Prempro

CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE

Manufacturer: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Score: 148.0

Quick Summary

Prempro is a combination hormone replacement therapy used to treat moderate to severe vasomotor symptoms, vulvar and vaginal atrophy, and prevent postmenopausal osteoporosis in women with a uterus. It contains conjugated estrogens and medroxyprogesterone acetate. The therapy should be used with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Prempro has several contraindications, including undiagnosed abnormal genital bleeding, known or suspected breast cancer, and active arterial thromboembolic disease. Common adverse reactions include abdominal pain, asthenia, back pain, headache, and breast pain.

Key Clinical Findings and Indications

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
Prevention of Postmenopausal Osteoporosis

Important Safety Information

Warning

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

Contraindications

Undiagnosed abnormal genital bleeding
Known, suspected, or history of breast cancer
Known or suspected estrogen-dependent neoplasia
Active DVT, PE, or a history of these conditions
Active arterial thromboembolic disease
Known anaphylactic reaction or angioedema to PREMPRO/PREMPHASE
Known liver dysfunction or disease
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
Known or suspected pregnancy

Adverse Reactions

Abdominal pain
Asthenia
Back pain
Headache
Flatulence
Nausea
Depression
Pruritus
Breast pain
Dysmenorrhea
Leukorrhea

Dosing Recommendations

General Guidance

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

Moderate to Severe Vasomotor Symptoms due to Menopause

Adult Dose

One tablet containing conjugated estrogens (CE) plus medroxyprogesterone acetate (MPA) taken orally once daily

Pediatric Dose

Not indicated in children

Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

Adult Dose

One tablet containing conjugated estrogens (CE) plus medroxyprogesterone acetate (MPA) taken orally once daily

Pediatric Dose

Not indicated in children

Prevention of Postmenopausal Osteoporosis

Adult Dose

One tablet containing conjugated estrogens (CE) plus medroxyprogesterone acetate (MPA) taken orally once daily

Pediatric Dose

Not indicated in children

Special Population Considerations

Pregnancy

PREMPRO and PREMPHASE should not be used during pregnancy

Nursing Mothers

PREMPRO and PREMPHASE should not be used during lactation

Pediatric Use

PREMPRO and PREMPHASE are not indicated in children

Geriatric Use

There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PREMPRO or PREMPHASE to determine whether those over 65 years of age differ from younger subjects in their response to PREMPRO or PREMPHASE