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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PREMARIN NEWS HIGHLIGHTS Media 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)
A randomized study of low-dose conjugated estrogens on sexual function and quality of life in postmenopausal women. [2008.11.20]
OBJECTIVE:: To evaluate the effects of combined vaginal and oral low-dose estrogen plus progestogen therapy (EPT) on the frequency and severity of dyspareunia, sexual function, and quality of life in recently postmenopausal women... CONCLUSIONS:: EPT provided a statistically significant improvement compared with placebo in dyspareunia, sexual experience, and quality of life as measured in this study. In general, EPT also improved self-reported sexual perception and enjoyment significantly compared with placebo.
Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. [2008.10]
OBJECTIVE: To evaluate the safety and efficacy of synthetic conjugated estrogens [generic for Premarin] B (SCE-B; 0.3 mg/d) for 12 weeks in the treatment of vulvovaginal atrophy in symptomatic, postmenopausal women... Significant improvement was seen in vaginal maturation index, vaginal pH, and severity of MBS from baseline to the end of treatment.
Conjugated Equine Estrogens and Colorectal Cancer Incidence and Survival: The Women's Health Initiative Randomized Clinical Trial. [2008.10]
CONCLUSIONS: In contrast to the preponderance of observational studies, conjugated equine estrogens in a randomized clinical trial did not reduce colorectal cancer incidence nor improve survival after diagnosis. (Cancer Epidemiol Biomarkers Prev 2008;17(10):2609-18).
Conjugated equine estrogen, raloxifene and arterial stiffness in postmenopausal women. [2008.10]
CONCLUSIONS: Conjugated equine estrogen and raloxifene do not seem to affect arterial stiffness of healthy normotensive women less than 10 years since menopause. Reduction in arterial stiffness seems related to its basal level.
Conjugated equine estrogens and breast cancer risk in the Women's Health Initiative clinical trial and observational study. [2008.06.15]
The Women's Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogen-alone preparations... For women who begin use soon after menopause, combined analyses of clinical trial and observational study data do not provide clear evidence of either an overall reduction or an increase in breast cancer risk with CEEs, although hazard ratios appeared to be relatively higher among women having certain breast cancer risk factors or a low body mass index.
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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PREMARIN PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 11 ratings/reviews, Premarin has an overall score of 6.55. The effectiveness score is 7.27 and the side effect score is 6.73. 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 39 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | .625 mg taken 1/per day for the period of 1 year |
| Other conditions: | | high blood pressure |
| Other drugs taken: | | hzt | | |
Reported Results |
| Benefits: | | benefits included stopping hot flashes,night sweats, hair loss, and it made my skin more supple and much less dry. |
| Side effects: | | there were no bad side effects at all with this medication I have been thoroughly pleased with it, i did notice being a bit more thirsty but not really bad enough to speak of or lis as a side effect |
| Comments: | | my treatment consisted of taking one pill per day |
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| | Premarin review by 50 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | vaginal dryness |
| Dosage & duration: | | 1 gram (dosage frequency: once daily for 14 days, then twice/week) for the period of six months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | improved vaginal lubrication, decreased sensitivity, improved urinary continence, improved urethral tone, |
| Side effects: | | some breakthrough bleeding/spotting at the once a day dosage after fourteen days, very intermittent, did not persist after dose reduced to twice weekly. |
| Comments: | | Medicine was inserted vaginally once daily at bedtime for the first 2 weeks; patient abstained from sexual intercourse during that time so that male partner would not be exposed to the effects of estrogen. |
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| | Premarin review by 53 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | not sure (dosage frequency: once a day) for the period of 2 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | there were no treatment benifits that I could desern because I quit taking the drug because of the severe side effects |
| Side effects: | | I had extreme weight gain, fluctuating emotions. I felt I was going insane so I stopped taking the drug. |
| Comments: | | I was starting menopause and was having hot flashes and disturbed sleep, and migrane headaches. the doctor prescribed premerin and I only took it for 2 months. I saw a natural medicine doctor and started on a natural hormone therapy that worked very well. My headaches stopped and My sleep pattern returned to normal and I lost the weight I gained while on the premerin. |
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Page last updated: 2009-02-07
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