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PREMARIN®(conjugated estrogens)
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Our medical information is accurate, up to date, and scientifically balanced.
PREMARIN® Quick Finder
Highlights
Boxed Warning
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
Estrogen-Alone Therapy
...
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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
Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer [see...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
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Contraindications
4 CONTRAINDICATIONS
PREMARIN therapy is contraindicated in individuals with any of the following conditions:
- Undiagnosed abnormal genital bleeding
- Known,...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Disorders
An increased risk of stroke and DVT has been reported with estrogen-alone therapy. An increased risk of PE,...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in 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...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
PREMARIN should not be used during pregnancy [see Contraindications (4)]....
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Overdosage
10 OVERDOSAGE
Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of...
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Description
11 DESCRIPTION
PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens purified from pregnant mares' urine and consists of the sodium salts of...
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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...
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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
- 1.
- Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465–1477.
- 2.
- Hsia J, et...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
PREMARIN (conjugated estrogens tablets, USP)
- —
- Each oval green tablet contains 0.3 mg, in...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
17.1 Vaginal Bleeding
Inform...
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FDA-Approved Patient Labeling
PATIENT INFORMATION
PREMARIN®(prem-uh-rin)
(Conjugated estrogen tablets, USP)
Read this PATIENT INFORMATION before you start taking...
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