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Lorabid (Loracarbef) - Summary

 
 



LORABID SUMMARY

LORABID

Lorabid® (loracarbef, USP) is a syntheticβ-lactam antibiotic of the carbacephem class for oral administration.

Lorabid is indicated in the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific recommendations.)

Lower Respiratory Tract

Secondary Bacterial Infection of Acute Bronchitis caused by S. pneumoniae, H. influenzae (includingβ-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).

Acute Bacterial Exacerbations of Chronic Bronchitis caused by S. pneumoniae, H. influenzae (includingβ-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).

Pneumonia caused by S. pneumoniae or H. influenzae (non-β-lactamase-producing strains only). Data are insufficient at this time to establish efficacy in patients with pneumonia caused by β-lactamase-producing strains of H. influenzae.

Upper Respiratory Tract

Otitis Media † caused by S. pneumonia, H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes.

Acute Maxillary Sinusitis † caused by S. pneumoniae, H. influenzae (non-β-lactamase-producing strains only), or M. catarrhalis (includingβ-lactamase-producing strains). Data are insufficient at this time to establish efficacy in patients with acute maxillary sinusitis caused by β-lactamase-producing strains of H. influenzae.

† NOTE: In a patient population with significant numbers of β-lactamase-producing organisms, loracarbef's clinical cure and bacteriological eradication rates were somewhat less than those observed with a product containing a β-lactamase inhibtor. Lorabid's decreased potential for toxicity compared to products containing β-lactamase inhibitors along with the susceptibility patterns of the common microbes in a given geographic area should be taken into account when considering the use of an antimicrobial (see CLINICAL STUDIES section). For information on use in pediatric patients, see PRECAUTIONS—Pediatric Use.

Pharyngitis and Tonsillitis caused by S. pyogenes. (The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin administered by the intramuscular route. Lorabid is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Lorabid in the subsequent prevention of rheumatic fever are not available at present.)

Skin and Skin Structure

Uncomplicated Skin and Skin Structure Infections caused by S. aureus (including penicillinase-producing strains) or S. pyogenes. Abscesses should be surgically drained as clinically indicated.

Urinary Tract

Uncomplicated Urinary Tract Infections (cystitis) caused by E.coli or S. saprophyticus*.

NOTE: In considering the use of Lorabid in the treatment of cystitis, Lorabid's lower bacterial eradication rates and lower potential for toxicity should be weighed against the increased eradication rates and increased potential for toxicity demonstrated by some other classes of approved agents (see CLINICAL STUDIES section).

Uncomplicated Pyelonephritis caused by E. coli.

*Although treatment of infections due to this organism in this organ system demonstrated a clinically acceptable overall outcome, efficacy was studied in fewer than 10 infections.

Culture and susceptibility testing should be performed when appropriate to determine the causative organism and its susceptibility to loracarbef. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.


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NEWS HIGHLIGHTS

Published Studies Related to Lorabid (Loracarbef)

Improvement of otitis media with effusion after treatment of asthma with leukotriene antagonists in children with co-existing disease. [2005]
Otitis media with effusion (OME) is a common pediatric disease and there is great controversy concerning its management... Given that no medication has been shown to be effective in OME therapy, further investigation of the possible effects of leukotriene inhibitors is warranted.

Penicillin V, loracarbef and clindamycin in tonsillar surface fluid during acute group A streptococcal pharyngotonsillitis. [2005]
Patients with acute group A- strepotococcal pharyngotonsillitis were randomly assigned to treatment for 10 d with either phenoxymethylpenicillin (PcV), loracarbef or clindamycin. The concentrations of the drugs, respectively, were determined in tonsillar surface fluid (TSF), serum and the saliva in each patient on altogether 5 occasions; before, during and 4 d after end of therapy.

A comparison of a five-day regimen of cefdinir with a seven-day regimen of loracarbef for the treatment of acute exacerbations of chronic bronchitis. [2000.06]
To compare the efficacy and safety of five-day cefdinir treatment with seven-day loracarbef treatment in patients with acute exacerbations of chronic bronchitis, 586 patients were enrolled in a multicentre, randomised, double-blind trial. Patients received either five days of treatment with cefdinir (n = 291) at 300 mg twice daily or seven days of treatment with loracarbef (n = 295) at 400 mg twice daily...

Loracarbef versus clarithromycin in children with acute otitis media with effusion. [1999.04]
Two multicenter, randomized, single-masked, parallel-group studies compared loracarbef and clarithromycin with regard to efficacy, tolerability, and patient acceptance. Three hundred thirty-four children aged 6 months to 3 years with acute otitis media with effusion received loracarbef (15 mg/kg) or clarithromycin (7.5 mg/kg) orally twice daily for 10 days...

Loracarbef versus phenoxymethylpenicillin in the treatment of recurrent streptococcal pharyngotonsillitis. [1997]
Knowledge of the treatment of recurrent group A streptococcal pharyngotonsillitis has, so far, been based on studies of non-recurrent rather than recurrent episodes of the disease. This multicentre, double-blind, randomized trial was designed to compare the efficacy of loracarbef (200 mg twice daily) vs phenoxymethylpenicillin (penicillin V) (800/1000 mg twice daily) each for 10 days in the treatment of recurrent group A streptococcal pharyngotonsillitis...

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Clinical Trials Related to Lorabid (Loracarbef)

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: 2007-05-03

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