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JANUVIA 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: JANUVIA® (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: JANUVIA® is indicated in adult patients with type…
Verbatim from this product's HC label. Tap a section to expand.
and 10 CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS • Patients with a history of a hypersensitive reaction to JANUVIA 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 JANUVIA® is used in combination with metformin and a sulfonylurea or with insulin (with or without metformin), a lower dose of the insulin secretagogue or insulin may be considered to JANUVIA® (sitagliptin) Page 5 of 55 reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
2 Recommended Dose and Dosage Adjustment The recommended dose of JANUVIA® 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:
JANUVIA® is renally excreted. Renal function must be assessed prior to initiation of JANUVIA® 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 JANUVIA® is 25 mg once daily. JANUVIA® may be administered without regard to the timing of dialysis. 73 m2, the dose of JANUVIA® 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 JANUVIA® 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.
Pediatrics (<18 years of age):
, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS • Patients with a history of a hypersensitive reaction to JANUVIA 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 JANUVIA 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.
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).
5 Missed Dose If a dose of JANUVIA® is missed, it should be taken as soon as the patient remembers. A double dose of JANUVIA® 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.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging. 5 mg of sitagliptin phosphate monohydrate Tablets JANUVIA®, 25 mg, are pink, round, film-coated tablets with “221” on one side.
They are supplied in bottles of 30. Tablets JANUVIA®, 50 mg, are light beige, round, film-coated tablets with “112” on one side. They are supplied in bottles of 30. Tablets JANUVIA®, 100 mg, are beige, round, film-coated tablets with “277” on one side.
They are supplied in bottles of 30 and 100. For management of a suspected drug overdose, contact your regional poison control centre. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets: sitagliptin (as sitagliptin phosphate monohydrate) 25 mg§ 50 mg§§ 100 mg§§§ Anhydrous dibasic calcium phosphate (calcium hydrogen phosphate, anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol (macrogol), polyvinyl alcohol, propyl gallate, red iron oxide, sodium stearyl fumarate, talc, titanium dioxide, and yellow iron oxide.
JANUVIA® (sitagliptin) Page 7 of 55 7 WARNINGS AND PRECAUTIONS General JANUVIA® 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 JANUVIA® 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 JANUVIA® was used in combination with metformin and a sulfonylurea, or with a stable dose of insulin (with or without metformin), the incidence of hypoglycemia was increased over that of placebo used in combination with metformin and a sulfonylurea or in combination with insulin (with or without metformin) (see 8 ADVERSE REACTIONS).
To reduce the risk of hypoglycemia associated with these indications, a lower dose of sulfonylurea or insulin may be considered (see 4 DOSAGE AND ADMINISTRATION). Loss of Control of Blood […]
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