Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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.

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

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: LOSS OF BONE MINERAL DENSITY

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Pregnancy

2.2 Switching From Other Methods of Contraception

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Loss of Bone Mineral Density

5.2 Thromboembolic Disorders

5.3 Cancer Risks

5.4 Ectopic Pregnancy

5.5 Anaphylaxis and Anaphylactoid Reaction

5.6 Injection Site Reactions

5.7 Liver Function

5.8 Convulsions

5.9 Depression

5.10 Bleeding Irregularities

5.11 Weight Gain

5.12 Carbohydrate Metabolism

5.13 Lactation

5.14 Fluid Retention

5.15 Return of Fertility

5.16 Sexually Transmitted Diseases

5.17 Pregnancy

5.18 Monitoring

5.19 Interference With Laboratory Tests

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

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

7.2 Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Contraception

14.2 Bone Mineral Density Changes in Women Treated with Depo-Provera CI

14.3 Bone Mineral Density Changes in Adolescent Females (12 to 18 Years of Age) Treated with Depo-Provera CI

14.4 Bone Fracture Incidence in Women Treated with Depo-Provera CI

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event