Conjugated Estrogen + Bazedoxifene

This preparation is indicated for 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).

Take Bestron once daily, without regard to meals. Tablets should be swallowed whole. Women taking Bestron for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin-D to their diet if daily intake is inadequate.

Use in Children: Bestron is not indicated for use in children.

No drug interaction studies were conducted with This tablet. Estrogens are metabolized partially by CYP3A4. Concomitant use of this tablet with CYP3A4 inhibitors may increase the exposure of conjugated estrogens and thereby may increase the risk of endometrial hyperplasia.

Bestron is contraindicated in women with undiagnosed abnormal uterine bleeding; known, suspected, or past history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep venous thrombosis, pulmonary embolism, or history of these conditions; active arterial thromboembolic disease; hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients; known hepatic impairment or other known thrombophilic disorders.

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 etc.

Pregnancy Category X. Bestron must not be used in women who are or may become pregnant. Bestron should not be used by lactating women. It is not known whether this drug is excreted in human milk. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk.

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.

In case of overdosage, there is no specific antidote, and the treatment should besymptomatic. Symptoms of overdosage of estrogen-containing products may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, fatigue; withdrawal bleeding may occur.

Female Sex hormones

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