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GLN-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.
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................
5 1 INDICATIONS ................................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 6 2 CONTRAINDICATIONS ....................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 6 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 5 Missed Dose ................................................................................................................ 8 5 OVERDOSAGE .................................................................................................................
8
Heart Failure In the DAPA-HF study, 2714 (57%) patients were older than 65 years of age. In the DELIVER study, a total of 4759 (76%) patients were older than 65 years of age. Safety and efficacy in both studies were similar for patients 65 years and younger and those older than 65.
2 CONTRAINDICATIONS • GLN-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.
• GLN-DAPAGLIFLOZIN is contraindicated in patients on dialysis. See 7 WARNINGS AND PRECAUTIONS. 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 tablets 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, GLN-DAPAGLIFLOZIN should be discontinued immediately. • GLN-DAPAGLIFLOZIN should not be used for the treatment of DKA or in patients with a history of DKA. • GLN-DAPAGLIFLOZIN is not indicated, and should not be used, in patients with type 1 diabetes.
1 Dosing Considerations • GLN-DAPAGLIFLOZIN may be taken at any time of the day with or without food. • Assess renal function prior to initiation of GLN-DAPAGLIFLOZIN therapy and regularly thereafter. See 7 WARNINGS AND PRECAUTIONS. • Assess volume status and, if necessary, correct volume depletion prior to initiation of GLN- DAPAGLIFLOZIN therapy.
4 Geriatrics 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................
5 1 INDICATIONS ................................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 6 2 CONTRAINDICATIONS ....................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 6 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 5 Missed Dose ................................................................................................................ 8 5 OVERDOSAGE .................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................... 9 PrGLN-DAPAGLIFLOZIN (Dapagliflozin Tablets, 5 mg and 10 mg) Page 3 of 83 Protected B / Protégé B 7 WARNINGS AND PRECAUTIONS ...................................................................................
1 Special Populations .................................................................................................... 14 8 ADVERSE REACTIONS..................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. • Temporary interruption for surgery: GLN-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 GLN-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 GLN-DAPAGLIFLOZIN is 5 mg taken orally once daily. In patients tolerating GLN-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 GLN- DAPAGLIFLOZIN is 10 mg once daily. Heart Failure In patients with heart failure the recommended dose of GLN-DAPAGLIFLOZIN is 10 mg taken orally once daily.
Chronic Kidney Disease In patients with chronic kidney disease, the recommended dose of GLN-DAPAGLIFLOZIN is 10 mg taken orally once daily.
Considerations for Special Populations Renal impairment:
The glucose-lowering efficacy of GLN-DAPAGLIFLOZIN is dependent on renal function and declines with decreasing renal function. Monitoring of renal function is required prior to initiation of GLN-DAPAGLIFLOZIN therapy and regularly thereafter.
73 m2, more frequent monitoring of renal dysfunction is recommended. See 7 WARNINGS AND PRECAUTIONS. 73 m2. 73 m2. 73 m2. On dialysis GLN-DAPAGLIFLOZIN is contraindicated in patients on dialysis. See 2 CONTRAINDICATIONS.
Hepatic impairment:
No dosage adjustment for GLN-DAPAGLIFLOZIN is required for patients with mild or moderate hepatic impairment. GLN-DAPAGLIFLOZIN exposure is increased in patients with severe hepatic impairment. See 10 CLINICAL PHARMACOLOGY. Therefore, GLN-DAPAGLIFLOZIN is not recommended for use in this population.
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 GLN-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 GLN-DAPAGLIFLOZIN is missed, it should be taken as soon as the patient remembers.
A double dose of GLN-DAPAGLIFLOZIN should not be taken on the same day. 5 OVERDOSAGE It is reasonable to employ supportive measures, as […]
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 ................................................................................. 29 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 ..............................................................................
33 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ................................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
34 11 STORAGE, STABILITY AND DISPOSAL ....................................................................... 37 PrGLN-DAPAGLIFLOZIN (Dapagliflozin Tablets, 5 mg and 10 mg) Page 4 of 83 Protected B / Protégé B 12 SPECIAL HANDLING INSTRUCTIONS ..........................................................................
38 13 PHARMACEUTICAL INFORMATION............................................................................. 38 14 CLINICAL TRIALS ..........................................................................................................
1 Trial Design and Study Demographics ..................................................................... 2 Study Results ........................................................................................................... 3 Comparative Bioavailability Studies […]