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DUAVEE®(conjugated estrogens/bazedoxifene)

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DUAVEE® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA

  • Women taking DUAVEE should not take additional estrogens [see Warnings and...
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1 INDICATIONS AND USAGE

DUAVEE is indicated in women with a uterus for:

1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

...
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2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

The recommended dosage is one DUAVEE tablet daily.

...
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3 DOSAGE FORMS AND STRENGTHS

DUAVEE (conjugated estrogens/bazedoxifene) tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side.

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4 CONTRAINDICATIONS

DUAVEE is contraindicated in women with any of the following conditions:

  • Undiagnosed abnormal uterine bleeding
  • Known, suspected, or past history of breast cancer
  • ...
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5 WARNINGS AND PRECAUTIONS

5.1 Drugs Containing Progestins, Estrogens or Estrogen Agonist/Antagonists

DUAVEE contains conjugated estrogens and bazedoxifene, an...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Cardiovascular Disorders [see

    6.1 Clinical Trials...

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7 DRUG INTERACTIONS

7.1 Cytochrome P450 (CYP)

In vitro and in vivo studies have shown that estrogens are...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

DUAVEE is...

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10 OVERDOSAGE

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,...

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11 DESCRIPTION

DUAVEE (conjugated estrogens/bazedoxifene), contains conjugated estrogens with bazedoxifene, an estrogen agonist/antagonist.

Conjugated estrogens are purified from pregnant mares' urine and consist of...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

DUAVEE pairs conjugated estrogens with bazedoxifene. Conjugated estrogens and bazedoxifene function by binding to...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis...

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14 CLINICAL STUDIES

14.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause in Women with a Uterus

The safety and efficacy of DUAVEE as a...

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16 HOW SUPPLIED/STORAGE AND HANDLING

DUAVEE tablets contain 0.45 mg conjugated estrogens and 20 mg bazedoxifene. The tablets are oval, biconvex, and pink, branded with "0.45/20" in black ink on one side.

DUAVEE...

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17 PATIENT COUNSELING INFORMATION

See

17.1 Instructions for Patients

  • Keep DUAVEE in the original container to protect from moisture. Do not place DUAVEE in pill boxes or pill organizers....
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Patient Information
DUAVEE® (DEW' ah-vee)
(conjugated estrogens/bazedoxifene)
Tablets

Read this Patient Information before you start taking DUAVEE and each time you get a refill....

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

...

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Resources

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