|Click on "►" to expand:|
|Click on "►" to expand:|
 BRAND NAMES
- International: Crinone (Vaginal Gel 8%), Utrogestan (Oral/Vaginal Capsules), Progestogel (1% gel for cutaneous application)
- Australia: Crinone (Vaginal Gel 8%) PI
- Canada: Crinone (Vaginal Gel 8%) PI, Prometrium (Oral/Vaginal Capsules), Endometrin (Vaginal Insert)
- Israel: Crinone (Vaginal Gel 8%) PI
- Italy: Prometrium (Oral/Vaginal Capsules)
- U.S.: Crinone (Vaginal Gel 4%-8%) PI, Prometrium (Oral/Vaginal Capsules), Endometrin (Vaginal Insert)
- Other: Lutinus (vaginal tablets), Gestone (100mg in 2ml for injection), Cyclogest (vaginal pessaries)
 MECHANISM OF ACTION
Progesterone is a hormone produced by the ovaries and, later, if pregnancy occurs, by the placenta. Progesterone is essential to achieve and maintain a healthy pregnancy. In the second half of a woman’s menstrual cycle, progesterone prepares the endometrium, or uterine lining, to receive the fertilized egg. If implantation is successful and pregnancy occurs, progesterone continues to support the uterine lining, providing the perfect environment for the growing embryo.
Progesterone plays 2 important roles:
- Progesterone thickens and prepares the lining of the uterus for implantation of a fertilized egg.
- After implantation, progesterone is required to maintain pregnancy as it suppresses menstruation and uterine contractility.
- Treatment of infertility due to inadequate luteal phase.
- Maintaining early pregnancy in women who have had three or more miscarriages due to an inadequate luteal phase.
- progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency.
- postmenopausal hormone replacement therapy: Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogen . (In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration)
- Menstrual disorders such as heavy menstrual bleeding (menorrhagia), irregular periods, or continuous, heavy menstrual bleeding.
- 1% gel for cutaneous application (Progestogel): treatment of painful pressure in the breasts (mastodynies) and/or associated with benign cystic pathologies of the breasts (mastopathies).
- post-menopausal hormone replacement therapy: 200 mg/day for 12-14 days sequentially per cycle. Alternatively 100mg can be given at bedtime from day 1 to day 25 of each therapeutic cycle
- Luteal support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women:
- Vaginal inserts: The dose is 100 mg insert administered vaginally three times daily starting at oocyte retrieval. The administration of Progesterone Vaginal insert should be continued for 30 days, if pregnancy has been confirmed.
- Vaginal gel (Crinone): one application (1.125g 8% gel) every day, starting after documented ovulation or arbitrarily on the 18th-21st day of the cycle. Daily application of Progesterone gel should be continued for 30 days if there is laboratory evidence of pregnancy.
- Repeated abortions: 200-400 mg/day up to the 12th week of pregnancy
- Known sensitivity to progesterone or any of the other ingredients
- Undiagnosed vaginal bleeding
- Liver dysfunction or disease
- Known or suspected malignancy of the breast or genital organs
- Missed abortion
- Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders
- Acute porphyria
 WARNINGS AND PRECAUTIONS
- Life-threatening arterial or venous thromboembolic disorders may occur during hormone treatment, including treatment with Progesterone. Discontinue Progesterone if any of these are suspected.
- Observe patients with a history of depression closely. Consider discontinuationif symptoms worsen.
- Vaginal inserts are not recommended for use with other vaginal products(such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert.
- Progesterones should be used with caution in patients with cardiovascular or renal impairment, diabetes mellitus, asthma, epilepsy, migraine or other conditions which may be aggravated by fluid retention
 PREGNANCY AND LACTATION
 SIDE EFFECTS
Side-effects of progesterone may include gastro-intestinal disturbances (Abdominal pain, nausea, abdominal distension, constipation, vomiting), acne, fluid retention or edema, mass gain, fatigue, urinary tract infection, headache, allergic skin rashes or urticaria, mental depression, breast changes including discomfort or less frequently gynecomastia and changes in libido. Alterations in liver function tests have been reported and jaundice has been reported less frequently.