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AG-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: AG-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: AG-Canagliflozin (canagliflozin) is indicated for…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women 11/2024 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 ..........................................................................................................
1 Pediatrics...................................................................................................... 2 Geriatrics ...................................................................................................... 4 2 CONTRAINDICATIONS...........................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................... 5 4 DOSAGE AND ADMINISTRATION ......................................................................... 1 Dosing Considerations .................................................................................
2 Recommended Dose and Dosage Adjustment ............................................. 4 Administration ............................................................................................... 5 Missed Dose.................................................................................................
7 5 OVERDOSAGE ....................................................................................................... 7
, 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 AG-Canagliflozin, or other sodium-glucose co-transporter 2 (SGLT2) inhibitors.
Fatal cases of DKA have been reported in patients taking AG-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, AG- Canagliflozin treatment should be immediately discontinued, and patients should be assessed for DKA immediately. • AG-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 AG-Canagliflozin. • AG-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 AG- 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 11/2024 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 ..........................................................................................................
1 Pediatrics...................................................................................................... 2 Geriatrics ...................................................................................................... 4 2 CONTRAINDICATIONS...........................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................... 5 4 DOSAGE AND ADMINISTRATION ......................................................................... 1 Dosing Considerations .................................................................................
2 Recommended Dose and Dosage Adjustment ............................................. 4 Administration ............................................................................................... 5 Missed Dose.................................................................................................
7 5 OVERDOSAGE ....................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................ 7 7 WARNINGS AND PRECAUTIONS .........................................................................
1 Special Populations .................................................................................... 1 Pregnant Women ....................................................................................... 2 Breast-feeding ............................................................................................
• 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 AG-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 AG-Canagliflozin for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue AG-Canagliflozin if these complications occur. • See 7 WARNINGS AND PRECAUTIONS, Cardiovascular.
1 Dosing Considerations • Renal function should be assessed before initiating AG-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 AG-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: AG-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 AG-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. Consider another antihyperglycemic agent in Product Monograph AG-Canagliflozin (Canagliflozin Tablets) Page 7 of 86 For management of a suspected drug overdose, contact your regional poison control centre.
73 m2 receiving concurrent therapy with a UGT […]
3 Pediatrics.................................................................................................... 4 Geriatrics .................................................................................................... 5 Hepatic Impairment ....................................................................................
14 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 ................................................................. 34 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 .............................................................. 37 10 CLINICAL PHARMACOLOGY ..............................................................................
1 Mechanism of Action .................................................................................. 2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics .......................................................................................
39 11 STORAGE, STABILITY AND DISPOSAL............................................................. 42 12 SPECIAL HANDLING INSTRUCTIONS ................................................................ 42 PART II: SCIENTIFIC INFORMATION ..............................................................................
43 13 PHARMACEUTICAL INFORMATION ................................................................... 43 14 CLINICAL TRIALS ................................................................................................ 1 Clinical Trials by Indication .........................................................................
44 Type 2 Diabetes Mellitus ....................................................................................... 44 Cardiovascular Outcomes ..................................................................................... 64 Diabetic Nephropathy ............................................................................................
2 Comparative Bioavailability Studies ............................................................... 75 15 MICROBIOLOGY................................................................................................... 77 16 NON-CLINICAL TOXICOLOGY […]