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

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA

1 INDICATIONS AND USAGE

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

1.3 Prevention of Postmenopausal Osteoporosis

2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

2.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

2.3 Prevention of Postmenopausal Osteoporosis

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Disorders

5.2 Malignant Neoplasms

5.3 Probable Dementia

5.4 Gallbladder Disease

5.5 Hypercalcemia

5.6 Visual Abnormalities

5.7 Addition of a Progestin When a Woman Has Not Had a Hysterectomy

5.8 Elevated Blood Pressure

5.9 Hypertriglyceridemia

5.10 Hepatic Impairment and/or Past History of Cholestatic Jaundice

5.11 Hypothyroidism

5.12 Fluid Retention

5.13 Hypocalcemia

5.14 Exacerbation of Endometriosis

5.15 Anaphylactic Reaction and Angioedema

5.16 Hereditary Angioedema

5.17 Exacerbation of Other Conditions

5.18 Laboratory Tests

5.19 Drug-Laboratory Test Interactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Metabolic Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Effects on Vasomotor Symptoms

14.2 Effects on Vulvar and Vaginal Atrophy

14.3 Effects on the Endometrium

14.4 Effects on Uterine Bleeding or Spotting

14.5 Effects on Bone Mineral Density

14.6 Women's Health Initiative Studies

14.7 Women's Health Initiative Memory Study

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

17.1 Abnormal Vaginal Bleeding

17.2 Possible Serious Adverse Reactions with Estrogen Plus Progestin Therapy

17.3 Possible Less Serious but Common Adverse Reactions with Estrogen Plus Progestin Therapy

*
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