Drug Guide
Empagliflozin and Metformin Hydrochloride
Classification
Therapeutic: Antidiabetic agent, oral combination
Pharmacological: SGLT2 inhibitor (Empagliflozin), Biguanide (Metformin)
FDA Approved Indications
- Type 2 diabetes mellitus
Mechanism of Action
Empagliflozin inhibits SGLT2 in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity.
Dosage and Administration
Adult: Based on combination therapy, typically 10 mg empagliflozin once daily with meals, and titrated metformin dose up to a maximum of 2000 mg/day in divided doses.
Pediatric: Not recommended for pediatric use.
Geriatric: Adjust doses based on renal function, monitor closely for adverse effects.
Renal Impairment: Use with caution; contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m²).
Hepatic Impairment: Use with caution; contraindicated in hepatic disease associated with hypoxia.
Pharmacokinetics
Absorption: Empagliflozin is well absorbed; Metformin has variable absorption, with a bioavailability of 50-60%.
Distribution: Empagliflozin is extensively distributed; Metformin distributes into red blood cells.
Metabolism: Empagliflozin is minimally metabolized; Metformin is not metabolized.
Excretion: Both drugs are renally excreted; Empagliflozin mainly unchanged; Metformin primarily unchanged via urine.
Half Life: Empagliflozin approx. 13 hours; Metformin approx. 4-8 hours.
Contraindications
- Hypersensitivity to components
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Diabetic ketoacidosis
Precautions
- Use with caution in hypovolemia, hypotension, urinary tract infections, renal impairment.
Adverse Reactions - Common
- Genital fungal infections in females and males (Common)
- Urinary tract infections (Common)
- Nausea, vomiting (Common)
Adverse Reactions - Serious
- Lactic acidosis (Rare)
- Ketoacidosis (Rare)
- Severe renal impairment or failure (Rare)
Drug-Drug Interactions
- Diuretics, antihypertensive agents, other antidiabetic agents, drugs affecting renal function
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor blood glucose, renal function (serum creatinine, eGFR), signs of dehydration or hypotension.
Diagnoses:
- Risk for hypoglycemia
- Risk for dehydration
- Risk for infection
Implementation: Administer with meals to reduce gastrointestinal side effects; advise adequate hydration.
Evaluation: Assess blood glucose control and renal function regularly.
Patient/Family Teaching
- Take with meals to reduce gastrointestinal side effects.
- Report signs of urinary tract infections, genital infections, or symptoms of ketoacidosis.
- Maintain adequate hydration.
- Follow prescribed laboratory monitoring.
Special Considerations
Black Box Warnings:
- Risk of lactic acidosis with metformin, especially in renal impairment.
Genetic Factors: None specific.
Lab Test Interference: May affect renal function tests.
Overdose Management
Signs/Symptoms: Hypoglycemia, lactic acidosis (metformin overdose), dehydration.
Treatment: Discontinue medication, provide supportive care, correct hypoglycemia with glucose, treat lactic acidosis with supportive measures and possibly hemodialysis.
Storage and Handling
Storage: Store at room temperature, 20-25°C (68-77°F).
Stability: Stable for at least 24 months when stored properly.