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Clarithromycin extended-release tablet: a review of its use in the management of respiratory tract infections.
Am J Respir Med. 2003; 2(2):175-201.AJ

Abstract

Clarithromycin is an orally active, advanced-generation macrolide that has been reformulated as an extended-release tablet (Biaxin) XL Filmtab allowing convenient once-daily administration. The reformulation is intended to improve patient compliance and the tolerability of the drug. Although maximum plasma clarithromycin concentrations are lower and reached later with the extended-release tablets than with the immediate-release tablets, the two formulations are bioequivalent with respect to the area under the plasma concentration-time curve. Bioequivalence is also achieved between the formulations for the microbiologically active metabolite, 14-hydroxy-clarithromycin. Two randomized trials in patients with acute exacerbations of chronic bronchitis (AECB) showed that a 7-day course of clarithromycin extended-release 1000 mg once daily produced clinical cure rates of 83% and 85% and bacteriologic cure rates of 86% and 92% at the test-of-cure study visit. Similar rates of cure were achieved with a 7-day course of twice-daily clarithromycin immediate-release and with a 10-day course of twice-daily amoxicillin/clavulanic acid.A 7-day course of clarithromycin extended-release 1000 mg once daily produced clinical and bacteriologic cure rates of 88% and 86%, respectively, in patients with community-acquired pneumonia (CAP). Similar cure rates were achieved in recipients of once-daily levofloxacin in the same trial. In patients with acute maxillary sinusitis, a 14-day course of either once-daily clarithromycin extended-release or twice-daily clarithromycin immediate-release produced statistically equivalent clinical cure rates of 85% and 79%, respectively. Both treatment groups achieved similar rates of radiographic success and resolution of sinusitis. Recent results indicate that clarithromycin extended-release 500 mg once daily for 5 days is also effective in the treatment of patients with streptococcal pharyngitis/tonsillitis and in the treatment of AECB. The most frequently reported drug-related events with clarithromycin extended-release were abnormal taste (7% incidence), diarrhea (6%) and nausea (3%). Most adverse drug reactions were of a mild and transient nature. In comparative clinical trials, clarithromycin extended-release had an improved gastrointestinal tolerability profile compared with the immediate-release formulation. In addition, clarithromycin extended-release was better tolerated than amoxicillin/clavulanic acid and as well tolerated as levofloxacin. Further studies are required to assess the cost-effectiveness ratio of clarithromycin relative to comparator antibacterial agents.

CONCLUSION

Clarithromycin extended-release is an effective treatment for AECB, CAP, acute maxillary sinusitis, and pharyngitis (although not approved for the latter in the US), and is administered in a convenient dosage regimen that has the potential to encourage good compliance. The reformulation modulates clarithromycin absorption kinetics thereby improving tolerability. Therefore, clarithromycin extended-release provides a useful option for the treatment of specific respiratory tract infections.

Authors+Show Affiliations

Adis International Inc, Langhorne, Pennsylvania, USA.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Review

Language

eng

PubMed ID

14720016

Citation

Darkes, Malcolm J M., and Caroline M. Perry. "Clarithromycin Extended-release Tablet: a Review of Its Use in the Management of Respiratory Tract Infections." American Journal of Respiratory Medicine : Drugs, Devices, and Other Interventions, vol. 2, no. 2, 2003, pp. 175-201.
Darkes MJ, Perry CM. Clarithromycin extended-release tablet: a review of its use in the management of respiratory tract infections. Am J Respir Med. 2003;2(2):175-201.
Darkes, M. J., & Perry, C. M. (2003). Clarithromycin extended-release tablet: a review of its use in the management of respiratory tract infections. American Journal of Respiratory Medicine : Drugs, Devices, and Other Interventions, 2(2), 175-201.
Darkes MJ, Perry CM. Clarithromycin Extended-release Tablet: a Review of Its Use in the Management of Respiratory Tract Infections. Am J Respir Med. 2003;2(2):175-201. PubMed PMID: 14720016.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clarithromycin extended-release tablet: a review of its use in the management of respiratory tract infections. AU - Darkes,Malcolm J M, AU - Perry,Caroline M, PY - 2004/1/15/pubmed PY - 2004/1/31/medline PY - 2004/1/15/entrez SP - 175 EP - 201 JF - American journal of respiratory medicine : drugs, devices, and other interventions JO - Am J Respir Med VL - 2 IS - 2 N2 - UNLABELLED: Clarithromycin is an orally active, advanced-generation macrolide that has been reformulated as an extended-release tablet (Biaxin) XL Filmtab allowing convenient once-daily administration. The reformulation is intended to improve patient compliance and the tolerability of the drug. Although maximum plasma clarithromycin concentrations are lower and reached later with the extended-release tablets than with the immediate-release tablets, the two formulations are bioequivalent with respect to the area under the plasma concentration-time curve. Bioequivalence is also achieved between the formulations for the microbiologically active metabolite, 14-hydroxy-clarithromycin. Two randomized trials in patients with acute exacerbations of chronic bronchitis (AECB) showed that a 7-day course of clarithromycin extended-release 1000 mg once daily produced clinical cure rates of 83% and 85% and bacteriologic cure rates of 86% and 92% at the test-of-cure study visit. Similar rates of cure were achieved with a 7-day course of twice-daily clarithromycin immediate-release and with a 10-day course of twice-daily amoxicillin/clavulanic acid.A 7-day course of clarithromycin extended-release 1000 mg once daily produced clinical and bacteriologic cure rates of 88% and 86%, respectively, in patients with community-acquired pneumonia (CAP). Similar cure rates were achieved in recipients of once-daily levofloxacin in the same trial. In patients with acute maxillary sinusitis, a 14-day course of either once-daily clarithromycin extended-release or twice-daily clarithromycin immediate-release produced statistically equivalent clinical cure rates of 85% and 79%, respectively. Both treatment groups achieved similar rates of radiographic success and resolution of sinusitis. Recent results indicate that clarithromycin extended-release 500 mg once daily for 5 days is also effective in the treatment of patients with streptococcal pharyngitis/tonsillitis and in the treatment of AECB. The most frequently reported drug-related events with clarithromycin extended-release were abnormal taste (7% incidence), diarrhea (6%) and nausea (3%). Most adverse drug reactions were of a mild and transient nature. In comparative clinical trials, clarithromycin extended-release had an improved gastrointestinal tolerability profile compared with the immediate-release formulation. In addition, clarithromycin extended-release was better tolerated than amoxicillin/clavulanic acid and as well tolerated as levofloxacin. Further studies are required to assess the cost-effectiveness ratio of clarithromycin relative to comparator antibacterial agents. CONCLUSION: Clarithromycin extended-release is an effective treatment for AECB, CAP, acute maxillary sinusitis, and pharyngitis (although not approved for the latter in the US), and is administered in a convenient dosage regimen that has the potential to encourage good compliance. The reformulation modulates clarithromycin absorption kinetics thereby improving tolerability. Therefore, clarithromycin extended-release provides a useful option for the treatment of specific respiratory tract infections. SN - 1175-6365 UR - https://www.unboundmedicine.com/medline/citation/14720016/Clarithromycin_extended_release_tablet:_a_review_of_its_use_in_the_management_of_respiratory_tract_infections_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=14720016.ui DB - PRIME DP - Unbound Medicine ER -