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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{Ammu}}
|genericName=Conjugated estrogens
|aOrAn=a
|aOrAn=a
|drugClass=[[hormone]]
|indicationType=treatment
|indicationType=treatment
|indication=atrophic vaginitis and kraurosis vulvae and severe dyspareunia
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=[edema]], [[vasodilatation]], [[chloasma]], [[hirsutism]], [[injection site reaction]], [[pruritus]], [[weight]] change, [[abdominal pain]], [[bloating]], [[diarrhea]], [[flatulence]], [[nausea]], [[vomiting]], [[backache]], [[leg]] cramp, [[asthenia]], [[headache]], [[migraine]], [[depression]], disturbance in [[mood]], disorder of [[menstruation]], [[pain]] of [[breast]], [[vaginitis]], withdrawal [[bleeding]], [[cough]], and [[pharyngitis]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=Estrogen-Alone Therapy
Endometrial Cancer


* Content
* 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.


<!--Adult Indications and Dosage-->
Cardiovascular Disorders and Probable Dementia


<!--FDA-Labeled Indications and Dosage (Adult)-->
* 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) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.
 
* The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the 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 dosage 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.
 
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 WHI estrogen plus progestin substudy reported increased risks of 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 CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
 
* The WHIMS estrogen plus progestin ancillary study of the 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 also 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.
|fdaLIADAdult======Condition1=====
|fdaLIADAdult======Condition1=====


Revision as of 01:06, 19 May 2015

Conjugated estrogens (vaginal)
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: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer
See full prescribing information for complete Boxed Warning.
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 Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the 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 dosage 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.

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 WHI estrogen plus progestin substudy reported increased risks of 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 CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
  • The WHIMS estrogen plus progestin ancillary study of the 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 also 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.

Overview

Conjugated estrogens (vaginal) is a hormone that is FDA approved for the treatment of atrophic vaginitis and kraurosis vulvae and severe dyspareunia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include [edema]], vasodilatation, chloasma, hirsutism, injection site reaction, pruritus, weight change, abdominal pain, bloating, diarrhea, flatulence, nausea, vomiting, backache, leg cramp, asthenia, headache, migraine, depression, disturbance in mood, disorder of menstruation, pain of breast, vaginitis, withdrawal bleeding, cough, and pharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Conjugated estrogens (vaginal) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Conjugated estrogens (vaginal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Conjugated estrogens (vaginal) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Conjugated estrogens (vaginal) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Conjugated estrogens (vaginal) in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer
See full prescribing information for complete Boxed Warning.
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 Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the 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 dosage 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.

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 WHI estrogen plus progestin substudy reported increased risks of 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 CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
  • The WHIMS estrogen plus progestin ancillary study of the 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 also 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.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Conjugated estrogens (vaginal) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Conjugated estrogens (vaginal) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Conjugated estrogens (vaginal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Conjugated estrogens (vaginal) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Conjugated estrogens (vaginal) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Conjugated estrogens (vaginal) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Conjugated estrogens (vaginal) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Conjugated estrogens (vaginal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Conjugated estrogens (vaginal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Conjugated estrogens (vaginal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Conjugated estrogens (vaginal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Conjugated estrogens (vaginal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Conjugated estrogens (vaginal) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Conjugated estrogens (vaginal) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Conjugated estrogens (vaginal) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Conjugated estrogens (vaginal) in the drug label.

Pharmacology

There is limited information regarding Conjugated estrogens (vaginal) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Conjugated estrogens (vaginal)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Conjugated estrogens (vaginal) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Conjugated estrogens (vaginal) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Conjugated estrogens (vaginal) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Conjugated estrogens (vaginal) in the drug label.

How Supplied

Storage

There is limited information regarding Conjugated estrogens (vaginal) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Conjugated estrogens (vaginal) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Conjugated estrogens (vaginal) in the drug label.

Precautions with Alcohol

  • Alcohol-Conjugated estrogens (vaginal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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