This product helps to treat hot flashes and prevent osteoporosis (). Call your doctor at once if you have any unusual vaginal bleeding while using Mimvey.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. Progesterone receptors have been identified in the female reproductive tract, breast, pituitary, hypothalamus, and central nervous system.There are no pharmacodynamic data known for Mimvey and Mimvey Lo tablets.Estradiol is absorbed through the gastrointestinal tract. An increased risk of probable dementia in postmenopausal women 65 years of age or older has also been reported. A total of 462 postmenopausal women with intact uteri and baseline BMD values for lumbar spine within 2 standard deviations of the mean in healthy young women (T-score > - 2) were enrolled. However, bleeding tended to decrease over time, and after 12 months of treatment with Mimvey 1 mg/0.5 mg, about 86 percent of women were amenorrheic (see Figure 4).Note: The percentage of patients who were amenorrheic in a given cycle and through cycle 13 is shown.If data were missing, the bleeding value from the last reported day was carried forward (LOCF).In the clinical trial with Mimvey Lo 0.5 mg/0.1 mg, 88% of women were amenorrheic after 6 months of treatment (See Figure 5).The results of two randomized, multicenter, calcium-supplemented (500 to 1000 mg per day), placebo-controlled, 2 year clinical trials have shown that Mimvey 1 mg/0.5 mg and estradiol 0.5 mg are effective in preventing bone loss in postmenopausal women. An increased risk of stroke and DVT has been reported with estrogen-alone therapy.
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It is unknown whether this finding applies to younger postmenopausal women 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.Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment.Disorders [see Boxed Warning, Warnings and Precautions (ALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIPALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIP1 TABLET OF Mimvey 1 MG/0.5 MG OR 2 TABLETS OF Mimvey LO 0.5 MG/0.1 MGINCIDENCE OF ENDOMETRIAL HYPERPLASIA WITH UNOPPOSED ESTRADIOL ANDPatients Treated with Mimvey 1 mg/0.5 mg with Cumulative Amenorrhea over TimePercentage of Women with no Bleeding or Spotting at any Cycle Through Cycle 13Patients Treated with Mimvey Lo 0.5 mg/0.1 mg with CumulativePercentage of Women with no Bleeding or Spotting at any Cycle ThroughPERCENTAGE CHANGE (MEAN ± SD) IN BONE MINERAL DENSITY (BMD) FOR(Intent to Treat Analysis, Last Observation Carried Forward)Percentage Change in Bone Mineral Density (BMD) ± SEM of the Lumbar Spine (L1 to L4) for(Intent to Treat Analysis with Last Observation Carried Forward)Table 6: Relative and Absolute Risk Seen in the Estrogen-Plus-Progestin Substudy of WHI at an Average[hazard ratio (HR) 0.69 (95 percent CI, 0.44 to 1.07)]Table 7: Relative and Absolute Risk Seen in the Estrogen-Alone Substudy of WHIWhat is the most important information I should know about Mimvey and Mimvey Lotreat moderate to severe menopausal changes in and around the vaginahelp reduce your chances of getting osteoporosis (thin weak bones)Do not take Mimvey or Mimvey Lo if you have had your uterus removed (hysterectomy)are allergic to Mimvey (estradiol and norethindrone acetate tablets) 1 mg/0.5 mg or Mimvey Lo (estradiol and norethindrone acetate tablets) 0.5 mg/0.1 mg or any of their ingredientsWhat should I tell my healthcare provider before taking Mimvey or Mimvey Lo?Before you take Mimvey or Mimvey Lo, tell your healthcare provider if you:Tell your healthcare provider about all the medicines you take,How should I take Mimvey 1 mg/0.5 mg or Mimvey Lo 0.5 mg/0.1 mg?What are the possible side effects of Mimvey and Mimvey Lo?Side effects are grouped by how serious they are and how often they happen when you are treated.Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:What can I do to lower my chances of a serious side effect with Mimvey 1 mg/0.5 mg or Mimvey Lo 0.5 mg/0.1 mg?Keep Mimvey and Mimvey Lo and all medicines out of the reach of children.General information about the safe and effective use of Mimvey and Mimvey Loestradiol and norethindrone acetate tablet, film coatedWe comply with the HONcode standard for trustworthy health information - 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