- Side Effects
- Drug Interactions
- Warnings and Precautions
Brand Name: DepoProvera, Depo-SubQ Provera 104, MPA, Provera
Generic Name: Medroxyprogesterone
Drug Class: Antineoplastics, Hormones; Progestins
What Is Medroxyprogesterone and How Does It Work?
Medroxyprogesterone is a prescription drug indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone is also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
What Are Dosages of Medroxyprogesterone?
- 2.5 mg
- 5 mg
- 10 mg
- 150 mg/ml
- 400 mg/ml
Prefilled syringe suspension
- 104 mg/0.65 ml
Dosage Considerations – Should be Given as Follows:
Adult dosing only. Safety and efficacy not established for pediatric dosages.
Amenorrhea, Uterine Bleeding
- Uterine bleeding: 5-10 mg/day orally for 5-10 days; beginning day 16 or 21 of the menstrual cycle; withdrawal bleeding may be expected within 3 to 7 days after discontinuing medroxyprogesterone
- Amenorrhea, secondary: 5-10 mg/day orally for 5-10 days; may be started at any time; withdrawal bleeding may be expected within 3-7 days after discontinuing medroxyprogesterone
- 150 mg deep intramuscular or 104 mg subcutaneously every 3 months
- 100-600 mg intramuscular weekly; alternatively, 100-500 mg orally daily; maintenance 100 mg intramuscularly every 1-4 weeks
What Are Side Effects Associated with Using Medroxyprogesterone?
Common side effects of medroxyprogesterone include:
- absence of menstruation
- breakthrough bleeding
- change in menstrual flow
- loss of appetite
- pain at the injection site
- rapid swelling
- excessive production of breast milk
- abdominal pain
- obstructive liver disease
- deep vein thrombosis (DVT)
- blot clots formed by inflammation
- breast tenderness
- blood clot in the lung (pulmonary embolism)
- mental depression
- hair loss
- male-pattern hair growth
- blood clot in the eye
- inflammation of the optic nerve
- weight gain
- weight loss
- menstrual cramps/pelvic pain
- uterine fibroids
- inflammation of the vagina
- yeast infection
- cervical eversion
- ovarian cancer
- thickening of the lining of the uterus
- uterine cancer
- nipple discharge
- fibrocystic breast changes
- breast cancer
- heart attack (myocardial infarction)
- increase in blood pressure
- enlargement of noncancerous tumors in the liver (hepatic hemangiomas)
- skin changes during pregnancy/mask of pregnancy
- hypersensitivity with skin eruptions (erythema multiforme)
- acute eruptions on the legs
- bleeding eruption
- intolerance to contact lenses
- abnormal involuntary movement
- mood disturbances
- exacerbation of epilepsy
- porphyria (abdominal pain, chest pain, vomiting, confusion, constipation, fever, and seizures)
- joint pain
- leg cramps
- changes in libido
- severe allergic reaction (anaphylactoid/anaphylactic reaction)
- low blood calcium levels
- exacerbation of asthma
- increased triglycerides
Postmarketing reports of medroxyprogesterone:
- Rash (allergic) with and without itching, change in weight (increase or decrease), fever, swelling/fluid retention, fatigue, decreased glucose tolerance
- Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria (abdominal pain, chest pain, vomiting, confusion, constipation, fever, and seizures); swelling; joint pain; leg cramps; changes in sex drive (libido); hives, rapid swelling, acute allergic reaction (anaphylactoid/anaphylactic reactions); low blood calcium levels; exacerbation of asthma; increased triglycerides
- Injection site reaction, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling, abnormal adipose tissue (lipodystrophy) acquired, injection site nodules/lumps
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
What Other Drugs Interact with Medroxyprogesterone?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.
Medroxyprogesterone has no known severe interactions with any other drugs.
- Serious interactions of medroxyprogesterone include:
- Medroxyprogesterone has moderate interactions with at least 57 different drugs.
- Mild interactions of medroxyprogesterone include:
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.
What Are Warnings and Precautions for Medroxyprogesterone?
Bone mineral density loss (injection)
- Medroxyprogesterone contraceptive injection may cause significant loss of bone mineral density.
- Bone loss is greater with increasing duration of use and may not be completely reversible.
- Unknown whether use during the critical period of bone accretion (adolescence or early adulthood) will reduce peak bone mass and increase osteoporotic fracture risk in later life.
- Use for long-term (over 2 years) birth control only if other contraceptive methods are inadequate or poorly tolerated.
Cardiovascular risks (oral)
- Estrogens with progestins should not be used to prevent cardiovascular disease.
- Women's Health Initiative (WHI) Estrogen Plus Progestin substudy reported increased risks of heart attack (myocardial infarction), stroke, invasive breast cancer, pulmonary embolism, and deep vein thrombosis (DVT) in postmenopausal women aged 50-79 years undergoing 5.
- 6 years of treatment with oral conjugated estrogens (CE) 0.625 mg/day plus medroxyprogesterone acetate (MPA) 2.5 mg/day versus placebo
Dementia risks (oral)
- Estrogens with progestins should not be used to prevent dementia.
- Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported an increased risk of probable dementia in postmenopausal women aged 65 years or older undergoing 4 years of treatment with CE 0.625 mg/day plus MPA 2.5 mg/day versus placebo.
- Unknown whether this finding applies to younger postmenopausal women.
Dose and duration (oral)
- In the absence of comparable data, cardiovascular and dementia risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins
- Accordingly, estrogens, with or without progestins, should be prescribed at the lowest effective dosage and for the shortest duration consistent with treatment goals and individual risks.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
- Known or suspected pregnancy or as a diagnostic test for pregnancy
- Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease
- Known or suspected malignancy of breast
- Malignancy of breast or genital organs
- Missed abortion
- Undiagnosed vaginal bleeding
- Known or suspected estrogen-or progesterone-dependent neoplasia
- A known anaphylactic reaction or rapid swelling
- Known liver impairment or disease
- Documented hypersensitivity
Effects of Drug Abuse
- See "What Are Side Effects Associated with Using Medroxyprogesterone?"
- See "What Are Side Effects Associated with Using Medroxyprogesterone?"
- Use caution in patients with asthma, diabetes mellitus, history of depression, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas.
- Not recommended as primary therapy for renal or endometrial cancer.
- If used with conjugated estrogens, may increase the risk of heart attack (myocardial infarction), stroke, pulmonary emboli, deep vein thrombosis (DVT), breast cancer; discontinue therapy in patients who develop thrombosis.
- Depo-Provera: Prolonged use may result in significant loss of bone density.
- Monitor women with a strong family history of breast cancer.
- Consider ectopic pregnancy if a woman receiving therapy becomes pregnant or complains of severe abdominal pain.
- Provide emergency medical treatment if a severe allergic reaction occurs.
- Discontinue if yellowing eyes and skin (jaundice) or disturbances of liver function develop.
- Use may mask the onset of menopause in women treated for endometrial cancer.
- Not for use in children before menarche.
- Adding progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.
- In some epidemiologic studies, the use of estrogen plus progestin and estrogen-only products, in particular for 5 or more years, has been associated with increased risk of ovarian cancer; however, duration of exposure associated with increased risk is not consistent across all epidemiologic studies, and some report no association.
- Discontinue if the following develop: hepatic impairment/cholestatic jaundice, visual problems, 4-6 weeks before major surgery, any symptoms of VTE, massive blood pressure increase, unusually severe migraines, or first-time migraines, depression.
- Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone; possible risks associated with the use of progestins with estrogens compared to estrogen-alone regimens include an increased risk of breast cancer.
- In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
- Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
- In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis; consider discontinuation of treatment if pancreatitis occurs.
- Progestins may cause some degree of fluid retention; women with conditions influenced by fluid retention including epilepsy, migraine, asthma, cardiac or kidney dysfunction, require careful observation.
- Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
- Therapy should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis; double vision, or migraine; if examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
- Patients may exhibit suppressed adrenal function; medroxyprogesterone acetate may have cortisol-like glucocorticoid activity and provide negative feedback to hypothalamus or pituitary; this may result in decreased plasma cortisol levels, decreased cortisol secretion, and low plasma ACTH levels; use of sterile aqueous suspension may, due to its cortisol-like glucocorticoid activity, also produce Cushingoid symptoms such as weight gain, swelling, and facial swelling.
- Medroxyprogesterone acetate reduces serum estrogen levels when given as 150 mg intramuscularly every 3 months and is associated with loss of bone mineral density (BMD); this loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion; unknown, if used by younger women, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life; an evaluation of BMD may be appropriate in some patients who use higher doses of medroxyprogesterone acetate for long-term treatment of endometrial or renal carcinoma.
- Monitor patients for hepatic dysfunction periodically and temporarily interrupt therapy if a patient develops hepatic dysfunction; do not resume use until markers of liver function return to normal.
- Any multi-dose use of vials may lead to contamination unless a strict aseptic technique is observed.
- Treatment with progestin may mask the onset of the climacteric.
- Persistent injection site reactions may occur after administration due to inadvertent subcutaneous administration or release of the drug into subcutaneous space while removing the needle.
Pregnancy and Lactation
- There is no available information for use of medroxyprogesterone during pregnancy. Consult your physician.
- Medroxyprogesterone is safe for use while breastfeeding
RxList. Provera Side Effect Center.