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NB-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: NB-Dapagliflozin (dapagliflozin) 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: NB-Dapagliflozin is indicated in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • NB-Dapagliflozin may be taken at any time of the day with or without food. • Assess renal function prior to initiation of NB-Dapagliflozin therapy and regularly thereafter. See 7 WARNINGS AND PRECAUTIONS. • Assess volume status and, if necessary, correct volume depletion prior to initiation of NB- Dapagliflozin therapy.
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: NB-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 NB-Dapagliflozin treatment reinitiation. See 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism.
2 Recommended Dose and Dosage Adjustment Type 2 Diabetes Mellitus (T2DM) To improve glycemic control, the recommended starting dose of NB-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 NB-Dapagliflozin is 10 mg once daily. Heart Failure In patients with heart failure the recommended dose of NB-Dapagliflozin is 10 mg taken orally once daily. Chronic Kidney Disease In patients with chronic kidney disease, the recommended dose of dapagliflozin is 10 mg taken orally once daily.
Considerations for Special Populations Renal impairment:
NB-Dapagliflozin Page 7 of 89 The glucose-lowering efficacy of Dapagliflozin is dependent on renal function and declines with decreasing renal function. Monitoring of renal function is required prior to initiation of NB- 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 NB-Dapagliflozin is contraindicated in patients on dialysis. See 2 CONTRAINDICATIONS.
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 • NB-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.
• NB-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 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, NB-Dapagliflozin should be discontinued immediately. • NB-Dapagliflozin should not be used for the treatment of DKA or in patients with a history of DKA. • NB-Dapagliflozin is not indicated, and should not be used, in patients with type 1 diabetes.
1 Dosing Considerations • NB-Dapagliflozin may be taken at any time of the day with or without food. • Assess renal function prior to initiation of NB-Dapagliflozin therapy and regularly thereafter. See 7 WARNINGS AND PRECAUTIONS. • Assess volume status and, if necessary, correct volume depletion prior to initiation of NB- Dapagliflozin therapy.
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
• NB-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.
• NB-Dapagliflozin is contraindicated in patients on dialysis. See 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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Hepatic impairment:
No dosage adjustment for NB-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, NB-Dapagliflozin is not recommended for use in this population.
Pediatrics (< 18 years of age):
Safety and effectiveness of dapagliflozin 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 NB-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 NB-Dapagliflozin is missed, it should be taken as soon as the patient remembers.
A double dose of NB-Dapagliflozin should not be taken on the same day.
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: NB-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 NB-Dapagliflozin treatment reinitiation. See 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism.
2 Recommended Dose and Dosage Adjustment Type 2 Diabetes Mellitus (T2DM) To improve glycemic control, the recommended starting dose of NB-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 NB-Dapagliflozin is 10 mg once daily. Heart Failure In patients with heart failure the recommended dose of NB-Dapagliflozin is 10 mg taken orally once daily. Chronic Kidney Disease In patients with chronic kidney disease, the recommended dose of dapagliflozin is 10 mg taken orally once daily.
Considerations for Special Populations Renal impairment:
NB-Dapagliflozin Page 7 of 89 The glucose-lowering efficacy of Dapagliflozin is dependent on renal function and declines with decreasing renal function. Monitoring of renal function is required prior to initiation of NB- 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 NB-Dapagliflozin is contraindicated in patients on dialysis. See 2 CONTRAINDICATIONS.
Hepatic impairment:
No dosage adjustment for NB-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, NB-Dapagliflozin is not recommended for use in this population.
Pediatrics (< 18 years of age):
Safety and effectiveness of dapagliflozin 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 NB-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 NB-Dapagliflozin is missed, it should be taken as soon as the patient remembers.
A double dose of NB-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.
NB-Dapagliflozin Page 8 of 89 For management of a […]