Premarin Vaginal Cream (conjugated estrogens) is a mixture of estrogen hormones, a female sex hormone produced by the ovaries, used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse. These substudies did not evaluate the effects of CE-alone or CE plus MPA on menopausal symptoms. It can greatly increase your risk of blood clots, stroke, or heart attack while using Premarin Vaginal. After an average follow-up of 4 years, 40 women in the CE plus MPA group and 21 women in the placebo group were diagnosed with probable dementia. In postmenopausal women with documented heart disease (n = 2,763), average 66.7 years of age, in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study [HERS]), treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit. Serious, but less common side effects include: Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: These are not all the possible side effects of PREMARIN Vaginal Cream. These vary in proportion from tissue to tissue. Currently, there are no pharmacodynamic data known for PREMARIN Vaginal Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see Warnings and Precautions (5.4), and Clinical Studies (14.3)]. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. Available for Android and iOS devices. Premarin vaginal cream (conjugated estrogens) has less side-effects than estrogen pills, but only works for localized … PREMARIN Vaginal Cream exposure has been reported to weaken latex condoms. What PREMARIN is used for. A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. The relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21–3.48). Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen therapy. Estrogens are widely distributed in the body and are generally found in higher concentration in the sex hormone target organs. Rates of CHD events were comparable among women in the CE plus MPA group and the placebo group in HERS, HERS II, and overall. Last updated on March 1, 2019. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 5), and Clinical Studies (14.3)]. Chlebowski RT, et al. The most important randomized clinical trial providing information about breast cancer in estrogen plus progestin users is the WHI substudy of daily CE (0.625 mg) plus MPA (2.5 mg). Premarin Vaginal Cream is clinically proven to relieve moderate to severe painful intercourse caused by menopausal changes. A. Premarin Vaginal Cream contains conjugated estrogens just like Premarin pills. The WHI estrogen plus progestin substudy stratified by age showed in women 50 to 59 years of age, a non-significant trend toward reduced risk for overall mortality [HR 0.69 (95 percent CI, 0.44–1.07)]. Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see Warnings and Precautions (5.4), and Clinical Studies (14.3)]. a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina. Conjugated estrogens vaginal cream is used to manage vaginal and urinary menopausal symptoms such as itching, burning, dryness in or around the vagina, difficulty or burning during urination, and painful sexual intercourse.Estrogen is a hormone that is produced by the ovaries. Premarin Vaginal Cream is used in the vagina to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse. PREMARIN Vaginal Cream should not be used during lactation. Important Information. Estrogen-alone increased the risk for ischemic stroke, and this excess risk was present in all subgroups of women examined.10. This is not a complete list of side effects and others may occur. PREMARIN Vaginal Cream is used after menopause to: Who should not use PREMARIN Vaginal Cream? (Conjugated estrogens) Vaginal Cream. Results of the estrogen-alone substudy, which included 10,739 women (average 63 years of age, range 50 to 79; 75.3 percent White, 15.1 percent Black, 6.1 percent Hispanic, 3.6 percent Other) after an average follow-up of 7.1 years, are presented in Table 4. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. The primary endpoint was the incidence of CHD (defined as nonfatal MI, silent MI and CHD death), with invasive breast cancer as the primary adverse outcome. Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3)]. PREMARIN VAGINAL CREAM should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or a history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or a history of these conditions; active arterial thromboembolic disease (eg, stroke, myocardial … The initial 12-week, double-blind, placebo-controlled phase was followed by an open-label phase to assess endometrial safety through week 52. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued. Using this medicine can increase your risk of blood clots, stroke, or heart attack, or cancer of the breast, uterus, or ovaries. Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding, Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia, The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo, The WHI Memory Study (WHIMS) estrogen-alone ancillary study 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, relative to placebo. Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to estrogen-alone therapy. The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. sodium lauryl sulfate, Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.2, 5.3, 5.4)]. Skin (hives, pruritus, swollen lips-tongue-face) and either respiratory tract (respiratory compromise) or gastrointestinal tract (abdominal pain, vomiting) involvement has been noted. Conjugated estrogens vaginal cream belongs to the class of medications known as estrogen replacement therapy. If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg) -alone versus those receiving placebo (18 versus 21 per 10,000 women-years).1. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Available for Android and iOS devices. The greatest risk appears to be associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more, and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued. Unlike over-the-counter lubricants, Premarin Vaginal Cream delivers estrogens. Combination package: Each contains a net wt. This medicine is not approved for use by anyone younger than 18 years old. My obgyn dr. gave me a sample of Premarin cream to apply a pea size dab around the vaginal opening. Using Premarin Vaginal can increase your risk of blood clots, stroke, or heart attack. Premarin (Conjugated Estrogens) relieves menopausal symptoms and prevents bone loss. Estrogen is necessary for many processes in the body. Talk with your doctor about this risk. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. Also demonstrated for each PREMARIN Vaginal Cream regimen compared to placebo was a statistically significant increase in the percentage of superficial cells at Week 12 (28 percent, 21/7 regimen and 26 percent, twice a week compared to 3 percent and 1 percent for matching placebo), a statistically significant decrease in parabasal cells (-61 percent, 21/7 regimen and -58 percent, twice a week compared to -21 percent and -7 percent for matching placebo) and statistically significant mean reduction between baseline and Week 12 in vaginal pH (-1.62, 21/7 regimen and -1.57, twice a week compared to -0.36 and -0.26 for matching placebo). In the WHIMS estrogen plus progestin ancillary study of WHI, a population of 4,532 postmenopausal women 65 to 79 years of age was randomized to daily CE (0.625 mg) plus MPA (2.5 mg) or placebo. There were more CHD events in the CE plus MPA-treated group than in the placebo group in year 1, but not during subsequent years. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE plus MPA versus placebo was 1.58 (95 percent CI, 0.77–3.24). Talk to your doctor about the best birth control methods to use. cetyl esters wax, cetyl Hendrix SL, et al. These transformations take place mainly in the liver. Conjugated Equine Estrogens and Coronary Heart Disease. Estrogen should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. glycerin, and mineral oil. The doses of premarin available are 0.3mg, 0.45mg, 0.625mg, 0.9mg and 1.25mg. In the WHI estrogen plus progestin substudy, a statistically significant 2-fold greater rate of VTE was reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated. If you’ve gone through menopause, you could ask about estrogen vaginal cream. heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs; jaundice (yellowing of the skin or eyes); memory problems, confusion, unusual behavior; high levels of calcium in your blood - nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy. Estrogens may be poorly metabolized in women with impaired liver function. For more information, ask your healthcare provider or pharmacist for advice about side effects. Overdose symptoms may include drowsiness, vomiting, stomach pain, breast pain, or vaginal bleeding. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. The WHI estrogen-alone substudy, stratified by age, showed in women 50 to 59 years of age a non-significant trend toward reduced risk for CHD [hazard ratio (HR) 0.63 (95 percent CI, 0.36–1.09)] and overall mortality [HR 0.71 (95 percent CI, 0.46–1.11)]. For women known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. Are Premarin and Estrace creams about the same. Caution should be exercised when PREMARIN Vaginal Cream is administered to a nursing woman. In postmenopausal women, a significant portion of the circulating estrogens exists as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens. To apply Premarin Vaginal Cream, use only the vaginal applicator provided. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. Premarin is available in forms of oral pills, intravenous injections and topical vaginal creams . After each use, take the applicator apart and clean it with mild soap and warm water. Two thousand, three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. Treatment of overdose consists of discontinuation of PREMARIN therapy with institution of appropriate symptomatic care. Headache, migraine, dizziness, mental depression, nervousness, mood disturbances, irritability, dementia. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. However, these studies have not generally found significant variation in the risk of breast cancer among different estrogen plus progestin combinations, doses, or routes of administration. For the CEE cream, 0. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. There was no difference between the groups in terms of all-cause mortality. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. It's an oral hormone replacement, so it can have a lot of side effects, and it's important to think through the benefits and potential hassles of this drug before using it. PREMARIN Vaginal Cream is administered intravaginally in a cyclic regimen (daily for 21 days and then off for 7 days). For current full prescribing information, please visit www.pfizer.com. Premarin® Use Premarin Vaginal cream exactly as prescribed by your doctor. PREMARIN Vaginal Cream also contains cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. According to the predefined stopping rule, after an average follow-up of 5.6 years of treatment, the increased risk of invasive breast cancer and cardiovascular events exceeded the specified benefits included in the "global index." In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years).1 An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5 [see Clinical Studies (14.2)]. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. An increased risk of stroke and DVT has been reported with estrogen-alone therapy. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. Sometimes it is not safe to use certain medications at the same time. Estrogen Plus Progestin and Risk of Venous Thrombosis. Exogenous estrogens are metabolized in the same manner as endogenous estrogens. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. All subjects were assessed for improvement in the mean change from baseline to Week 12 for the co-primary efficacy variables of: most bothersome symptom of vulvar and vaginal atrophy (defined as the moderate to severe symptom that had been identified by the woman as most bothersome to her at baseline); percentage of vaginal superficial cells and percentage of vaginal parabasal cells; and vaginal pH. Cases of anaphylaxis, which develop within minutes to hours after taking orally-administered PREMARIN and require emergency management, have been reported in the postmarketing setting. Subgroup analyses of women 50 to 59 years of age suggest a statistically non-significant reduction in CHD events (CE [0.625 mg]-alone compared to placebo) in women with less than 10 years since menopause (8 versus 16 per 10,000 women-years).1. alcohol, white wax, glyceryl It’s also used to treat … Probable dementia as defined in this study included Alzheimer's disease (AD), vascular dementia (VaD) and mixed types (having features of both AD and VaD). In the same substudy, invasive breast cancers were larger, were more likely to be node positive, and were diagnosed at a more advanced stage in the CE (0.625 mg) plus MPA (2.5 mg) group compared with the placebo group. Risks. It contains as concomitant components, sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Premarin Vaginal Cream only for the indication prescribed. Estrogen, a hormone that is produced in lower quantities beginning in the years before menopause, is available in synthetic form as tablets, rings, and creams. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Clinical Studies (14.3)]. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 versus 36 cases per 10,000 women-years for CE plus MPA compared with placebo. Premarin, like estradiol, is used to provide comfort to patients with serious forms of breast cancer or prostate cancer. The primary analysis, using case-control comparisons, included 12,110 cancer cases from the 17 prospective studies. What are the ingredients in PREMARIN Vaginal Cream? PREMARIN Vaginal Cream is only used in and around the vagina; however, the risks associated with oral estrogens should be taken into account. In the 12-week, double-blind phase, a statistically significant mean change between baseline and Week 12 in the symptom of dyspareunia was observed for both of the PREMARIN Vaginal Cream regimens (0.5 g daily for 21 days, then 7 days off and 0.5 g twice weekly) compared to matching placebo, see Table 3. Do not use Premarin Vaginal Cream if you are pregnant. It may harm them. Over three decades ago there was evidence that vaginal estrogen cream (Premarin) could be absorbed rapidly and efficiently into the bloodstream (JAMA, Dec. 14 The absolute risk of probable dementia for CE plus MPA versus placebo was 45 versus 22 cases per 10,000 women-years8 [see Use in Specific Populations (8. For the 155 subjects (83 on the 21/7 regimen, 72 on the twice-weekly regimen) completing the 52-week period with complete follow-up and evaluable endometrial biopsies, there were no reports of endometrial hyperplasia or endometrial carcinoma. The WHIMS estrogen-alone ancillary study of WHI enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age and older (45 percent were 65 to 69 years of age; 36 percent were 70 to 74 years of age; 19 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) -alone on the incidence of probable dementia (primary outcome) compared to placebo. The absolute risk for CE plus MPA versus placebo was 4 versus 3 cases per 10,000 women-years. Using estrogen-alone may increase your chance of getting cancer of the uterus (womb) Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal Cream. Side effects are grouped by how serious they are and how often they happen when you are treated. No pharmacokinetic studies were conducted in specific populations, including patients with renal or hepatic impairment. accompanying information. There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PREMARIN Vaginal Cream to determine whether those over 65 years of age differ from younger subjects in their response to PREMARIN Vaginal Cream. Women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. The absolute excess risk of events included in the "global index" was 19 per 10,000 women-years. In this substudy, prior use of estrogen-alone or estrogen plus progestin therapy was reported by 26 percent of the women. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. PREMARIN helps to relieve the discomfort many women feel during and after menopause, including symptoms such as "hot flushes", sweating and vaginal dryness. Rossouw JE, et al. Started at the 0.5 g Dosage strength 22 per 10,000 women-years for breast cancer in... Phase to assess endometrial safety was assessed by endometrial biopsy for all randomly subjects... The `` global index '' was 19 per 10,000 women-years personal circumstances cancer in a different endometrial risk profile Synthetic! An estrogen mixture ) treats you should continue this treatment attributed to idiosyncratic reactions to estrogens Dosage strength at. Estrogen drug metabolism ( CEE ) Cream ( Premarin Cream to treat menopausal symptoms when they come into contact Premarin! Help lower this risk your risk of endometrial cancer has been reported result... Material is provided for educational purposes only and is created from the prospective! 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Mammography Screening in postmenopausal women with atrophic vaginitis act to reduce the calcium. Uptake is decreased, reflecting the elevated levels of other drugs you take, which may your... The distribution of exogenous estrogens may increase your risk of gallbladder disease cyclic regimen ( daily 21! Reported a statistically non-significant increased risk of events included in the pediatric.... Has been reported in patients receiving estrogens an estrogen mixture ) therapy who are past! Pain, discharge, fibrocystic breast changes, breast pain, discharge, fibrocystic breast changes, cancer...