WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
Cardiovascular Disorders and Probable Dementia
Estrogen...
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PROVERA® (medroxyprogesterone acetate)
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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
PROVERA® Quick Finder
Indications and Usage
INDICATIONS AND USAGE
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....
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Dosage and Administration
DOSAGE AND ADMINISTRATION
Secondary Amenorrhea
PROVERA tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory...
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Contraindications
CONTRAINDICATIONS
PROVERA is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected...
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Warnings and Precautions
WARNINGS
See BOXED WARNINGS.
1. Cardiovascular Disorders
An increased risk of PE, DVT, stroke, and MI...
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Adverse Reactions
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Overdosage
OVERDOSAGE
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. Treatment of overdose...
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Description
DESCRIPTION
PROVERA® tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and...
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Clinical Pharmacology
CLINICAL PHARMACOLOGY
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic...
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Clinical Studies
CLINICAL STUDIES
Effects on the Endometrium
In a 3-year, double-blind, placebo-controlled study of 356 nonhysterectomized, postmenopausal women between 45 and 64...
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How Supplied/Storage and Handling
HOW SUPPLIED
PROVERA Tablets are available in the following strengths and package sizes:
2.5 mg tablets (scored, round, orange, imprinted PROVERA 2.5)
- Bottles of 100: NDC...
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Medication Guide
PATIENT INFORMATION
PROVERA
(pro-VE-rah)
(medroxyprogesterone acetate tablets, USP)
Read this Patient Information before you start...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.