Conjugated estrogens (oral)
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
Cardiovascular Disorders and Probable Dementia
Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia
Breast Cancer
|
Overview
Conjugated estrogens (oral) is a hormone that is FDA approved for the treatment of vasomotor symptoms due to menopause, symptoms of vulvar and vaginal atrophy due to menopause, hypogonadism, castration or primary ovarian failure, breast cancer (for palliation only), androgen-dependent carcinoma of the prostate,. 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)
Indication
Treatment of moderate to severe vasomotor symptoms due to menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Dosage
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (for example at 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women with a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
PREMARIN may be taken without regard to meals.
For treatment of moderate to severe vasomotor symptoms and/or moderate to severe symptoms of vulvar and vaginal atrophy due to menopause: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.
PREMARIN therapy may be given continuously, with no interruption in therapy, or in cyclical regimens (regimens such as 25 days on drug followed by five days off drug), as is medically appropriate on an individualized basis.
For prevention of postmenopausal osteoporosis: When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily. Subsequent dosage adjustment may be made based upon the individual clinical and bone mineral density responses. This dose should be periodically reassessed by the healthcare provider.
PREMARIN therapy may be given continuously, with no interruption in therapy, or in cyclical regimens (regimens such as 25 days on drug followed by five days off drug), as is medically appropriate on an individualized basis.
For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure: Female hypogonadism — 0.3 mg or 0.625 mg daily, administered cyclically (e.g., three weeks on and one week off). Doses are adjusted depending on the severity of symptoms and responsiveness of the endometrium.
In clinical studies of delayed puberty due to female hypogonadism, breast development was induced by doses as low as 0.15 mg. The dosage may be gradually titrated upward at 6-to-12 month intervals as needed to achieve appropriate bone age advancement and eventual epiphyseal closure. Clinical studies suggest that doses of 0.15 mg, 0.3 mg, and 0.6 mg are associated with mean ratios of bone age advancement to chronological age progression (ΔBA/ΔCA) of 1.1, 1.5, and 2.1, respectively. (PREMARIN in the dose strength of 0.15 mg is not available commercially). Available data suggest that chronic dosing with 0.625 mg is sufficient to induce artificial cyclic menses with sequential progestin treatment and to maintain bone mineral density after skeletal maturity is achieved.
Female castration or primary ovarian failure — 1.25 mg daily, cyclically. Adjust dosage, upward or downward, according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.
For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease: Suggested dosage is 10 mg three times daily, for a period of at least three months.
For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only: 1.25 mg to 2 x 1.25 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Conjugated estrogens (oral) 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)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Conjugated estrogens (oral) 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 (oral) 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 (oral) 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
Cardiovascular Disorders and Probable Dementia
Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia
Breast Cancer
|
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Conjugated estrogens (oral) 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 (oral) 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
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Conjugated estrogens (oral) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Conjugated estrogens (oral) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Conjugated estrogens (oral) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Conjugated estrogens (oral) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Conjugated estrogens (oral) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Conjugated estrogens (oral) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Conjugated estrogens (oral) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Conjugated estrogens (oral) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Conjugated estrogens (oral) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Conjugated estrogens (oral) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Conjugated estrogens (oral) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Conjugated estrogens (oral) in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Conjugated estrogens (oral) 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 (oral) in the drug label.
Pharmacology
There is limited information regarding Conjugated estrogens (oral) Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Conjugated estrogens (oral) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Conjugated estrogens (oral) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Conjugated estrogens (oral) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Conjugated estrogens (oral) in the drug label.
How Supplied
Storage
There is limited information regarding Conjugated estrogens (oral) 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 Patient Counseling Information of Conjugated estrogens (oral) in the drug label.
Precautions with Alcohol
- Alcohol-Conjugated estrogens (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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