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LUPIN-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: , 1.1. Pediatrics, 1.2 Geriatrics 09/2022
Verbatim from this product's HC label. Tap a section to expand.
5 Missed Dose 09/2022 7 WARNINGS AND PRECAUTIONS, General 09/2022 7 WARNINGS AND PRECAUTIONS, Hyperlipoproteinemia / Hyperglycemia 09/2022 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
Error! Bookmark not defined. TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION.........................................................................
4 1 INDICATIONS ................................................................................................................. 1 Pediatrics.............................................................................................................
2 Geriatrics.............................................................................................................. 4 2 CONTRAINDICATIONS....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................... 5 4 DOSAGE AND ADMINISTRATION.................................................................................... 1 Dosing Considerations...........................................................................................
2 Recommended Dose and Dosage Adjustment........................................................ 5 Missed Dose ......................................................................................................... 6 5 OVERDOSAGE ................................................................................................................
6
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.
Page 13 of 30LUPIN-ESTRADIOL (17β-estradiol) 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:
, General 09/2022 7 WARNINGS AND PRECAUTIONS, Hyperlipoproteinemia / Hyperglycemia 09/2022 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
Error! Bookmark not defined. TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION.........................................................................
4 1 INDICATIONS ................................................................................................................. 1 Pediatrics.............................................................................................................
2 Geriatrics.............................................................................................................. 4 2 CONTRAINDICATIONS....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................... 5 4 DOSAGE AND ADMINISTRATION.................................................................................... 1 Dosing Considerations...........................................................................................
2 Recommended Dose and Dosage Adjustment........................................................ 5 Missed Dose ......................................................................................................... 6 5 OVERDOSAGE ................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 6 7 WARNINGS AND PRECAUTIONS ..................................................................................... 23 Page 4 of 30LUPIN-ESTRADIOL (17β-estradiol) PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS LUPIN-ESTRADIOL (17β-estradiol tablets) is indicated for: The symptomatic relief of menopausal symptoms.
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.
Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3-6 weeks) may occur.
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.
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 tocontinue for an additional 6 months. 0 mg 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.
LUPIN-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 vitamin D intake, smoking cessation and regular physical weight bearing exercises.
The use of LUPIN-ESTRADIOL in the prevention of osteoporosis is to be considered in light of other available therapies. In patients with an intact uterus, LUPIN-ESTRADIOL should always be supplemented by sequential […]