Label: MEDROXYPROGESTERONE ACETATE injection, suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to useMEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION safely and effectively. See full prescribing information for MEDROXYPROGESTERONE ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: LOSS OF BONE MINERAL DENSITY

    • Women who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible[see Warnings and Precautions (5.1)] .
    • It is unknown if use of medroxyprogesterone acetate injectable suspension during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life[see Warnings and Precautions (5.1)] .
    • Medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e. longer than 2 years) birth control method unless other options are considered inadequate [see Indications and Usage (1)and Warnings and Precautions (5.1)].
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  • 1 INDICATIONS AND USAGE
    Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Prevention of Pregnancy - Both the 1 mL vial and the 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension should be vigorously shaken just before use to ensure that the ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Sterile Aqueous suspension: 150 mg/mL - Prefilled syringes are available packaged with 22-gauge x 1 1/2 inch Needles.
  • 4 CONTRAINDICATIONS
    The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Active thrombophlebitis, or current or history of thromboembolic disorders, or ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Loss of Bone Mineral Density - Use of medroxyprogesterone acetate reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of ...
  • 6 ADVERSE REACTIONS
    The following important adverse reactions observed with the use of medroxyprogesterone acetate are discussed in greater detail in the - Warnings and Precautionssection(5): Loss of Bone ...
  • 7 DRUG INTERACTIONS
    7.1 Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products - If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There is no use for contraception in pregnancy; therefore, medroxyprogesterone acetate should be discontinued during pregnancy. Epidemiologic studies and ...
  • 11 DESCRIPTION
    Medroxyprogesterone Acetate Injectable Suspension, USP contains medroxyprogesterone acetate, USP, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate, USP is active ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Medroxyprogesterone acetate (MPA) inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - [see Warnings and Precautions ( 5.3, 5.14) and - Use in Specific Populations ( 8.3)].
  • 14 CLINICAL STUDIES
    14.1 Contraception - In five clinical studies using medroxyprogesterone acetate, the 12-month failure rate for the group of women treated with medroxyprogesterone acetate was zero (no pregnancies ...
  • 15 REFERENCES
    1.   Li CI, Beaber EF, Tang, MCT et al. Effect of Depo-Medroxyprogesterone Acetate on Breast Cancer Risk among Women 20 to 44 years of Age. Cancer Research 2012;72:2028-2035. 2.   Paul C, Skegg ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Medroxyprogesterone Acetate Injectable Suspension, USP is supplied in the following strength and package configuration: Medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL - NDC ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise patients at the beginning of treatment that their menstrual cycle may be disrupted and that irregular ...
  • Patient Information
    Medroxyprogesterone Acetate(med rox'' ee proe jes' ter one as' e tate) Injectable Suspension - , USP - Read this Patient Information carefully before you decide if medroxyprogesterone acetate ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: medroxyprogesterone acetate - GENERIC: medroxyprogesterone acetate - DOSAGE: INJECTION, SUSPENSION - ADMINSTRATION: INTRAMUSCULAR - NDC: 70518-4324-0 - PACKAGING: 1 mL in 1 SYRINGE, GLASS - OUTER ...
  • INGREDIENTS AND APPEARANCE
    Product Information