Monotherapy
- SITAPIN (sitagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus and for whom metformin is inappropriate due to contraindications or intolerance.
Combination with Metformin
- SITAPIN is indicated in combination with metformin in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise, plus metformin do not provide adequate glycemic control.
Combination with Metformin and a Sulfonylurea
- SITAPIN is indicated in combination with metformin and a sulfonylurea in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise, and dual therapy with these agents, do not provide adequate glycemic control.
Combination with Insulin
- SITAPIN is indicated as add-on combination therapy with premixed or long/intermediate acting insulin (with or without metformin) in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when diet and exercise, and therapy with premixed or long/intermediate acting insulin (with or without metformin) do not provide adequate glycemic control.
Combination with Pioglitazone
- SITAPIN is indicated in combination with pioglitazone in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise, plus pioglitazone do not provide adequate glycemic control.
Combination with Metformin and Pioglitazone
- SITAPIN is indicated in combination with metformin and pioglitazone in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise, and dual therapy with these agents, do not provide adequate glycemic control.
SITAPIN can be taken with or without food.
Recommended dose of SITAPIN is 100 mg once daily as monotherapy or as combination therapy with metformin and a sulfonylurea, with insulin or with pioglitazone. When used in combination, the doses of other drugs (e.g. insulin, sulfonylurea or pioglitazone) can be reduced and lead to reduced events of hypoglycemia.
Patients with renal insufficiency:
SITAPIN is renally excreted. So to achieve the plasma concentrations of SITAPIN similar to those in patients with normal renal function, dosage recommendations are as follows,
- For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥50 mL/min), no dosage adjustment for SITAPIN is required.
- For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min), the dose of SITAPIN is 50 mg once daily.
- For patients with severe renal insufficiency (CrCl <30 mL/min) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of SITAPIN is 25 mg once daily.
- SITAPIN may be administered without regard to the timing of dialysis.
Patients with hepatic insufficiency:
- Use of sitagliptin in patients with severe hepatic insufficiency is not recommended.
Geriatrics:
- No dosage adjustment is necessary for geriatric patients.
Pediatrics:
- There are no data available on the use in patients younger than 18 years of age. Therefore, use of SITAPIN in pediatric patients is not recommended.
Missed Dose:
- If a dose of SITAPIN is missed, it should be taken as soon as the patient remembers.
SITAPIN is contraindicated in the case of following events,
- Pancreatitis
- Renal impairments
- With medications known to cause hypoglycemia (Sulfonylureas or insulin)
- Hypersensitivity reactions to the components of SITAPIN which may lead to events like anaphylaxis and angioedema
- Pancreatitis
- Renal Impairment
- Use with Medications Known to Cause Hypoglycemia
- Hypersensitivity Reactions
- Macrovascular Outcomes
Reported in 5% of patients and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis and headache. In the add on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with JANUVIA compared to placebo.
- Do not store above 25°C (77°F). Protect from moisture.
- Store in a cool and dry place away from sunlight.
SITAPIN 50: 5×10’s
SITAPIN 100: 5x1x14’s
