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APO-SITAGLIPTIN MALATE 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: Monotherapy: APO-SITAGLIPTIN MALATE (sitagliptin) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance. Add-on combination: APO-SITAGLIPTIN MALATE is indicated…
Verbatim from this product's HC label. Tap a section to expand.
and 10 ACTION AND CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS Patients with a history of a hypersensitive reaction to APO-SITAGLIPTIN MALATE 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
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section). , Sulfonylurea) When APO-SITAGLIPTIN MALATE is used in combination with metformin and a APO-SITAGLIPTIN MALATE Page 5 of 59 sulfonylurea or with insulin (with or without metformin), a lower dose of the insulin secretagogue or 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 APO-SITAGLIPTIN MALATE 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 APO-SITAGLIPTIN MALATE 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 withend-stage renal disease (ESRD) including those requiring hemodialysis or peritoneal dialysis, the dose of APO-SITAGLIPTIN MALATE is 25 mg once daily. APO-SITAGLIPTIN MALATE may be administered without regard to the timing of dialysis.
73 m2, the dose of APO-SITAGLIPTIN MALATE 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 APO-SITAGLIPTIN MALATE 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.
, 4 DOSAGE AND ADMINISTRATION and 10 ACTION AND CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS Patients with a history of a hypersensitive reaction to APO-SITAGLIPTIN MALATE or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container (see 7 WARNINGS AND PRECAUTIONS and
Patients with a history of a hypersensitive reaction to APO-SITAGLIPTIN MALATE 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 assesse d more frequently in elderly patients (see 7 WARNINGS AND PRECAUTIONS, Special Populations).
4 Administration APO-SITAGLIPTIN MALATE can be taken with or without food. 5 Missed Dose If a dose of APO-SITAGLIPTIN MALATE is missed, it should be taken as soon as the patient remembers. A double dose of APO-SITAGLIPTIN MALATE 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 regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets: sitagliptin (as sitagliptin malate) 25 mg§ 50 mg§§ 100 mg§§§ Croscarmellose sodium, dibasic calcium phosphate, ferric oxide red, ferric oxide yellow, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.
979 mg of sitagliptin malate which is equivalent to 100 mg of free base APO-SITAGLIPTIN MALATE tablets, 25 mg, are pink, round, biconvex coated tablets. Engraved “SIT” over “25” on one side, “APO” on the other side. They are supplied in bottles of 100.
APO-SITAGLIPTIN MALATE Page 7 of 59 APO-SITAGLIPTIN MALATE tablets, 50 mg, are light beige, round, biconvex coated tablets. Engraved “SIT” over “50” on one side, “APO” on the other side. They are supplied in bottles of 100. APO-SITAGLIPTIN MALATE tablets, 100 mg, are Beige, round, biconvex coated tablets.
Engraved “SIT” over “100” on one side, “APO” on the other side. They are supplied in bottles of 100. 7 WARNINGS AND PRECAUTIONS General APO-SITAGLIPTIN MALATE 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 APO-SITAGLIPTIN MALATE 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 sitaglipin was used in combination with metformin and a sulfonylurea, or with a stable dose of insulin (with or without metformin), the incidence of […]
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