Conjugated estrogens (injection)

Conjugated estrogens (injection)
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 (injection) is a hormone that is FDA approved for the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology. 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)

Abnormal Uterine Bleeding

Premarin Intravenous (conjugated estrogens, USP) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.Premarin Intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels.

• For treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology:

• One 25 mg injection, intravenously or intramuscularly.
• Intravenous use is preferred since more rapid response can be expected from this mode of administration. Repeat in 6 to 12 hours if necessary. The use of Premarin Intravenous for injection does not preclude the advisability of other appropriate measures.
• One should adhere to the usual precautionary measures governing intravenous administration. Injection should be made SLOWLY to obviate the occurrence of flushes.
• Infusion of Premarin Intravenous for injection with other agents is not generally recommended. In emergencies, however, when an infusion has already been started it may be expedient to make the injection into the tubing just distal to the infusion needle. If so used, compatibility of solutions must be considered.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Bleeding, Renal Failure

• Dosing Information

• 10–50 mg IV/IM per day

Gender Identity Disorder

• Dosing Information

• 10 mg IV/IM

Hemorrhagic Cystitis

• Dosing Information

• 5–50 mg IV

Postcoital Contraception

• Dosing Information

• A single 50 mg intravenous (IV) dose, followed by a second 50 mg IV dose 24 hours later.

Postoperative Hemorrhage

• Dosing Information

• 1 mg/kg IV

Turner Syndrome

• Dosing Information

• 0.375 mg/kg IV

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in the pediatric population below the age of 12 years have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Conjugated estrogens (injection) Contraindications in the drug label.

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.

There is limited information regarding Conjugated estrogens (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Conjugated estrogens (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Conjugated estrogens (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Conjugated estrogens (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Conjugated estrogens (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Conjugated estrogens (injection) in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Conjugated estrogens (injection) Administration in the drug label.

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Conjugated estrogens (injection) and IV administrations.

Overdosage

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

Mechanism of Action

There is limited information regarding Conjugated estrogens (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Conjugated estrogens (injection) Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Conjugated estrogens (injection) How Supplied in the drug label.

Storage

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

Precautions with Alcohol

Alcohol-Conjugated estrogens 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 Conjugated estrogens (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Conjugated estrogens (injection) 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.