Sita-Met Special Precautions

Special Populations: Hypersensitivity: There have been reports of serious hypersensitivity reactions in patients treated with sitagliptin. Reactions include anaphylaxis, angioedema, and exfoliative skin conditions, including Steven-Johnson syndrome.
Renal Function: Contraindicated in patients with renal dysfunction. Metformin accumulation and lactic acidosis risk increases with the degree of renal function impairment.
Hepatic Function: Avoid metformin in patients with clinical or laboratory evidence of hepatic disease.
Special Risk Patients: Debilitated, malnourished, or elderly patients and patients with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in elderly patients, and in people who are taking beta-blocking agents.
Changes in clinical status: Promptly evaluate patients with previously well-controlled type 2 diabetes who develop laboratory abnormalities or clinical illness for ketoacidosis or lactic acidosis.
Hypoxic states: Immediately discontinue therapy in any condition characterized by hypoxemia (eg, acute HF, MI).
Loss of blood glucose control: Patients exposed to stress (e.g., fever, infection, surgery, trauma) may experience a loss in glycemic control. It may be necessary to withhold sitagliptin/metformin and temporarily administer insulin until an acute episode has been resolved.
Pancreatitis: If pancreatitis is suspected, promptly discontinue sitagliptin/metformin and initiate appropriate management.
Surgical patients: Temporarily suspend treatment for any surgical procedure, except in procedures not associated with restricted intake of food and fluids and do not restart treatment until oral intake has resumed and renal function has been evaluated as healthy.
Vitamin B₁₂ levels: Metformin may decrease vitamin B₁₂ levels.
Use in Pregnancy: Category B.
Use in Lactation: Metformin is excreted, but is considered compatible with breast-feeding; undetermined for sitagliptin.
Use in Children: Safety and efficacy not established.
Use in Elderly: Use with caution because of possible age-related reduction in renal function.