Medroxyprogesterone acetate

Labeled for secondary amenorrhea and hormone-related abnormal uterine bleeding after excluding organic pathology. It also prevents endometrial hyperplasia in postmenopausal patients with a uterus receiving daily oral conjugated estrogens 0.625 mg. The usual oral daily regimen does not reliably inhibit ovulation and is not a contraceptive substitute. These indications are not a blanket treatment instruction for unexplained bleeding.

Depo-Provera CI 150 mg IM prevents pregnancy in females of reproductive potential. Depo-subQ Provera 104 prevents pregnancy and manages endometriosis-associated pain. Neither is indicated before menarche or in postmenopausal patients. Use beyond two years is not recommended by the selected labels unless other options are inadequate. This review covers oral Provera and these contraceptive/endometriosis depot products; separate oncology formulations require their own oncology label/regimen.

For secondary amenorrhea, use 5 or 10 mg daily for 5–10 days; 10 mg daily for 10 days is the label’s optimal secretory-transformation course in an estrogen-primed endometrium. Hormonal abnormal bleeding uses 5 or 10 mg daily for 5–10 days beginning calculated cycle day 16 or 21; the suggested optimal course is 10 mg daily for 10 days from day 16. Withdrawal bleeding usually begins 3–7 days after stopping. Confirm pregnancy status and the cause of bleeding first.

The cyclic oral course applies specifically to the reviewed daily conjugated-estrogen regimen in patients with a uterus. Start at the lowest dose, use the lowest effective dose/duration consistent with goals and reassess periodically, for example at 3–6 months. Persistent or recurrent unexplained bleeding requires evaluation, potentially endometrial sampling; it is not managed by independently increasing Provera. Other estrogen regimens need their own prescribed endometrial-protection plan.

Shake the suspension vigorously immediately before use. IM administration uses deep gluteal/deltoid injection with aseptic technique and site rotation; assess needle length/body habitus to avoid unintended SC placement. SC administration uses the entire single-dose syringe into upper anterior thigh or abdomen, rotating sites; the selected label specifies healthcare-professional administration. Neither dose requires body-weight adjustment. Do not inject either into a vein.

Selected labels start during the first five days of normal menses after excluding pregnancy; IM also allows the first five postpartum days when not exclusively breastfeeding. For exclusively breastfeeding IM users, and breastfeeding SC users, initiate during or after postpartum week six as labeled. Switching depends on the prior method, with exact timing/back-up instructions; SC after IUD removal outside cycle day one requires seven days of nonhormonal back-up. Arrange late-dose, pregnancy-exclusion and emergency-contraception decisions with the clinician rather than apply an invented grace period.

Oral Provera is contraindicated with known liver impairment/disease; significant liver disease contraindicates the selected depot products. The labels provide no validated renal-reduction table or dialysis algorithm. Renal/cardiac disease can increase concern about fluid retention. Do not convert a depot dose to an oral daily regimen or alter repeat intervals independently.

Oral Provera contraindications include unexplained genital bleeding; known/suspected/history of breast cancer; estrogen- or progesterone-dependent neoplasia; active/history of DVT/PE or arterial thromboembolic disease; anaphylaxis/angioedema; liver disease and known/suspected pregnancy. Depot labels contraindicate active thrombophlebitis or current/history of thromboembolic/cerebrovascular disease, relevant breast malignancy, significant liver disease, ingredient hypersensitivity and undiagnosed vaginal bleeding. Pregnancy requires stopping contraceptive treatment and assessment, although current depot §4 does not list it as the same formal contraindication entry.

Provera’s box addresses cardiovascular disorders, probable dementia and breast cancer in estrogen-plus-progestin therapy; it does not establish cardiovascular/dementia prevention or identical risk estimates for short oral courses or depot contraception. Both selected depot labels carry the loss-of-bone-mineral-density box and the beyond-two-years limitation unless alternatives are inadequate. Meningioma is an additional current warning, not the depot boxed-warning title.

Possible effects include irregular bleeding/spotting or amenorrhea, headache, mood changes, breast symptoms, weight change, nausea and fluid retention. Depot products may cause injection-site nodules, pain or persistent indentation/atrophy. Serious reports include allergy, thrombotic events, liver problems and bone effects. Separate oral-alone, estrogen-combination and depot trial rates are not interchangeable.

Current IM labeling advises additional or alternative contraception with enzyme inducers such as carbamazepine, rifampin and St. John’s wort. Current SC labeling advises avoiding moderate/strong CYP3A inducers and considering back-up/alternate contraception, noting the exposure effect was not confirmed in a clinical study. Oral Provera has in-vitro CYP3A metabolism but lacks specific clinical inducer/inhibitor interaction studies. These statements do not establish a safe universal spacing interval or prove every antibiotic reduces depot efficacy.

Antiretroviral effects can differ by agent; reconcile the complete regimen and consult its label. Estrogen-associated risk and laboratory changes apply to the actual combination. Progestins can affect hormone, binding-protein, coagulation, glucose and lipid results; inform clinicians/pathologists about treatment. Estrogen-containing co-therapy can alter thyroid-binding proteins and thyroid-replacement requirements, which should not be attributed uniformly to depot MPA alone.

Oral Provera is not indicated in children in its selected label. Depot contraception is not indicated before menarche; postmenarchal adolescent efficacy is expected to resemble adult efficacy, with special concern about bone accrual. Depot products are not indicated in postmenopausal patients. Older oral users need individual assessment; WHIMS dementia findings came from estrogen-combination treatment in patients 65–79, not a pediatric or depot trial.

Renal PK effects are unstudied and depot hepatic/renal PK effects are unknown; no numeric adjustment is established. Liver contraindications remain binding even though treatment is intermittent. Monitor fluid-sensitive renal/cardiac disease and diabetes; stop and assess jaundice or new liver-test abnormalities before any re-administration.

Do not use oral Provera in known/suspected pregnancy; report exposure. Contraceptive depot therapy has no pregnancy purpose and should be discontinued if pregnancy occurs; current labels report reassuring epidemiologic birth-defect findings without guaranteeing an individual outcome. Depot ovulation/fertility can return months after stopping. IM studies reported a median ten months to conception among those who conceived; SC’s small repeat-dose study reported a median ten months to ovulation. These are different outcomes and neither proves infertility or guarantees timing.

Selected oral Provera states not to use during lactation. Current depot labels acknowledge measurable milk drug without observed infant harm in available studies and call for individualized feeding/treatment consideration; initiation before six postpartum weeks has uncertain lactation effects, so labeled initiation is during/after week six for exclusively breastfeeding IM users and breastfeeding SC users. Do not transfer oral wording into a blanket depot prohibition or infer zero milk exposure.

In an estrogen-primed endometrium, MPA promotes secretory transformation. Depot products suppress gonadotropins/follicular maturation and ovulation, with thicker cervical mucus contributing to contraception; SC estradiol suppression likely contributes to endometriosis-pain relief. Usual once-daily oral courses do not provide the same ovulation suppression. This is an acetate progestin, distinct from micronized progesterone.

Oral peak concentrations occur around two to four hours, with food increasing exposure; metabolism is predominantly hepatic and metabolites are mainly urinary conjugates. Depot release is much slower: IM apparent half-life about 50 days; SC about 40 days, with substantial variation. Hepatic CYP metabolism and protein binding do not make oral/depot exposure equivalent. Use labeled repeat intervals and clinical pregnancy assessment rather than calculate protection from half-life alone.

Confirm bleeding diagnosis/pregnancy status, breast/liver/thrombotic history, bone risks and interacting drugs before use. Reassess symptoms, mood, weight, glucose risk, fluid retention and blood pressure as appropriate. Depot labels recommend BMD evaluation when continuing long-term; adolescent interpretation considers maturity. Monitor meningioma symptoms and investigate concerning neurologic changes. Oral estrogen-combination use needs periodic benefit-risk reassessment and evaluation of persistent bleeding; no universal MRI or every-injection DXA schedule is established.

Keep the next injection appointment and seek advice promptly if late. Do not double oral doses or change routes to compensate. Explain possible bleeding changes and delayed fertility return, effective back-up when indicated and STI protection needs. Seek urgent care for serious allergy, suspected clot/stroke, severe abdominal pain or pregnancy concern; report new persistent severe headaches, vision/hearing changes or other neurologic symptoms for assessment. Significant depression or liver symptoms also require contact.

Provera 10 mg is a scored round white tablet marked PROVERA 10, bottle-of-100 NDC 0009-0051-01; 2.5 mg and 5 mg tablets are orange and blue. Selected Depo-Provera CI 1 mL prefilled syringe is NDC 0009-7376-11. Depo-subQ Provera 104 single-dose syringe is NDC 0009-4709-13. Verify the actual manufacturer/route, not color alone.

Oral Provera: 2.5, 5 and 10 mg medroxyprogesterone acetate tablets. IM contraceptive product: 150 mg/mL in 1 mL vial or syringe. SC product: 104 mg/0.65 mL single-dose syringe, supplied with its specific needle. Do not treat different depot concentrations or specialist oncology preparations as the same injection. These selected products are prescription medicines.

Store selected tablets at 20–25°C. IM vials must be upright at 20–25°C. SC syringes: 20–25°C; do not refrigerate; bring to room temperature and shake vigorously as instructed before administration. Use aseptic technique, inspect the suspension and dispose of used syringes/needles appropriately. No conversion between storage instructions or unverified opened-vial beyond-use interval is supplied.