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Clarithromycin

Classification: A

Drug products: Clarithromycin Aurobindo, Clarithromycin HEC, Clarithromycin HEC Pharm, Clarithromycin Hexal, Clarithromycin Krka, Clarithromycin Ranbaxy, Clarithromycin Teva, Klacid, Klaritromycin Ebb, Klaritromycin STADA, Nexium® HP

ATC code: A02BD06, J01FA09

Substances: clarithromycin

Summary

Claritromycin is associated with QT-prolongation on ECG and thus a risk of potentially fatal arrhythmias of the type Torsade de pointes ventricular tacycardia. No difference in risk between men and women has been shown for clarithromycin but a known risk factor for Torsade de pointes is female sex.

A systematic review found the resistance of Helicobacter pylori to claritromycin to be higher in women.
 
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.

Additional information

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding pharmacokinetics or dosing of clarithromycin have been found.

Effects

In a retrospective observational cohort study, patients (44 men, 59 women) with severe asthma or bronchiectasis were treated with clarithromycin or azithromycin in addition to their standard treatment. Men with bronchiectasis were more likely to respond (symptom score) to treatment with macrolides than women, 53% vs. 27% [1].

Adverse effects

Clarithromycin has been associated with prolonged QT-interval and a risk of Torsades de pointes ventricular tachycardia [2, 3]. Among the known risk factors of drug-induced ventricular arrhythmias are female sex, hypokalemia, bradycardia, and base line QT-prolongation [4].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

Several studies report differences in Helicobacter pyloriantibiotic resistance between men and women. A systematic review of 31 studies, published worldwide 2006-2009, found that overall, primary clarithromycin resistance was more common among women than men (20.5% vs. 15.5%). Also, clarithromycin resistance rate varied widely between different populations. High resistance was reported from Spain and Japan while low resistance was found in Sweden, the Netherlands and Malaysia [5].

Updated: 2019-02-26

Date of litterature search: 2015-01-27

References

  1. Coeman M, van Durme Y, Bauters F, Deschepper E, Demedts I, Smeets P et al. Neomacrolides in the treatment of patients with severe asthma and/or bronchiectasis: a retrospective observational study. Ther Adv Respir Dis. 2011;5:377-86. PubMed
  2. Shaffer D, Singer S, Korvick J, Honig P. Concomitant risk factors in reports of torsades de pointes associated with macrolide use: review of the United States Food and Drug Administration Adverse Event Reporting System. Clin Infect Dis. 2002;35:197-200. PubMed
  3. BIAXIN (clarithromycin). Summary of Product Characteristics. European Medicines Agency (EMA); 2015.
  4. Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med. 2004;350:1013-22. PubMed
  5. De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C et al. Worldwide H pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010;19:409-14. PubMed
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Anna Garmén, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson