PREGNANCY AND BREASTFEEDING SAFETY:
- Progesterone intravaginal gel has been used to support embryo implantation and to maintain pregnancies as part of an ART treatment regimen. Progestins are secreted in breast milk.
- Progesterone intravaginal gel should be stored at room temperature, 20 C to 25 C (68 F to 77 F)
- For ART, the recommended dose of the 8% gel is 90 mg once daily in women who require progesterone supplementation, and 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.
- For the treatment of secondary amenorrhea, the 4% gel is administered vaginally every other day for six doses. Women who do not respond should receive the 8% gel.
DRUG CLASS AND MECHANISM:
- Progesterone is a female hormone and is the principal progestational hormone. Progestational hormones prepare the uterus (the womb) to receive and sustain the fertilized egg. Progesterone promotes the development of the mammary glands, causes changes in the endometrium, which lines the uterus, relaxes uterine smooth muscles, blocks ovulation within the ovaries, and maintains pregnancy.
- The FDA approved progesterone intravaginal gel in July 1997.
REFERENCE: FDA Prescribing Information.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Need help identifying pills and medications?
Use the pill identifier tool on RxList.