Bestron Tablet

Bazedoxifene + Conjugated estrogens

20 mg + 450 mcg

Incepta Pharmaceuticals Ltd.

Pack size	20's pack
Unite Price	80.00 BDT

Indications

Bestron Tablet is used for: Menopausal Vasomotor Symptoms, Osteoporosis

Adult Dose

Oral Menopausal Vasomotor Symptoms Indicated for vasomotor symptoms associated with menopause 20 mg/0.45 mg (1 tablet) once daily Osteoporosis Indicated for prevention of postmenopausal osteoporosis 20 mg/0.45 mg (1 tablet) once daily Hepatic impairment: Contraindicated

Child Dose

Renal Dose

Renal impairment: Not evaluated, and therefore not recommended

Administration

May take with or without food

Contra Indications

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 (eg, stroke, MI) or history of these conditions Hypersensitivity (eg, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients Known hepatic impairment or disease Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders Pregnancy, women who may become pregnant, and nursing mothers; may cause fetal harm when administered to a pregnant woman

Precautions

Endometrial hyperplasia Increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens; bazedoxifene/conjugated estrogens has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Estrogens and estrogen agonist/antagonists are known to increase risk of thromboembolism, including DVT, PE, and stroke Discontinue 4-6 weeks before surgery that is associated with increased risk of thromboembolism, or during periods of prolonged immobilization Retinal vascular thrombosis reported Estrogens may exacerbate pre-existing hypertriglyceridemia and lead to pancreatitis Caution with history of cholestatic jaundice associated with past estrogen use or with pregnancy Do not use with conditions that predispose to hyperkalemia Use caution in individuals with severe hypocalcemia

Pregnancy-Lactation

Pregnancy Contraindicated for use in pregnant women; not indicated for use in females of reproductive potential There are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy There are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes Based on animal data, bazedoxifene administration may adversely affect female fertility; ;owever, clinical fertility studies with bazedoxifene not conducted Animal data Animal studies have shown that oral bazedoxifene administered during period of organogenesis to pregnant rats or rabbits at 0.3 and 2 times, respectively, exposure at maximum recommended dose, can cause fetal harm; based on mechanism of action, bazedoxifene may block important functions that estrogen has during all stages of pregnancy Lactation Not indicated for use in females of reproductive potential Estrogens are present in human milk and can reduce milk production in breast-feeding females; this reduction can occur at any time but is less likely to occur once breast-feeding is well-established There are no data on presence of bazedoxifene in either human or animal breast milk, effect on breastfed infant, or on milk production; based on mechanism of action, bazedoxifene may block important functions that estrogen has in mammary tissue during lactation

Interactions

Side Effects

Side effects of Bazedoxifene + Conjugated estrogens : 1-10% Muscle spasms (9%) Nausea (8%) Diarrhea (8%) Dyspepsia (7%) Upper abdominal pain (7%) Oropharyngeal pain (7%) Neck pain (5%) Dizziness (5%)

Mode of Action

Bazedoxifene: Selective estrogen receptor modulator (SERM); estrogen-like effects on bone (increase bone density) and lipids (decrease LDL); antiestrogenic in uterus and breast (reduces risk of endometrial hyperplasia that can occur with conjugated estrogens) Conjugated estrogens: Replaces endogenous estrogen

Note

Bestron 20 mg + 450 mcg Tablet generic name is Bazedoxifene + Conjugated estrogens. Bestron 20 mg + 450 mcg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Bestron is availble in all over Bangladesh. Mes BD drug index information on Bestron Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.