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, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (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 CE and MPA, and other combinations and dosage forms of estrogens and progestins.
Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
If you take too much Prometrium, call your local Poison Control Center or seek emergency medical attention right away.
- Prometrium Capsules are to be taken at bedtime as some women become very drowsy and/or dizzy after taking Prometrium Capsules. In a few cases, symptoms may include blurred vision, difficulty speaking, difficulty with walking, and feeling abnormal. If you experience these symptoms, discuss them with your healthcare provider right away.
- If you experience difficulty in swallowing Prometrium Capsules, it is recommended that you take your daily dose at bedtime with a glass of water while in the standing position.
Grapefruit and grapefruit juice may interact with Prometrium and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Prometrium is a prescription medication used to cause menstruation in women with an absence of menstrual periods due to a decrease in progesterone. Prometrium is also used in combination with estrogen-containing medications in postmenopausal women with a uterus (womb) to reduce the risk of developing cancer of the uterus.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Prometrium Capsules work. Prometrium Capsules may also affect how your other medicines work.
Side effects are grouped by how serious they are and how often they happen when you are treated:
Serious, but less common side effects include:
- Risk to the Fetus: Cases of cleft palate, cleft lip, hypospadias, ventricular septal defect, patent ductus arteriosus, and other congenital heart defects.
- Abnormal Blood Clotting: Stroke, heart attack, pulmonary embolus, visual loss or blindness.
Some of the warning signs of serious side effects include:
- Changes in vision or speech
- Sudden new severe headaches
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
- Dizziness and faintness
- Vomiting
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.
Less serious, but common side effects include:
- Headaches
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach or abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
These are not all the possible side effects of Prometrium Capsules. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to Abbott Laboratories at 1-800-241-1643 or to FDA at 1-800-FDA-1088.
What you can do to lower your chances of getting a serious side effect with Prometrium Capsules:
- Talk with your healthcare provider regularly about whether you should continue taking Prometrium Capsules.
- See your healthcare provider right away if you get unusual vaginal bleeding while taking Prometrium Capsules.
- Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
Store Prometrium capsules at room temperature 15° to 30°C (59° to 86°F). Protect from excessive moisture (keep out of bathroom).
Keep this and all medicines out of the reach of children.
Tell your healthcare provider:
- If you are pregnant or breastfeeding.
- About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, or kidneys, or have high calcium levels in your blood.
- About all the medicines you take.
Tell your doctor if you are breastfeeding or plan to breastfeed. The hormone in Prometrium Capsules can pass into your breast milk.
Active ingredient: 100 mg or 200 mg micronized progesterone
The inactive ingredients for Prometrium Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Red No. 40.
The inactive ingredients for Prometrium Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.
- Prevention of Endometrial Hyperplasia: A postmenopausal woman with a uterus who is taking estrogens should take a single daily dose of 200 mg Prometrium Capsules at bedtime for 12 continuous days per 28-day cycle.
- Secondary Amenorrhea: Prometrium Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days.
Prometrium prescribing information, like all progesterone-like medications, states that Prometrium should not be taken during pregnancy.
Researchers have theorized that having low progesterone levels before a miscarriage may play a role in causing miscarriage. Others suggest that low progesterone levels indicate the body is preparing to miscarry a pregnancy for reasons unknown. More research is needed to determine if progesterone supplements are beneficial.
If your doctor prescribes Prometrium during pregnancy to prevent a miscarriage or other pregnancy complications, you should know that although the prescribing information indicates Prometrium should not be used during pregnancy, some research suggests there may not be an increased risk to the fetus.
Discuss your concerns about Prometrium use during pregnancy with your doctor.
THIS PRODUCT CONTAINS PEANUT OIL AND SHOULD NOT BE USED IF YOU ARE ALLERGIC TO PEANUTS.
- Progestins with estrogens should not be used to prevent heart disease, heart attacks, strokes, or dementia.
- Using progestins with estrogens may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
- Using progestins with estrogens may increase your chance of getting dementia, based on a study of women age 65 and older.
- You and your healthcare provider should talk regularly about whether you still need treatment with Prometrium Capsules.
Do not start taking Prometrium Capsules if you:
- Are allergic to peanuts
- Have unusual vaginal bleeding
- Currently have or have had certain cancers
Estrogen plus progestin treatment may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Prometrium Capsules. - Had a stroke or heart attack
- Currently have or have had blood clots
- Currently have or have had liver problems
- Are allergic to Prometrium Capsules or any of its ingredients
- Think you may be pregnant
Prometrium (generic: progesterone) is a prescription medication used to cause menstrual periods in women who are premenopausal but have stopped having periods due to low progesterone levels in their bodies. It is also used to prevent abnormal thickening of the lining of the uterus in women taking estrogen.
Prometrium belongs to a group of drugs called progestins, which work to bring menstruation by causing “withdrawal” bleeding when the medication is stopped.
This medication comes in capsule form and is taken once a day, at bedtime for 10 or 12 continuous days per cycle, depending on the condition being treated.
Common side effects of Prometrium include headaches, breast pain, and irregular vaginal bleeding or spotting.