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Black Box Warning
WARNINGS:
See full prescribing information for complete Boxed Warning.
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER:
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens result in a different endometrial risk profile than “synthetic” estrogens at equivalent estrogen doses
CARDIOVASCULAR AND OTHER RISKS:
Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, CARDIOVASCULAR DISORDERS.)
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES.)
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy.
Overview
Estropipate (oral) is a Endocrine-Metabolic Agent that is FDA approved for the treatment of vasomotor symptoms associated with the menopause, vulval and vaginal atrophy, hypoestrogenism due to hypogonadism, Prevention of postmenopausal osteoporosis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Edema, Chloasma, Hirsutism, Bloating, Nausea, Stomach cramps, Vomiting, Headache, Migraine, Depression, Breast tenderness, Disorder of menstruation.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Estropipate tablets are indicated in the:
Treatment of moderate to severe vasomotor symptoms associated with the menopause.
Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the 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.
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 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 (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See BOXED WARNINGS and WARNINGS.) For women who have 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.
For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Attempts to discontinue or taper medication should be made at 3month to 6-month intervals. Usual dosage ranges:
Vasomotor symptoms—One estropipate 0.75 mg tablet to two estropipate 3 mg tablets per day. The lowest dose that will control symptoms should be chosen. If the patient has not menstruated within the last two months or more, cyclic administration is started arbitrarily. If the patient is menstruating, cyclic administration is started on day 5 of bleeding.
Vulval and vaginal atrophy—One estropipate 0.75 mg tablet to two estropipate 3 mg tablets daily, depending upon the tissue response of the individual patient. The lowest dose that will control symptoms should be chosen. Administer cyclically.
For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. Usual dosage ranges:
Female hypogonadism—A daily dose of one estropipate 1.5 mg tablet to three estropipate 3 mg tablets may be given for the first three weeks of a theoretical cycle, followed by a rest period of eight to ten days. The lowest dose that will control symptoms should be chosen. If bleeding does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen therapy necessary to produce bleeding may vary depending on the responsiveness of the endometrium. If satisfactory withdrawal bleeding does not occur, an oral progestogen may be given in addition to estrogen during the third week of the cycle.
Female castration or primary ovarian failure—A daily dose of one estropipate 1.5 mg tablet to three estropipate 3 mg tablets may be given for the first three weeks of a theoretical cycle, followed by a rest period of eight to ten days. 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.
Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.
For prevention of osteoporosis. A daily dose of one estropipate 0.75 mg tablet for 25 days of a 31-day cycle per month.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Estropipate (oral) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Estropipate (oral) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Estropipate (oral) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Estropipate (oral) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Estropipate (oral) in pediatric patients.
Contraindications
Estropipate tablets should not be used in women with any of the following conditions:
Undiagnosed abnormal genital bleeding.
Known, suspected, or history of cancer of the breast.
Known or suspected estrogen-dependent neoplasia.
Active deep vein thrombosis, pulmonary embolism or history of these conditions.
Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
Liver dysfunction or disease.
Estropipate tablets should not be used in patients with known hypersensitivity to its ingredients.
Known or suspected pregnancy. There is no indication for estropipate tablets in pregnancy.
There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.
Warnings
WARNINGS:
See full prescribing information for complete Boxed Warning.
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER:
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens result in a different endometrial risk profile than “synthetic” estrogens at equivalent estrogen doses
CARDIOVASCULAR AND OTHER RISKS:
Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, CARDIOVASCULAR DISORDERS.)
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES.)
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy.
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Estropipate (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 Estropipate (oral) in the drug label.
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