Indications And Usage

DIABETOSE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

DIABETOSE 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.

DIABETOSE 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 DIABETOSE.

There have been post marketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking DIABETOSE. After initiation of DIABETOSE, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, DIABETOSE should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using DIABETOSE.

Administration

Recommended Dosing

The recommended dose of DIABETOSE is 100 mg once daily. DIABETOSE can be taken with or without food.

Contraindications

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

Precautions

Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking DIABETOSE. After initiation of DIABETOSE, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, DIABETOSE should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using DIABETOSE. Heart Failure, Assessment of Renal Function, Use with Medications Known to Cause Hypoglycemia, Hypersensitivity Reactions, Severe and Disabling Arthralgia, Bullous Pemphigoid, Macrovascular Outcomes.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pregnancy and lactation

Follow your doctor's instructions about using sitagliptin if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester. Your name may need to be listed on a sitagliptin pregnancy registry when you start using this medicine. It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks. Sitagliptin is not approved for use by anyone younger than 18 years old.

Renal and liver Impairment

For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m2 to less than 90 mL/min/1.73 m2, no dosage adjustment for DIABETOSE is required.

For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2), the dose of DIABETOSE is 50 mg once daily.

For patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of DIABETOSE is 25 mg once daily. DIABETOSE may be administered without regard to the timing of dialysis.

Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of DIABETOSE and periodically thereafter. There have been postmarketing reports of worsening renal function in patients with renal impairment, some of whom were prescribed inappropriate doses of sitagliptin.

Laboratory Tests