Conjugated Estrogens + Bazedoxifene

Conjugated Estrogens + Bazedoxifene is a combination medicine indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis. Conjugated Estrogens and Bazedoxifene function by binding to and activating estrogen receptors (ER) α and β. Bazedoxifene is an estrogen agonist / antagonist that acts as an agonist in some estrogen-sensitive tissues and an antagonist in others (e.g., uterus). This combination provides the benefits of estrogen therapy while reducing the potential risk of estrogen on the uterine lining.

• Moderate to severe vasomotor symptoms associated with menopause (hot flashes)
• Prevention of postmenopausal osteoporosis

Conjugated Estrogens and Bazedoxifene function by binding to and activating estrogen receptors (ER) α and β. Bazedoxifene is an estrogen agonist / antagonist that acts as an agonist in some estrogen-sensitive tissues and an antagonist in others (e.g. uterus).

Conjugated Estrogens activate estrogen receptors to relieve vasomotor symptoms and maintain bone density. Bazedoxifene blocks estrogen effects on the uterine lining, reducing the risk of endometrial hyperplasia.

Dosage: 1 tablet once daily, without regard to meals. Tablets should be swallowed whole.

Women taking this for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin-D to their diet if daily intake is inadequate.

Take 1 tablet once daily, with or without food. Swallow whole, do not chew or crush.

If you miss a dose of this medicine, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

Common Side Effects:

• High blood pressure
• Blood clots
• Liver problems
• Thyroid problems
• Fluid retention
• Hypocalcemia
• Dementia
• Breast lumps
• Unusual vaginal bleeding
• Severe headache
• Muscle spasms
• Weakness and fatigue
• Nausea
• Diarrhea
• Throat pain
• Dizziness

• Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia.
• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.
• Do not use in women with undiagnosed abnormal uterine bleeding, breast cancer history, estrogen-dependent neoplasia, active DVT/PE, arterial thromboembolic disease, hepatic impairment, or thrombophilic disorders.

• Undiagnosed abnormal uterine bleeding
• Known, suspected, or past history of breast cancer
• Known or suspected estrogen-dependent neoplasia
• Active DVT, PE, or history of these conditions
• Active arterial thromboembolic disease
• Hypersensitivity to estrogens, bazedoxifene, or any ingredients
• Known hepatic impairment or other thrombophilic disorders
• Pregnancy and lactation

Estrogens are metabolized partially by CYP3A4. Concomitant use with CYP3A4 inhibitors may increase the exposure of conjugated estrogens and thereby may increase the risk of endometrial hyperplasia.

Can be taken with or without food.

Pregnancy Category X. Must not be used in women who are or may become pregnant.

Should not be used by lactating women. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk.

Not indicated for use in children.

Limited information is available regarding dose adjustment for elderly patients.

Contraindicated in hepatic impairment.

Overdose symptoms: nausea, vomiting, breast tenderness, dizziness, abdominal pain, fatigue; withdrawal bleeding may occur. No specific antidote; treatment should be symptomatic.

Do not store above 30°C. Keep away from light. After opening foil pouch, product must be used within 60 days. Keep out of reach of children.

Conjugated Estrogens + Bazedoxifene