Empagliflozin Dosage

Medically reviewed by Drugs.com. Last updated on Oct 11, 2021.

Applies to the following strengths: 10 mg; 25 mg

Usual Adult Dose for:

Diabetes Type 2
Cardiovascular Risk Reduction
Heart Failure with Reduced Ejection Fraction

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Diabetes Type 2

Initial dose: 10 mg orally once a day in the morning

May increase to 25 mg orally once a day for patients tolerating therapy and requiring additional glycemic control

Maximum dose: 25 mg per day

Comments:

Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
Not recommended to improve glycemic control in patients with an eGFR less than 30 mL/min/1.73 m2 as it is unlikely to be effective.
Volume depletion should be corrected prior to initiating therapy.

Uses:

An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease (CVD).

Usual Adult Dose for Cardiovascular Risk Reduction

Initial dose: 10 mg orally once a day in the morning

May increase to 25 mg orally once a day for patients tolerating therapy and requiring additional glycemic control

Maximum dose: 25 mg per day

Comments:

Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
Not recommended to improve glycemic control in patients with an eGFR less than 30 mL/min/1.73 m2 as it is unlikely to be effective.
Volume depletion should be corrected prior to initiating therapy.

Uses:

An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease (CVD).

Usual Adult Dose for Heart Failure with Reduced Ejection Fraction

10 mg orally once a day

Comments:

Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
Volume depletion should be corrected prior to initiating therapy.
For patients with heart failure (HF) and reduced ejection fraction, there is insufficient date to recommend use in patients with an eGFR less than 20 mL/min/1.73 m2.

Use: To reduce the risk of cardiovascular death plus hospitalization for HF in adults with heart failure and reduced ejection fraction.

Renal Dose Adjustments

Patients with type 2 diabetes mellitus:

eGFR 30 mL/min/1.73 m2 or greater: No adjustment recommended
eGFR Less than 30 mL/min/1.73m2): Not recommended

Patients without type 2 diabetes mellitus:

eGFR 20 mL/min/1.73 m2 or greater: No adjustment recommended
eGFR Less than 20 mL/min/1.73 m2: Not recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Concomitant Use of Insulin and Insulin Secretagogues:

A lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycemia.

Precautions

CONTRAINDICATIONS:

Serious hypersensitivity reaction to the active substance or any product excipients; angioedema has occurred
Patients on dialysis

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Contraindicated

Other Comments

Administration advice:

Take orally once a day in the morning, with or without food

Missed dose: If a dose is missed, take as soon as remembered; do not double next dose.

General:

Correct volume depletion prior to initiating treatment.
Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
Patients with stable CVD and type 2 diabetes (EMP-REG-OUTCOME study [n=7020]) who received this drug in addition to standard care for diabetes and atherosclerotic CVD showed a 38% relative risk reduction in cardiovascular mortality compared to placebo.
Patients with chronic heart failure (EMPEROR-Reduced) who received this drug (10 mg/day) and standard of care heart failure therapy showed reduction in the risk of the primary composite endpoint of cardiovascular death or hospitalization for HF compared with placebo, mostly through a reduction in hospitalization for HF.

Monitoring:

Assess fluid status in patients at risk of volume depletion prior to initiation (i.e., patients with eGFR less than 60 mL/min/1.73 m2, elderly patients, or patients on loop diuretics); monitor for signs and symptoms of volume depletion during therapy
Assess renal function prior to initiating therapy and as clinically indicated; consider assessing renal function prior to initiating concomitant drugs that may negatively impact renal function
Evaluate for the presence of ketoacidosis in symptomatic patients, regardless of blood sugar reading
Monitor hemoglobin A1C
Provide routine footcare as outlined by the diabetes guidelines

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide).
Instruct patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness to stop this drug and seek immediate medical attention.
Explain to patients that this drug will cause urine to test positive for glucose.
Patients should be instructed to maintain adequate fluid intake to avoid adverse reactions related to volume depletion such as orthostatic hypotension.
Patients should understand the importance of adhering to dietary instructions, regular physical exercise, and routine lab monitoring; they should understand how to treat low and high blood sugars and when to seek medical advice (for example, during periods of stress as medical management of glycemic control may change).
Inform patients that genital mycotic infections, urinary tract infections, and hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
Patients should be instructed to seek immediate medical attention for symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, especially if they have a fever and are feeling unwell.
Patients should be instructed to seek medical attention promptly for signs and symptoms of acute kidney injury such as decreased urine, swelling in the legs or feet.
Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.