Empagliflozin Dosage

Medically reviewed by Drugs.com. Last updated on March 31, 2020.

Applies to the following strengths: 10 mg; 25 mg

Usual Adult Dose for:

Diabetes Type 2
Cardiovascular Risk Reduction

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:
-Limitation of use: Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-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 (CV) death in adult patients with type 2 diabetes mellitus and established CV disease.

Usual Adult Dose for Cardiovascular Risk Reduction

Renal Dose Adjustments

Mild to moderate renal impairment (eGFR 45 mL/min/1.73 m2 or greater): No dose adjustment
Moderate renal impairment (eGFR less than 45 mL/min/1.73 m2): Do not initiate therapy
Severe renal impairment (eGFR 30 mL/min/1.73m2), ESRD, or dialysis: Contraindicated

If during therapy, eGFR is persistently less than 45 mL/min/1.73 m2: Therapy should be discontinued

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
-Severe renal impairment, ESRD, or 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 or for the treatment of diabetic ketoacidosis.
-Patients with and stable cardiovascular (CV) disease and type 2 diabetes who received this drug in addition to standard care for diabetes and atherosclerotic CV disease in the EMP-REG-OUTCOME study (n=7020) showed a 38% relative risk reduction in CV mortality compared to placebo; because of these findings, this drug is now indicated in the US for improving survival in adults with type 2 diabetes and CV disease.

Monitoring:
-Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy
-Monitor renal function prior to initiating therapy, at least yearly thereafter; more frequent monitoring is recommended in patients with and eGFR below 60 mL/min/1.73 m2; monitor prior to initiation of any concomitant medicinal product that may have a negative impact on 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.