sitagliptin hydrochloride monohydrate: clinical use

Prescribing considerations

• Confirm treatment is for type 2 diabetes; sitagliptin is not indicated for type 1 diabetes or diabetic ketoacidosis.
• Assess renal function before initiation and periodically thereafter because exposure increases as renal function declines.
• Review hypoglycaemia risk when prescribing with insulin or a sulphonylurea.
• Use caution with a history of pancreatitis and counsel about characteristic symptoms.
• The selected SmPCs lack adequate efficacy evidence for children and adolescents.

Contraindications and cautions

• Hypersensitivity to sitagliptin or any product excipient.

Monitoring

• Glycaemic response, including HbA1c as clinically appropriate.
• Renal function before treatment and periodically thereafter.
• Symptoms of pancreatitis, serious hypersensitivity or bullous pemphigoid.
• Hypoglycaemia when combined with insulin or a sulphonylurea.

Clinical pharmacology

A selective DPP-4 inhibitor that prolongs active incretin activity, producing glucose-dependent increases in insulin and reductions in glucagon. It undergoes limited metabolism and is eliminated mainly unchanged through the kidneys.

Formulation and product differences

• The selected film-coated tablet should be swallowed whole with water and is essentially sodium-free.
• The selected oral solution is supplied with an oral syringe, requires refrigerated storage and contains sodium methyl parahydroxybenzoate, benzyl alcohol and a small amount of ethanol; these excipients may cause allergic reactions in susceptible people.

Oral solution

Route: Oral

Strengths: 25 mg/mL

Tablet

Route: Oral

Strengths: 25 mg, 50 mg, 100 mg