Revised SPC: Diflucan (fluconazole) 150 Capsules
SPC updated to note that for longer courses of treatment, contraception may be considered, as appropriate, in women of childbearing potential throughout the treatment period and for 1 week after the final dose. Data from a meta-analysis on cardiac malformations have been added.
Source:
electronic Medicines compendium
SPS commentary:
The SPC already recommended a washout period of one week (corresponding to 5-6 half-lives) after single dose treatment, before becoming pregnant. It previously recommended the same washout period after discontinuation of a course of treatment, but this has been amended to include consideration of the use of contraception throughout the treatment period and for one week after the final dose.
The following text has also been added:
“Available epidemiological studies on cardiac malformations with use of fluconazole during pregnancy provide inconsistent results. However, a meta-analysis of 5 observational studies including several thousand pregnant women exposed to fluconazole during the first trimester finds a 1.8-2 fold increased risk of cardiac malformations when compared to no fluconazole use and/or topical azoles use.”