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TARO-MEDROXYPROGESTERONE is a brand name for Medroxyprogesterone (also known as Medroxyprogesterone Acetate), supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 04/2025 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 04/2025 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 04/2025 7 WARNINGS AND PRECAUTIONS 04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 04/2025 7 WARNINGS AND PRECAUTIONS 04/2025 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............................................................................................................................. 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS.................................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................................. 6 4 DOSAGE AND ADMINISTRATION .................................................................................................
2 Recommended Dose and Dosage Adjustment...................................................................... 4 Administration ................................................................................................................
5 Missed Dose ................................................................................................................... 8 5 OVERDOSAGE............................................................................................................................
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5 Post-Market Adverse Reactions). Generally, it is not clear if the risk of cardiovascular events is different for users of medroxyprogesterone acetate than for non-users. Hypertension TARO-MEDROXYPROGESTERONE INJECTION (medroxyprogesterone acetate injectable suspension) Page 12 of 54 Product Monograph Protected B / Protégé B There have been reports of cerebro/cardiovascular adverse events in medroxyprogesterone acetate users who are suffering from hypertension.
Patients with essential hypertension whose blood pressure is well controlled may be given hormonal contraceptives but only under close supervision. If a significant elevation of blood pressure in previously normotensive or hypertensive subjects occurs at any time during the administration of the drug, cessation of medication is necessary (see also 2 CONTRAINDICATIONS).
Endocrine and Metabolism Loss of Bone Mineral Density Use of medroxyprogesterone acetate reduces serum estrogen levels and is associated with a statistically significant loss of BMD as bone metabolism accommodates to a lower estrogen level.
This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if the use of medroxyprogesterone acetate by younger women will reduce peak bone mass and increase the risk for osteoporotic fractures in later life.
In both adult and adolescent females, the decrease in BMD during treatment appears to be substantially reversible after medroxyprogesterone acetate injection is discontinued and ovarian estrogen production increases. In adolescence, following medroxyprogesterone acetate use for more than 2 years, subjects did not recover to their baseline BMD level at the femoral neck and total hip even up to 60 months.
04/2025 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............................................................................................................................. 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS.................................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................................. 6 4 DOSAGE AND ADMINISTRATION .................................................................................................
2 Recommended Dose and Dosage Adjustment...................................................................... 4 Administration ................................................................................................................
5 Missed Dose ................................................................................................................... 8 5 OVERDOSAGE............................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING...................................................... 8 7 WARNINGS AND PRECAUTIONS ...................................................................................................
TARO-MEDROXYPROGESTERONE INJECTION (medroxyprogesterone acetate injectable suspension) is contraindicated in women with: • Known or suspected pregnancy or as a diagnostic test for pregnancy • Undiagnosed vaginal and/or urinary tract bleeding TARO-MEDROXYPROGESTERONE INJECTION (medroxyprogesterone acetate injectable suspension) Page 5 of 54 Product Monograph Protected B / Protégé B • Known or suspected carcinoma of the breast • Undiagnosed breast pathology • Known or suspected progestin-dependent neoplasia • History of or actual thrombophlebitis or thromboembolic disorders • History of or actual cerebrovascular disorders including cerebral apoplexy • History of or actual myocardial infarction or coronary artery disease • Presence of severe or multiple risk factor(s) for arterial or venous thrombosis: - Severe hypertension (persistent values of ≥160/100 mm Hg) - Hereditary or acquired predisposition for venous or arterial thrombosis, such as Factor V Leiden and Prothrombin G20210 A mutation, activated protein C(APC-) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant) - Severe dyslipoproteinemia - Heavy smoking (>15 cigarettes per day) and over age 35 - Diabetes mellitus with vascular involvement • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields • Current or history of migraine with focal aura • Active liver disease or history of or actual benign or malignant liver tumours • Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. TARO-MEDROXYPROGESTERONE INJECTION should not be used before menarche. TARO-MEDROXYPROGESTERONE INJECTION (medroxyprogesterone acetate injectable suspension) Page 6 of 54 Product Monograph Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Medroxyprogesterone in Canada.
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In adults, there was only partial recovery of mean BMD at total hip, femoral neck and lumbar spine towards baseline by 24 months post-treatment. Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Long term use BMD should be monitored in women using TARO-MEDROXYPROGESTERONE INJECTION for longer than 2 years, or earlier as clinically appropriate.
In adolescent females, interpretation of BMD results should take into account patient age and skeletal maturity. If a clinically significant decrease in BMD is detected, treatment with TARO-MEDROXYPROGESTERONE INJECTION should be reconsidered.
Use of TARO-MEDROXYPROGESTERONE INJECTION should be considered a risk factor for osteoporosis. , anorexia nervosa or bulimia • Metabolic bone disease • Strong family history of osteoporosis BMD Changes in Adult Women and BMD Recovery Post-treatment in Adult Women In a controlled, open-label, non-randomized clinical study (medroxyprogesterone acetate n=248, placebo n=360), adult women using medroxyprogesterone acetate (150 mg IM) for up to 5 years for contraception showed spine and hip mean BMD decreases of 5-6%, compared to no significant change in BMD in the control group.
The decline in BMD was more pronounced during the first 2 years of use, with smaller declines in subsequent years. 38% after 1, 2, 3, 4 and 5 years, respectively, were observed. Mean decreases in BMD of the total hip and femoral neck were similar.
There were no significant changes in BMD in the control women over the same period of time. Table 2 shows the extent of recovery of BMD for women who received one or more medroxyprogesterone acetate injections during Years 1 through 5.
36% * Intent-to-treat population consisted of patients who enrolled in the study and had BMD measured at screening/baseline and at least one post-baseline time point. ** medroxyprogesterone acetate group consisted of women who received one or more medroxyprogesterone acetate injections during Years 1 through 5.
*** The control group consisted of women who did not use medroxyproge ste rone acetate prior to the indicated time point. TARO-MEDROXYPROGESTERONE INJECTION (medroxyprogesterone acetate injectable suspension) Page 14 of 54 Product Monograph Protected B / Protégé B Time in Study Lumbar Spine Total Hip Femoral Neck Medroxy- progesterone acetate Control*** Medroxy- progesterone acetate Control*** Medroxy- progesterone acetate Control*** † Women who took one or more doses of medroxyprogesterone acetate, and then stopped treatment, entered the Post-therapy phase of the study; BMD results from such subjects would no longer be reported in the on-therapy section of the Table.
For Control women, results from Years 6 and 7 are shown in the Post- therapy section. […]
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