Estradiol and Medroxyprogesterone interaction

…increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo [see CLINICAL PHARMACOLOGY , Clinical Studies ].

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo.

Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar.

CARDIOVASCULAR AND OTHER RISKS Estrogens and progestins should not be used for the prevention of cardiovascular disease [see WARNINGS , Cardiovascular disorders ].

Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

The following laboratory tests may be affected by progestins including MPA Injectable Suspension, USP: (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol).

Loss of Bone Mineral Density Use of MPA Injectable Suspension, USP reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD).

Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including MPA Injectable Suspension, USP, because breast cancer may be hormonally sensitive [see Contraindications (4) ].

Monitoring A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare professional for a blood pressure check and for other indicated healthcare.

Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives.