EMPAZINE-25 TABLETS (EACH CONTAING EMPAGLIFOZIN 25MG

Indications

• Type 2 diabetes mellitus
• Cardiovascular risk reduction in patients with type 2 diabetes and established cardiovascular disease

Dosage

Children: Refer to BNF for Children for specific dosing guidelines as empagliflozin is not typically used in pediatric populations.

Adults: Refer to BNF for specific dosing guidelines as they may vary based on individual patient factors.

Mechanism of action

Empagliflozin works by inhibiting the SGLT2 protein in the renal proximal tubules, which reduces glucose reabsorption and increases glucose excretion in the urine. This mechanism leads to lower blood glucose levels and may also lead to weight loss and a reduction in blood pressure.

Pharmacodynamics

The pharmacodynamic effects of empagliflozin include a reduction in plasma glucose levels, primarily through glycosuria, which is the excretion of glucose in the urine. It may also have beneficial effects on weight and blood pressure due to osmotic diuresis and reduced insulin resistance, promoting better cardiovascular outcomes in patients with type 2 diabetes.

Pharmacokinetics

Empagliflozin is well absorbed after oral administration, with peak plasma concentrations occurring approximately 1.5 hours after dosing. It has a bioavailability of around 78% and is approximately 86% bound to plasma proteins. The drug undergoes extensive metabolism in the liver, mainly via glucuronidation, and is eliminated primarily through urine, with a half-life of about 12 hours.

Contra-indications

• Hypersensitivity to empagliflozin or any of its excipients
• Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
• End-stage renal disease requiring dialysis
• Diabetic ketoacidosis

Adverse effects

• Urinary tract infections
• Genital mycotic infections
• Dehydration
• Hypoglycaemia (when used with insulin or insulin secretagogues)
• Acute kidney injury
• Bone fractures
• Hypotension

Interactions

• Diuretics may increase the risk of dehydration and hypotension
• Insulin and insulin secretagogues may increase the risk of hypoglycaemia
• RAAS inhibitors (e.g., ACE inhibitors, ARBs) may increase the risk of renal impairment
• Other antidiabetic agents may have additive effects on glycaemic control

Precautions

• Monitor renal function regularly during treatment
• Assess patients for signs and symptoms of urinary tract infections
• Consider risks of dehydration, especially in elderly patients or those on diuretics
• Caution in patients with a history of genital infections

Pregnancy

Not recommended during pregnancy. Insufficient data on the use of empagliflozin in pregnant women to assess risks.

Breast-feeding

Not recommended during breastfeeding. It is not known whether empagliflozin is excreted in human milk.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

• Tablets: 10 mg, 25 mg