
(proe jess’ ter own)
Progesterone in oil (parenteral):
Progesterone aqueous
progesterone
Crinone, Prometrium
Vaginal insert: Endometrin
PREGNANCY CATEGORY B (ORAL)
PREGNANCY CATEGORY X (INJECTION)
Drug Classes
Hormone
Progestin
Therapeutic Actions
Endogenous female progestational substance; transforms proliferative endometrium into secretory endometrium; inhibits the secretion of
pituitary gonadotropins, which prevents follicular maturation and ovulation; inhibits spontaneous uterine contractions; may have some estrogenic, anabolic, or androgenic activity.
pituitary gonadotropins, which prevents follicular maturation and ovulation; inhibits spontaneous uterine contractions; may have some estrogenic, anabolic, or androgenic activity.
Indications
Treatment of primary and secondary amenorrhea
Treatment of abnormal uterine bleeding
Prevention of endometrial hyperplasia
Treatment of endometrial hyperplasia in non-hysterectomized women who are receiving conjugated estrogens
Vaginal: To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology treatment program for infertile women
Gel: Infertility, as part of assisted reproductive technology for infertile women
Unlabeled uses: Treatment of PMS, prevention of premature labor and habitual abortion in the first trimester, treatment of menorrhagia (intrauterine system)
Contraindications and Cautions
Contraindicated with allergy to progestins, allergy to peanuts (oral), thrombophlebitis, thromboembolic disorders, cerebral hemorrhage or history of these conditions, hepatic disease, carcinoma of the breast or genital organs, undiagnosed vaginal bleeding, missed abortion, diagnostic test for pregnancy, pregnancy (fetal abnormalities, including masculinization of the female fetus have occurred), PID, venereal disease, postpartum endometritis, pelvic surgery, uterine or cervical carcinoma (intrauterine system).
Use cautiously with epilepsy, migraine, asthma, cardiac dysfunction, renal impairment, lactation (oral).
Available Forms
Injection—50 mg/mL; vaginal gel—45 mg (4%), 90 mg (8%); capsules—100, 200 mg; vaginal insert—100 mg
Dosages
Administer parenteral preparation by IM route only.
Adults
Amenorrhea: 5–10 mg/day IM for 6–8 consecutive days. Expect withdrawal bleeding 48–72 hr after the last injection. Or use 400 mg PO in the evening for 10 days. Spontaneous normal cycles may follow.
Secondary amenorrhea: Using 4% gel, 45 mg vaginally every other day to maximum of 6 doses. For women who do not respond, trial of 8% gel every other day to maximum of 6 doses.
Uterine bleeding: 5–10 mg/day IM for six doses. Bleeding should cease within 6 days. If estrogen is being given, begin progesterone after 2 wk of estrogen therapy. Discontinue injections when menstrual flow begins.
Endometrial hyperplasia: 200 mg/day PO in the evening for 12 days per 28-day cycle in combination with a daily conjugated estrogen.
Infertility: 90 mg vaginally daily in women requiring progesterone supplementation; 90 mg vaginally bid for replacement—continue for 10–12 wk into pregnancy if it occurs.
Support for implantation: 100 mg inserted vaginally two to three times daily starting at oocyte retrieval and continuing for up to 10 wk.