Label Changes for:
Terconazole Vaginal Cream
Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010
- Terconazole vaginal cream, 0.8% is contraindicated in patients with known hypersensitivity to terconazole or to any of the components of the cream. There is no information regarding cross-hypersensitivity between terconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.
Clinical Trial Experience
- Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultraviolet light. Photosensitivity reactions were not observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream 0.8%.
USE IN SPECIFIC POPULATIONS
- Terconazole vaginal cream, 0.8% should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. There are no adequate and well-controlled clinical trials of terconazole vaginal cream 0.8% in pregnant women.
- Caution should be exercised when terconazole is administered to a nursing woman