HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DEPO-PROVERA CI safely and effectively. See full prescribing information for DEPO-PROVERA CI.
DEPO-PROVERA CI (medroxyprogesterone acetate) injectable suspension, for intramuscular use
Initial U.S. Approval: 1959
WARNING: LOSS OF BONE MINERAL DENSITY
See full prescribing information for complete boxed warning.
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
Most common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Depo-Provera CI. (7.1)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.