Bestron0.45 mg + 20 mg
Tablet
Conjugated Estrogen + Bazedoxifene
Incepta Pharmaceuticals Ltd.
Product Code : 19332
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Medicine overview
Indications of Bestron 0.45 mg + 20 mg
This is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:
Treatment of moderate to severe vasomotor symptoms associated with menopause
Prevention of postmenopausal osteoporosis
Interaction of Bestron 0.45 mg + 20 mg
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.
Contraindications
Undiagnosed abnormal uterine bleeding
Known, suspected, or past history of breast cancer
Known or suspected estrogen-dependent neoplasia
Active or past history of venous thromboembolism
Active or past history of arterial thromboembolism
Hypersensitivity (angioedema, anaphylaxis) 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
Side Effects of Bestron 0.45 mg + 20 mg
In four prospective, randomized, placebo-controlled trials the common adverse reactions (incidence ≥5%) were muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.
Precautions & Warnings
Women taking this tablet should not take progestins, additional estrogens or additional estrogen agonist/antagonists
Cardiovascular disorders, including venous thromboembolism, pulmonary embolism, stroke, and retinal vascular thrombosis
Malignant neoplasms, including endometrial cancer, breast cancer, and ovarian cancer
Estrogens increase the risk of gallbladder disease
Discontinue estrogen if loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs
Monitor thyroid function in women on thyroid replacement therapy
Overdose Effects of Bestron 0.45 mg + 20 mg
In case of overdosage, there is no specific antidote, and the treatment should be symptomatic. Symptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur.
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Drug Classes
Female Sex hormones
Mode Of Action
This tablet pairs conjugated estrogens with bazedoxifene. Conjugated estrogens and bazedoxifene function by binding to and activating estrogen receptors (ER) α and β, which vary in proportion from tissue to tissue. Conjugated estrogens are composed of multiple estrogens and are agonists of 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). The pairing of conjugated estrogens with bazedoxifene produces a composite effect that is specific to each target tissue. The bazedoxifene component reduces the risk of endometrial hyperplasia that can occur with the conjugated estrogens component.
Pregnancy
Pregnancy Category X. This tablet must not be used in women who are or may become pregnant. No studies were performed on animals to evaluate the effects on reproduction with conjugated estrogens/bazedoxifene. This tablet should not be used by lactating women. It is not known whether this drug is excreted in human milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving conjugated estrogens. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk
Pediatric Uses
Pediatric Use: This tablet is not indicated for use in children.Geriatric Use: This tablet was not studied in women aged 75 or older; use in this population is not recommended. An increased risk of probable dementia in women over 65 years of age was reported in the Women’s Health Initiative Memory ancillary studies of the Women’s Health Initiative.Renal Impairment: This tablet was not studied in women with renal impairment; use in this population is not recommended.Body Mass Index: Women with BMI >27 kg/m 2 may have an increased risk of endometrial hyperplasia.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.