PROVERA® medroxyprogesterone acetate Patient information US

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 another study, the steady-state pharmacokinetics of MPAwere determined under fasting conditions in 30 postmenopausal women followingdaily administration of one PROVERA 10 mg tablet for 7 days. In both studies,MPA was quantified in serum using a validated gas chromatography-massspectrometry (GC-MS) method.

• To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of PROVERA daily for 10 days beginning on the 16th day of the cycle is suggested.
• A 10 mg dose of PROVERA, taken immediately before orafter a meal, increased MPA Cmax (50 to 70%) and AUC (18 to 33%).
• PROVERA tablets are 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.
• Self-examine your breasts for lumps on a monthly basis, and have regular pelvic exam, breast exam and mammograms while taking Provera.

Provera is not the same thing as Depo-Provera, the injectable birth control drug. You’ll need to use another birth control method to avoid pregnancy. Keep in mind that Provera can’t always be taken along with hormonal birth control. Add your drug list to My Med List to view medical information in a simple, easy-to-read, personalized format. Automatically receive FDA alerts, drug interaction warnings, plus data on food, allergy & condition interactions.

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The use of contraceptives is contraindicated when there is an undiagnosed abnormal genital bleeding. Adequate diagnostic measures should be undertaken to rule synthroid prolactin out the presence of any malignancy. Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

Reduction Of Endometrial Hyperplasia In Postmenopausal

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. PROVERA tablets are 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. They are 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. PROVERA tablets are indicated for the treatment ofsecondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance inthe absence of organic pathology, such as fibroids or uterine cancer.

Provera may actually increase your risk of developing these conditions. Provera is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed. Provera is prescribed to treat irregular menstruation and conditions like PCOS and endometrial hyperplasia.

Also, your healthcare provider may want you to get more frequent lab work to check your thyroid hormone levels. Any vaginal bleeding in a postmenopausal female with a uterus should be evaluated to rule out cancer. If you’ve never taken estrogens, your healthcare provider may prescribe it first for certain conditions. If you don’t tolerate estrogen or it’s not effective enough, you may be switched to Provera or have Provera added to your estrogen regimen.

• On the contrary, a decrease in TBG and, consequently, thyroxine concentration, has been reported by the manufacturers of the progestin-only (norethindrone) oral contraceptives.
• I go over with them the fact that they should check the label at the pharmacy, on the bottle, to make sure it says brand-name SYNTHROID and not generic levothyroxine.
• (See CLINICAL STUDIES.) Should a VTE occur or be suspected, estrogen plus progestin therapy should be discontinued immediately.

The pharmacokinetics of MPA were determined in 20 postmenopausal women following a single-dose administration of eight PROVERA 2.5 mg tablets or a single administration of two PROVERA 10 mg tablets under fasting conditions. In another study, the steady-state pharmacokinetics of MPA were determined under fasting conditions in 30 postmenopausal women following daily administration of one PROVERA 10 mg tablet for 7 days. In both studies, MPA was quantified in serum using a validated gas chromatography-mass spectrometry (GC-MS) method. Estimates of the pharmacokinetic parameters of MPA after single and multiple doses of PROVERA tablets were highly variable and are summarized in Table 1. Timing of the initiation of estrogen plus progestintherapy relative to the start of menopause may affect the overall risk benefitprofile. The WHI estrogen plus progestin substudy stratified by age showed in women50 to 59 years of age a nonsignificant trend toward reduced risk in overallmortality hazard ration (HR) 0.69 (95 percent CI, 0.44–1.07).

PROVERA® Warnings and Precautions

Read this Patient Information before you start taking PROVERA and read what you get each time you refill your PROVERA prescription. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Read this Patient Information before you start takingPROVERA and read what you get each time you refill your PROVERA prescription.There may be new information.

MPA is approximately 90% protein bound, primarily to albumin; no MPA binding occurs with sex hormone binding globulin. Administration of PROVERA with food increases the bioavailability of MPA. A 10 mg dose of PROVERA, taken immediately before or after a meal, increased MPA Cmax (50 to 70%) and AUC (18 to 33%). 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. Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.

Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal genital bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.