Medroxyprogesterone (Oral), Provera
Description: Progestin; Contraceptive
“ALERT: US Boxed Warning
Cardiovascular disorders (tablet):
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease. 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 (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.
Breast cancer (tablet):
The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.
Dementia (tablet):
Estrogen plus progestin therapy should not be used for the prevention of dementia. 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 or older during 4 years of treatment with daily conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Long-term use (injection [contraceptive, endometriosis formulations]):
Medroxyprogesterone is not recommended as a long-term (ie, longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate.
Loss of bone mineral density (injection [contraceptive, endometriosis formulations]):
Women who use medroxyprogesterone may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if the use of medroxyprogesterone during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.
Risk vs benefits (tablet):
In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and medroxyprogesterone acetate and other combinations and dosage forms of estrogens and progestins. Estrogens with progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.”
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Medroxyprogesterone (Oral), Provera (MPA) is a synthetic analog of progesterone, which is a steroid hormone that plays a regulatory role in the female reproductive system by allowing the endometrium to transition from a proliferative to the secretory stage, facilitates blastocyst nesting and is essential to the maintenance of pregnancy. Progesterone also plays an important role in several tissues not belonging to the reproductive system, such as the mammary gland in preparation for breastfeeding, the cardiovascular system, the central nervous system, and bones.
Medroxyprogesterone acetate (MPA) transforms a proliferative endometrium into secretory endometrium. When administered with conjugated estrogens, MPA reduces the incidence of endometrial hyperplasia and risk of adenocarcinoma. When used as an injection for contraception, MPA inhibits the secretion of pituitary gonadotropins, which prevents follicular maturation and ovulation and causes endometrial thinning. Progestogens, such as medroxyprogesterone when used for endometriosis, leading to atrophy of the endometrial tissue. They may also suppress new growth and implantation. Pain associated with endometriosis is decreased.
Indications For Use
Abnormal uterine bleeding, secondary amenorrhea, prophylaxis of endometrial hyperplasia
Precautions
Before starting Medroxyprogesterone (Oral), Provera, make sure your physician is aware of any medications you take, if you have any allergies, a clotting or bleeding disorder, a history or high risk of cerebrovascular events, have undiagnosed vagina bleeding, a history or high risk of breast cancer, have liver disease, experience migraines with aura, have asthma, depression, cardiovascular disease, epilepsy, hypoparathyroidism, porphyria, systemic lupus erythematosus, are pregnant, or breastfeeding. Medroxyprogesterone (Oral), Provera use has been associated with rare but potentially serious adverse events such as adrenal suppression, hypersensitivity reactions, bone mineral density loss, breast cancer, dementia, ectopic pregnancy, endometrial cancer, hypertriglyceridemia, ovarian cancer, retinal vascular thrombosis, vaginal bleeding, and weight gain.
Usual Dosing
Oral: 5 or 10 mg daily for various lengths of time at various times of cycle depending on the indication
Pharmacist Tips On Using
How to Take: Take with food and follow instructions on the label carefully.
Side Effects
Amenorrhea, change in menstrual flow, hot flashes, menstrual disease, weight gain, weight loss, abdominal pain, headache, anxiety
Note this is not a complete list of side effects, only the most common ones.