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SYNJARDY 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: , 1.1 Pediatrics 03/2023 1 INDICATIONS, 1 .2 Geriatrics 03/2023
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 03/2023 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 Product Monograph Synjardy® (Empagliflozin and metformin hydrochloride) Page 3 of 74 Protected B / Protégé B 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 7 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations .............................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ..........................................................................................................
5 Missed Dose .............................................................................................................. 9 5 OVERDOSAGE...........................................................................................................
10
There have been no clinical studies conducted with SYNJARDY (empagliflozin/metformin hydrochloride) tablets. 1 Adverse Reaction Overview Empagliflozin A total of 10 004 patients with type 2 diabetes were treated with empagliflozin in clinical studies to evaluate the safety of empagliflozin, alone or in combination to support the indications.
In clinical trials, 2856 patients received treatment with empagliflozin 10 mg and 3738 patients received treatment with empagliflozin 25 mg for at least 24 weeks; 601 were treated with empagliflozin 10 mg and 881 patients were treated with empagliflozin 25 mg for at least 76 weeks.
9%). Placebo controlled double-blinded trials of 18 to 24 weeks of exposure included 2971 patients, of which 995 were treated with placebo, 999 were treated with empagliflozin 10 mg and 977 were treated with empagliflozin 25 mg. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data, Clinical Trial Findings, Hypoglycemia).
Metformin hydrochloride Lactic Acidosis:
Very rare (<1/10, 000 and isolated reports) (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Lactic Acidosis, and 5 OVERDOSAGE, Metformin Hydrochloride).
Gastrointestinal Reactions:
Very common (>1/10). Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal bloating, flatulence, and anorexia) are the most common reactions to metformin hydrochloride and are approximately 30% more frequent in patients on metformin monotherapy than in placebo-treated patients, particularly during initiation of metformin therapy.
Because significant diarrhea and/or vomiting can cause dehydration and prerenal azotemia, SYNJARDY should be temporarily discontinued, under such circumstances. For patients who have been stabilized on metformin, nonspecific gastrointestinal symptoms should not be attributed to therapy unless intercurrent illness or lactic acidosis have been excluded.
4 Geriatrics 03/2023 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 Product Monograph Synjardy® (Empagliflozin and metformin hydrochloride) Page 3 of 74 Protected B / Protégé B 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 7 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations .............................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ..........................................................................................................
5 Missed Dose .............................................................................................................. 9 5 OVERDOSAGE...........................................................................................................
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.
Special Senses:
Common (≥1/100). , metallic taste. Product Monograph Synjardy® (Empagliflozin and metformin hydrochloride) Page 24 of 74 Protected B / Protégé B Dermatologic Reactions: Very rare (<1/10,000 and isolated reports). The incidence of rash/dermatitis in controlled clinical trials was comparable to placebo for metformin monotherapy and to sulfonylurea for metformin/sulfonylurea therapy.
Reports of skin reactions such as erythema, pruritus, and urticaria are very rare.
Hematologic:
Decrease of vitamin B12 absorption with decrease of serum levels during long-term use of metformin is rare (≥1/10,000 and <1/1,000). Consideration of such etiology is recommended if a patient presents with megaloblastic anemia.
Hepatic:
Very rare (<1/10,000 and isolated reports). Liver function tests abnormalities or hepatitis resolving upon metformin discontinuation has been documented in isolated reports. Empagliflozin and Metformin hydrochloride A total of 7052 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin plus metformin, of which 4740 patients were treated with empagliflozin plus metformin, either alone, or in combination to support the indications.
In these trials 1270 patients received treatment with empagliflozin 10 mg plus metformin and 2065 patients received treatment with empagliflozin 25 mg plus metformin for at least 24 weeks; 643 patients received treatment with empagliflozin 10 mg plus metformin and 1286 patients received treatment with empagliflozin 25 mg plus metformin for at least 76 weeks.
Placebo controlled double-blinded trials of 18 to 24 weeks of exposure included 3456 patients, of which 1271 were treated with empagliflozin 10 mg plus metformin and 1259 with empagliflozin 25 mg plus metformin. The most frequently reported adverse event in clinical trials was hypoglycaemia, which depended on the type of background therapy used in the respective studies (see description of selected side effects).
No additional side effects were identified in clinical trials with empagliflozin plus metformin compared to the side effects of the single components. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In a pooled dataset of the five 24-week placebo-controlled clinical trials and 18-week data from the placebo-controlled study as add-on to insulin therapy, adverse events regardless of causality that occurred in ≥1% of patients receiving empagliflozin and more commonly than in patients given placebo (excluding hypoglycemia), are shown in Table 3.
8) Upper […]
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 1 Physical Characteristics ........................................................................................... 11 7 WARNINGS AND PRECAUTIONS ................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
22 8 ADVERSE REACTIONS................................................................................................ 1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions ..............................................................................
3 Less Common Clinical Trial Adverse Reactions (<1%)............................................. 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.......................................................................... 37 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ..............................................................................................
39 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 42 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 42 PART II: SCIENTIFIC INFORMATION […]