Drospirenone/Estradiol

DEA Class; Rx

Common Brand Names; Angeliq

Indicated for treatment of moderate to severe vasomotor symptoms (hot flashes) of menopause and/or related genitourinary symptoms including atrophic vaginitis, vulvar atrophy (kraurosis vulvae) in women with an intact uterus.

Hypersensitivity

Undiagnosed abnormal genital bleeding

Known, suspected, or history of cancer of the breast

Known or suspected estrogen-dependent neoplasia

Active DVT, PE, or a history of these conditions

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

Renal impairment

Known liver impairment or disease

Adrenal insufficiency

Known or suspected pregnancy

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

Known anaphylactic reaction, angioedema, or hypersensitivity

Use caution in bone mineral density changes, current/history of depression, DM, HTN, hyperlipidemia, obesity, endometriosis, family history of breast cancer, DVT/PE, smoking

Discontinue if the following develop: jaundice, visual problems, 4-6 wk before major surgery, any symptoms of VTE, massive BP increase, unusually severe migraines or first-time migraines, depression

Increased risk of post-op thromboembolic complications, arterial/venous thromboembolic disorder, hyperkalemia, exacerbation of endometriosis

Do not use with conditions that predispose to hyperkalemia

Conditions exacerbated by fluid retention (eg, asthma, migraine, cardiac/renal dysfunction, epilepsy)

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

History of migraine with aura

Cholelithiasis

Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema

Consider topical vaginal products when used solely for vulvovaginal atrophy

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

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

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

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

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

Pregnancy Category: contraindicated in pregnancy

Lactation: enters breast milk/not recommended