FDA prescribing information, side effects and uses. Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause. Limitation of Use. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure. 0.025mg; 0.0375mg; 0.05mg; 0.06mg; 0.075mg; 0.1mg; topical emulsion. 4.35mg/1.74g (0.25%) more. Vulvar and Vaginal Atrophy in Menopause. Estrace: 1-2 mg PO once daily for 3. 70 to the 0.1 mg estradiol patch, and 72 to placebo. Potential subjects were postmenopausal women in good general health who experienced vasomotor symptoms. Change your Climara patch 1 time each week or every 7 days. Mylan manufactures ESTRADIOL TRANSDERMAL SYSTEM Continuous Delivery (Once-Weekly), USP (Climara) in strengths of 0.025 mg/day, 0.0375 mg/day. ESTRADIOL TRANSDERMAL SYSTEM Continuous Delivery (Once-Weekly). Each patch should be carefully folded in half so that it sticks to. 0.1 mg per day—each 25.0 cm. Climara (estradiol transdermal system), 0.1 mg per day — each 25 cm Climara (estradiol) Strengths Available: Price: Quantity: 0.025 mg: $50: 4. Medroxyprogesterone (generic. Change your Climara Pro patch 1 time each week or every 7 days. Additional Climara Information. Climara Side Effects Center; Climara in detail including Side Effects and Drug. Converting Between Estrogen Products. Prevention of Postmenopausal Osteoporosis. Limitation of Use. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non- estrogen medication should be carefully considered. Climara Dosage and Administration. Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin . Postmenopausal women should be re- evaluated periodically as clinically appropriate to determine if treatment is still necessary. Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. CLIMARA (Estradiol) drug. Apply 1 patch once weekly to lower abdomen or upper. Other uses: initially one 0.025mg/day patch. Give cyclically (3 weeks on, 1 week off). Children: Not applicable. Start therapy with 0. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals. Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause. Start therapy with 0. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals. Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure. Start therapy with 0. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Climara transdermal system, especially in women with an intact uterus. Prevention of Postmenopausal Osteoporosis. Start therapy with 0. Application of the Climara Transdermal System. Site Selection. The waistline should be avoided, since tight clothing may rub the transdermal system off. If the system cannot be reapplied, a new system should be applied for the remainder of the 7- day dosing interval. Then gently rubbing the area with an oil- based cream or lotion should remove the adhesive residue. Each patch should be carefully folded in half so that it sticks to itself before throwing it away. Dosage Forms and Strengths. An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. Stroke. In the WHI estrogen- alone substudy, a statistically significant increased risk of stroke was reported in women 5. CE (0. 6. 25 mg)- alone compared to women in the same age group receiving placebo (4. The increase in risk was demonstrated in year 1 and persisted . Should a stroke occur or be suspected, estrogen- alone therapy should be discontinued immediately. Subgroup analyses of women 5. CE (0. 6. 25 mg)- alone versus those receiving placebo (1. In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 5. CE (0. 6. 25 mg) plus MPA (2. The increase in risk was demonstrated after the first year and persisted. Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. Coronary Heart Disease. In the WHI estrogen- alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) was reported in women receiving estrogen- alone compared to placebo. During an average follow- up of 4. CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE plus MPA- treated group than in the placebo group in year 1, but not during the subsequent years. A total of 2,3. 21 women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow- up in HERS II was an additional 2. Rates of CHD events were comparable among women in the CE plus MPA group and the placebo group in HERS, HERS II, and overall. Venous Thromboembolism. In the WHI estrogen- alone substudy, the risk of VTE (DVT and PE) was increased for women receiving daily CE (0. DVT reached statistical significance (2. The increase in VTE risk was demonstrated during the first 2 years. Should a VTE occur or be suspected, estrogen- alone therapy should be discontinued immediately. In the WHI estrogen plus progestin substudy, a statistically significant 2- fold greater rate of VTE was reported in women receiving daily CE (0. MPA (2. 5 mg) compared to women receiving placebo (3. Statistically significant increases in risk for both DVT (2. PE (1. 8 versus 8 per 1. The increase in VTE risk was demonstrated during the first year and persisted. Should a VTE occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. Malignant Neoplasms. Endometrial Cancer. An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a woman with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2 to 1. Most studies show no significant increased risk associated with use of estrogens for less than 1 year. The greatest risk appears associated with prolonged use, with increased risks of 1. This risk has been shown to persist for at least 8 to 1. Clinical surveillance of all women using estrogen- alone or estrogen plus progestin therapy is important. 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. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestin to estrogen therapy in postmenopausal women has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Breast Cancer. The most important randomized clinical trial providing information about breast cancer in estrogen- alone users is the WHI substudy of daily CE (0. In the WHI estrogen- alone substudy, after an average follow- up of 7. CE- alone was not associated with an increased risk of invasive breast cancer . After a mean follow- up of 5. CE plus MPA. In this substudy, prior use of estrogen- alone or estrogen plus progestin therapy was reported by 2. The relative risk of invasive breast cancer was 1. CE plus MPA compared with placebo. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1. CE plus MPA compared with placebo . Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1. CE plus MPA compared with placebo. 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. MPA (2. 5 mg) group compared with the placebo group. Metastatic disease was rare, with no apparent difference between the two groups. Other prognostic factors, such as histologic subtype, grade and hormone receptor status did not differ between the groups. The risk increased with duration of use, and appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). 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. 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. The use of estrogen- alone and estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self- examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. Ovarian Cancer. The WHI estrogen plus progestin substudy reported a statistically non- significant increased risk of ovarian cancer. After an average follow- up of 5. CE plus MPA versus placebo was 1. CI, 0. 7. 7- 3. 2. The absolute risk for CE plus MPA versus placebo was 4 versus 3 cases per 1. In some epidemiological studies, the use of estrogen plus progestin and estrogen- only products, in particular for 5 or more years, has been associated with an increased risk of ovarian cancer. However, the duration of exposure associated with increased risk is not consistent across all epidemiologic studies, and some report no association. Probable Dementia. In the WHIMS estrogen- alone ancillary study of WHI, a population of 2,9. CE (0. 6. 25 mg)- alone or placebo.
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