Abstract

A 28-year-old woman who was treated for vaginal candidiasis with Gyno-Daktarin vaginal capsules (miconazole nitrate) became pregnant because a condom used during intercourse had ruptured. Incubation in vitro with 400 and 1200 mg miconazole nitrate vaginal capsules (Gyno-Daktarin 3 and Gyno-Daktarin I), but not miconazole nitrate vaginal cream (20 mg/g), was shown to damage rubber condoms. Patients using vaginal medicines should be aware of a possible adverse effect on rubber condoms or contraceptive diaphragms and a subsequent increased risk of pregnancy or contagious diseases such as AIDS. Fatty excipients such as glycerin, paraffin, petrolatum or Witepsol may be involved.

PIP:

A 28-year-old woman who was treated for vaginal candidiasis with Gyno-Daktarin vaginal capsules (1 capsule per day containing 400 mg miconazole nitrate for 3 days) became pregnant because a condom used during intercourse on the 3rd day had ruptured. The pregnancy was later was terminated by vacuum aspiration. With the collaboration of Janssen Pharmaceutica the TNO Plastics and Rubber Institute studied the effect of Gyno-Daktarin on the quality of condoms. Three different forms were investigated: Gyno-Daktarin cream (20 mg miconazole nitrate/g), Gyno-Daktarin in 1 vaginal capsule (1200 mg miconazole nitrate), and Gyno-Daktarin in 3 vaginal capsules (400 mg miconazole nitrate). Before the investigation six different types of condoms were selected from among the commonly sold types in the Netherlands. The condoms were brought into contact with the above three products. Then they were exposed for one hour to a temperature of 37 degrees Celsius and cooled off to room temperature. Among 450 condoms that were handled in this fashion (75 per brand) length changes, bursting volume, and bursting strength measured by means of ISO 4074, the valid standard of the International Standard Organization, were compared to the outcome of 600 condoms (100 per brand) that had not been exposed to Gyno-Daktarin. The three different combination forms of Gyno-Daktarin were each tested on 150 condoms (25 per brand). There was no change in the length of condoms that were brought into contact with the cream (20 mg/g), however, after incubation in vitro with both 400 and 1200 mg miconazole nitrate vaginal capsules (Gyno-Daktarin 3 and Gyno-Daktarin 1) the length was augmented by an average of 20%. After treatment with the two kinds of capsules the bursting pressure and the bursting volume were reduced by an average 35-44%. Patients using vaginal medicines should be aware of a possible adverse effect on rubber condoms or contraceptive diaphragms and a subsequent increased risk of pregnancy or contagious diseases such as AIDS.