Clinical Pharmacology Details


Ertugliflozin and Sitagliptin


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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.

Side Effects:

Most common Female genital mycotic infections.


pper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin, hypoglycemia was also more commonly reported in patients treated with sitagliptin 


Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. 


Lactation: Breastfeeding not recommended.


Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume. 


Renal Impairment: Higher incidence of adverse reactions 


 

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: