History of hypertriglyceridemia. Geriatrics (> 65 years of age): There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PREMARIN to determine whether those over 65 years of age differ from younger subjects in their response to PREMARIN. For women who have intact uteri, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Hepatic hemangiomasParticular caution is indicated in women with hepatic hemangiomas, as HRT may cause an exacerbation of this condition. Cardiovascular riskERT has been reported to increase the risk of stroke and deep venous thrombosis (DVT). 10. Breakthrough bleeding; spotting; change in menstrual flow and abnormal withdrawal bleeding or flow, dysmenorrheal/pelvic pain; vaginal itching/discharge; dyspareunia; endometrial hyperplasia; pre-menstrual-like syndrome; reactivation of endometriosis; changes in cervical erosion and amount of cervical secretion; vaginal candidiasis, amenorrhea, vaginitis, increase in size of uterine leiomyomata, breast swelling and tenderness, breast pain, enlargement, galactorrhea, breast discharge; growth potentiation of benign meningioma; leukorrhea. Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases. Un programa que dej de tener gracia cuando se. Lab tests: Monitor serum phosphatase levels with prostate cancer. Estrogens should be used with caution in individuals with pre-existing severe hypocalcemia. Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug, Menopause, Osteoporosis, Atrophic Vaginitis, Kraurosis Vulvae. The greatest risk appears associated with prolonged use, with increased risks of 15- to 24- fold for five years or more, and this risk has been shown to persist for at least 8 to15 years after ERT is discontinued. Where an assessment of the risk to benefit ratio suggests the use of this product in nursing women is unfavourable, formula feeding should be substituted for breast feeding. %%EOF PREMARIN may be taken without regard to meals. Combined Estrogen and Progestin Therapy:There are additional and/or increased risks that may be associated with the use of combination estrogen-plus-progestin therapy compared with using estrogen-alone regimens. The following additional adverse reactions have been reported with estrogen replacement therapy or are undesirable effects associated with hormone replacement therapy: Altered coagulation tests (see WARNINGS AND PRECAUTIONS, Drug-Laboratory Tests Interactions). Porphyria. The estrogen-alone arm of the WHI trial (mean age 63.6 years) indicated an increased risk of stroke and deep vein thrombosis in hysterectomized women treated with CEE-alone (0.625 mg/day) for 6.8 years compared to those receiving placebo. A worsening of glucose tolerance and lipid metabolism has been observed in a significant percentage of peri- and post-menopausal patients. PREMARIN (0.3 mg, 0.45 mg, and 0.625 mg tablets) was shown to be statistically better than placebo at weeks 4 and 12 for relief of both the frequency and severity of moderate to severe vasomotor symptoms. Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the intestine followed by reabsorption. AbsorptionConjugated estrogens are soluble in water and are well absorbed from the gastrointestinal tract after release from the drug formulation. Numerous reports of ingestion of large doses of estrogen products and estrogen-containing oral contraceptives by young children have not revealed acute serious ill effects. Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women. Gallbladder disorder; cholestatic jaundice. It is also used to treat vaginal pain during sexual intercourse. At the end of the study, Cycle 13, all but the FSH were performed. ?EUUMv{ b1w Tmciqv4+)6jzmYmEx`E[(96{p.mzAg[}VydL Zi1~(qYpd[V4;.O2]i# . visibility: inherit; Nursing mothers: not recommended. Ovarian cancerIn some epidemiologic studies, the use of estrogen therapy has been associated with an increased risk of ovarian cancer over multiple years of use. These include an increased risk of myocardial infarction, pulmonary embolism, invasive breast cancer and ovarian cancer. By contrast, synthetic estrogens, such as ethinyl estradiol and the nonsteroidal estrogens, are degraded very slowly in the liver and other tissues, which results in their high intrinsic potency. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid have been noted when these drugs were administered with certain ethinyl estradiol-containing drug products (eg., oral contraceptives containing ethinyl estradiol). A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . From the original HERS trial, 2321 women consented to participate in an open label extension of HERS known as HERS II. Premarin (conjugated estrogens) vaginal cream Premphase (conjugated estrogens plus medroxyprogesterone acetate tablets) Prempro (conjugated estrogens/ medroxyprogesterone acetate tablets) Pristiq (desvenlafaxine) Relpax (eletriptan HBr) Skelaxin (metaxalone) Synarel (nafarelin acetate) Tikosyn (dofetilide) Toviaz (fesoterodine fumarate) Hepatic metabolismInteractions can occur with drugs that induce microsomal enzymes which can decrease ethinyl estradiol concentrations (eg., rifampin, barbiturates, phenytoin, carbamazepine, troglitazone). Significantly (p< 0.05) fewer (12%) PREMARIN treated patients reported breast pain than in the PREMARIN /MPA groups. Our scientific content is evidence-based, scientifically balanced and non-promotional. to the vial by aiming it at the side of the vial. Actions. and offers clinical decision support services. Premarin is also used to prevent osteoporosis in postmenopausal women, and replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Thus, food slightly lowered the Cmax, but did not affect the AUC, of the estrogens from a 0.625 mg PREMARIN tablet; food significantly increased the Cmax and AUC of MPA from a 2.5-mg tablet. stroke, myocardial infarction, coronary heart disease). Those changes are called secondary sex characteristics. Latest News Your top articles for Thursday, Continuing Medical Education (CME/CE) Courses. Estrogen therapy should be used with caution in individuals with hypoparathyroidism as estrogen-induced hypocalcemia may occur. Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3-6 weeks) may occur, arthralgia, leg cramps. Effects on female hypogonadismIn clinical studies of delayed puberty due to female hypogonadism, breast development was induced by doses as low as 0.15 mg. Fatigue; changes in appetite; changes in body weight; changes in libido, exacerbation of porphyria, hypocalcemia (in patients with disease that can predispose to severe hypocalcemia), exacerbation of asthma, angioedema, hypersensitivity; anaphylactic/anaphlactoid reactions, increased triglycerides. After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Endometriosis. Below, check out the tour dates, as well as a weird tour . The Womens Health Initiative StudyIn the Womens Health Initiative (WHI) estrogen-alone substudy (daily [0.625 mg] versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age. These vasomotor symptoms are seen in women whether menopause is surgically induced or spontaneous. Diabetes. Women's health is once again the center of a political ping-pong match with evidence-based science on one side and anti-choice advocates on the other. Drug-lifestyle interactionsAcute alcohol ingestion during HRT may lead to elevations in circulating estradiol levels. Generally, women should be started at the 0.5 g dosage strength. Smoothie. Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Patients should be re- evaluated periodically as clinically appropriate to determine if treatment is still necessary (see boxed Serious Warnings and Precautions). |8ygqyDDGlh-mNtgO#h %OK ^zutPW*X")ZJ'xRs/RR=Jl4e]3X:j^f-cJZPZHwQ"rh"ma'J5LT3gQCR.b;5)(Ww&Xg@ibIo]AB_tptB@oAG[zvA{Ym[m( n%mF+e=#6yf+Ue# j-u>/4[cM^FRt=Q}L_yR74!hz. Vulvar AtrophyPatients should be treated with the lowest effective dose. Monitor/Modify Tx. anthrax immune globulin. Cerebrovascular insufficiencyPatients who develop visual disturbances, classical migraine, transient aphasia, paralysis or loss of consciousness should discontinue medication. It is recommended that women undergo mammography prior to the start of HRT treatment and at regular intervals during treatment, as deemed appropriate by the treating physician and according to the perceived risks for each patient. Cardiovascular disorders. DistributionThe distribution of exogenous estrogens is similar to that of endogenous estrogens. Stroke. Pfizer Canada accepts no responsibility for the content of linked sites. Other clinical drug-drug interaction studies have not been conducted with conjugated estrogens. In patients with rare hereditary galactose intolerance, lactase deficiency or gIucose-galactose malabsorption, the severity of the condition should be taken into careful consideration before prescribing PREMARIN. When given orally, naturally-occurring estrogens and their esters are extensively metabolized (first pass effect) and circulate primarily as estrone sulfate, with smaller amounts of other conjugated and unconjugated estrogenic species. It is recommended that estrogens not be given to women with existing breast cancer or those with a previous history of the disease (see CONTRAINDICATIONS). The benefits and risks of HRT must always be carefully weighed, including consideration of the emergence of risks as therapy continues. Atrophic vaginitis, kraurosis vulvae: 0.52g/day intravaginally given cyclically (3 weeks on, 1 week off). Estrogens may be poorly metabolized in patients with impaired liver function. endstream endobj 206 0 obj <> endobj 207 0 obj <> endobj 208 0 obj <>stream Concomitant thyroid replacement; may need to increase thyroid dose. These transformations take place mainly in the liver. The color ingredients are: - 0.3 mg (green color tablet with 0.3 printed in white ink): hypromellose, quinoline yellow lake, macrogol, FD&C Blue No. Effects on the EndometriumThe use of unopposed estrogen therapy has been associated with an increased risk of endometrial hyperplasia, a possible precursor of endometrial adenocarcinoma. Know signs of thrombophlebitis (see Appendix F). 1 interaction. This is reflected by the greater percentage of patients with breast pain on combination therapy than on PREMARIN alone. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Hereditary angioedema. SLE. given continuously or cyclically (3 weeks on, 1 week off). This hormone therapy helps better align the body with a person's gender identity. Store ampule and reconstituted solution at 28 C (3846 F) and protected from light; stable Would you like to proceed? Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy. Continuous, non-cyclic therapy may be indicated in hysterectomized women or in cases where the signs and symptoms of estrogen deficiency become problematic during the treatment-free interval. Baseline tests should include mammography, measurements of blood glucose, calcium, triglycerides and cholesterol, and liver function tests. In the estrogen plus progestin arm of the WHI trial, among 10,000 women over a one-year period, there were: The WHI study also reported that the invasive breast cancers diagnosed in the estrogen plus progestin group were similar in histology but were larger (mean [SD], 1.7 cm [1.1] vs 1.5 cm [0.9], respectively; P=0.04) and were at a more advanced stage compared with those diagnosed in the placebo group. Systemic lupus erythematosusParticular caution is indicated in women with systemic lupus erythematosus, as HRT may cause an exacerbation of this condition. The regimens . Breasts and pelvic organs should be appropriately examined and a Papanicolaou smear should be performed. Give cyclically except when used for treatment of postpartum breast engorgement and for palliation of cancer. Serious, but less common side effects include: Heart attack. Liver dysfunction or disease as long as liver function tests have failed to return to normal. Fibrocystic breast changes; enlargement of hepatic hemangiomas. Known, suspected, or past history of breast cancer. EyesRetinal vascular thrombosis, intolerance to contact lenses. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Estrogens, conjugated. EndometriosisEndometriosis may be exacerbated with administration of estrogen therapy. The results, when extrapolated to 10,000 women treated over a one-year period showed: In the estrogen-alone arm of the WHIMS (n=2947), women with prior hysterectomy were treated with daily 0.625 mg CEE or placebo for an average of 5.21 years. Product description Each gram of PREMARIN (conjugated estrogens) Vaginal Cream contains 0.625 mg conjugated estrogens, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. 8 more cases of invasive breast cancer (38 on combined HRT versus 30 on placebo). See additional implications under estradiol. PREMARIN Vaginal Cream (conjugated estrogens) | Pfizer Medical Information - Canada In order to provide you with relevant and meaningful content we need to know more about you. Clinical surveillance of all women taking combined estrogen plus progestin HRT is important. Monitor for and report breakthrough vaginal bleeding. AngioedemaExogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema. Increased risk of breast or ovarian cancer. May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). This medication is a female hormone. It is a mixture of sodium estrone sulphate and sodium equilin sulphate. display: contents; The white branding ink contains the following: titanium dioxide, purified water, isopropyl alcohol, propylene glycol, hypomellose. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. No dose-dependent incidence of adverse experiences was seen in the multicenter efficacy and safety study. Protein C, protein S, or antithrombin deficiency, or other thrombophilias. He armed himself with a balaclava, latex gloves, condoms and Viagra pills and posed as a cab driver in a Mercedes to roam the streets of Brighton, East Sussex. Drug-Food InteractionsCYP3A4 inhibitors such as grapefruit juice may increase plasma concentrations of 17 -estradiol and may result in side effects. 1513 0 obj <>stream Patients should not take 2 doses at the same time. In some cases, hysterectomized women with a history of endometriosis may need a progestin, see WARNINGS AND PRECAUTIONS, Endometriosis. One clinical study demonstrated that even when estrogen was started as late as fifteen years after menopause, further loss of bone mass was prevented, but was not restored to premenopausal levels. For maintenance therapy one should always use the lowest dose that still proves effective. 1. the relief of menopausal and postmenopausal symptoms occurring in naturally or surgically induced estrogen deficiency states including vulvar and vaginal atrophy. The following section contains information on drug interactions with ethinyl estradiol-containing products (specifically, oral contraceptives) that have been reported in the public literature. You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect. Genitourinary syndrome of menopause (vulvovaginal atrophy): Treatment. A total of 1,724 generally healthy postmenopausal women (mean age, 54.0 years SD 4.6) participated in the study. The PREMARIN tablet releases conjugated estrogens slowly over several hours. Pediatrics (< 16 years of age): PREMARIN is not indicated for use in children. PREMARIN (conjugated estrogens sustained release tablets) is indicated for the following: In patients with an intact uterus, PREMARIN should be prescribed with an appropriate dosage of a progestin for women with intact uteri, in order to prevent endometrial hyperplasia/carcinoma. Moderate-to-severe dyspareunia due to menopause. If feasible, PREMARIN should be discontinued at least 4 weeks before major surgery which may be associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. Also, patients with varicose veins should be closely supervised. Premarin Vaginal Cream Page 3 of 40 Premarin Vaginal Cream (Conjugated Estrogens CSD, 0.625 mg/g) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients vaginal conjugated estrogens vaginal cream 0.625 mg/g Other known risk factors for the development of breast cancer such as nulliparity, obesity, early menarche, late age at first full term pregnancy and at menopause should also be evaluated. 205 0 obj <> endobj The same time numerous reports of ingestion of large doses of estrogen products and oral. 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