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PREMARIN®(conjugated estrogens)

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PREMARIN® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

Estrogen-Alone Therapy

...
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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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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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3 DOSAGE FORMS AND STRENGTHS

...
PREMARIN (conjugated estrogens tablets, USP)
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4 CONTRAINDICATIONS

PREMARIN therapy is contraindicated in individuals with any of the following conditions:

  • Undiagnosed abnormal genital bleeding
  • Known,...
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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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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in labeling:

  • Cardiovascular Disorders [see

    6.1 Clinical Study Experience...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

PREMARIN should not be used during pregnancy [see

8.3 Nursing Mothers

...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term continuous administration of natural and synthetic estrogens in...

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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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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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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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17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (

17.1 Vaginal Bleeding

Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare...

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PATIENT INFORMATION

PREMARIN®(prem-uh-rin)

(Conjugated estrogen tablets, USP)

Read this PATIENT INFORMATION before you start taking...

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Resources

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