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PREMPRO® AND PREMPHASE® (conjugated estrogens and medroxyprogesterone acetate)
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.
PREMPRO® AND PREMPHASE® Quick Finder
Highlights
Boxed Warning
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of Moderate...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman...
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Contraindications
4 CONTRAINDICATIONS
PREMPRO or PREMPHASE therapy should not be used in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding
- ...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Disorders
An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin therapy. An...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see Boxed Warning,...
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Drug Interactions
7 DRUG INTERACTIONS
Data from a single-dose drug-drug interaction study involving conjugated estrogens and medroxyprogesterone acetate indicate that the pharmacokinetic disposition of both drugs is not altered when the drugs...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
PREMPRO and PREMPHASE should not be used during pregnancy [see Contraindications (4)...
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Overdosage
10 OVERDOSAGE
Overdosage of estrogen plus progestin may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of...
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Description
11 DESCRIPTION
Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term continuous administration of natural and synthetic estrogens in certain...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Effects on Vasomotor Symptoms
In the first year of the Health and Osteoporosis, Progestin and Estrogen (HOPE) Study, a total of 2,805...
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References
15 REFERENCES
- Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465–1477.
- Hsia J, et al....
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
PREMPRO therapy consists of a single tablet to be taken once daily.
PREMPRO 0.3 mg/1...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling.
17.1 Abnormal Vaginal Bleeding
Inform...
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FDA-Approved Patient Labeling
PATIENT INFORMATION
PREMPRO®
(Conjugated Estrogens/Medroxyprogesterone Acetate Tablets)
PREMPHASE®
(Conjugated Estrogens plus Medroxyprogesterone Acetate...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information 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.