Conjugated Estrogens/​Medroxyprogesterone

DEA Class; Rx

Common Brand Names; Premphase, Prempro

Undiagnosed abnormal genital bleeding

Known, suspected, or history of breast cancer

Known or suspected estrogen-dependent neoplasiaActive DVT, PE, or a history of these conditions

Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions

Known anaphylactic reaction or angioedema to PREMPRO/PREMPHASE

Known liver dysfunction or disease

Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Known or suspected pregnancy

An increased risk of PE, DVT, stroke and MI reported with estrogen plus progestin therapy; an increased risk of stroke and DVT reported with estrogen-alone therapy;should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately

Use caution in patients with bone mineral density changes, current/history of depression, diabetes mellitus, HTN, hyperlipidemia, hypertriglyceridemia, obesity, endometriosis, family history of breast cancer and/or DVT/PE, smoking, severe hypocalcemia

If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery or prolonged immobilization or there are any symptoms of VTE, massive BP increase, unusually severe migraines or first-time migraines, depression

Retinal vascular thrombosis reported in patients receiving estrogens; discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine; if examination reveals papilledema or retinal vascular lesions, estrogens should be discontinued

Increased risk of post-op thromboembolic complications, MI, stroke, pulmonary emboli, DVT, Alzheimer’s disease, cardiovascular disorders, probable dementia, and endometrial cancer

Increased risk of endometrial cancer reported with use of unopposed estrogen therapy in a woman with a uterus; the reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 times greater than in non-users and appears dependent on duration of treatment and on estrogen dose

Manage appropriately risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (eg, personal history or family history of VTE, obesity, and systemic lupus erythematosus)

Use caution in patients with conditions exacerbated by fluid retention (eg, asthma, migraine, cardiac/renal dysfunction, epilepsy)

Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions

Patients on warfarin/oral anticoagulants: estrogens increase thromboembolic risk; increase in anticoagulant dose may be warranted

Angioedema involving the tongue, larynx, face, hands, and feet requiring medical intervention has occurred postmarketing in patients taking this therapy; if angioedema involves the tongue, glottis, or larynx, airway obstruction may occur; patients who develop an anaphylactic reaction with or without angioedema after treatment should permanently discontinue therapy

Not for use with conditions that predispose to hyperkalemia

Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases; if hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce serum calcium level

Increased risk of ovarian cancer reported in women who used hormonal therapy for menopausal symptoms

Clinical surveillance of all women using estrogen-alone or estrogen plus progestin therapy is important; adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding

A 2 to 4-fold increase in risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens reported

There are, possible risks that may be associated with use of progestins with estrogens compared to estrogen-alone regimens, including a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL), and impairment of glucose tolerance

This drug combination should not be used during pregnancy; there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy

This drug combination should not be used during lactation; estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk

0.625 mg/day PO of conjugated estrogens with 5 mg/day PO of medroxyprogesterone.

0.625 mg/day PO of conjugated estrogens with 5 mg/day PO of medroxyprogesterone.

Not indicated.

Not indicated.

Not indicated.