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PREMPRO® AND PREMPHASE®(conjugated estrogens and medroxyprogesterone acetate)

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PREMPRO® AND PREMPHASE® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia...

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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

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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3 DOSAGE FORMS AND STRENGTHS

...
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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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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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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular Disorders [see

    6.1 Clinical Trials 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 drugs...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

PREMPRO and PREMPHASE should not be used during pregnancy [see

8.3 Nursing Mothers

...

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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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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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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 certain...

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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 al....
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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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17 PATIENT COUNSELING INFORMATION

See

17.1 Abnormal Vaginal Bleeding

Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as...

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PATIENT INFORMATION

PREMPRO®
(Conjugated Estrogens/Medroxyprogesterone Acetate Tablets)
PREMPHASE®
(Conjugated Estrogens plus Medroxyprogesterone Acetate...

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This product's label may have been updated. For current package...
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