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BIJUVA is a brand name for Estradiol (also known as Oestradiol), supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BIJUVA (estradiol and progesterone capsule) is indicated for: • Treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus. BIJUVA is recommended for use only in patients with an intact uterus since the regimen includes a progestogen whose role is to assist in the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • BIJUVA is a continuous combined Hormone Replacement Therapy (HRT) intended for use in women with an intact uterus. • BIJUVA should be used at the lowest effective dose and for a duration consistent with treatment goals and the benefits and risks for the individual woman.
Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. 2 Recommended Dose and Dosage Adjustment • Take a single BIJUVA (estradiol and progesterone) capsule, orally each evening with food.
• BIJUVA has not been studied in women over 65 years old; therefore, BIJUVA is not recommended in women over 65 years of age. • BIJUVA is not indicated for pediatric use. 4 Administration BIJUVA is administered orally. 5 Missed Dose BIJUVA 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. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
). Women with pre-existing hypertriglyceridemia should be followed closely during hormone replacement therapy. HRT in these women may be associated with a further increase in triglyceride levels bearing the risk of pancreatitis. 5 mg estradiol/50 mg progesterone [N = 421] treatment arms (see 8 ADVERSE REACTIONS).
4 mmol/L). Heme Metabolism Women with porphyria need special surveillance. BIJUVA (estradiol and progesterone) Page 10 of 40 Unclassified / Non classifié Calcium and Phosphorus Metabolism Because the prolonged use of estrogens with or without progestins influences the metabolism of calcium and phosphorus, estrogens with or without progestins should be used with caution in patients with metabolic and malignant bone diseases associated with hypercalcemia and in patients with renal insufficiency.
7 Drug-Laboratory Test Interactions). Genitourinary Vaginal Bleeding Abnormal vaginal bleeding, due to its prolongation, irregularity or heaviness, occurring during therapy should prompt diagnostic measures like hysteroscopy, endometrial biopsy, or curettage to rule out the possibility of uterine malignancy and the treatment should be re-evaluated.
Uterine Leiomyomata Pre-existing uterine leiomyoma may increase in size during estrogen use. Growth, pain, or tenderness of uterine leiomyoma requires discontinuation of medication and appropriate investigation. Endometriosis Symptoms and physical findings associated with a previous diagnosis of endometriosis may reappear or become aggravated with estrogen use.
Hematologic Venous Thromboembolism Available epidemiological data indicate that use of estrogen with or without progestin by postmenopausal women is associated with an increased risk of developing venous thromboembolism (VTE). In the estrogen plus progestin arm of the WHI trial, among 10 000 women on combined HRT over a one-year period, there were 18 more cases of venous thromboembolism, including 8 more cases of pulmonary embolism (Writing Group for the Women’s Health Initiative Investigators, JAMA.
, Carcinogenesis and Mutagenesis 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 13 8 ADVERSE REACTIONS ................................................................................................
17 9 DRUG INTERACTIONS ................................................................................................ 18 10 CLINICAL PHARMACOLOGY .......................................................................................
20 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 22 PART II: SCIENTIFIC INFORMATION .......................................................................................
BIJUVA 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.
, stroke, myocardial infarction, coronary heart disease) • Patients with classical migraine • Patients with 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 due to ophthalmic vascular disease BIJUVA (estradiol and progesterone) Page 5 of 40 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.
2002). In the estrogen-alone arm of the WHI trial, among 10 000 women on estrogen therapy over a one-year period, there were 7 more cases of venous thromboembolism, although there was no statistically significant difference in the rate of pulmonary embolism (The Women’s Health Initiative Steering Committee, JAMA.
2004). 5 mg estradiol/50 mg progesterone treatment group. Generally recognized risk factors for VTE include a personal history, a family history (the occurrence of VTE in a direct relative at a relatively early age may indicate genetic predisposition), severe obesity (body mass index >30 kg/m2), and systemic lupus erythematosus.
The risk of VTE also increases with age and smoking. The risk of VTE may be temporarily increased with prolonged immobilization, major surgery, or trauma. In women on HRT, attention should be given to prophylactic measures to prevent VTE following surgery.
Also, patients with varicose veins should be closely supervised. The physician should be alert BIJUVA (estradiol and progesterone) Page 11 of 40 Unclassified / Non classifié to the earliest manifestations of thrombotic disorders (thrombophlebitis, retinal thrombosis, cerebral embolism and pulmonary embolism).
If these occur or are suspected, hormone therapy should be discontinued immediately, given the risks of long-term disability or fatality. If feasible, estrogens with or without progestins should be discontinued at least 4 weeks before major surgery which may be associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.
Hepatic/Biliary/Pancreatic Gallbladder Diseases A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in women receiving postmenopausal estrogens has been reported. Hepatic hemangioma Particular caution is indicated in women with hepatic hemangiomas as estrogens may cause an exacerbation of this condition.
Jaundice Caution is advised in patients with a history of liver and/or biliary disorders. If cholestatic jaundice develops during treatment, the treatment should be discontinued, and appropriate investigations carried out. Liver Function Tests Liver function tests should be done periodically in subjects who are suspected of having hepatic disease.
For information on endocrine and liver function tests, see the section under 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests Immune Angioedema Estrogen may induce or exacerbate symptoms of angioedema, in particular in women with hereditary angioedema.
Systemic Lupus Erythematosus Particular caution is indicated in women with systemic lupus erythematosus, as HRT may cause an exacerbation of this condition. Monitoring and Laboratory Tests Before BIJUVA is administered, the patient should have a complete physical examination, including a blood pressure determination.
Breasts and pelvic organs should be appropriately examined and a Papanicolaou smear should be performed. Endometrial biopsy should be done when indicated. Baseline tests should include mammography, measurement of blood glucose, calcium, triglycerides and cholesterol, and liver function tests.
The first follow-up examination should be done within 3 to 6 months after initiation of treatment to assess response to treatment. Thereafter, examinations should be made at intervals of at least once a year. […]
23 13 PHARMACEUTICAL INFORMATION ............................................................................ 23 14 CLINICAL TRIALS ........................................................................................................
24 15 MICROBIOLOGY ........................................................................................................ 29 16 NON-CLINICAL TOXICOLOGY .....................................................................................
29 PATIENT MEDICATION INFORMATION .................................................................................. 31 BIJUVA (estradiol and progesterone) Page 4 of 40 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS BIJUVA (estradiol and progesterone capsule) is indicated for: • Treatment of moderate to severe vasomotor symptoms associated with menopause in women with an […]