Duavee
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
DUAVEE is indicated in women with a uterus for:
- Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
- When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
History
There is currently no drug history available for this drug.
Other Information
DUAVEE (conjugated estrogens/bazedoxifene), contains conjugated estrogens with bazedoxifene, an estrogen agonist/antagonist.
Conjugated estrogens are purified from pregnant mares' urine and consist of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. Conjugated estrogens are a mixture of sodium estrone sulfate and sodium equilin sulfate, and also contain as concomitant components, sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin.
Bazedoxifene is supplied as the acetate salt (bazedoxifene acetate) and has the chemical name 1H-Indol-5-ol, 1-[[4-[2-(hexahydro-1H-azepin-1-yl) ethoxy]phenyl]methyl]-2-(4-hydroxyphenyl)-3-methyl-, monoacetate. The empirical formula is C30H34N2O3 ∙ C2H4O2, and the molecular weight is 530.65.
Bazedoxifene acetate is a white to tan powder. The aqueous solubility of bazedoxifene is pH-dependent. Solubility is higher at lower pH. The solubility of bazedoxifene acetate in unbuffered sterile water was measured to be 923 μgA/mL at pH 5.4. The following represents the chemical structure of bazedoxifene acetate:
DUAVEE is available for oral administration as tablets containing 0.45 mg of conjugated estrogens with 20 mg of bazedoxifene (equivalent to 22.6 mg of bazedoxifene acetate). Each tablet of DUAVEE contains the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, ascorbic acid, sucrose palmitic acid ester, hydroxyethylcellulose, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, povidone, polydextrose, maltitol, poloxamer 188, propylene glycol, and isopropyl alcohol.
Sources
Duavee Manufacturers
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Wyeth Pharmaceuticals Company, A Subsidiary Of Pfizer Inc.
![Duavee (Conjugated Estrogens/bazedoxifene) Tablet, Film Coated [Wyeth Pharmaceuticals Company, A Subsidiary Of Pfizer Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Duavee | Aspen Veterinary
Horse ............................... 1 pt.
Cattle ............................... 1 pt.
Sheep .............................. 5 oz.
Hogs ............................... 1 pt.Dogs:
Toy breeds ................ 1 oz.
Puppies ...................... 1 oz.
Adult Dogs ............... 2 oz.According to size.
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U.s. Pharmaceuticals
Duavee | U.s. Pharmaceuticals
2.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with MenopauseThe recommended dosage is one DUAVEE tablet daily.
2.2 Prevention of Postmenopausal OsteoporosisThe recommended dosage is one DUAVEE tablet daily.
2.3 General Dosing InformationTake DUAVEE once daily, without regard to meals. Tablets should be swallowed whole.
2.4 Recommendations for Calcium and Vitamin D SupplementationWomen taking DUAVEE for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin D to their diet if daily intake is inadequate.
2.5 Administration Instructions for Missed DosesIf a dose of DUAVEE is missed, instruct patients to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time.
2.6 Use in Patients with Renal ImpairmentThe pharmacokinetics of DUAVEE have not been evaluated in patients with renal impairment. Use in patients with renal impairment is not recommended [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.7 Use in the ElderlyDUAVEE has not been studied in women over 75 years of age. Use in women over 75 years of age is not recommended.
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U.s. Pharmaceuticals
Duavee | U.s. Pharmaceuticals
2.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with MenopauseThe recommended dosage is one DUAVEE tablet daily.
2.2 Prevention of Postmenopausal OsteoporosisThe recommended dosage is one DUAVEE tablet daily.
2.3 General Dosing InformationTake DUAVEE once daily, without regard to meals. Tablets should be swallowed whole.
2.4 Recommendations for Calcium and Vitamin D SupplementationWomen taking DUAVEE for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin D to their diet if daily intake is inadequate.
2.5 Administration Instructions for Missed DosesIf a dose of DUAVEE is missed, instruct patients to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time.
2.6 Use in Patients with Renal ImpairmentThe pharmacokinetics of DUAVEE have not been evaluated in patients with renal impairment. Use in patients with renal impairment is not recommended [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.7 Use in the ElderlyDUAVEE has not been studied in women over 75 years of age. Use in women over 75 years of age is not recommended.
![Duavee (Conjugated Estrogens/bazedoxifene) Tablet, Film Coated [U.s. Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e16705d8-4472-4f83-96ac-69fa2be066cb&name=duavee-03.jpg)
![Duavee (Conjugated Estrogens/bazedoxifene) Tablet, Film Coated [U.s. Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bfdd5d5b-7569-4848-afa2-e820fbe3c8fb&name=duavee-03.jpg)
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