There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. This medicine may actually increase your risk of developing these conditions. This medication should not be used during pregnancy. -Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with this drug. It is also used to prevent endometrial hyperplasia (thickening of the lining of the uterus or womb) in women who are taking conjugated estrogens. It is used to treat uterine bleeding due to hormonal imbalance. Metastatic disease was rare with no apparent difference between the two groups. The risk may be increased with exposure to MPA tablets. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Talk to your pharmacist for more details. This drug may make you dizzy or drowsy. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized starch, and sodium lauryl sulfate. However, many people have no side effects or only have minor side effects. What can I do to lower my chances of a serious side effect with medroxyprogesterone acetate tablets? There may be an increased risk of minor birth defects in children whose mothers are exposed to progestins during the first trimester of pregnancy. & Articles, All Medically reviewed by Drugs.com. See your healthcare provider right away if you get vaginal bleeding while taking medroxyprogesterone acetate tablets. Tell your doctor if you have swelling, weight gain, or trouble breathing. For more information, ask your healthcare provider or pharmacist, All Drug FDA Safety Recalls, This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. CLINICAL PHARMACOLOGY PROVERA = medroxyprogesterone acetate tablets 10 mg/day for 12 days. View NDC Code(s)NEW! Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It may harm them. The presence of other medical problems may affect the use of this medicine. Known anaphylactic reaction or angioedema to MPA. Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. You should not use medroxyprogesterone if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor. Signs of an allergic reaction, like rash; Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight. If you are a consumer or patient please visit )The increase in risk was demonstrated after the first year and persisted. Examples include rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin). Properly discard this product when it is expired or no longer needed. MPA may also affect how other medicines work. 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. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For all uses of this medicine (medroxyprogesterone tablets): Use this medicine (medroxyprogesterone tablets) as ordered by your doctor. Discuss the risks and benefits of treatment and your personal health history with your doctor. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6)-. It also works as a contraceptive. Patients should be started at the lowest dose. The relative risk of invasive breast cancer was 1.24, and the absolute risk was 41 versus 33 cases per 10,000 women-years, for CE plus MPA compared with placebo. ChildrenUse is not recommended. Long-term use of medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. 59762-3741-4, 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 16 th day of the cycle Store at room temperature away from light and moisture. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia. Medroxyprogesterone systemic 10 mg (b 555 779). Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. 1. Medroxyprogesterone acetate: Provera: Tablet: 2.5, 5 and 10 mg: Daily: Continuous HRT: $ 15.93 (6.60 to 8.95) 5 or 10 mg daily for 12 days per month starting on day 1 or day 16: Cyclic HRT: 9.48 . Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Progestins may cause some degree of fluid retention. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay, T3 resin uptake is decreased, reflecting the elevated TBG. WebMD does not provide medical advice, diagnosis or treatment. Drug classes: Contraceptives, Hormones / antineoplastics, Progestins. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. In Canada - Call your doctor for medical advice about side effects. Be ready to tell or show what was occur when the usually recommended oral dosage is given as single daily doses. Do not take 2 doses at the same time or extra doses. In these cases, your doctor may want to change the dose, or other precautions may be necessary. RxNorm, If you are taking this medicine together with an estrogen medicine, carefully follow the schedule your doctor gives you for both medicines. Other medications can affect the removal of medroxyprogesterone from your body, which may affect how medroxyprogesterone works. -Therapy may be started at any time. Estimates of the pharmacokinetic parameters of MPA after single and multiple doses of MPA tablets were highly variable and are summarized in Table 1. 59762-0056-2, 59762-0058-1, -Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Consistent with the WHI clinical trial, observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller risk for estrogen-alone therapy, after several years of use. This medication may cause blotchy, dark areas on your face and skin (melasma). A very serious allergic reaction to this drug is rare. An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5. -10 mg daily for 10 day If you think you have become pregnant while using the medicine, tell your doctor right away. The WHI estrogen plus progestin substudy was stopped early. An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. 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. This treats painful, irregular/absent menstrual periods and prevents overgrowth of the lining of the uterus in menopausal women taking oestrogen (another female hormone). 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. In postmenopausal women with documented heart disease (n = 2,763, average 66.7 years of age), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study [HERS]), treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit. For the treatment of stopped menstrual periods (amenorrhea) and abnormal bleeding from the uterus, take this drug usually once daily for 5-10 days during the second half of the planned menstrual cycle or as directed by your doctor. -In women with uterus, endometrial sampling should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. 59762-0058-2, Using this medicine while you are pregnant can harm your unborn baby. Pharmacokinetics The pharmacokinetics of MPA were determined in 20 postmenopausal women . A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. Retinal vascular thrombosis, intolerance to contact lenses. This medicine comes with a patient information leaflet. Your doctor may adjust your dose as needed. MPA is rapidly absorbed from the gastrointestinal tract, and maximum MPA concentrations are obtained between 2 to 4 hours after oral administration. Tell your Brand name: Provera Dosage forms such as TAB and CAP, ORAL are considered immediate release. Clinical studies have not been conducted in the pediatric population. (See WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use). Comments: 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. You can get more information by calling the toll-free number, 1-800-438-1985. A "global index" included the earliest occurrence of CHD, invasive breast cancer, stroke, PE, endometrial cancer (only in the CE plus MPA substudy), colorectal cancer, hip fracture, or death due to other cause. To do so may cause unwanted side effects. Tell all of your health care providers and lab workers that you take this medicine (medroxyprogesterone tablets). Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), family medical history (especially breast lumps and cancer), kidney disease, obesity, heart disease (such as past heart attacks, coronary artery disease, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes. If you have any questions about this medicine (medroxyprogesterone tablets), please talk The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. You should not use this medicine if you are allergic to medroxyprogesterone, or if you have: abnormal vaginal bleeding that has not been checked by a doctor; a history of heart attack, stroke, or blood clot; or. These substudies did not evaluate the effects of CE-alone or CE plus MPA on menopausal symptoms. This medicine is a progestin hormone. Mental depression, insomnia, somnolence, dizziness, headache, nervousness. Why is my poop green? During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. Check with your pharmacist. Limit your time in the sun. Read all information given to you. Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. After a mean follow-up of 5.6 years, the estrogen plus progestin substudy reported an increased risk of invasive breast cancer in women who took daily CE plus MPA. (current), medroxyPROGESTERone acetate 10 MG Oral Tablet, medroxyprogesterone acetate 10 MG Oral Tablet, medroxyPROGESTERone acetate 2.5 MG Oral Tablet, medroxyprogesterone acetate 2.5 MG Oral Tablet, medroxyPROGESTERone acetate 5 MG Oral Tablet, medroxyprogesterone acetate 5 MG Oral Tablet. It is usually taken everyday for 12 to 14 consecutive days per month. When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. Call your doctor for medical If you miss a dose of this medicine, take it as soon as possible. In the WHIMS estrogen plus progestin ancillary study, of WHI, a population of 4,532 postmenopausal women aged 65 to 79 years was randomized to daily CE (0.625 mg) plus MPA (2.5 mg) or placebo. Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Medroxyprogesterone is used to treat amenorrhea (unusual stopping of menstrual periods) and abnormal uterine bleeding. Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted. No specific investigation on the absolute bioavailability of MPA in humans has been conducted. Ask your doctor for more details. In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years). Avoid smoking while you are taking medroxyprogesterone. Medroxyprogesterone acetate tablets are used to: Who should not take medroxyprogesterone acetate tablets? Report Adverse This leaflet provides a summary of the most important information about medroxyprogesterone acetate tablets. (See CLINICAL STUDIES.). This condition occurs naturally in approximately 5 to 8 per 1,000 male births. In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years). Last updated on May 17, 2022. In a second 1-year study, 832 postmenopausal women between 45 and 65 years of age . (See WARNINGS, Probable Dementia.). It is used to treat females who do not have a monthly period cycle. Talk with your doctor about your individual risk. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins. Do not start taking medroxyprogesterone acetate tablets if you: What should I tell my healthcare provider before taking MPA? Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine. Store at room temperature in a dry place. Food and Drug Administration (FDA) Provera tablets Product Label, Medroxyprogesterone Injection (400 mg/mL), Medroxyprogesterone Injection (Intramuscular), Medroxyprogesterone Injection (Subcutaneous). Depo-Provera, Provera, depo-subQ provera 104. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. PROVERA is used to: Treat menstrual periods that have stopped or to treat abnormal uterine bleeding. Last updated on Oct 1, 2022. 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