Loading…
ACTIVELLE is a brand name for Estradiol (also known as Oestradiol), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Activelle® (estradiol/norethindrone acetate) is indicated for: • Treatment of moderate to severe vasomotor symptoms occurring in naturally or surgically induced estrogen deficiency states. • Treatment of vulvar or vaginal atrophy associated with menopause. Activelle® is recommended only in women with intact uteri…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Activelle® is a continuous combined Hormone Replacement Therapy (HRT) intended for use in women with intact uteri. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
In women with amenorrhea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Activelle® may be started on any convenient day. In women in transition from sequential HRT regimens, treatment should start right after their withdrawal bleeding has ended.
5 mg) should be taken orally once a day without interruption, preferably at the same time every day. Patients should be re-evaluated within 3-6 months after initiation of treatment, to assess response to treatment. 5 Missed Dose If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours.
After 12 hours the tablet should be discarded and next dose taken at the normal time. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting. Activelle® Product Monograph Page 6 of 43
1 Adverse Reaction Overview See 7 WARNINGS AND PRECAUTIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives. g. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug. Adverse events reported by investigators in the Activelle® Phase 3 studies regardless of causality assessment are shown in Table 1 below.
4% 1. 6%). There were no significant changes in mean body weight from baseline to the end of the trial (3 months or 12 months) in any Activelle® study. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data None of the observed changes with regard to hematology and clinical chemistry in clinical studies of Activelle® were clinically relevant.
5 Post-Market Adverse Reactions Cardiac Disorders: Myocardial infarction Eye Disorders: Visual disturbances Gastrointestinal Disorders: Dyspepsia, vomiting […]
General For the treatment of postmenopausal symptoms, Hormone Replacement Therapy (HRT) should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
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. 04) and were at a more advanced stage compared with those diagnosed in the placebo group.
The percentage of women with abnormal mammograms (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.
2 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 (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.
Taking estrogens with progestins may increase the density of breast tissue, potentially adversely affecting the capability of mammography to detect breast cancer. The overall benefits and possible risks of hormone replacement therapy should be fully considered and discussed with patients.
• Patients with known hypersensitivity to this drug or any ingredient in the formulation or components of the container. For complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
g. g. stroke, myocardial infarction, coronary heart disease) • Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis • Partial or complete loss of vision from ophthalmic vascular disease • Porphyria • Classical migraine • Breastfeeding Activelle® Product Monograph Page 5 of 43
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Estradiol in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
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 the 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 counseling. Endometrial Hyperplasia & Endometrial Carcinoma The risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods to women with intact uteri.
The role of a progestin, when combined with estrogen, is to prevent endometrial hyperplasia/carcinoma in women with intact uteri. The addition of progestin for at least 12 days per cycle in non-hysterectomised women reduces this risk.
32])1. Because endometrial cancer has a relatively low incidence rate, the incidence of endometrial hyperplasia is used as a surrogate endpoint in clinical studies. 5 mg (n=295). 6% with 1 mg unopposed estradiol. All women taking estrogen/progestin combination should undergo clinical surveillance for endometrial abnormalities.
Adequate diagnostic measures, including endometrial sampling, should be performed in all cases of undiagnosed persistent or recurring abnormal genital bleeding. 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 5 or more years, has been associated with an increased risk of ovarian cancer.
1,2 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 […]