WARNINGS
ENDOMETRIAL CANCER
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. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Dementia.)
The estrogen alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated estrogens (CE 0.625 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.)
The estrogen plus progestin substudy of WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.)
The Women's Health Initiative Memory Study (WHIMS), a substudy 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 and 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. (See CLINICAL STUDIES and WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)
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. Because of these risks, 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.
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PREMARIN SUMMARY
What is the most important information I should know about PREMARIN (an estrogen mixture)?
Premarin® (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17(alpha)-dihydroequilin, 17(alpha)-estradiol, and 17(beta)-dihydroequilin.
Premarin therapy is indicated in the:
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Treatment of moderate to severe vasomotor symptoms associated with the menopause.
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Treatment of moderate to severe symptoms of vulvar 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.
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Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
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Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
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Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
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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. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
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.
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NEWS HIGHLIGHTSMedia Articles Related to Premarin (Conjugated Estrogens)
estrogens conjugated, Premarin
Source: MedicineNet Hepatic Hemangioma Specialty [2006.03.28]
Title: estrogens conjugated, Premarin
Category: Medications
Created: 12/31/1997
Last Editorial Review: 3/28/2006
Published Studies Related to Premarin (Conjugated Estrogens)
Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. [2009.09]
OBJECTIVE: To evaluate the efficacy of the tissue-selective estrogen complex, bazedoxifene/conjugated estrogens (BZA/CE), for postmenopausal osteoporosis prevention... CONCLUSION(S): BZA/CE combinations decreased bone turnover and bone loss in postmenopausal women at increased risk for osteoporosis.
Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. [2009.09]
OBJECTIVE: To evaluate the effects of a tissue-selective estrogen complex (TSEC) composed of bazedoxifene/conjugated estrogens (BZA/CE) on menopausal symptoms, metabolic parameters, and overall safety... CONCLUSION: The TSEC composed of BZA (20 mg)/CE (0.625 or 0.45 mg) is an effective and safe treatment for menopausal symptoms.
Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. [2009.09]
OBJECTIVE: To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women... This new menopausal therapy may offer a favorable bleeding and tolerability profile.
Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy. [2009.09]
OBJECTIVE: To evaluate the endometrial safety of a tissue selective estrogen complex (TSEC; pairing of a selective estrogen receptor modulator [SERM] with estrogens) composed of bazedoxifene/conjugated estrogens (BZA/CE) in postmenopausal women... CONCLUSION(S): When combined with CE (0.625 mg or 0.45 mg), BZA (20 mg) was the lowest effective dose that prevented endometrial hyperplasia over 2 years of study, creating the possibility for a new, progestin-free menopausal therapy.
Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. [2009.07]
OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens (CE) cream for treatment of atrophic vaginitis... CONCLUSIONS: Daily and twice-weekly use of low-dose CE cream was equally effective in relieving symptoms of vulvovaginal atrophy. Both regimens showed endometrial safety and sustained efficacy during 1 year of therapy.
Clinical Trials Related to Premarin (Conjugated Estrogens)
Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer [Active, not recruiting]
The purpose of this study is to see if Premarin is useful against androgen-independent
prostate cancer and to help understand how drugs such as Premarin may work.
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis [Completed]
The purpose of this study is to characterize the systemic exposure and bioavailability at
steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in
postmenopausal women with atrophic vaginitis.
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro) [Completed]
To evaluate three new investigational tablet formulations of the Food and Drug Administration
(FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate
(MPA).
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. [Completed]
This study will compare the bioequivalence of two new investigational combination
formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
formulation of Premarin and medroxyprogesterone, Prempro™.
Prempro is indicated for use after menopause in women with a uterus to reduce moderate to
severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around
the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The
purpose of this study is to determine if these new formulations of Premarin and MPA provide
the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation [Completed]
This study will compare the bioavailabity of three new investigational combination
formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in
women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe
dryness, itching, and burning, in and around the vagina; and to help reduce your chances of
getting osteoporosis (thin weak bones). The purpose of this study is to determine if these
new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as
Prempro in healthy postmenopausal women.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 14 ratings/reviews, Premarin has an overall score of 7.21. The effectiveness score is 7.86 and the side effect score is 7.29. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Premarin review by 62 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | hormone replacement therapy |
| Dosage & duration: | | .625 mg taken once daily for the period of 10 years |
| Other conditions: | | migraines |
| Other drugs taken: | | zomig | | |
Reported Results |
| Benefits: | | I had a complete hysterectomy at age 52 and started HRT to avoid the immediate menapause which occurred right after surgery. Unfortunately the hospital staff put me on the estrogen patch which did not work and I was miserable the first couple of nights with severe hot flashes and poor sleep waking up often with soaked clothes and the sensation of itching everywhere during the day. Once my GYN doc changed me over to Premarin .625mg everything adverse disappeared and I enjoyed no menapausal hot flashes,mood swings, loss of sleep, vaginal dryness and my skin benefited as well, no lines or wrinkles and good elasticity.
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| Side effects: | | may have made migraines better or worse..don't know for sure
hyperpigmentation on neck
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| Comments: | | one tablet per day .625mg-took for ten years-yearly mamograms with no problems |
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| | Premarin review by 44 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | estrogen replacement therapy |
| Dosage & duration: | | 0.625 mg once a day taken every day for the period of 15 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The drug has assisted over the years in providing body with appropriate estrogen to keep bones healthy. It has also assisted in elimating hot flashes and causing menapausal systems. Taking hormone replacement therapy assisted me over the years to feel healthy and strong. It replaced needed hormone to my body. |
| Side effects: | | The medication has had few side affects. When first starting to use of when increasing the dosage I experienced pain in my breast. Estrogen replacement assists in lubricating the virgina. One can sometimes become nausated when takin this form of estrogen and is sometimes explosed to yeast infections, Medication has been linked to breast cancer. |
| Comments: | | I began taking estrogen replacement after my hysterectomy. Due to having to have both ovaries and womb removed. I take estrogen once a day everyday and have been taking it since 93. I believe I have benifited greatly from this hormone replacemend |
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| | Premarin review by 52 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | hot flashes / night sweats |
| Dosage & duration: | | maximum dosage (dosage frequency: daily) for the period of approx. 24 months |
| Other conditions: | | low thyroid |
| Other drugs taken: | | Generic synthetic thyroid (Levoxyl?) I cannot now remember the specific name for it | | |
Reported Results |
| Benefits: | | The Premarin did reduce the frequency and severity of hot flashes and night sweats. From that perspective, the drug was somewhat effective. However, the side effects were devastating and worse than dealing with the menopausal symptoms. It took me two years to discern that the problems I encountered were attributable directly to the Premarin. |
| Side effects: | | I developed strange lesions on my arms, which were sore and very embarrassing. I could not wear short-sleeved shirts, because of the mess my arms had become. Obviously, I showed them to the doctor; he simply shrugged his shoulders and said he didn't have a clue what might be causing the lesions. When I went off the Premarin, on my own volition, the lesions disappeared to a significant degree. When I added proteolytic enzymes and hydrochloric acid to my diet, the lesions disappeared completely. I am now able to use bioidentical hormone replacement therapy with complete success and no side effects whatsoever. |
| Comments: | | The doctor put me on the maximum dosage because I was "young" for menopause. Did not test estrogen levels either before beginning treatment or after starting the HRT. I simply took one Premarin pill per day, every day. |
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Page last updated: 2009-10-20
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