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Metronidazole – topical

Classification: A

Drug products: Flagyl, Flagyl®, Metronidazol Actavis

ATC code: P01AB01

Summary

One study of topical metronidazole in treatment of rosacea showed similar effect and safety in men and women.
 
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of topical metronidazole have been found. No difference between men and women has been shown for transdermal absorption in general [1].

Effects

In an open-label community-based study (145 men, 437 women) investigating the responsiveness to twice-daily application of metronidazole topical gel 0.75% in subjects with rosacea, the efficacy in reducing lesion count and improving rosacea severity was equivalent in men and women [2]. A small study of patients with mild or moderate papulopustular rosacea (7 men, 25 women) showed that 8 weeks treatment with topical metronidazole or terbinafine yielded similar effect in men and women [3]. Rosacea is a common chronic facial skin disease in which women are approximately 2-3 times more likely than men to be affected [4].

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of topical metronidazole have been found.

Reproductive health issues

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

Updated: 2019-02-26

Date of litterature search: 2017-01-17

References

  1. Schwartz JB. The influence of sex on pharmacokinetics. Clin Pharmacokinet. 2003;42:107-21. PubMed
  2. Wolf JE, Del Rosso JQ. The CLEAR trial: results of a large community-based study of metronidazole gel in rosacea. Cutis. 2007;79:73-80. PubMed
  3. Serdar ZA, Yaşar Ş. Efficacy of 1% terbinafine cream in comparison with 075% metronidazole gel for the treatment of papulopustular rosacea. Cutan Ocul Toxicol. 2011;30:124-8. PubMed
  4. Blount BW, Pelletier AL. Rosacea: a common, yet commonly overlooked, condition. Am Fam Physician. 2002;66:435-40. PubMed
  5. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2017-01-26.] länk

Authors: Alaa Falemban, Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson