RiteMed SITAGLIPTIN

Therapeutic indication

For adult patients with type 2 diabetes mellitus, sitagliptin tablets is indicated to improve glycemic control:

As monotherapy

• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

As dual oral therapy in combination with

• metformin when diet and exercise plus metformin alone do not provide adequate glycemic control.
• a sulfonylurea when diet and exercise plus maximal tolerated dose of a sulfonylurea alone do not provide adequate glycemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycemic control.

As triple oral therapy in combination with

• a sulfonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycemic control.

Sitagliptin tablet is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycemic control

DOSAGE AND ADMINISTRATION

Dosage

The dose is 100 mg sitagliptin once daily. When used in combination with metformin and/or a PPARγ agonist, the dose of metformin and/or PPARγ agonist should be maintained, and sitagliptin tablets administered concomitantly.

When sitagliptin tablet is used in combination with a sulfonylurea or with insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia.

If a dose of sitagliptin tablet is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

Special Populations

Renal Impairment

When considering the use of sitagliptin in combination with another anti-diabetic medicinal product, its conditions for use in patients with renal impairment should be checked.

For patients with mild renal impairment (creatinine clearance [CrCl] ≥ 50 mL/min), no dose adjustment is required.

For patients with moderate renal impairment (CrCl ≥ 30 to < 50 mL/min), the dose of sitagliptin tablets is 50 mg once daily.

For patients with severe renal impairment (CrCl < 30 mL/min) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of sitagliptin tablets is 25 mg once daily. Treatment may be administered without regard to the timing of dialysis.

Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of sitagliptin tablets and periodically thereafter.

Hepatic Impairment

No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Sitagliptin tablets have not been studied in patients with severe hepatic impairment and care should be exercised.

However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.

Elderly

No dose adjustment is necessary based on age.

Pediatric Population

The safety and efficacy of sitagliptin in children and adolescents under 18 years of age have not yet been established. No data are available.