Empagliflozin Dosage
Medically reviewed by Drugs.com. Last updated on Aug 28, 2023.
Applies to the following strengths: 10 mg; 25 mg
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
10 mg orally once a day in the morning
- May increase to 25 mg orally once a day in the morning for additional glycemic control, if tolerated
Comments:
- Assess renal function before starting this drug, and as clinically indicated.
- Evaluate volume status before therapy initiation; correct volume depletion if indicated.
- Consider using a lower dose of insulin or insulin secretagogue when used in combination with this drug.
- Use for glycemic control is not recommended in patients with an estimated GFR less than 30 mL/min/1.73 m2.
Use: As an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus
Usual Adult Dose for Heart Failure
10 mg orally once a day in the morning
Comments:
- Assess renal function before starting this drug, and as clinically indicated.
- Evaluate volume status before therapy initiation; correct volume depletion if indicated.
- The risk of volume depletion is higher in patients with heart failure.
Uses:
- To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure
- To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease (CVD)
- To reduce the risk of sustained decline in estimated GFR, end-stage kidney disease, cardiovascular death, and hospitalization in patients with chronic kidney disease at risk of progression
Usual Adult Dose for Cardiovascular Risk Reduction
10 mg orally once a day in the morning
Comments:
- Assess renal function before starting this drug, and as clinically indicated.
- Evaluate volume status before therapy initiation; correct volume depletion if indicated.
- The risk of volume depletion is higher in patients with heart failure.
Uses:
- To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure
- To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease (CVD)
- To reduce the risk of sustained decline in estimated GFR, end-stage kidney disease, cardiovascular death, and hospitalization in patients with chronic kidney disease at risk of progression
Usual Adult Dose for Chronic Kidney Disease
10 mg orally once a day in the morning
Comments:
- Assess renal function before starting this drug, and as clinically indicated.
- Evaluate volume status before therapy initiation; correct volume depletion if indicated.
- The risk of volume depletion is higher in patients with heart failure.
Uses:
- To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure
- To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease (CVD)
- To reduce the risk of sustained decline in estimated GFR, end-stage kidney disease, cardiovascular death, and hospitalization in patients with chronic kidney disease at risk of progression
Usual Pediatric Dose for Diabetes Type 2
Age 10 years and older: 10 mg orally once a day in the morning
- May increase to 25 mg orally once a day in the morning for additional glycemic control, if tolerated
Comments:
- Assess renal function before starting this drug, and as clinically indicated.
- Evaluate volume status before therapy initiation; correct volume depletion if indicated.
- The risk of hypoglycemia is higher in pediatric patients regardless of concomitant insulin use.
- Consider using a lower dose of insulin or insulin secretagogue if used concomitantly with this drug.
Use: As an adjunct to diet and exercise, to improve glycemic control in patients aged 10 years and older with type 2 diabetes mellitus.
Renal Dose Adjustments
Estimated GFR less than 30 mL/min/1.73 m2: Use for glycemic control is not recommended
Comments:
- The glucose lowering benefit of empagliflozin 25 mg decreases with worsening renal function.
- The risk of renal impairment and adverse reactions related to volume depletion or urinary tract infections increases with worsening renal function.
Liver Dose Adjustments
Liver dysfunction: No adjustment recommended
Dose Adjustments
Concomitant use of insulin or insulin secretagogues (e.g., sulfonylurea): A lower dose of insulin or insulin secretagogue may be required to reduce the risk of hypoglycemia.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to the active component or any of the ingredients; reactions such as angioedema have occurred
Safety and efficacy have not been established in patients younger than 10 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Comments:
- In clinical trials, patients whose estimated GFR worsened to less than 20 mL/min/1.73 m2 or who initiated dialysis were not required to discontinue therapy.
Other Comments
Administration advice:
- For oral use
- Administer with or without food.
- Missed dose: If a dose is missed, instruct patients to take the dose as soon as possible; do NOT double up the next dose.
- For surgical procedures: Withhold this drug for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume treatment once patient is clinically stable and has resumed oral intake.
Storage requirements:
- Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
General:
LIMITATIONS OF USE:
- This drug is not recommended for glycemic control in patients with type 1 diabetes mellitus; the risk of diabetic ketoacidosis is increased.
- This drug is not recommended for glycemic control in patients with type 2 diabetes mellitus with an estimated GFR less than 30 mL/min/1.73 m2; based on the mechanism of action, this drug is likely ineffective.
- This drug is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease, or patients requiring (or with a recent history of) intravenous immunosuppressive therapy or use of greater than 45 mg of prednisone or equivalent for kidney disease; this drug is not expected to be effective.
Monitoring:
- Infections/Infestations: For signs/symptoms of urinary tract, genital mycotic, and foot infections (during therapy)
- Metabolic: Volume status (before starting therapy); for signs/symptoms of: volume depletion (during therapy), hypoglycemia (during therapy, especially in pediatric patients or during concomitant use with insulin/insulin secretagogues), and ketoacidosis (in predisposing clinical situations)
- Renal: Kidney function (before starting therapy and as clinically indicated)
Patient advice:
- Read the US FDA-approved patient labeling (Medication Guide).
- Discontinue this drug and seek immediate medical attention if signs/symptoms of ketoacidosis occur.
- Recognize the symptoms of hypoglycemia.
- Contact your health care provider if symptomatic hypotension occurs; maintain adequate fluid intake.
- Consult your health care provider if symptoms of urinary tract or genital mycotic infection occur.
- Regularly examine feet for signs of infection or ulceration.
- Promptly seek medical attention if pain/tenderness, redness, or swelling of the genitals/area occur along with fever above 100.4F or malaise.
- Immediately report any skin reaction/angioedema; discontinue therapy until you have consulted with prescribing health care provider.
- Report a pregnancy to your health care provider as soon as possible.
Frequently asked questions
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