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Premarin I.V. (Conjugated Estrogens) - Summary

 
 



BOX 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 results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen doses.

CARDIOVASCULAR AND OTHER RISKS

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease.

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 (0.625 mg) combined with medroxyprogesterone acetate (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 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. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. 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 I.V. SUMMARY

Premarin® Intravenous (conjugated estrogens, USP) for injection 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 materials 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 Intravenous (conjugated estrogens, USP) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.

Premarin Intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels.


See all Premarin I.V. indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Premarin I.V. (Conjugated Estrogens)

Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. [2014]
alone, hormone therapy, and placebo (PBO)... CONCLUSIONS: BZA/CE showed low rates of endometrial hyperplasia and improved

Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial. [2014]
and active-controlled phase 3 trial... CONCLUSIONS: Symptomatic postmenopausal women who are treated with BZA/CE for 1

Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. [2014]
types in phase 3 clinical trials... CONCLUSIONS: CE/BZA significantly improved overall and vasomotor-related MSQOL

Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. [2013]
and active-controlled phase 3 study... CONCLUSION: Bazedoxifene 20 mg and conjugated estrogens 0.45 and 0.625 mg did not

Application of machine learning methods to describe the effects of conjugated equine estrogens therapy on region-specific brain volumes. [2011.05]
Use of conjugated equine estrogens (CEE) has been linked to smaller regional brain volumes in women aged >/=65 years; however, it is unknown whether this results in a broad-based characteristic pattern of effects. Structural magnetic resonance imaging was used to assess regional volumes of normal tissue and ischemic lesions among 513 women who had been enrolled in a randomized clinical trial of CEE therapy for an average of 6.6 years, beginning at ages 65-80 years...

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Clinical Trials Related to Premarin I.V. (Conjugated Estrogens)

Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer [Completed]
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.

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. [Completed]
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.

Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation [Completed]
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women [Completed]
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Beneficial Effects of Oral Premarin Estrogen Replacement Therapy Assessed by Human Genome Array [Completed]
The purpose of this study is to assess the immunological status of patients using Premarin. Premarin use is associated with an enhanced immune status, and possibly even some anti-cancer effect. The researchers will compare the use of Premarin with those not using hormone replacement therapy (HRT) to track the effects of Premarin in reducing the risk of infection and swelling.

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Page last updated: 2015-08-10

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