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APO-DAPAGLIFLOZIN-METFORMIN 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: APO-DAPAGLIFLOZIN-METFORMIN (dapagliflozin and metformin hydrochloride tablets) is indicated for: • use as an adjunct to diet and exercise in adults with type 2 diabetes mellitus who are already being treated with dapagliflozin and metformin as separate tablets and achieving glycemic control. See 14 CLINICAL TRIALS. •…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 09/2023 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
• Patients should be assessed for diabetic ketoacidosis 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, APO- DAPAGLIFLOZIN-METFORMIN should be discontinued immediately. • APO-DAPAGLIFLOZIN-METFORMIN is contraindicated for the treatment of DKA or in patients with a history of DKA. • APO-DAPAGLIFLOZIN-METFORMIN is contraindicated in patients with type 1 diabetes.
See 2 CONTRAINDICATIONS. , sulfonylurea), a lower dose of insulin or an insulin secretagogue may be necessary to reduce the risk of hypoglycemia. See 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS. 73 m2). See Renal. • Assess volume status and, if necessary, correct volume depletion prior to initiation of APO- DAPAGLIFLOZIN-METFORMIN therapy.
See Cardiovascular.
Temporary interruption for surgery:
APO-DAPAGLIFLOZIN-METFORMIN 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 APO-DAPAGLIFLOZIN-METFORMIN treatment reinitiation.
See Endocrine and Metabolism. 2 Recommended Dose and Dosage Adjustment The recommended dose of APO-DAPAGLIFLOZIN-METFORMIN is one tablet twice daily with meals. Each tablet is a fixed dose of dapagliflozin and metformin. Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to APO- DAPAGLIFLOZIN-METFORMIN should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
4 Geriatrics 09/2023 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 APO-DAPAGLIFLOZIN-METFORMIN (Dapagliflozin and Metformin Hydrochloride Tablets) Page 3 of 85 Unclassified / Non classifié 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.
The maximum daily dose is 10 mg dapagliflozin and 2000 mg metformin. 73 m2 is APO-DAPAGLIFLOZIN-METFORMIN (Dapagliflozin and Metformin Hydrochloride Tablets) Page 8 of 85 Unclassified / Non classifié 1000 mg. The following dosage strengths are available: • 5 mg dapagliflozin / 850 mg metformin hydrochloride • 5 mg dapagliflozin / 1000 mg metformin hydrochloride Considerations for Special Populations Pediatrics (<18 years of age): Safety and effectiveness of dapagliflozin and metformin hydrochloride tablets in pediatric patients have not been established.
Therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
APO-DAPAGLIFLOZIN-METFORMIN should be used with caution as age increases because metformin is eliminated in part by the kidney, and elderly patients are more likely to have decreased renal function associated with aging and the risk of developing lactic acidosis.
In elderly patients, the initial and maintenance dose should be conservative, and any dose adjustment should be based on careful assessment of renal function. Renal function should be monitored more frequently and generally, patients should not be titrated to the maximum dose.
4 Geriatrics.
Renal impairment:
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 APO-DAPAGLIFLOZIN-METFORMIN therapy and regularly thereafter.
73 m2, more frequent monitoring of renal dysfunction is recommended. 73 m2. See Renal. 73 m2 is 1000 mg daily. 73 m2), end-stage renal disease or patients on dialysis. See 2 CONTRAINDICATIONS.
Hepatic impairment:
APO-DAPAGLIFLOZIN-METFORMIN is contraindicated in patients with severe hepatic dysfunction and should not be used in patients with clinical or laboratory evidence of hepatic disease. See 2 CONTRAINDICATIONS. Dapagliflozin exposure is increased in patients with severe hepatic impairment.
3 Pharmacokinetics. Metformin use in patients with impaired hepatic function has been associated with some cases of lactic acidosis. See 7 WARNINGS AND PRECAUTIONS. 4 Administration To minimize gastric intolerance for metformin component in APO-DAPAGLIFLOZIN-METFORMIN such as nausea and vomiting, APO-DAPAGLIFLOZIN-METFORMIN tablets should be taken orally with meals and should be taken whole, with a glass of water.
Do not break or crush tablets. 5 Missed Dose If a dose of APO-DAPAGLIFLOZIN-METFORMIN is missed, the patient should wait for the next dose at the usual time. A double dose of APO-DAPAGLIFLOZIN-METFORMIN should not be taken on the same day.
5 OVERDOSAGE Dapagliflozin 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. Metformin hydrochloride Available information concerning treatment of a massive overdosage of metformin hydrochloride is very limited.
It would be expected that adverse reactions of a more intense character including epigastric discomfort, nausea and vomiting followed by diarrhea, drowsiness, weakness, dizziness, […]
1 Special Populations .......................................................................................... 1 Pregnant Women .......................................................................................... 2 Breast-feeding ...............................................................................................
3 Pediatrics....................................................................................................... 4 Geriatrics .......................................................................................................
21 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 ...................................................................... 36 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 ................................................................. 50 12 SPECIAL HANDLING INSTRUCTIONS ................................................................... 50 PART II: SCIENTIFIC INFORMATION ....................................................................................
51 13 PHARMACEUTICAL INFORMATION .................................................................... 51 14 CLINICAL TRIALS ................................................................................................ 1 Clinical Trials by Indication ............................................................................
52 Add-On Combination Therapy with Metformin ....................................................... 52 APO-DAPAGLIFLOZIN-METFORMIN (Dapagliflozin and Metformin Hydrochloride Tablets) Page 4 of 85 Unclassified / Non classifié Add-On Therapy with Metformin and a Sulfonylurea […]