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DEPO-PROVERA® CI (medroxyprogesterone acetate injectable suspension, for intramuscular use)
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DEPO-PROVERA® CI Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
1 INDICATIONS AND USAGE
Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy.
...
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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Depo-Provera CI should not be administered during pregnancy. [See Contraindications...
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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
[See Warnings and Precautions, (5.3,...
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Clinical Studies
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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References
15 REFERENCES
- 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.
- Paul C, Skegg DCG, Spears...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Depo-Provera CI is supplied in the following strengths and package configurations:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
"See FDA-approved patient labeling (Patient Information)."
- Advise patients at the beginning of treatment that their menstrual cycle...
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