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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 daily. May supplement diet with calcium and/or Vit. D, if inadequate.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal uterine bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy (Cat.X). Women who may become pregnant. Nursing mothers.

Warnings/Precautions:

Not for prevention of cardiovascular disease. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Risk of probable dementia in women ≥65yrs of age. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Breast or ovarian cancer. Gallbladder disease. Visual abnormalities. Hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Renal impairment: not recommended. Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Premenopausal women or women >75 years of age: not recommended. Women with BMI >27kg/m2: increased risk of endometrial hyperplasia. Reevaluate periodically.

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. Duavee may interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).

Pharmacological Class:

Conjugated estrogens + estrogen agonist/antagonist.

Adverse Reactions:

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

How Supplied:

Blisters—2 × 15

Indications for DUAVEE:

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

Adult:

Swallow whole. 1 tab daily.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal uterine bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy (Cat.X). Women who may become pregnant. Nursing mothers.

Warnings/Precautions:

Not for prevention of cardiovascular disease. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Risk of probable dementia in women ≥65yrs of age. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Breast or ovarian cancer. Gallbladder disease. Visual abnormalities. Hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Renal impairment: not recommended. Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Premenopausal women or women >75 years of age: not recommended. Women with BMI >27kg/m2: increased risk of endometrial hyperplasia. Reevaluate periodically.

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. Duavee may interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).

Pharmacological Class:

Conjugated estrogens + estrogen agonist/antagonist.

Adverse Reactions:

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

How Supplied:

Blisters—2 × 15

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