EMPIGET M TABLETS 5MG/500MG TABLETS

Indications

• Type 2 diabetes mellitus
• Cardiovascular risk reduction in patients with type 2 diabetes
• Chronic kidney disease in the context of diabetes

Dosage

Children: Empagliflozin is not typically recommended for paediatric use; refer to the BNF for Children for specific guidance.

Adults: Refer to the BNF for specific dosing recommendations based on individual patient factors and comorbidities.

Mechanism of action

Empagliflozin selectively inhibits the SGLT2 transporter in the proximal renal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. This results in lower plasma glucose concentrations and, subsequently, improved glycaemic control. Additionally, empagliflozin promotes osmotic diuresis, leading to reduced blood pressure and potential weight loss.

Pharmacodynamics

The pharmacodynamic effects of empagliflozin include significant reductions in HbA1c levels, fasting plasma glucose, and body weight. It also has beneficial effects on cardiovascular outcomes, notably reducing the risk of cardiovascular death and hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease.

Pharmacokinetics

Empagliflozin is rapidly absorbed following oral administration, with peak plasma concentrations occurring within 1.5 hours. It has a bioavailability of approximately 78% and is highly bound to plasma proteins (approximately 86%). The drug is extensively metabolized in the liver, primarily by UDP-glucuronosyltransferases, with renal excretion accounting for about 75% of the dose as metabolites. The elimination half-life is between 12 to 13 hours, allowing for once-daily dosing.

Contra-indications

• Hypersensitivity to empagliflozin or any of the excipients
• Severe renal impairment (eGFR < 30 mL/min)
• End-stage renal disease or patients on dialysis
• Diabetic ketoacidosis

Adverse effects

• Genital mycotic infections
• Urinary tract infections
• Dehydration and volume depletion
• Hypoglycemia when used with insulin or insulin secretagogues
• Kidney injury
• Hypotension
• Increased urination

Interactions

• Diuretics may increase the risk of dehydration and hypotension
• Insulin or insulin secretagogues may enhance the risk of hypoglycemia
• Other antidiabetic medications may have additive effects on glycemic control
• Renal impairment can affect the clearance of empagliflozin

Precautions

• Monitor renal function regularly
• Assess for signs of dehydration, particularly in elderly patients
• Take care in patients with a history of urinary tract infections
• Monitor for symptoms of ketoacidosis

Pregnancy

Empagliflozin is not recommended during pregnancy due to insufficient data on safety. It is essential to consider alternative treatments for diabetes management during this period.

Breast-feeding

There is insufficient data on the excretion of empagliflozin in human milk. Caution is advised when administering to breastfeeding women.

Storage

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

Formulations

• Tablets: 10 mg, 25 mg

Dosage

Children: As with adult dosing, methane is not used therapeutically in paediatrics, and thus no specific paediatric doses are provided. Refer to clinical guidelines for any relevant applications.

Adults: Methane is not typically administered as a drug in therapeutic contexts. Therefore, specific dosage recommendations for adults do not apply. Consult relevant guidelines or literature for any potential applications.

Mechanism of action

Methane serves as a carbon source in various metabolic processes, particularly in methanogenic archaea and certain bacteria. It participates in biochemical pathways such as methylphosphonate degradation and the oxidation of methane to methanol, facilitating energy production and carbon cycling in anaerobic environments.

Pharmacodynamics

In the context of environmental and biological systems, methane acts as a substrate for methanogenic organisms. These organisms utilize methane to produce energy through anaerobic respiration. The dynamics of methane in the environment are influenced by factors such as temperature, pH, and the presence of other substrates or microorganisms.

Pharmacokinetics

Methane is generally not absorbed in a conventional pharmacokinetic sense as it is primarily a gas. Its distribution and metabolism occur in the environment rather than within a biological system. Methane's clearance from the atmosphere occurs through various processes, including oxidation to carbon dioxide and assimilation by methanotrophic bacteria.

Pregnancy

Methane is not recommended during pregnancy due to potential risks associated with exposure to flammable gases.

Breast-feeding

There is limited information regarding the effects of methane during breastfeeding, exercise caution.

Storage

Store in a cool, dry place away from sources of ignition and incompatible materials.