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SANDOZ CANAGLIFLOZIN is a brand name for Canagliflozin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Monotherapy: Sandoz Canagliflozin (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance. Add-on combination: Sandoz Canagliflozin (canagliflozin) is…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women 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 .......................................................................
5 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ...................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 6 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ......................................................................................................... 5 Missed Dose.............................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9
, Elderly Patients, 4 DOSAGE AND ADMINISTRATION, Geriatrics). 1 Special Populations). 2 CONTRAINDICATIONS • Patients who are hypersensitive 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.
• Patients on dialysis (see 4 DOSAGE AND ADMINISTRATION). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Diabetic Ketoacidosis • Clinical trial and post-market cases of diabetic ketoacidosis (DKA), a serious life- threatening condition requiring urgent hospitalization, have been reported in patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin, or other sodium- glucose co-transporter 2 (SGLT2) inhibitors.
Fatal cases of DKA have been reported in patients taking canagliflozin. 9 mmol/L (250 mg/dL) (see 8 ADVERSE REACTIONS, Description of Selected Adverse Reactions). • The risk of DKA must be considered in the event of non-specific symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, anorexia, excessive thirst and unusual fatigue or sleepiness.
If these symptoms occur, regardless of blood glucose level, Sandoz Canagliflozin treatment should be immediately discontinued, and patients should be assessed for DKA immediately. • Sandoz Canagliflozin should not be used for the treatment of DKA or in patients with a history of DKA.
• Nephropathy may increase the risk of DKA during treatment with Sandoz Canagliflozin. • Sandoz Canagliflozin is not indicated, and should not be used, in patients with type 1 diabetes. • See 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism.
Lower Limb Amputation • An approximately 2-fold increased risk of lower limb amputations associated with Sandoz Canagliflozin Page 7 of 93 Unclassified / Non classifié canagliflozin use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
1 Pregnant Women 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 .......................................................................
5 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ...................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 6 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ......................................................................................................... 5 Missed Dose.............................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 9 7 WARNINGS AND PRECAUTIONS..................................................................................
• Patients who are hypersensitive 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. • Patients on dialysis (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Canagliflozin 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.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs. • Before initiating Sandoz Canagliflozin, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving Sandoz Canagliflozin for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue Sandoz Canagliflozin if these complications occur. • See 7 WARNINGS AND PRECAUTIONS, Cardiovascular.
1 Dosing Considerations • Renal function should be assessed before initiating Sandoz Canagliflozin and periodically thereafter (see 7 WARNINGS AND PRECAUTIONS, Renal). In patients with volume depletion not previously treated with canagliflozin, normalize volume status before initiating Sandoz Canagliflozin (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
, sulfonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism and 8 ADVERSE REACTIONS). • Temporary Interruption for Surgery: Sandoz Canagliflozin treatment should be interrupted for a minimum of 3 days, when possible, prior to major surgery or procedures associated with prolonged fasting.
Monitor for DKA in the post-operative period. Ensure risk factors for ketoacidosis are resolved and that the patient is clinically stable and has resumed oral intake before considering Sandoz Canagliflozin treatment re-initiation (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
4 Drug-Drug Interactions). 2 Recommended Dose and Dosage Adjustment See Table 1 for dosage recommendations based on estimated glomerular filtration rate (eGFR). 73 m2) Recommended Dosage eGFR ≥ 60 100 mg orally once daily, taken before the first meal of the day.
Dose can be increased to 300 mg once daily for additional glycemic control. 73 m2. 9 mg/mmol, therapy can be continued at 100 mg once daily. 73 m2 or CrCl ≥ 60 mL/min and require additional glycemic control. 73 m2 receiving concurrent therapy with a UGT inducer.
Pediatrics (< 18 years of age):
The safety and efficacy of canagliflozin have not been established in pediatric […]
1 Special Populations ................................................................................................ 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
5 Hepatic Impairment .......................................................................................... 18 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ......................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................ 5 Post-Market Adverse Reactions .............................................................................
38 9 DRUG INTERACTIONS ................................................................................................. 2 Drug Interactions Overview ...................................................................................
3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions ..........................................................................................
6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions ......................................................................... 42 10 CLINICAL PHARMACOLOGY.........................................................................................
1 Mechanism of Action ......................................................................................... 2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ...............................................................................................
44 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 48 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 48 PART II: SCIENTIFIC INFORMATION .......................................................................................
49 13 PHARMACEUTICAL INFORMATION ............................................................................. 49 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication ................................................................................. 50 Type 2 Diabetes Mellitus .................................................................................................
50 Sandoz Canagliflozin Page 4 of 93 Unclassified / Non classifié […]