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DUAVEE
Bone disorders
Menopause and HRT
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Drug Name:

DUAVEE Rx

Generic Name and Formulations:
Conjugated estrogens 0.45mg, bazedoxifene 20mg; tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for DUAVEE:

Prevention of postmenopausal osteoporosis.

Adult:

Swallow whole. 1 tab once daily. May supplement diet with calcium and/or Vit. D, if inadequate.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal uterine bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy (Cat.X). Nursing mothers.

Boxed Warning:

Endometrial cancer. Cardiovascular disorders. Probable dementia.

Warnings/Precautions:

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Renal impairment: not recommended. Premenopausal women or women >75 years of age: not recommended. Obese women (BMI ≥30). Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically.

Pharmacological Class:

Conjugated estrogens + estrogen agonist/antagonist.

Interactions:

Avoid concomitant progestins, additional estrogens, or estrogen agonist/antagonists. Antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s Wort). Potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. Bazedoxifene: may be antagonized by UGT inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin). May affect or be affected by ibuprofen, atorvastatin, azithromycin, aluminum and magnesium hydroxide. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Adverse Reactions:

Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, neck pain; thromboembolism, neoplasms.

How Supplied:

Blisters—2 x 15

Indications for DUAVEE:

Moderate-to-severe vasomotor symptoms of menopause. Limitation of use: use for shortest duration consistent with treatment goals and risks.

Adult:

Swallow whole. 1 tab once daily.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal uterine bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy (Cat.X). Nursing mothers.

Boxed Warning:

Endometrial cancer. Cardiovascular disorders. Probable dementia.

Warnings/Precautions:

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Renal impairment: not recommended. Premenopausal women or women >75 years of age: not recommended. Obese women (BMI ≥30). Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically.

Pharmacological Class:

Conjugated estrogens + estrogen agonist/antagonist.

Interactions:

Avoid concomitant progestins, additional estrogens, or estrogen agonist/antagonists. Antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s Wort). Potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. Bazedoxifene: may be antagonized by UGT inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin). May affect or be affected by ibuprofen, atorvastatin, azithromycin, aluminum and magnesium hydroxide. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Adverse Reactions:

Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, neck pain; thromboembolism, neoplasms.

How Supplied:

Blisters—2 x 15

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