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Limited Use
[what does this mean?]
Generic drug name:
progesterone
(proe JES ter one)
Brand name(s):
PROMETRIUM
GENERIC:
not available
FAMILY:
Progestins
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
The progestins have caused genital abnormalities in both male and female infants born to mothers taking these drugs during pregnancy. Because of the potential for serious adverse effects to the fetus, these drugs should not be used by pregnant women.
Breast-feeding Warning
Progestins are excreted in human milk. Because of the potential for adverse effects in nursing infants, you should not take these drugs while nursing.
Safety Warnings For This Drug [top]
FDA Black Box Warning
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
Cardiovascular Disorders and Probable Dementia
Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (clots in the large veins, typically in the legs), pulmonary embolism (clots in the lungs), stroke and heart attack in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (MPA) (2.5 mg), relative to placebo.
The WHI Memory Study (WHIMS) estrogen plus progestin substudy of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during four years of treatment with daily conjugated estrogen (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogen and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
Consistent with the WHI clinical trials, observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller increased risk for estrogen-alone therapy, after several years of use. One large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to >10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy. Extension of the WHI trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy.[1]
Beware of Compounding Pharmacists
Progesterone capsules are promoted by compounding pharmacists for various uses.
Drugs compounded by pharmacists are not FDA-approved. They have not been shown to be safe or effective for use and are produced in facilities that do not have to meet good manufacturing practice guidelines.
Prometrium capsules contain peanut oil and should never be used by patients allergic to peanuts.
Facts About This Drug [top]
This drug is approved by the FDA to prevent endometrial hyperplasia (changes in the cells of the lining of the uterus that may be precancerous) in women who are taking conjugated estrogens and to treat women who have secondary amenorrhea (lack of menstruation for at least three months in women who had been menstruating in the absence of pregnancy or menopause).[2] It is available in oral capsules and an injectable form.
Progesterone should not be used in a number of situations. These...
This drug is approved by the FDA to prevent endometrial hyperplasia (changes in the cells of the lining of the uterus that may be precancerous) in women who are taking conjugated estrogens and to treat women who have secondary amenorrhea (lack of menstruation for at least three months in women who had been menstruating in the absence of pregnancy or menopause).[2] It is available in oral capsules and an injectable form.
Progesterone should not be used in a number of situations. These include during pregnancy; in women who have blood clots or a history of blood clots, severe liver problems, cancer of the breast or genital organs, undiagnosed vaginal bleeding or missed abortion; or as a diagnostic test for pregnancy.
Progesterone can mask onset of menopause. It may precipitate attacks of porphyria, a rare enzyme deficiency; symptoms are pain in the abdomen, arms, back and legs and muscle weakness.
A common adverse effect is drowsiness, which may decline over time. It may cause edema (swelling of ankles and feet), which may be aggravated by epilepsy, migraine, asthma or heart or kidney dysfunction.
There is no evidence that progesterone is effective for treating premenstrual syndrome.[3]
The injectable form of progesterone, which contains sesame oil, is associated with a severe type of lung disease called acute eosinophilic pneumonia.[4] Symptoms include fever and shortness of breath and generally develop within two to four weeks after starting the drug.
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
Evaluations of Drug Interactions 2003 lists no drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods as causing “highly clinically significant” or “clinically significant” interactions when used together with the drugs in this section. We also found no interactions in the drugs’ FDA-approved professional package inserts. However, as the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed April 30, 2024
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