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Premarin (Conjugated Estrogens) - Summary

 
 



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.

 

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:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. 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.
  3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
  4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
  5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
  6. 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.


See all Premarin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Premarin (Conjugated Estrogens)

Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. [2011.04.06]
CONTEXT: The Women's Health Initiative Estrogen-Alone Trial was stopped early after a mean of 7.1 years of follow-up because of an increased risk of stroke and little likelihood of altering the balance of risk to benefit by the planned trial termination date. Postintervention health outcomes have not been reported. OBJECTIVE: To examine health outcomes associated with randomization to treatment with conjugated equine estrogens (CEE) among women with prior hysterectomy after a mean of 10.7 years of follow-up through August 2009... CONCLUSIONS: Among postmenopausal women with prior hysterectomy followed up for 10.7 years, CEE use for a median of 5.9 years was not associated with an increased or decreased risk of CHD, deep vein thrombosis, stroke, hip fracture, colorectal cancer, or total mortality. A decreased risk of breast cancer persisted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000611.

Effects of percutaneous estradiol-oral progesterone versus oral conjugated equine estrogens-medroxyprogesterone acetate on breast cell proliferation and bcl-2 protein in healthy women. [2011.03.01]
In a prospective, randomized clinical study 77 women were assigned randomly to receive sequential hormone therapy with either conventional oral conjugated equine estrogens (0.625 mg) with the addition on 14 of the 28 days of oral medroxyprogesterone acetate (5 mg) or natural E(2) gel (1.5 mg) with oral micronized P (200 mg) on 14 of the 28 days of each cycle.

Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. [2011]
a mean of 10.7 years of follow-up through August 2009... CONCLUSIONS: Among postmenopausal women with prior hysterectomy followed up for

Preventing osteoporosis with a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens (BZA/CE). [2011]
Hormone therapy classically consists of an estrogen with an added progestin; however, concerns have been raised about the potential negative effects of progestin. The recent realization that estrogen agonist-antagonists or selective estrogen receptor modulators might be paired with estrogens instead of a progestin has led to the development of a novel form of menopausal therapy called tissue selective estrogen complex (TSEC).

Long-term effects of conjugated equine estrogen therapies on domain-specific cognitive function: results from the Women's Health Initiative study of cognitive aging extension. [2010.07]
OBJECTIVES: To determine whether small decrements in global cognitive function that conjugated equine estrogen (CEE) therapies have been shown to produce in older women persist after cessation and extend to specific cognitive domains... CONCLUSION: CEE-based therapies, when initiated after the age of 65, produce a small broad-based decrement in cognitive function that persists after their use is stopped, but the differences in cognitive function are small and would not be detectable or have clinical significance for an individual woman. Differences in effects between cognitive domains suggest that more than one mechanism may be involved.

more studies >>

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.

A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions. [Recruiting]
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.

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.

more trials >>

Reports of Suspected Premarin (Conjugated Estrogens) Side Effects

Hot Flush (142)Drug Ineffective (123)Breast Cancer Female (92)Headache (77)Feeling Abnormal (69)Depression (65)Malaise (63)Vulvovaginal Burning Sensation (49)Pain (47)Insomnia (44)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 22 ratings/reviews, Premarin has an overall score of 7.50. The effectiveness score is 8.27 and the side effect score is 7.82. 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.
Side effects:   may have made migraines better or worse..don't know for sure hyperpigmentation on neck
Comments:   one tablet per day .625mg-took for ten years-yearly mamograms with no problems

 

Premarin review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   partial hysterectomy
Dosage & duration:   .045 mg taken 1 time daily for the period of 2 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Had to have a partial hysterectomy due to endometreosis. After the surgery began experiencing hot flashes on a very frequent basis - approximately 1-2 times per hour. My gynecologist prescribed Premarin .030mg. Since then I have moved up to the .045 mg dosage which I take once a day. For the most part, this relieves my symptoms even though I wake up at night on occasion with a night sweat.
Side effects:   periodic headaches
Comments:   take once daily for relief of menopause symptoms

 

Premarin review by care giver of 76 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   hrt hysterectomy
Dosage & duration:   0.625 (dosage frequency: daily) for the period of 40 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   stopped hot flashes
Side effects:   breast lumps requiring surgery three times stroke cancer requiring surgery, three separate chemo therapies
Comments:   My grand mom was prescribed Premarin after her uterus was removed at age 34. She was a smoker with high blood pressure. Her doctor was aware of her smoking and blood pressure. At one point in her hrt therapy she was injecting Premarin per doctors orders. Now at age 76, grand mom continues to take Premarin because she was told by her doctor that it is the fountain of youth. She is very vain and does not care if this drug kills her as long as she looks young. She looks and acts older than her actual age. The risk do not out weigh the benefit. HRT should only be used to ease a woman into menopause. Grand mom still has hot flashes after 40 years of HRT. Had she not taken HRT she would be through menopause and never have suffered the stroke or cancers which took several years of her life away.

See all Premarin reviews / ratings >>

Page last updated: 2013-02-10

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