Difference between vagifem and yuvafem

Transcription

1 Difference between vagifem and yuvafem 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. Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or 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. During an average follow-up of 4.1 years, treatment with 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,

2 but not during subsequent years. 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. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE plus MPA group and the placebo group in HERS, HERS II, and overall. The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Yes Marie I realize the Triamcinolone ointment is a steroidal ointment, it can also be used for eczema and can cause thinning of the skin. For me, it has/does work and I have not experienced thinning of my skin in any areas. I am so very thankful the Triamcinolone ointment relieved me of AV as a couple other things did not work and as bad as I was suffering. Marie I really hope that you find/get something to find relief also. It's different for everyone but I have been on Estrace and now yuvafem since last August. After the first month I was thrilled when I would say I was about 75 % better, After months of depression and constant burning. Spent my days sitting with an ice pack between my legs and on Norco for the pain. About a month ago my symptoms returned so I increased my Yuvafem to three times a week. I'm at a point where this AV has changed my life so much that I am trying to figure out how to afford the mona lisa treatments. Thanks Deb, will go and discuss with GP and ask to look into bladder. The gynae has ruled out anything serious and said he does not recommend any further investigations but did not mention AV but to come back if I am

3 spotting. I have still got the ovestin gp prescribed but have not used due to sideeffects when I used it last time. I prefer to go with a non hormonal route gp told me to go in health shop. I can put up with it if I am certain it is nothing serious just AV. It does feel I am on fire down below. I understand as soon as treatment stops, the problem starts again therefore there is no long term relief without medicaion. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. [see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3) ]. [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Clinical Studies ( 14.3 )]. Hang in there you are not alone and being on this site to get advice has been a lifesaver to me. I get really down that at 62 this is what I have to learn to live with. I just can't accept this. Thanks, just been to GP, it is GP who diagnosed AV not Gynae. What medication are you on,told her do not want any HRT cream, will put up with it. I really believe I have got a urine infection but urine specimen was very clear and was neg, therefore I will stop worrying about urine infection & acccept it is AV I have got. [see Clinical Studies (14.2) ]. Should a VTE occur or be suspected, estrogen-alone therapy should be discontinued immediately. Addition of a Progestin When a Woman Has Not Had a Hysterectomy. An increased risk of stroke and DVT has been reported with estrogenalone therapy. 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. 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. When data from

4 the two populations in the WHIMS estrogen-alone and estrogen plus progestin ancillary studies were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, ). 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 8. After an average follow-up of 5.2 years, 28 women in the estrogen-alone group and 19 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CEalone versus placebo was 1.49 (95 percent CI, ). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years 8. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast selfexaminations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. Known anaphylactic reaction or angioedema to PREMARIN Vaginal Cream. [see Warnings and Precautions (5.2), and Clinical Studies (14.2) ]. Heart Disease Heart Attack vs. Cardiac Arrest vs. Heart Failure. Endometrial cancer, endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration. Table 2: Treatment-Emergent Adverse Reactions Reported at a Frequency of 5 Percent in Women Receiving Vagifem 25 mcg. The initial dose of Vagifem is one tablet, inserted vaginally, once daily for two weeks, at the same time each day. The maintenance dose is one tablet, inserted vaginally, twice weekly. Some products that may interact with Vagfem include aromatase inhibitors, fulvestrant, raloxifene, tamoxifen, or toremifene. Tell your doctor all medications you are taking. Vagifem must not be used during pregnancy. If you become pregnant or

5 think you may be pregnant, tell your doctor immediately. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding. mental/mood changes (such as depression, memory loss ),. Call your doctor at once if you have:. Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy. In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Vagifem 10 mcg inserts. Adverse reactions with an incidence of 5 percent in the Vagifem 10 mcg group and greater than those reported in the placebo group are listed in Table 1. In a 12-week, randomized, double-blind, placebo-controlled study, 138 postmenopausal women were randomized to receive either placebo or Vagifem 25 mcg inserts. Adverse reactions with an incidence of. heart attack symptoms -- chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;. unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged or recurrent bleeding),. Remove the vaginal ring and seek emergency medical attention if you have:. Our Vagifem (estradiol vaginal) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Read the entire detailed patient monograph for Vagifem (Estradiol Vaginal Tablets). Read the entire FDA prescribing information for Vagifem (Estradiol Vaginal Tablets). cold symptoms ( stuffy nose, sneezing, sore throat ),. Tell your doctor if you have serious side effects of Vagifem including:. swelling in your hands or feet, weight gain;. The following serious adverse reactions are discussed elsewhere in the labeling:. The following adverse reactions have been identified during post-approval

6 use of Vagifem 25 mcg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA Vagifem ( estradiol vaginal) is a female hormone ( estrogen ) used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness /burning/itching). Common side effects of Vagifem include: This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. 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. Endometrial hyperplasia may be a precursor to endometrial cancer. in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE). The use of estrogen-alone and estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. Clinical surveillance of all women using estrogen-alone or estrogen plus progestin therapy is important.

7 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. When data from the two populations in the WHIMS estrogen-alone and estrogen plus progestin ancillary studies were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, ). 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 8. Combination package: Each contains a net wt oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of 2 g. [see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3) ]. By using this site you agree to our use of cookies. You can opt out at any time or find out more by reading our cookie policy. Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. 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 postmenopausal estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal

8 mammograms, requiring further evaluation. WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA. This reply should have been sent to you Deb. (sorry). In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. 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. Treatment of Moderate to Severe Vulvar and Vaginal Atrop