Empagliflozin + Metformin Hydrochloride

Generic Details

Generic Name

Empagliflozin-Metformin Hydrochloride

Other Names

  • Empagliflozin/Metformin HCl

Drug Class

  • Antidiabetic Combination

Chemical Formula

C23H27Cl2N5O7

Molecular Weight

555.40 g/mol

Mechanism of Action

  • Empagliflozin: SGLT2 Inhibitor
  • Metformin: Biguanide - Decreases hepatic glucose production and intestinal glucose absorption

Indications

  • Type 2 diabetes mellitus

Common Dosage Forms

  • Tablet

Typical Dosage

  • Initially empagliflozin 5 mg/metformin 500 mg twice daily, maximum dose is empagliflozin 25 mg/metformin 2000 mg twice daily.

Pediatric Dosage

  • Safety and efficacy not established in children.

Geriatric Dosage

  • Dose adjustment may be necessary based on renal function.

Side Effects

  • Hypoglycemia
  • Genital Mycotic Infections
  • Urinary Tract Infections
  • Increased urination
  • Nausea
  • Vomiting

Contraindications

  • Renal impairment (eGFR <30 mL/min/1.73 m2)
  • Hypersensitivity to components

Pregnancy Category

  • Not recommended during pregnancy

Lactation Safety

  • Limited data available; use with caution or consider alternatives

Drug Interactions

  • Insulin or insulin secretagogues
  • Digoxin
  • Diuretics

Overdose Symptoms

  • Hypoglycemia
  • Lactic acidosis

Antidote for Overdose

  • Supportive care and symptomatic treatment

Storage Conditions

  • Store at controlled room temperature between 20°C to 25°C (68°F to 77°F)

Pharmacokinetics

  • Absorption: Both empagliflozin and metformin are well absorbed after oral administration
  • Distribution: Empagliflozin distributes mainly in the extracellular space, while metformin does not bind to plasma proteins
  • Metabolism: Empagliflozin: Metabolized by UGT2B7 and CYP3A4; Metformin: Not extensively metabolized
  • Excretion: Empagliflozin: Renal excretion; Metformin: Renal elimination

Precautions

  • Monitor renal function periodically
  • Assess volume status and correct if necessary

Warnings

  • Risk of lactic acidosis
  • Hypoglycemia risk when used with insulin or insulin secretagogues

Others

  • Empagliflozin-metformin-hydrochloride is a fixed-dose combination medication and should be used as part of a comprehensive diabetes management plan.