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DAPAGLIFLOZIN is a brand name for Dapagliflozin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Type 2 Diabetes Mellitus (T2DM) Monotherapy: DAPAGLIFLOZIN (dapagliflozin tablets) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with T2DM for whom metformin is inappropriate due to contraindications or intolerance. Add-on combination: DAPAGLIFLOZIN is indicated…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 09/2025 7 WARNINGS AND PRECAUTIONS 09/2025 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 09/2025 7 WARNINGS AND PRECAUTIONS, Peri-Operative Considerations 09/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph 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 ........................................................................ 5 Missed Dose ..................................................................................................................................
7 5 OVERDOSAGE ................................................................................................................... 7
DAPAGLIFLOZIN
Product Monograph Page 5 of 65 Protected B / Protégé B 2 CONTRAINDICATIONS • DAPAGLIFLOZIN 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. 73m2, end-stage renal disease (ESRD), or patients on dialysis. See 7 WARNINGS AND PRECAUTIONS, Renal. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Diabetic Ketoacidosis in Patients with Diabetes • Clinical trial and post-market cases of diabetic ketoacidosis (DKA), a serious life- threatening condition requiring urgent hospitalization, have been reported in patients with T2DM treated with dapagliflozin and other sodium-glucose co-transporter 2 (SGLT2) inhibitors.
9 mmol/L (250 mg/dL). Some cases of DKA have been fatal. See 8 ADVERSE REACTIONS. • Patients should be assessed for DKA immediately if non-specific symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, anorexia, excessive thirst and unusual fatigue or sleepiness occur, regardless of blood glucose level.
If DKA is suspected or diagnosed, DAPAGLIFLOZIN should be discontinued immediately. • DAPAGLIFLOZIN should not be used for the treatment of DKA or in patients with a history of DKA. • DAPAGLIFLOZIN is not indicated, and should not be used, in patients with type 1 diabetes.
1 Dosing Considerations • DAPAGLIFLOZIN may be taken at any time of the day with or without food. • Assess renal function prior to initiation of DAPAGLIFLOZIN therapy and regularly thereafter. See 7 WARNINGS AND PRECAUTIONS. • Assess volume status and, if necessary, correct volume depletion prior to initiation of DAPAGLIFLOZIN therapy.
09/2025 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 09/2025 7 WARNINGS AND PRECAUTIONS, Peri-Operative Considerations 09/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph 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 ........................................................................ 5 Missed Dose ..................................................................................................................................
7 5 OVERDOSAGE ................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING........................................ 7 7 WARNINGS AND PRECAUTIONS ........................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dapagliflozin 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.
See 7 WARNINGS AND PRECAUTIONS. , sulfonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia. See 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS. DAPAGLIFLOZIN Product Monograph Page 6 of 65 Protected B / Protégé B • Temporary interruption for surgery: DAPAGLIFLOZIN treatment should be interrupted for a minimum of 3 days, when possible, prior to major surgical procedures or procedures associated with prolonged fasting.
Monitor for DKA in the post-procedural period. Ensure risk factors for ketoacidosis are resolved and that the patient is clinically stable and has resumed oral intake before considering DAPAGLIFLOZIN treatment re- initiation. See Endocrine and Metabolism.
2 Recommended Dose and Dosage Adjustment Type 2 Diabetes Mellitus (T2DM) To improve glycemic control, the recommended starting dose of DAPAGLIFLOZIN is 5 mg taken orally once daily. In patients tolerating DAPAGLIFLOZIN 5 mg once daily and who require additional glycemic control, the dose can be increased to 10 mg daily.
To reduce the risk of hospitalization due to HF, the recommended dose of DAPAGLIFLOZIN is 10 mg once daily.
Considerations for Special Populations Renal impairment:
The glycemic efficacy of DAPAGLIFLOZIN is dependent on renal function and declines with decreasing renal function. 73 m2. 73m2). 73m2, severe renal impairment, ESRD, or patients on dialysis as the glycemic efficacy of dapagliflozin is dependent on renal function (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS).
73m2, end- stage renal disease (ESRD), or patients on dialysis (see 2 CONTRAINDICATIONS).
Hepatic impairment:
No dosage adjustment for DAPAGLIFLOZIN is required for patients with mild or moderate hepatic impairment. DAPAGLIFLOZIN exposure is increased in patients with severe hepatic impairment. See 10 CLINICAL PHARMACOLOGY. Therefore, DAPAGLIFLOZIN is not recommended for use in this population.
DAPAGLIFLOZIN Product Monograph Page 7 of 65 Protected B / Protégé B Pediatrics (<18 years of age): Safety and effectiveness of dapagliflozin tablets in pediatric and adolescent patients have not been established; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
No dosage adjustment for DAPAGLIFLOZIN is required based on age; however renal function and risk of volume depletion should be taken into account. 4 Geriatrics. 5 Missed Dose If a dose of DAPAGLIFLOZIN is missed, it should be taken as soon as the patient remembers.
A double dose of DAPAGLIFLOZIN should not be taken on the same day. 5 OVERDOSAGE It is reasonable to employ supportive measures, as dictated by the patient’s clinical status. The removal of dapagliflozin by hemodialysis has not been studied.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669). 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition All Non-medicinal […]
1 Special Populations .................................................................................................................... 1 Pregnant Women ....................................................................................................................
2 Breast-feeding ......................................................................................................................... 3 Pediatrics..................................................................................................................................
4 Geriatrics .................................................................................................................................. 13 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 ....................................................................................... 25 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 ..........................................................................................
29 10 CLINICAL PHARMACOLOGY ........................................................................................... 1 Mechanism of Action ..............................................................................................................
2 Pharmacodynamics.................................................................................................................. 3 Pharmacokinetics .....................................................................................................................
30 11 STORAGE, STABILITY AND DISPOSAL ............................................................................. 33 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 33 PART II: SCIENTIFIC INFORMATION ....................................................................................
34 13 PHARMACEUTICAL INFORMATION ................................................................................ 34 14 CLINICAL TRIALS............................................................................................................
1 Trial Design and Study Demographics […]