HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 DENSITYSee full prescribing information for complete boxed warning.
RECENT MAJOR CHANGES
INDICATIONS AND USAGEDOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions (incidence >5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lb 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. DRUG INTERACTIONSDrugs 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 POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 7/2024 |
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 DENSITYSee full prescribing information for complete boxed warning.
RECENT MAJOR CHANGES
INDICATIONS AND USAGEDOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions (incidence >5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lb 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. DRUG INTERACTIONSDrugs 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 POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 7/2024 |
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