파루탈정(메드록시프로게스테론아세테이트)

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) ] . Medroxyprogesterone acetate injectable suspension is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1) 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. (1 , 5.1)

The use of medroxyprogesterone acetate injectable suspension 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 (medroxyprogesterone acetate) 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 ) ] . Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. (4) Known or suspected malignancy of breast. (4) Known hypersensitivity to medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate or any of its other ingredients). (4) Significant liver disease. (4) Undiagnosed …

Thromboembolic Disorders: Discontinue medroxyprogesterone acetate in patients who develop thrombosis. (5.2) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. (5.3) Meningioma: Discontinue medroxyprogesterone acetate if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. ( 5.4 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate becomes pregnant or complains of severe abdominal pain. (5.5) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. (5.6) Liver Function: Discontinue medroxyprogesterone acetate if jaundice or disturbances of liver function develop. (5.8) Carbohydrate Metabolism: Monitor diabetic patients carefully. (5.13) 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 particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of medroxyprogesterone acetate by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. A study to assess the reversibility of loss of BMD in adolescents was conducted with medroxyprogesterone acetate. After discontinuing medroxyprogesterone acetate in these adolescents, mean BMD loss at the total hip and femoral neck did not fully recover by 5 years (60 months) …

8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, medroxyprogesterone acetate should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to progestins before conception or during early pregnancy. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.