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PROVERA® medroxyprogesterone acetate Medication Guide US
PROVERA® medroxyprogesterone acetate Medication Guide US
Other drugs may interact with medroxyprogesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted. Inducers and/or inhibitors of CYP3A4 may affect the metabolism of MPA. The following adverse reactions have been reported with estrogen plus progestin therapy. Medroxyprogesterone acetate (MPA) is metabolized in-vitroprimarily by hydroxylation via the CYP3A4.
- In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use medroxyprogesterone only for the indication prescribed.
- It also helps your patient pay the lowest possible price for the product you write if it is billed through insurance.
- Use ofestrogen, alone or in combination with a progestin, should be with the lowesteffective dose and for the shortest duration consistent with treatment goalsand risks for the individual woman.
- This is important as 32% of patients who think they are on SYNTHROID are actually not given this because substitutions are made at the pharmacy.
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- In addition to testing TSH, sometimes it may be important to run other labs such as a free T4, in addition to the TSH, to ensure you have accurate dosing in the medication.
- The pharmacokinetics of MPA were determined in 20postmenopausal women following a single-dose administration of eight PROVERA2.5 mg tablets or a single administration of two PROVERA 10 mg tablets underfasting conditions.
- In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
- Do not stop using any medications without first talking to your doctor.
- Clinical surveillance of all women using estrogen plusprogestin therapy is important.
- Should any of these events occuror be suspected, estrogen plus progestin therapy should be discontinuedimmediately.
They arealso indicated for use in the prevention of endometrial hyperplasia in nonhysterectomizedpostmenopausal women who are receiving daily oral conjugated estrogens 0.625 mgtablets. Clinical surveillance of all women using estrogen plusprogestin therapy is important. Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.
Provera is usually given for only a few days in a row each month. You will need to take a pregnancy test before, during, and after treatment with Provera. Leuprolide is used to treat endometriosis, prostate cancer, and early-onset puberty. We’re here to listen and help.You’ll talk to an experienced advisor right here in Maine. If taking Provera, do so as directed and watch for any symptoms or side effects. If you take Provera with estrogen, be sure you’re aware of the estrogen side effects, as well.
My doctor wants me to use Provera, but I’ve read it’s a synthetic hormone. Should I?
(See CLINICAL STUDIES.) Should a VTE occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary (see WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Consistent with the WHI clinical trial, observationalstudies have also reported an increased risk of breast cancer for estrogen plusprogestin therapy, and a smaller risk for estrogen-alone therapy, after severalyears of use.
MPA is approximately 90% protein bound, primarily toalbumin; no MPA binding occurs with sex hormone binding globulin. Administration of PROVERA with food increases thebioavailability of MPA. A 10 mg dose of PROVERA, taken immediately before orafter a meal, increased MPA Cmax (50 to 70%) and AUC (18 to 33%).
- Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
- A key part for the patients is to make sure that they’re getting the brand-name SYNTHROID that we have prescribed.
- For women whohave a uterus, adequate diagnostic measures, such as endometrial sampling, whenindicated, should be undertaken to rule out malignancy in cases of undiagnosedpersistent or recurring abnormal vaginal bleeding.
- In the elderly and in patients with cardiovascular disease, SYNTHROID should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease.
- Most women using medroxyprogesterone experience disruption of menstrual bleeding patterns.
Most women using medroxyprogesterone experience disruption of menstrual bleeding patterns. Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding. Rule out the possibility of organic pathology if abnormal bleeding persists or is severe, and institute appropriate treatment. The use of intramuscular medroxyprogesterone for contraception synthroid toprol has been shown to induce bone loss, particularly during the early years of therapy. With continued use, the decline in bone density subsequently approaches the normal rate of age-related loss.
So, my job as a thyroid specialist in these patients is to make sure my patient is treated and gets to a point of consistency, because it is a lifelong course of medication. Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
However, most hormones, including progestational hormones, are known to be extensively metabolized by the liver. Medroxyprogesterone should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. There may be increased risks for hypospadias, clitoralenlargement and labial fusion in children whose mothers are exposed to PROVERAduring the first trimester of pregnancy. However, a clear association betweenthese conditions with use of PROVERA has not been established.
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. These results reflect centrally adjudicated data after an average follow-up of 5.6 years. In 14 patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination). In patients with fatty liver, the mean percent dose excreted in the 24-hour urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively. No specific investigation on the absolute bioavailability of MPA in humans has been conducted. MPA is rapidly absorbed from the gastrointestinal tract, and maximum MPA concentrations are obtained between 2 to 4 hours after oral administration.
Related/similar drugs
Look to see if the tablets have Synthroid embossed on them to ensure they’re getting the right product. There are certain foods that can interfere with the way SYNTHROID works, particularly we think about high-fiber foods that can interact with the absorption of thyroid medications. There are also certain vitamins and supplements that can interfere with the absorption of SYNTHROID. Some key points that I discuss with the patients during appointments are, one, is that this is an open conversation. A levothyroxine product that is not therapeutically equivalent with SYNTHROID might not have the exact same effect on the patient’s TSH as SYNTHROID.
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