estradiol
Generic: ESTRADIOL
Basic Information
Manufacturer
Zydus Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TRANSDERMAL
FDA Set ID
684850eb-d889-4370-a0a7-4a5c3113266a
Indications & Usage
1 INDICATIONS AND USAGE Estradiol transdermal system is indicated for: Estradiol transdermal system is an estrogen indicated for: Prevention of Postmenopausal Osteoporosis ( 1.1 ) 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 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.
Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1 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.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions ( 5.1 )] Malignant Neoplasms [see Boxed Warning, Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥ 10 percent) with estradiol transdermal system are upper respiratory tract infections, pain, arthralgia, and leukorrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Estradiol transdermal system was investigated in a 2-year double blind, placebo-controlled, multicenter study in the United States.
A total of 417 postmenopausal women (208 women on estradiol transdermal system, 209 on placebo) 60 to 80 years old, with an intact uterus were enrolled in the study.
At 24 months, 189 women remained in the estradiol transdermal system group and 186 remained in the placebo group.
Adverse events with an incidence of ≥5 percent in the estradiol transdermal system 0.014 mg group and greater than those reported in the placebo group are listed in Table 1.
Table 1 Summary of Most Frequently Reported Treatment Emergent Adverse Reactions (≥5 percent) by Treatment Groups Body System Adverse Reactions Estradiol Transdermal System 0.014 mg/day (N=208) Placebo (N=209) Body as a Whole Abdominal Pain Accidental Injury Infection Pain 95 (46%) 17 (8%) 29 (14%) 11 (5%) 26 (13%) 100 (48%) 17 (8%) 23 (11%) 10 (5%) 26 (12%) Cardiovascular 20 (10%) 19 (9%) Digestive System Constipation Dyspepsia 52 (25%) 11 (5%) 11 (5%) 44 (21%) 6 (3%) 9 (4%) Metabolic and Nutritional Disorders 25 (12%) 22 (11%) Musculoskeletal System Arthralgia Arthritis Myalgia 54 (26%) 24 (12%) 11 (5%) 10 (5%) 51 (24%) 13 (6%) 15 (7%) 6 (3%) Nervous System Dizziness 30 (14%) 11 (5%) 23 (11%) 6 (3%) Respiratory System Bronchitis Upper Respiratory Infection 62 (30%) 12 (6%) 33 (16%) 67 (32%) 9 (4%) 35 (17%) Skin and Appendages Application Site Reaction Breast Pain 50 (24%) 18 (9%) 10 (5%) 54 (26%) 18 (9%) 8 (4%) Urogenital System Cervical Polyps Leukorrhea 66 (32%) 13 (6%) 22 (11%) 40 (19%) 4 (2%) 3 (1%) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of the other estradiol transdermal systems and the estradiol transdermal system, 0.014 mg/day.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Genitourinary System Changes in bleeding pattern, pelvic pain Breast Breast cancer, breast pain, breast tenderness Cardiovascular Changes in blood pressure, palpitations, hot flashes Gastrointestinal Vomiting, abdominal pain, abdominal distension, nausea Skin Alopecia, hyperhidrosis, night sweats, urticaria, rash Eyes Visual disturbances, contact lens intolerance Central Nervous System Depression, migraine, paresthesia, dizziness, anxiety, irritability, mood swings, nervousness, insomnia, headache Miscellaneous Edema, fatigue, menopausal symptoms, weight increased, application site reaction, anaphylactic reactions
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Estradiol transdermal system was investigated in a 2-year double blind, placebo-controlled, multicenter study in the United States.
A total of 417 postmenopausal women (208 women on estradiol transdermal system, 209 on placebo) 60 to 80 years old, with an intact uterus were enrolled in the study.
At 24 months, 189 women remained in the estradiol transdermal system group and 186 remained in the placebo group.
Adverse events with an incidence of ≥5 percent in the estradiol transdermal system 0.014 mg group and greater than those reported in the placebo group are listed in Table 1.
Table 1 Summary of Most Frequently Reported Treatment Emergent Adverse Reactions (≥5 percent) by Treatment Groups Body System Adverse Reactions Estradiol Transdermal System 0.014 mg/day (N=208) Placebo (N=209) Body as a Whole Abdominal Pain Accidental Injury Infection Pain 95 (46%) 17 (8%) 29 (14%) 11 (5%) 26 (13%) 100 (48%) 17 (8%) 23 (11%) 10 (5%) 26 (12%) Cardiovascular 20 (10%) 19 (9%) Digestive System Constipation Dyspepsia 52 (25%) 11 (5%) 11 (5%) 44 (21%) 6 (3%) 9 (4%) Metabolic and Nutritional Disorders 25 (12%) 22 (11%) Musculoskeletal System Arthralgia Arthritis Myalgia 54 (26%) 24 (12%) 11 (5%) 10 (5%) 51 (24%) 13 (6%) 15 (7%) 6 (3%) Nervous System Dizziness 30 (14%) 11 (5%) 23 (11%) 6 (3%) Respiratory System Bronchitis Upper Respiratory Infection 62 (30%) 12 (6%) 33 (16%) 67 (32%) 9 (4%) 35 (17%) Skin and Appendages Application Site Reaction Breast Pain 50 (24%) 18 (9%) 10 (5%) 54 (26%) 18 (9%) 8 (4%) Urogenital System Cervical Polyps Leukorrhea 66 (32%) 13 (6%) 22 (11%) 40 (19%) 4 (2%) 3 (1%) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of the other estradiol transdermal systems and the estradiol transdermal system, 0.014 mg/day.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Genitourinary System Changes in bleeding pattern, pelvic pain Breast Breast cancer, breast pain, breast tenderness Cardiovascular Changes in blood pressure, palpitations, hot flashes Gastrointestinal Vomiting, abdominal pain, abdominal distension, nausea Skin Alopecia, hyperhidrosis, night sweats, urticaria, rash Eyes Visual disturbances, contact lens intolerance Central Nervous System Depression, migraine, paresthesia, dizziness, anxiety, irritability, mood swings, nervousness, insomnia, headache Miscellaneous Edema, fatigue, menopausal symptoms, weight increased, application site reaction, anaphylactic reactions