In this article, we will discuss about Sitagliptin (Dosage). So, let’s get started.
Monotherapy and Combination Therapy
Sitagliptin (JANUVIA®) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
Sitagliptin (JANUVIA®) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Sitagliptin (JANUVIA®) has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin (JANUVIA®).
The recommended dose of Sitagliptin (JANUVIA®) is 100 mg once daily. Sitagliptin (JANUVIA®) can be taken with or without food. Sitagliptin (JANUVIA®) should be swallowed whole.
Patients with Renal Insufficiency
For patients with mild renal insufficiency (creatinine clearance [CrCl] 250 mL/min, approximately corresponding to serum creatinine levels of 1.7 mg/dL in men and 1.5 mg/dL in women), no dosage adjustment for Sitagliptin (JANUVIA®) is required.
For patients with moderate renal insufficiency (CrCI ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to 3.0 mg/dL in men and >1.5 to 2.5 mg/dL in women), the dose of Sitagliptin (JANUVIA®) is 50 mg once daily.
For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women) or with end-stage renal disease
(ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Sitagliptin (JANUVIA®) is 25 mg once daily. Sitagliptin (JANUVIA®) may be administered without regard to the timing of hemodialysis because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitagliptin (JANUVIA®) and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. There have been postmarketing reports of worsening renal function in patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When Sitagliptin (JANUVIA®) is used in combination with an insulin secretagogue (eg, sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.
Warnings and Precautions
• There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue Sitagliptin (JANUVIA®).
• There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. Assessment of renal function is recommended prior to initiating Sitagliptin (JANUVIA®) and periodically thereafter.
• There is an increased risk of hypoglycemia when Sitagliptin (JANUVIA®) is added to an insulin secretagogue (e.g., sulfonylurea) or insulin therapy. Consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.
• There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with Sitagliptin (JANUVIA®) such as anaphylaxis, angioedema, and exfoliative skin conditions induding Stevens-Johnson syndrome. In such cases, promptly stop Sitagliptin (JANUVIA®), assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes.
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Sitagliptin (JANUVIA®) or any other anti-diabetic drug.