EMPALIZ 10 TABLETS (Each film coated tablet contains Empaglizin 10mg)

Indications

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

Dosage

Children: Refer to the BNF for Children for specific dosing information, as the safety and efficacy in pediatric populations have not been established.

Adults: Refer to the BNF for specific dosing information, as doses may vary based on individual patient factors.

Mechanism of action

Empagliflozin selectively inhibits the SGLT2 protein in the proximal renal tubules, which is responsible for the reabsorption of glucose from the renal filtrate back into the bloodstream. By blocking this transporter, empagliflozin increases urinary glucose excretion, thereby lowering plasma glucose levels and improving glycemic control.

Pharmacodynamics

Empagliflozin has been shown to reduce HbA1c levels, improve fasting and postprandial glucose levels, and may promote weight loss in patients with type 2 diabetes. The drug also has cardiovascular benefits, reducing the risk of cardiovascular death in patients with established cardiovascular disease.

Pharmacokinetics

Empagliflozin is rapidly absorbed after oral administration, with peak plasma concentrations occurring approximately 1.5 hours post-dose. It has a bioavailability of around 78%. The drug is extensively metabolized in the liver, primarily via glucuronidation, and has a half-life of approximately 12 hours. The majority of the drug is excreted in the urine, both as unchanged drug and as metabolites.

Contra-indications

• Hypersensitivity to empagliflozin or any of its excipients
• Severe renal impairment (eGFR < 30 mL/min)
• End-stage renal disease
• Dialysis

Adverse effects

• Hypoglycemia
• Genital mycotic infections
• Urinary tract infections
• Dehydration
• Hypotension
• Dizziness
• Nausea
• Constipation

Interactions

• Diuretics may enhance the risk of dehydration and hypotension
• Other antihyperglycemic agents may increase the risk of hypoglycemia
• ACE inhibitors or angiotensin II receptor antagonists may increase the risk of hypotension
• Lithium concentration may be affected due to changes in renal function

Precautions

• Monitor renal function prior to initiation and periodically during treatment
• Assess volume status, especially in patients on diuretics
• Educate patients on the signs and symptoms of urinary tract infections and genital infections
• Caution in patients with a history of recurrent urinary tract infections

Pregnancy

Empagliflozin is not recommended during pregnancy due to potential risks to the fetus. Consider alternative therapies for managing diabetes.

Breast-feeding

It is unknown whether empagliflozin is excreted in human milk. Caution is advised when administered to breastfeeding women.

Storage

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

Formulations

• Tablets (e.g. 10 mg, 25 mg)