Classes
DEA Class; Rx
Common Brand Names; Covaryx, Estratest, Estratest H.S.
- Estrogen and Androgen Combos
Description
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
Indications
Treatment of moderate-to-severe vasomotor symptoms associated with menopause in patients not improved by estrogens alone
Use lowest dose that will control symptoms
Contraindications
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
Adverse Effects
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
Warnings
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 and Lactation
Pregnancy Category: X
Lactation: Excreted into breast milk; contraindicated
Maximum Dosage
Females: 1.25 mg/day PO of esterified estrogens with 2.5 mg/day PO of methyltestosterone.
Females: 1.25 mg/day PO of esterified estrogens with 2.5 mg/day PO of methyltestosterone.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Estrogens esterified/methyltestosterone
tablet
- 0.625mg/1.25mg
- 1.25mg/2.5mg
