HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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DUAVEE®(conjugated estrogens/bazedoxifene)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
DUAVEE® Quick Finder
Highlights
Boxed Warning
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA
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- Women taking DUAVEE should not take additional estrogens [see Warnings and...
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Indications and Usage
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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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
DUAVEE is contraindicated in women with any of the following conditions:
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- Undiagnosed abnormal uterine bleeding
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- Known, suspected, or past history of breast cancer...
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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
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- Cardiovascular Disorders [see Warnings and...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Cytochrome P450 (CYP)
In vitro and in vivo studies have shown that estrogens are...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
DUAVEE is...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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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How Supplied/Storage and Handling
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
17.1 Instructions for Patients...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.