Estradiol patch

Estradiol patch
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA See full prescribing information for complete Boxed Warning. Estrogen-Alone Therapy: There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older Estrogen Plus Progestin Therapy: Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Overview

Estradiol patch is an estrogen that is FDA approved for the treatment of moderate to severe vasomotor symptoms, symptoms of vulvar and vaginal atrophy due to menopause, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, postmenopausal osteoporosis and prevention of postmenopausal osteoporosis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include breast pain, upper respiratory tract infections, headaches, abdominal pain, pain, and edema.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Climara is contraindicated in women with any of the following conditions:

• 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 (for example, stroke and MI), or a history of these conditions
• Known anaphylactic reaction or angioedema with Climara
• Known liver impairment or disease
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
• Known or suspected pregnancy

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Estradiol patch in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Estradiol patch in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Estradiol patch FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Estradiol patch in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Estradiol patch in pediatric patients.

Contraindications

There is limited information regarding Estradiol patch Contraindications in the drug label.

Warnings

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA See full prescribing information for complete Boxed Warning. Estrogen-Alone Therapy: There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older Estrogen Plus Progestin Therapy: Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

There is limited information regarding Estradiol patch Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Estradiol patch Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Estradiol patch Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Estradiol patch Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Estradiol patch in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Estradiol patch in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Estradiol patch during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Estradiol patch in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Estradiol patch in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Estradiol patch in geriatric settings.

Gender

There is no FDA guidance on the use of Estradiol patch with respect to specific gender populations.

Race

There is no FDA guidance on the use of Estradiol patch with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Estradiol patch in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Estradiol patch in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Estradiol patch in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Estradiol patch in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Estradiol patch Administration in the drug label.

Monitoring

There is limited information regarding Estradiol patch Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Estradiol patch and IV administrations.

Overdosage

There is limited information regarding Estradiol patch overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Estradiol patch Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Estradiol patch Mechanism of Action in the drug label.

Structure

There is limited information regarding Estradiol patch Structure in the drug label.

Pharmacodynamics

There is limited information regarding Estradiol patch Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Estradiol patch Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Estradiol patch Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Estradiol patch Clinical Studies in the drug label.

How Supplied

There is limited information regarding Estradiol patch How Supplied in the drug label.

Storage

There is limited information regarding Estradiol patch Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Estradiol patch Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Estradiol patch interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Estradiol patch Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Estradiol patch Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.