Medroxyprogesterone Acetate (12 brand names, 2 dosage forms, 5 routes)
Available dosage forms: INJECTABLE, TABLET.
Routes of administration: INJECTION, ORAL, ORAL-28, SUBCUTANEOUS, INTRAMUSCULAR.
Brand Names
- AMEN
- CURRETAB
- CYCRIN
- DEPO-PROVERA
- DEPO-SUBQ PROVERA 104
- LUNELLE
- MEDROXYPROGESTERONE ACETATE
- PREMPHASE (PREMARIN;CYCRIN 14/14)
- PREMPHASE 14/14
- PREMPRO
- PREMPRO (PREMARIN;CYCRIN)
- PROVERA
Boxed Warning
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)].
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 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 Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
Contraindications
The use of medroxyprogesterone acetate is contraindicated in the following conditions: Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2)]. Known or suspected malignancy of breast [see Warnings and Precautions (5.3)]. Known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients [see Warnings and Precautions (5.6)]. Significant liver disease [see Warnings and Precautions (5.8)]. Undiagnosed vaginal bleeding [see Warnings and Precautions (5.11)].
Adverse Reactions
The following important adverse reactions observed with the use of medroxyprogesterone acetate are discussed in greater detail in the Warnings and Precautions section ( 5 ): Loss of Bone Mineral Density [see Warnings and Precautions (5.1)] Thromboembolic disease [see Warnings and Precautions (5.2)] Breast Cancer [see Warnings and Precautions (5.3)] Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.6)] Bleeding Irregularities [see Warnings and Precautions (5.11)] Weight Gain [see Warnings and Precautions (5.12)]
Mechanism of Action
Medroxyprogesterone acetate (MPA) inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.