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PROVERA®(medroxyprogesterone acetate)

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PROVERA® Quick Finder

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY

Cardiovascular Disorders and Probable Dementia

Estrogen...

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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

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

PROVERA is contraindicated in women with any of the following conditions:

  1. Undiagnosed abnormal genital bleeding.
  2. Known, suspected, or history of breast cancer.
  3. Known or suspected...
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WARNINGS

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1. Cardiovascular Disorders

An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should any of these events occur or...

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ADVERSE REACTIONS

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1. Genitourinary system

Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea,...

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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

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

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

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

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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PATIENT INFORMATION

PROVERA
(
pro-VE-rah)
(medroxyprogesterone acetate tablets, USP)

Read this Patient Information before you start...

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Rx only

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LAB-0144-8.0
January 2018

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