high-fat and low-fat) and rice diets...

Cefaclor AF vs Clarithromycin in acute exacerbation of chronic bronchitis (B3M-PK-AJBG). [2003.08]
OBJECTIVE: To compare the efficacy and safety of Cefaclor AF vs Clarithromycin in the treatment of acute exacerbation of chronic bronchitis in adult subjects... CONCLUSIONS: The above results show that both Cefaclor AF and Clarithromycin are equally effective and safe in the treatment of acute exacerbation of chronic bronchitis in adult patients.

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Clinical Trials Related to Cefaclor Extended-Release (Cefaclor)

A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria [Completed]
The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use [Recruiting]
This study is designed to look at healthcare utilization following the removal of tonsils and adenoids in pediatric patients who are not given an antibiotic following surgery.

Patients Response to Early Switch To Oral:Osteomyelitis Study [Not yet recruiting]
Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.

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Page last updated: 2010-10-05

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