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 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.