Estradiol and Levonorgestrel

FDA Drug Profile — Climara Pro

Drug Details

Generic Name
Estradiol and Levonorgestrel
Brand Names
Climara Pro
Application Number
NDA021258
Sponsor
Bayer HealthCare Pharmaceuticals Inc.
NDC Codes
1
Dosage Forms
PATCH
Routes
TRANSDERMAL
Active Ingredients
ESTRADIOL, LEVONORGESTREL

Indications and Usage

1 INDICATIONS AND USAGE Climara Pro is indicated for: Climara Pro is an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.