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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).]

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