Drospirenone and estradiol

Drospirenone and estradiol
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: Ammu Susheela, M.D. [2]

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Black Box Warning

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA See full prescribing information for complete Boxed Warning. Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone relative to placebo . The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Overview

Drospirenone and estradiol is a oral contraceptive that is FDA approved for the treatment of moderate to severe vasomotor symptoms due to menopause, moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypersensitivity reactions, including rash, pruritis, urticaria, breast cancer, venous and arterial thromboembolism.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Drospirenone and estradiol FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Drospirenone and estradiol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Drospirenone and estradiol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Drospirenone and estradiol 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 Drospirenone and estradiol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Drospirenone and estradiol in pediatric patients.

Contraindications

There is limited information regarding Drospirenone and estradiol Contraindications in the drug label.

Warnings

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA See full prescribing information for complete Boxed Warning. Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone relative to placebo . The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

There is limited information regarding Drospirenone and estradiol Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Drospirenone and estradiol Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Drospirenone and estradiol Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Drospirenone and estradiol Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Drospirenone and estradiol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Drospirenone and estradiol in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Drospirenone and estradiol in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Drospirenone and estradiol in geriatric settings.

Gender

There is no FDA guidance on the use of Drospirenone and estradiol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Drospirenone and estradiol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Drospirenone and estradiol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Drospirenone and estradiol in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Drospirenone and estradiol in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Drospirenone and estradiol Administration in the drug label.

Monitoring

There is limited information regarding Drospirenone and estradiol Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Drospirenone and estradiol and IV administrations.

Overdosage

There is limited information regarding Drospirenone and estradiol 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 Drospirenone and estradiol Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Drospirenone and estradiol Mechanism of Action in the drug label.

Structure

There is limited information regarding Drospirenone and estradiol Structure in the drug label.

Pharmacodynamics

There is limited information regarding Drospirenone and estradiol Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Drospirenone and estradiol Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Drospirenone and estradiol Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Drospirenone and estradiol Clinical Studies in the drug label.

How Supplied

There is limited information regarding Drospirenone and estradiol How Supplied in the drug label.

Storage

There is limited information regarding Drospirenone and estradiol 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 Drospirenone and estradiol Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Drospirenone and estradiol 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 Drospirenone and estradiol Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Drospirenone and estradiol 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.