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SANDOZ SITAGLIPTIN is a brand name for Sitagliptin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 05/2022 4 DOSAGE AND ADMINISTRATION 05/2022 7 WARNINGS AND PRECAUTIONS 05/2022 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…
Verbatim from this product's HC label. Tap a section to expand.
05/2022 7 WARNINGS AND PRECAUTIONS 05/2022 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......................................................... 4 1 INDICATIONS ................................................................
............................ 1 Pediatrics................................................................................................................. 2 Geriatrics .................................................................................................................
4 2 CONTRAINDICATIONS................................................................ .................. 4 4 DOSAGE AND ADMINISTRATION................................ ................................ ..... 1 Dosing Considerations..............................................................................................
2 Recommended Dose and Dosage Adjustment........................................................... 4 Administration......................................................................................................... 5 Missed Dose ............................................................................................................
6 5 OVERDOSAGE ................................................................ ........................... 6
). For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section). , Sulfonylurea) When Sandoz Sitagliptin is used in combination with metformin and a sulfonylurea or with insulin (with or without metformin), a lower dose of the insulin secretagogue or Sandoz Sitagliptin Page 5 of 58 insulin may be considered to reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
2 Recommended Dose and Dosage Adjustment The recommended dose of Sandoz Sitagliptin is 100 mg once daily as monotherapy or as combination therapy with metformin, with metformin and a sulfonylurea, with insulin (with or without metformin), or with pioglitazone (with or without metformin).
Renal Impairment:
Sitagliptin is renally excreted. Renal function must be assessed prior to initiation of Sandoz Sitagliptin and periodically thereafter because, there is a dosage adjustment based upon renal function (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
73 m2) or with end-stage renal disease (ESRD) including those requiring hemodialysis or peritoneal dialysis, the dose of Sandoz Sitagliptin is 25 mg once daily. Sandoz Sitagliptin may be administered without regard to the timing of dialysis.
73 m2, the dose of Sandoz Sitagliptin is 50 mg once daily. 73 m2. 73 m2). When considering the use of sitagliptin in combination with another anti -diabetic product, its conditions for use in patients with renal impairment should be followed.
Hepatic Impairment:
No dosage adjustment of Sandoz Sitagliptin is necessary in patients with mild or moderate hepatic impairment. Sitagliptin has not been studied in patients with severe hepatic impairment and is not recommended for use in this population.
05/2022 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......................................................... 4 1 INDICATIONS ................................................................
............................ 1 Pediatrics................................................................................................................. 2 Geriatrics .................................................................................................................
4 2 CONTRAINDICATIONS................................................................ .................. 4 4 DOSAGE AND ADMINISTRATION................................ ................................ ..... 1 Dosing Considerations..............................................................................................
2 Recommended Dose and Dosage Adjustment........................................................... 4 Administration......................................................................................................... 5 Missed Dose ............................................................................................................
6 5 OVERDOSAGE ................................................................ ........................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 6 7 WARNINGS AND PRECAUTIONS................................
...................................... 1 Special Populations .................................................................................................. 1 Pregnant Women ..................................................................................................
Patients with a history of a hypersensitive reaction to Sandoz Sitagliptin or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sitagliptin 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.
Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
No dosage adjustment is necessary for geriatric patients. However, because sitagliptin is substantially excreted by the kidney, and because aging can be associated with reduced renal function, renal function should be assessed more frequently in elderly patients (see 7 WARNINGS AND PRECAUTIONS, Special Populations).
4 Administration Sandoz Sitagliptin can be taken with or without food. 5 Missed Dose If a dose of Sandoz Sitagliptin is missed, it should be taken as soon as the patient remembers. A double dose of Sandoz Sitagliptin should not be taken on the same day.
, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required. Sitagliptin is modestly dialyzable. 5% of the dose was removed over a 3- to 4-hour hemodialysis session.
Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis. For management of a suspected drug overdose, contact your re gional poison control centre. 5 mg of sitagliptin phosphate monohydrate Sandoz Sitagliptin tablets, 25 mg, are dark pink, round, biconvex film coated tablet debossed with “SN” on one side and “25” on the other side.
They are supplied in HDPE bottles of 100 tablets. Sandoz Sitagliptin Page 7 of 58 Sandoz Sitagliptin tablets, 50 mg, are pink, round, biconvex film coated tablet debossed with “SN” on one side and “50” on the other side. They are supplied in HDPE bottles of 100 and 500 tablets.
Sandoz Sitagliptin tablets, 100 mg, are brown, round, biconvex film coated tablet debossed with “SN” on one side and “100” on the other side. They are supplied in HDPE bottles of 100 and 500 tablets. 7 WARNINGS AND PRECAUTIONS General Sandoz Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Driving and Operating Machinery Patients should be warned about driving or operating a vehicle or potentially dangerous machinery under conditions where a risk of hypoglycemia is present. When sitagliptin is used in combination with metformin and a sulfonylurea, or in combination with insulin (with or without metformin), patients should be advised to take precautions to avoid hypoglycemia while driving or operating a vehicle or potentially dangerous machinery.
Endocrine and Metabolism Hypoglycemia:
When sitagliptin was used in combination with metformin and a sulfonylurea, or with a stable dose of insulin […]
2 Breast-feeding ...................................................................................................... 3 Pediatrics..............................................................................................................
4 Geriatrics ............................................................................................................ 10 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 .............................................................................. 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 .......................................................................... 29 10 CLINICAL PHARMACOLOGY ................................
......................................... 1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics ..............................................................................................
3 Pharmacokinetics................................................................................................. 31 11 STORAGE, STABILITY AND DISPOSAL ................................ .............................. 34 PART II: SCIENTIFIC INFORMATION ................................................................
...... 35 13 PHARMACEUTICAL INFORMATION ................................ ................................ 35 14 CLINICAL TRIALS................................ ....................................................... 1 Clinical Trials by Indication ...................................................................................
35 Monotherapy .............................................................................................................. 35 Sitagliptin in Combination with Metformin...................................................................
38 Sitagliptin Add-on Combination Therapy ...................................................................... 2 Comparative Bioavailability Studies ...................................................................... 51 15 MICROBIOLOGY ................................
....................................................... 52 16 NON-CLINICAL TOXICOLOGY ................................ ................................ ........ 52 17 SUPPORTING PRODUCT MONOGRAPHS ................................ ..........................
53 PATIENT MEDICATION INFORMATION ................................ ................................ .. 54 Sandoz Sitagliptin Page 4 of 58 PART I: HEALTH PROFESSIONAL INFORMATION 1 […]
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