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ESTALIS is a brand name for Estradiol (also known as Oestradiol), supplied as a patch. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ESTALIS® (NETA/estradiol-17ß) is indicated for: • the relief of menopausal and postmenopausal symptoms occurring in naturally or surgically induced estrogen deficiency states e.g. hot flushes, sleep disturbances and vulvar and vaginal atrophy. The above indication is only for women with intact uteri since the regimen…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • For initiation and maintenance of treatment, the lowest effective dose should always be used. • Hormone replacement therapy (HRT) involving either estrogen alone or estrogen- progestogen combined therapy should only be continued as long as the benefits outweigh the risks for the individual.
• ESTALIS is used as a continuous treatment (uninterrupted application twice weekly). • In women who are not currently taking oral estrogens, treatment with ESTALIS (NETA/estradiol-17ß) can be initiated at once. In women who are currently taking oral estrogen, treatment with ESTALIS can be initiated on reappearance of menopausal symptoms, following discontinuation of oral therapy.
Combination progestin/estrogen regimens are indicated for women with intact uteri. Two ESTALIS (NETA/estradiol-17ß) patches are available: 140 mcg norethindrone acetate with 50 ESTALIS® (Norethindrone Acetate and Estradiol-17ß) Page 6 of 48 Unclassified / Non classifié mcg estradiol per day (9 cm2) and 250 mcg norethindrone acetate with 50 mcg estradiol per day (16 cm2).
For all regimens, the requirement for hormone replacement therapy for menopausal symptoms should be reassessed periodically. Attempts to taper or discontinue the medication should be made at 3- to 6-month intervals. 2 Recommended Dose and Dosage Adjustment Continuous Combined Regimen: ESTALIS 140/50 or ESTALIS 250/50 mcg per day (16 cm2) is worn continuously on the abdomen or buttocks.
A new patch should be applied twice weekly during a 28-day cycle. Irregular uterine bleeding may occur particularly in the first 6 months, but generally decreases with time, and often to an amenorrheic state. If irregular uterine bleeding persists and uterine pathology has been ruled out by appropriate diagnostic measures, it may be more appropriate instead to prescribe ESTALIS using a sequential regimen.
No studies were performed in patients with renal and hepatic impairment. All estrogen preparations are contraindicated in the patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). ESTALIS is not indicated for use in children.
4 Administration Patch Application The physician should discuss the most appropriate placement of the patch with the patient. Immediately after removal of a patch from the pouch and removal of one-half of the protective liner, the adhesive side of the ESTALIS patch should be placed on a clean, dry area of intact skin and peel off the remaining one-half of the protective liner.
1 Adverse Reaction Overview See 7 WARNINGS AND PRECAUTIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives. The following adverse reactions have been reported with estrogen/progestin combinations in general.
Blood and lymphatic system disorders:
Altered coagulation tests (see
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Carcinogenesis and Mutagenesis Breast Cancer Available epidemiological data indicate that the use of combined estrogen plus progestin by postmenopausal women is associated with an increased risk of invasive breast cancer.
In the estrogen plus progestin arm of the WHI trial, among 10,000 women over a one-year period, there were: • 8 more cases of invasive breast cancer (38 on combined HRT versus 30 on placebo). 1) vs. 04) and were at a more advanced stage compared with those diagnosed in the placebo group.
The percentage of women with abnormal mammograms ESTALIS® (Norethindrone Acetate and Estradiol-17ß) Page 9 of 48 Unclassified / Non classifié (recommendations for short-interval follow-up, a suspicious abnormality, or highly suggestive of malignancy) was significantly higher in the estrogen plus progestin group versus the placebo group.
This difference appeared at year one and persisted in each year thereafter. In the estrogen-alone arm of the WHI trial, there was no statistically significant difference in the rate of invasive breast cancer in hysterectomized women treated with conjugated equine estrogens versus women treated with placebo.
It is recommended that estrogens with or without progestins not be given to women with existing breast cancer or those with a previous history of the disease (see 2 CONTRAINDICATIONS). There is a need for caution in prescribing estrogens with or without progestins for women with known risk factors associated with the development of breast cancer, such as strong family history of breast cancer (first degree relative) or who present a breast condition with an increased risk (breast nodules, fibrocystic disease of the breast, abnormal mammograms and/or atypical hyperplasia at breast biopsy).
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. 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.
ESTALIS is contraindicated in: • Patients with known or suspected hypersensitivity to this drug or to any ingredient in the formulation or to any component of the patch. For a complete listing, see 6 DOSAGE FORMS, STRENGHTS, COMPOSITION AND PACKAGING.
• Patients with known or suspected estrogen-dependent or progestin-dependent malignant neoplasia such as endometrial cancer. • Patients with endometrial hyperplasia • Patients with known, suspected or past history of breast cancer • Patients with known or suspected pregnancy • Patients with active or past history of confirmed venous thromboembolism (such as deep venous thrombosis or pulmonary embolism) or active thrombophlebitis • Patients with known thrombophilic disorders • Patients with liver dysfunction or disease as long as liver function tests have failed to return to normal.
g. stroke, myocardial infarction, coronary heart disease) • Patients with Porphyria • Patients with partial or complete loss of vision from ophthalmic vascular disease • Patients with Classical Migraine • Patients who are breastfeeding ESTALIS® (Norethindrone Acetate and Estradiol-17ß) Page 5 of 48 Unclassified / Non classifié
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Estradiol in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The area selected should not be oily, damaged or irritated, and not exposed to the sun. The site selected should also be one at which little wrinkling of the skin occurs during movement of the body (buttocks and lower abdomen). The waistline should be avoided, since tight clothing may dislodge the patch.
The patch should be pressed firmly in place with the palm of the hand for at least 10 seconds, making sure there is good contact, especially around the edges. In the event that a patch should fall off, it can be reapplied. If it fails to adhere, then a new patch may be applied.
In either case, the original treatment schedule should be continued. Patches should not be applied to the same skin site for at least one week. ESTALIS must not be applied to the breasts to avoid potentially harmful effects on the breast tissue.
5 Missed Dose Patients who miss applying a patch of ESTALIS should apply a new patch as soon as possible. The subsequent patch should be applied according to the original treatment schedule. The ESTALIS® (Norethindrone Acetate and Estradiol-17ß) Page 7 of 48 Unclassified / Non classifié interruption of treatment might increase the likelihood of recurrence of symptoms and breakthrough bleeding and spotting.
The overall benefits and possible risks of hormone replacement therapy should be fully considered and discussed with patients. It is important that the modest increased risk of being diagnosed with breast cancer after 4 years of treatment with combined estrogen plus progestin HRT (as reported in the results of WHI-trial) be discussed with the patient and weighed against its known benefits.
Instructions for regular self-examination of the breasts should be included in this counselling. Endometrial Hyperplasia & Endometrial Carcinoma Estrogen should be prescribed with an appropriate dosage of a progestin for women with intact uteri in order to prevent endometrial hyperplasia/carcinoma.
The risk of endometrial hyperplasia/carcinoma in users of unopposed estrogens who have intact uteri is greater than in non-users and appears to depend on the duration of treatment and the estrogen dose. The greatest risk appears to be associated with prolonged use.
It has been shown that adequate concomitant progestogen therapy lowers the incidence of endometrial hyperplasia and therefore the potential risk of endometrial carcinoma associated with prolonged use of estrogen therapy (see 10 CLINICAL PHARMACOLOGY, Coadministration of Progestins).
ESTALIS® (Norethindrone Acetate and Estradiol-17ß) Page 10 of 48 Unclassified / Non classifié Ovarian Cancer Some recent epidemiologic studies have found that the use of hormone replacement therapy (estrogen-alone and estrogen plus progestin therapies), in particular for five or more years, has been associated with an increased risk of ovarian cancer.
Epidemiologic evidence from a meta- analysis suggests that while the risk of ovarian cancer diminishes over time after discontinuation, the risk is still significantly increased more than five years (median time of 10 years since last use) after stopping long duration hormone therapy (median duration of treatment of nine years) for serous or endometrioid tumours.
Hepatocellular Carcinomas Hepatocellular carcinoma has also been reported in women taking estrogen-containing oral contraceptives. The causal relationship of this malignancy to these drugs is not known. Cardiovascular The results of the Heart and Estrogen/progestin Replacement Studies (HERS and HERS II) and the Women’s Health Initiative (WHI) trial indicate that the use of estrogen plus progestin is associated with an increased risk of coronary heart disease (CHD) in postmenopausal women.
The results of the WHI trial indicate that the use of estrogen-alone and estrogen plus progestin is associated with an increased risk of stroke in postmenopausal women. WHI trial findings In the combined estrogen plus progestin arm of the WHI trial, among 10,000 women over a one- year period, there were: • 8 more cases of stroke (29 on combined HRT versus 21 on placebo) • 7 more cases of CHD (37 on combined HRT versus 30 on placebo).
In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10,000 women over a one-year period, there were/was: • 12 more cases of stroke (44 on estrogen-alone therapy versus 32 on placebo) • no statistically significant difference in the rate of CHD.
5 mg medroxyprogesterone acetate (MPA) […]