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Estradiol/​Norgestimate

    Brands

    DEA Class; Rx

    Common Brand Names; Cilest, Prefest

    • Estrogens/Progestins-HRT

    Combination oral product; estradiol is the principal human circulating estrogen; norgestimate is a progestin of high progestational and low androgenic activity
    Norgestimate is added to estrogen therapy to reduce risk for endometrial hyperplasia
    Primarily used together in women with an intact uterus to treat moderate to severe vasomotor and genitourinary symptoms associated with menopause and for the prevention of osteoporosis

    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.
    For postmenopausal osteoporosis prophylaxis in women with an intact uterus.

    Hypersensitivity

    Pregnancy

    Estrogen-dependent neoplasia

    Current/history of: DVT/PE, arterial thromboembolic disease, breast cancer, liver disease/tumours

    Undiagnosed abnormal vaginal bleeding

    Jaundice with previous OCP use

    Porphyria

    History of pruritus gravidarum, pemphigoid gestationis, deterioration of otosclerosis or idiopathic jaundice during pregnancy

    Untreated endometrial hyperplasia

    Common

    • Headache

    • Breast pain

    • Abdominal pain

    • Back pain

    • URI

    • Influenza-like symptoms

    Less common

    • Cardiovascular disease

    • Deep vein thrombosis

    • Hypertension

    • Breast cancer

    • Endometrial neoplasia

    • Gallbladder disease

    Bone mineral density changes, current/history of depression, DM, HTN, hyperlipidemia, hypertriglyceridemia, obesity, endometriosis, family history of breast cancer and DVT/PE, smoking, epilepsy, migraine, renal impairment, severe hypocalcemia, ovarian cancer

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

    Increased risk of post-op thromboembolic complications

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

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

    History of migraine with aura

    Cholelithiasis

    Risk of developing dementia

    Monitor blood pressure

    Pregnancy Category: X

    Lactation: enters breast milk; use with caution

    Adults

    1 tablet/day PO, in the order directed on the blister card (e.g., Prefest).

    Geriatric

    1 tablet/day PO, in the order directed on the blister card (e.g., Prefest).

    Adolescents

    Not indicated.

    Children

    Not indicated.

    Estradiol/norgestimate

    tablet

    • Pink: 1mg (15 tabs)
    • White: 1mg/0.09mg (15 tabs)