Usual Adult Dose for Diabetes Type 2

Initial dose: Empagliflozin 10 mg-linagliptin 5 mg orally once a day in the morning

• For patients tolerating therapy, may increase to empagliflozin 25 mg-linagliptin 5 mg once a day

• Not recommended in patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
• Has not been studied in patients with a history of pancreatitis and it is not know whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis during therapy.
• When used in combination with insulin or insulin secretagogues, a lower dose of the insulin secretagogues or insulin may be necessary to reduce the risk of hypoglycemia.

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• Empagliflozin is indicated to reduce the risk of cardiovascular death in patients with diabetes mellitus and established cardiovascular disease.

Renal Dose Adjustments

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

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Consider holding therapy in any setting of reduced oral intake (e.g., acute illness or fasting) or fluid loss (e.g., gastrointestinal illness or excessive heat exposure)

Precautions

CONTRAINDICATIONS:

• Patients on dialysis
• Hypersensitivity to empagliflozin, linagliptin, or any product excipients, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity

Dialysis

Contraindicated

Other Comments

Administration advice:

• Take orally once a day in the morning with or without food
• If a dose is missed, take it as soon as you remember; do not double the next dose

• Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
• This drug has not been studied in patients with a history of pancreatitis.
• Correct any volume depletion prior to initiating therapy.

• Monitor for signs and symptoms of hypotension; more frequent monitoring should occur when volume contraction is expected
• Monitor volume status and electrolytes during treatment, especially in those with conditions that may lead to fluid loss
• Assess renal function prior to initiating therapy and as clinically indicated, e.g., prior to initiating concomitant drugs that may have a negative impact on renal function
• Monitor glycemic control
• Monitor for signs and symptoms of pancreatitis
• Evaluate for ketoacidosis in symptomatic patients, regardless of presenting blood glucose levels

• Read the US FDA-approved patient labeling (Medication Guide).
• Patients should be instructed to maintain adequate fluid intake to avoid adverse reactions related to volume depletion and they should contact their health care provider if they develop hypotension.
• Patients should understand this drug will cause their urine to test positive for glucose.
• Patients should understand that genital mycotic infections, urinary tract infections, and hypersensitivity reactions may occur; patients should be instructed to contact their healthcare provider if these occur.
• 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 experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to stop taking this drug and seek immediate medical attention even if their blood sugar is not elevated.
• Patient should be instructed to contact their health care provider if they develop severe and persistent joint pain or blisters or erosions of the skin.
• Patients should be instructed to contact their health care provider if they experience symptoms of heart failure.
• Patients should be instructed to stop therapy and contact their healthcare provider if persistent severe abdominal pain occurs.