
Bestron0.45 mg +
Incepta Pharmaceuticals Ltd.
Established (FDA-Approved) Indications Treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.
Conjugated Estrogen + Bazedoxifene is specifically formulated for women who have a uterus, because the bazedoxifene component in Conjugated Estrogen + Bazedoxifene protects the lining of the uterus (endometrium) against estrogen-related overgrowth, removing the need for a separate progestin. Conjugated Estrogen + Bazedoxifene is not indicated for women who have had a hysterectomy (no uterus), since a separate progestin is not required in that group and combined estrogen-only products are typically used instead.
Conjugated Estrogen + Bazedoxifene is not indicated for contraception, for use in premenopausal women, or for prevention of cardiovascular disease or dementia; clinical evidence does not support benefit for these uses and, for cardiovascular disease and dementia, suggests possible harm (see Precautions and Warnings).
| Indication | Recommended Dose of Conjugated Estrogen + Bazedoxifene |
|---|---|
| Moderate-to-severe vasomotor symptoms (hot flashes) of menopause | One tablet by mouth once daily |
| Prevention of postmenopausal osteoporosis (women with a uterus) | One tablet by mouth once daily |
No specific dose adjustment has been established for renal impairment. Conjugated Estrogen + Bazedoxifene is contraindicated in women with known hepatic impairment or liver disease (see Contraindications).
See Precautions and Warnings for serious cardiovascular, thromboembolic, and gallbladder risks associated with Conjugated Estrogen + Bazedoxifene. Contact a physician promptly for calf pain/swelling, sudden chest pain, sudden severe headache, vision changes, or signs of an allergic reaction.
Conjugated Estrogen + Bazedoxifene is contraindicated in women with any of the following:
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