Empagliflozin Dosage

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
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

Initial dose: 10 mg orally once a day in the morning
-May increase to 25 mg orally once a day for patients tolerating therapy
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.

Renal Dose Adjustments

-Severe renal impairment (eGFR 30 mL/min/1.73m2), ESRD, or dialysis: Contraindicated
-eGFR less than 45 mL/min/1.73 m2: Do not initiate therapy
-eGFR 45 mL/min/1.73 m2 or greater: No dose adjustment
-eGFR persistently less than 45 mL/min/1.73 m2: Therapy should be discontinued

Liver Dose Adjustments

No adjustment recommended

Precautions

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

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, and prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients.

Patient advice:
-Instruct patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness to 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 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.