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DEPO-PROVERA® CI (medroxyprogesterone acetate injectable suspension, for intramuscular use)

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DEPO-PROVERA® CI Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: LOSS OF BONE MINERAL DENSITY

Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely...

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1 INDICATIONS AND USAGE

Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy.

...
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2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Pregnancy

Both the 1 mL vial and the 1 mL prefilled syringe of Depo-Provera CI should be vigorously shaken just before...

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3 DOSAGE FORMS AND STRENGTHS

Sterile Aqueous suspension: 150mg/ml

Prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Terumo® SurGuard™ Needles.

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4 CONTRAINDICATIONS

The use of Depo-Provera CI is contraindicated in the following conditions:

  • Known or suspected pregnancy or as a diagnostic test for pregnancy.
  • Active thrombophlebitis, or current or...
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5 WARNINGS AND PRECAUTIONS

5.1 Loss of Bone Mineral Density

Use of Depo-Provera CI reduces serum estrogen levels and is associated with significant loss of bone...

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6 ADVERSE REACTIONS

The following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the Warnings and Precautions section (...

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7 DRUG INTERACTIONS

7.1 Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Products

If a woman on hormonal contraceptives takes a...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Depo-Provera CI should not be administered during pregnancy. [See Contraindications...

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11 DESCRIPTION

Depo-Provera CI contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Depo-Provera CI (medroxyprogesterone acetate [MPA]) inhibits the secretion of gonadotropins which primarily...

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14 CLINICAL STUDIES

14.1 Contraception

In five clinical studies using Depo-Provera CI, the 12-month failure rate for the group of women treated with Depo-Provera CI...

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15 REFERENCES

  1. Li CI, Beaber EF, Tang, MCT et al. Effect of Depo-Medroxyprogesterone Acetate on Breast Cancer Risk among Women 20 to 44 years of Age. Cancer Research 2012;72:2028–2035.
  2. Paul C, Skegg DCG, Spears...
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16 HOW SUPPLIED/STORAGE AND HANDLING

Depo-Provera CI is supplied in the following strengths and package configurations:

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FDA Medwatch
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.