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Esterified Estrogens/Methyltestosterone

    Brands

    DEA Class; Rx

    Common Brand Names; Covaryx, Estratest, Estratest H.S.

    • Estrogen and Androgen Combos

    Mixture of esterified estrogens plus an androgen
    Used for moderate to severe vasomotor symptoms associated with menopause which are not improved by estrogens alone
    Considered an unapproved drug product by the FDA; manufacturers must submit data for safety and efficacy to remain on market

    Treatment of moderate-to-severe vasomotor symptoms associated with menopause in patients not improved by estrogens alone

    Use lowest dose that will control symptoms

    For the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause in women not achieving adequate therapeutic response on estrogen replacement alone.

    Pregnancy, lactation

    Estrogen-dependent neoplasia

    Breast cancer

    Estrogen dependent tumor

    Liver dysfunction or disease

    Undiagnosed abnormal vaginal bleeding

    Active/history of DVT/PE

    Active/recent thromboembolic disease

    Hypersensitivity

    Edema

    Headache

    Acne, alopecia

    Breast soreness,

    Menstrual irregularities

    Bloating

    Nausea

    Hypercalcemia

    Hypercholesterolemia

    Cholestatic hepatitis

    Vomiting

    Anaphylaxis

    Suppression of clotting factors II, V, VII

    Polycythemia

    Paresthesia

    Cardiac disease, renal disease, DM, endometriosis, hyperlipidemias, HTN, hypothyroidism

    Increased risk of VTE

    Fluid retention may exacerbate asthma, epilepsy, migraines, & cardiac or renal dysfunction

    Increased risk of ovarian and endometrial cancer

    Concomitant warfarin, oral anticoagulants: may need to incr anticoagulant dose

    Estrogen may cause retinal vascular thrombosis; discontinue if migraine, proptosis, loss of vision, diplopia, or other vision abnormalities occur

    Women with thrombophilias may experience increased risk of venous thromboembolism

    Use caution in patients with familial defects of lipoprotein metabolism; triglycerides and HDL cholesterol may increase while LDL cholesterol may decrease

    Pregnancy Category: X

    Lactation: Excreted into breast milk; contraindicated

    Adults

    Females: 1.25 mg/day PO of esterified estrogens with 2.5 mg/day PO of methyltestosterone.

    Geriatric

    Females: 1.25 mg/day PO of esterified estrogens with 2.5 mg/day PO of methyltestosterone.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.
     

    Neonates

    Safety and efficacy have not been established.

    Estrogens esterified/methyltestosterone

    tablet

    • 0.625mg/1.25mg
    • 1.25mg/2.5mg