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ESTRADIOL 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: ESTRADIOL (17β-estradiol tablets) is indicated for: The symptomatic relief of menopausal symptoms. ESTRADIOL may also contribute to the prevention of osteoporosis in naturally occurring or surgically induced estrogen-deficiency states when combined with other important therapeutics such as diet, calcium and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The lowest dose of estrogen required to prevent menopausal symptoms and to prevent development of osteoporosis should be used. ESTRADIOL should be taken at the same time each day. 2 Recommended Dose and Dosage Adjustment In general, estrogen is usually administered cyclically for the first 21 to 25 days of each month.
In patients with intact uteri, a progestin should be sequentially administered for the last 12 to 14 days of estrogen administration in order to prevent development of endometrial hyperplasia/carcinoma as a result of estrogen stimulation.
In hysterectomized patients, estrogen alone should be given continuously.
Menopausal symptoms:
Treatment of menopausal symptoms is usually initiated with 1mg ESTRADIOL tablet per day. Thereafter, the dosage should be adjusted to the needs of the individual. Attempts to taper or discontinue the medication should be made at 3- to 6-month intervals.
5mg ESTRADIOL tablet per day as soon as possible after menopause. The dose may be titrated upward and downward based on the patient’s clinical status and plasma estradiol levels. Ideally, plasma estradiol levels should be maintained around 50 pg/mL.
5 Missed Dose ESTRADIOL should be taken as soon as possible after missing a dose. However, the missed dose should be skipped if it is almost time to take the next dose. Patients should be advised not to double the dose.
1 Adverse Reaction Overview See 7 WARNINGS AND PRECAUTIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives. If adverse symptoms persist, the prescription of HRT should be reconsidered.
The following adverse reactions have been reported with estrogen/progestin combination in general.
Blood and lymphatic system disorders:
Altered coagulation tests.
Cardiac disorders:
Increase in blood pressure; coronary thrombosis; palpitations.
Congenital, Familial and Genetic disorders:
Precipitation or aggravation of porphyria cutanea tarda in predisposed individuals.
Endocrine disorders:
Increased blood sugar levels; decreased glucose tolerance. , retinal thrombosis, optic neuritis); steepening of the corneal curvature; visual disturbances.
Gastrointestinal disorders:
Abdominal discomfort (cramps, pressure, pain, bloating); nausea; vomiting.
General disorders and administration site conditions:
Anorexia; changes in appetite; changes in body weight; fatigue; change in libido.
Hepatobiliary disorders:
Asymptomatic impaired liver function; cholestatic jaundice; gallbladder disorder.
Musculoskeletal and connective tissue disorders:
Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3-6 weeks) may occur.
, Special Populations. 2 CONTRAINDICATIONS Estrogen, including ESTRADIOL, should not be administered to patients with any of the following conditions: Liver dysfunction or disease as long as liver function tests have failed to return to normal.
, endometrial cancer). Endometrial hyperplasia. Known, suspected, or past history of breast cancer. Undiagnosed abnormal genital bleeding. Known or suspected pregnancy. , stroke, myocardial infarction, coronary heart disease). ESTRADIOL (17β-estradiol) Page 5 of 32 Classical migraine 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 or diplopia, from ophthalmic vascular disease. Estrogen, including ESTRADIOL, is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions The Women’s Health Initiative (WHI) trial examined the health benefits and risks of combined estrogen plus progestin therapy (n=16,608) and estrogen-alone therapy (n=10,739) in postmenopausal women aged 50 to 79 years.
2 years compared to those receiving placebo. 8 years compared to those receiving placebo. Therefore, the following should be given serious consideration at the time of prescribing: 1. Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases.
2. Estrogens with or without progestins should be prescribed at the lowest effective dose for the approved indication. 3. Estrogens with or without progestins should be prescribed for the shortest period possible for the approved indication.
Estrogen, including ESTRADIOL, should not be administered to patients with any of the following conditions: Liver dysfunction or disease as long as liver function tests have failed to return to normal. , endometrial cancer). Endometrial hyperplasia.
Known, suspected, or past history of breast cancer. Undiagnosed abnormal genital bleeding. Known or suspected pregnancy. , stroke, myocardial infarction, coronary heart disease). ESTRADIOL (17β-estradiol) Page 5 of 32 Classical migraine 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 or diplopia, from ophthalmic vascular disease. Estrogen, including ESTRADIOL, is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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.
Nervous system disorders:
Aggravation of migraine episodes; dizziness; headaches; neuritis.
Psychiatric disorders:
Irritability; mental depression; nervousness.
Renal and urinary disorders:
Cystitis; dysuria; edema; sodium retention.
ESTRADIOL (17β-estradiol) Page 14 of 32 Reproductive system and breast disorders:
Breakthrough bleeding; breast swelling, tenderness and secretion; changes in cervical erosion and amount of cervical secretion; change in menstrual flow; dysmenorrhea; dyspareunia; endometrial hyperplasia; increased cervical mucous; increase in size of uterine leiomyomata; pre-menstrual-like syndrome; reactivation of endometriosis; spotting; vaginal candidiasis; vaginal itching/discharge; itching related to estrogen use or during pregnancy.
Skin and subcutaneous tissue disorders:
Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; hirsutism and acne; itching, allergic reactions and rashes; loss of scalp hair; pigmentation of skin.
Vascular disorders:
Isolated cases of thromboembolic disorders; thrombophlebitis. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following table summarizes the adverse events reported in a controlled, randomized, double-blind study with ESTRADIOL for the treatment of osteoporosis in 64 post-menopausal women.
ESTRADIOL was administered in a cyclic manner for up to 18 months with an option to continue for an additional 6 months. 0mg ESTRADIOL n=16 (%) Placebo n=16 (%) Gastrointestinal Disorders constipation 2 (13%) 1 (6%) 0 1 (6%) nausea 0 0 0 2 (13%) General Disorders & Administration Site Conditions asthenia 0 0 2 (13%) 1 (6%) Investigations weight increased 3 (20%) 3 (19%) 2 (13%) 1 (6%) Nervous System Disorders headache 0 0 1 (6%) 2 (13%) Psychiatric Disorders nervousness 1 (7%) 2 (13%) 5 (31%) 2 (13%) depression 2 (13%) 0 3 (19%) 3 (19%) insomnia 0 1 (6%) 2 (13%) 2 (13%) libido decreased 0 0 0 2 (13%) Renal & Urinary Disorders edema 2 (13%) 1 (6%) 2 (13%) 1 (6%) Reproductive System & Breast disorders menopausal systems(1) 10 (67%) 11 (69%) 11 (69%) 13 (81%) vaginal hemorrhage 2 (13%)* 7 (44%)* 9 (56%)* 1 (6%) vaginitis 1 (7%) 2 (13%) 0 0 uterine spasm 0 0 2 (13%) 0 *statistically significant at 5% level (Fisher’s exact test) (1) according to MedDRA dictionary, including symptoms such as vasomotor symptoms or hot flushes and vaginal dryness.
ESTRADIOL (17β-estradiol) Page 16 of 32
4. The use of ESTRADIOL for the prevention of osteoporosis should be considered in light of other available therapies. 1 Dosing Considerations The lowest dose of estrogen required to prevent menopausal symptoms and to prevent development of osteoporosis should be used.
ESTRADIOL should be taken at the same time each day. 2 Recommended Dose and Dosage Adjustment In general, estrogen is usually administered cyclically for the first 21 to 25 days of each month. In patients with intact uteri, a progestin should be sequentially administered for the last 12 to 14 days of estrogen administration in order to prevent development of endometrial hyperplasia/carcinoma as a result of estrogen stimulation.
In hysterectomized patients, estrogen alone should be given continuously.
Menopausal symptoms:
Treatment of menopausal symptoms is usually initiated with 1mg ESTRADIOL tablet per day. Thereafter, the dosage should be adjusted to the needs of the individual. Attempts to taper or discontinue the medication should be made at 3- to 6-month intervals.
5mg ESTRADIOL tablet per day as soon as possible after menopause. The dose may be titrated upward and downward based on the patient’s clinical status and plasma estradiol levels. Ideally, plasma estradiol levels should be maintained around 50 pg/mL.
5 Missed Dose ESTRADIOL should be taken as soon as possible after missing a dose. However, the missed dose should be skipped if it is almost time to take the next dose. Patients should be advised not to double the dose. 5 OVERDOSAGE Symptoms: Numerous reports of ingestion of large doses of estrogen products and estrogen-containing oral contraceptives by young children have not revealed acute serious ill effects.
Overdosage with estrogen may cause nausea, breast discomfort, fluid retention, bloating or vaginal bleeding in women.
Treatment:
Remove ingested drug by gastric lavage and give symptomatic treatment. For management of a suspected drug overdose, contact your regional poison control centre. 5 mg acacia, cornstarch, dibasic calcium phosphate, lactose, magnesium stearate, silicon dioxide, talc.
oral Tablet 1 mg acacia cornstarch, dibasic calcium phosphate, lactose, magnesium stearate, silicon dioxide, talc and colour dyes [FD&C Blue #1 aluminum lake and D&C Red #27 aluminum lake]. 5mg of micronized 17-estradiol. Tablet is white with MJ logo and “021” on one side.
ESTRADIOL 1 mg:
Each tablet contains 1mg of micronized 17-estradiol. Tablet is lavender with MJ logo and “755” on one side.
ESTRADIOL 2 mg:
Each tablet contains 2mg of micronized 17-estradiol. Tablet is turquoise with MJ logo and “756” on one side. ESTRADIOL tablets are available as round, flat-faced, bevel-edged compressed tablets, supplied in bottles of 100’s. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General The overall benefits and possible risks of hormone replacement therapy should be fully considered and […]