DEPO-PROVERA® CI Use in Specific Populations

(medroxyprogesterone acetate injectable suspension, for intramuscular use)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Depo-Provera CI should not be administered during pregnancy. [See Contraindications and Warnings and Precautions (5.17).]

8.3 Nursing Mothers

Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. [See Warnings and Precautions (5.13).]

8.4 Pediatric Use

Depo-Provera CI is not indicated before menarche. Use of Depo-Provera CI is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of Depo-Provera CI by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

8.5 Geriatric Use

This product has not been studied in post-menopausal women and is not indicated in this population.

8.6 Renal Impairment

The effect of renal impairment on Depo-Provera CI pharmacokinetics has not been studied.

8.7 Hepatic Impairment

The effect of hepatic impairment on Depo-Provera CI pharmacokinetics has not been studied. Depo-Provera CI should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. [See Contraindications (4) and Warnings and Precautions (5.7).]

Find DEPO-PROVERA® CI medical information:

Find DEPO-PROVERA® CI medical information:

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 Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Depo-Provera CI should not be administered during pregnancy. [See Contraindications and Warnings and Precautions (5.17).]

8.3 Nursing Mothers

Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. [See Warnings and Precautions (5.13).]

8.4 Pediatric Use

Depo-Provera CI is not indicated before menarche. Use of Depo-Provera CI is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of Depo-Provera CI by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

8.5 Geriatric Use

This product has not been studied in post-menopausal women and is not indicated in this population.

8.6 Renal Impairment

The effect of renal impairment on Depo-Provera CI pharmacokinetics has not been studied.

8.7 Hepatic Impairment

The effect of hepatic impairment on Depo-Provera CI pharmacokinetics has not been studied. Depo-Provera CI should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. [See Contraindications (4) and Warnings and Precautions (5.7).]

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, 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 this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

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/medwatch or call (800) 822-7967.