Indications & Dose:

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

Limitations of Use:

Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. 

Has not been studied in patients with a history of pancreatitis. 

DOSAGE 

Recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food. 

Increase dose to 15 mg ertugliflozin/100 mg sitagliptin once daily in those tolerating ertugliflozin and sitagliptin and needing additional glycemic control.

Contraindications:

Severe renal impairment, end stage renal disease, or dialysis. 

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

Cautions:

Precautions:

Pancreatitis: If pancreatitis is suspected, promptly discontinue. 

Hypotension: Monitor for signs and symptoms during therapy. 

Ketoacidosis: Discontinuation of therapy in clinical situations known to predispose to ketoacidosis.

Acute Kidney Injury and Impairment in Renal Function: Monitor renal function.

Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Lower Limb Amputation: Monitor patients for infections or ulcers

of lower limbs, and discontinue if these occur.

Heart Failure: Monitor patients for signs and symptoms.

Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. 

Genital Mycotic Infections: Monitor and treat if indicated. 

Hypersensitivity: Anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly discontinue, assess for other potential causes, institute

appropriate monitoring and treatment, and initiate alternative treatment for diabetes. 

Pemphigoid: Discontinue. 

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: