(See You can ask for information about Medroxyprogesterone acetate that is written for health professionals.
A 10 mg dose of medroxyprogesterone acetate, taken immediately before or after a meal, increased MPA C Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle.The lowest effective dose of medroxyprogesterone acetate has not been determined.Medroxyprogesterone Acetate Tablets USP are available as:2.5 mg: White, round, scored, biconvex tablet. According to the predefined stopping rule, after an average follow-up of 5.6 years of treatment, the increased risk of invasive breast cancer and cardiovascular events exceeded the specified benefits included in the “global index.” The absolute excess risk of events included in the “global index” was 19 per 10,000 women-years.For those outcomes included in the WHI “global index” that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women-years in the group treated with CE plus MPA were 7 more CHD events, 8 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reduction per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures.Results of the CE plus MPA substudy which included 16,608 women (average 63 years of age, range 50 to 79; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other) are presented in Table 4.
Debossed with 555/872 on the scored side and stylized b on the other side, available in bottles of 30 (NDC 72789-043-30).Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Read this Patient Information before you start taking medroxyprogesterone acetate and read what you get each time you refill your medroxyprogesterone acetate prescription. Medroxyprogesterone acetate is also used to treat endometriosis. 59762-3741-4,
Enlargement of the clitoris and fusion of the labia may occur in female babies. For more information, ask your healthcare provider or pharmacist What can I do to lower my chances of a serious side effect with medroxyprogesterone acetate tablets?General information about safe and effective use of medroxyprogesterone acetate tabletsKeep medroxyprogesterone acetate tablets out of the reach of children.What are the ingredients in medroxyprogesterone acetate tablets? Acne, alopecia and hirsutism have been reported.Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.Mental depression, insomnia, somnolence, dizziness, headache, nervousness.Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance.The following adverse reactions have been reported with estrogen plus progestin therapy.Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.Retinal vascular thrombosis, intolerance to contact lenses.Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women.
It is unknown whether these findings apply to younger postmenopausal women.
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPYTable 1. Enlargement of the clitoris and fusion of the labia may occur in female babies. Medroxyprogesterone is a type of female hormone (progestin).
( If feasible, estrogens plus progestins should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.The most important randomized clinical trial providing information about breast cancer in estrogen plus progestin users is the WHI substudy of daily CE (0.625 mg) plus MPA (2.5 mg).
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