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JARDIANCE is a brand name for Empagliflozin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 01/2024 1 INDICATIONS, 1.1 Pediatrics 01/2024 1 INDICATIONS, 1.2 Geriatrics 01/2024 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 01/2024 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations, Temporary interruption for surgery 09/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 01/2024 4 DOSAGE…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 02/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS .............................................................................................................
2 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 ..............................................................................................................
8 5 OVERDOSAGE............................................................................................................. 8
, Ketoacidosis. • Cases of ketoacidosis have also been reported in patients without T2DM taking JARDIANCE. • The risk of ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue, or sleepiness.
If these symptoms occur, regardless of blood glucose level, JARDIANCE treatment should be immediately discontinued, and patients should be assessed for ketoacidosis immediately. • JARDIANCE should not be used for the treatment of ketoacidosis or in patients with a history of ketoacidosis.
• JARDIANCE is not indicated, and should not be used, in patients with type 1 diabetes. 1 Dosing Considerations • JARDIANCE may be taken at any time of the day with or without food. • Assess renal function prior to initiation of JARDIANCE therapy and regularly thereafter.
See 7 WARNINGS AND PRECAUTIONS, Renal. Product Monograph JARDIANCE (empagliflozin) Page 7 of 83 Protected B / Protégé B • Assess volume status and, if necessary, correct volume depletion prior to initiation of JARDIANCE therapy. See 7 WARNINGS AND PRECAUTIONS, Cardiovascular.
, sulfonylurea): When JARDIANCE is used as add-on therapy with insulin or an insulin secretagogue, 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, Use with Medications Known to Cause Hypoglycemia and 8 ADVERSE REACTIONS.
• Temporary interruption for surgery: JARDIANCE 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 ketoacidosis 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 JARDIANCE treatment re-initiation. See 7 WARNINGS and PRECAUTIONS, Endocrine and Metabolism, Treatment Interruption considerations.
4 Geriatrics 02/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS .............................................................................................................
2 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 ..............................................................................................................
8 5 OVERDOSAGE............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
• JARDIANCE 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Empagliflozin 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.
• Diuretics: JARDIANCE should be used with caution in patients taking diuretics, particularly loop diuretics, due to the increased risk of adverse events due to volume depletion during co- administration. 4 Drug-Drug Interactions, Pharmacodynamic interactions, Diuretics.
• Patients hospitalized for acute heart failure (de novo or decompensated chronic heart failure) should be adequately stabilised and should receive heart failure therapies in accordance with clinical guidelines. 2 Recommended Dose and Dosage Adjustment Type 2 diabetes mellitus (T2DM) To improve glycemic control, the recommended starting dose of JARDIANCE is 10 mg taken orally, once daily.
73 m2, the dose can be increased to 25 mg once daily. To reduce the incidence of cardiovascular death in patients with T2DM and established cardiovascular disease the recommended dose of JARDIANCE is 10 mg taken orally once daily. Heart Failure (HF) The recommended dose of JARDIANCE is 10 mg taken orally once daily.
Chronic kidney disease (CKD) The recommended dose of JARDIANCE is 10 mg taken orally once daily.
Considerations for Special Populations Renal Impairment:
The glucose-lowering efficacy of JARDIANCE is dependent on renal function and decreases with declining renal function. 73m² the recommended dose of JARDIANCE is limited to 10 mg and additional glucose lowering treatment should be considered if needed.
See 7 WARNINGS AND PRECAUTIONS, Renal. • JARDIANCE 10 mg can be used regardless of renal function. 73 m2 or on dialysis. Due to limited experience, it is not recommended to initiate treatment with JARDIANCE in patients on dialysis. See 7 WARNINGS AND PRECAUTIONS, Renal.
Product Monograph JARDIANCE (empagliflozin) Page 8 of 83 Protected B / Protégé B Hepatic Impairment: No dosage adjustment for JARDIANCE is necessary for patients with mild or moderate hepatic impairment. JARDIANCE exposure is increased in patients with severe hepatic impairment.
See 10 CLINICAL PHARMACOLOGY, Hepatic insufficiency. Experience in patients with severe hepatic impairment is limited. Therefore, JARDIANCE is not recommended for use in this population.
Pediatrics (<18 years of age):
The safety and efficacy of JARDIANCE have not been established; therefore, Health Canada has not authorized an indication for use in pediatric patients.
Geriatrics (≥65 years of age):
No dose adjustment for JARDIANCE is required based on age; however renal function and risk of volume depletion should be taken into account. 4 Geriatrics. 4 Administration JARDIANCE tablets should be taken whole and should not be cut or divided.
5 Missed Dose If a dose is missed, it should be taken as soon as the patient remembers. A double dose of JARDIANCE should not be taken on the same day. , remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient’s clinical status.
The removal of JARDIANCE by haemodialysis has not been studied. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition and Packaging Description JARDIANCE 10 mg film-coated tablets are pale yellow, round, biconvex and bevel-edged, debossed with “S10” on one side and the Boehringer Ingelheim company symbol on the other side.
JARDIANCE 25 mg film-coated tablets are pale yellow, oval, biconvex and debossed with “S25” on one side and the Boehringer Ingelheim logo on […]
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
14 8 ADVERSE REACTIONS................................................................................................ 1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions ..............................................................................
3 Less Common Clinical Trial Adverse Reactions (<1%)a ........................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data..............................................................................................................
5 Post-Market Adverse Reactions.............................................................................. 27 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.......................................................................... 32 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ..............................................................................................
33 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 35 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 35 Product Monograph JARDIANCE (empagliflozin) Page 4 of 83 Protected B / Protégé B PART II: SCIENTIFIC INFORMATION ......................................................................................
36 13 PHARMACEUTICAL INFORMATION ........................................................................... 36 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ............................................................................... 37 Type 2 diabetes mellitus (T2DM) […]