linagliptin + metformin: clinical use

Prescribing considerations

• Licensed only for adults with type 2 diabetes; not for type 1 diabetes or diabetic ketoacidosis.
• Assess renal function before initiation and periodically thereafter.
• Review acute dehydration, sepsis, hypoxia, cardiorespiratory deterioration, surgery and iodinated contrast exposure.
• Consider hypoglycaemia risk with insulin or a sulphonylurea.
• Review promptly if pancreatitis or bullous pemphigoid is suspected.

Contraindications and cautions

• Hypersensitivity to either active ingredient or an excipient
• Acute metabolic acidosis or diabetic pre-coma
• Severe renal impairment
• Acute conditions likely to alter renal function, including dehydration, severe infection or shock
• Acute or worsening disease causing tissue hypoxia
• Hepatic impairment, acute alcohol intoxication or alcoholism

Monitoring

• Renal function at baseline and periodically
• Glycaemic response and hypoglycaemia when combined with insulin or a sulphonylurea
• Vitamin B12 when deficiency is suspected and periodically in people with risk factors
• Symptoms of lactic acidosis, pancreatitis and blistering skin disease

Clinical pharmacology

Linagliptin inhibits DPP-4 and increases glucose-dependent incretin effects. Metformin reduces hepatic glucose output and improves insulin sensitivity; it is excreted unchanged in urine. The fixed combination is bioequivalent to co-administration of its separate components.

Formulation and product differences

• Film-coated fixed-combination tablets are available in two presentations containing the same linagliptin component but different metformin content.
• The presentations differ in colour, dimensions and tablet imprint.
• Store in the original packaging, or keep the bottle tightly closed, to protect the tablets from moisture.

Tablet

Route: Oral

Strengths: 2.5 mg + 1000 mg, 2.5 mg + 850 mg