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The declining levels of oestrogen can cause distressing symptoms, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching.Oestrogen (in this case in the form of estradiol hemihydrate) can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause.

The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.Table 1: Summary of Most Frequently Reported Adverse Reactions (Vivelle versus Placebo) Regardless of Relationship Reported at a Frequency ≥ 5 PercentGeneral disorders and administration site conditionsTable 2: Mean (SD) Serum Pharmacokinetic Parameters of Baseline-Uncorrected Estradiol following a Single Dose of Estradiol Transdermal System (Twice-Weekly) (N = 36)Table 3: Relative and Absolute Risk Seen in the Estrogen Alone Substudy of WHI[hazard ratio (HR) 0.63 (95 percent CI, 0.36 to 1.09)]Table 4: Relative and Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 YearsStore at room temperature 20° to 25°C (68° to 77°F). Clinical studies have not been conducted in the pediatric population.There have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol transdermal system (twice-weekly) to determine whether those over 65 years of age differ from younger subjects in their response to estradiol transdermal system (twice-weekly).In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal womenThe effect of renal impairment on the pharmacokinetics of estradiol transdermal system (twice-weekly) has not been studied.The effect of hepatic impairment on the pharmacokinetics of estradiol transdermal system (twice-weekly) has not been studied.Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. The relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21 to 3.48). The baseline mean daily number of hot flushes in these 255 subjects was 11.5. After removal of the transdermal systems, serum concentrations of estradiol and estrone returned to baseline concentrations within 24 hours.Based on combined data from bioequivalence and dose proportionality studies consisting of 208 estradiol transdermal system (twice-weekly) observations, approximately 98 percent of the observations had an adhesion score of 0 (i.e., the skin adhesion rate was greater than or equal to 90 percent) over the 84-hour wear period. For women known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.Cases of anaphylactic/anaphylactoid reactions, which developed anytime during the course of estradiol transdermal system (twice-weekly) treatment and required emergency medical management, have been reported in the postmarketing setting. These include an increased risk of breast cancer.In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. Used transdermal systems should not be flushed in the toilet.Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare providers as soon as possible Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia Inform postmenopausal women of less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting.The brands listed are trademarks of their respective owners.Read this patient information before you start using estradiol transdermal system (twice-weekly) and each time you get a refill. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.Medicines and their possible side effects can affect individual people in different ways. We earn a commission for products purchased through some links in this article.

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