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Empagliflozin / Linagliptin Dosage

Applies to the following strength(s): 25 mg-5 mg ; 10 mg-5 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Diabetes Type 2

Initial dose: Empagliflozin 10 mg-linagliptin 5 mg orally once a day in the morning
-May increase to empagliflozin 25 mg-linagliptin 5 mg orally once a day for patients tolerating the lower dose
Maximum dose: Empagliflozin 25 mg-linagliptin 5 mg per day

Comments:
-Empagliflozin has been shown to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV; however, the effectiveness of this combination drug on reducing the risk of CV death in patients with type 2 diabetes mellitus and CV disease has not been established.
-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.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Renal Dose Adjustments

-Severe renal impairment (eGFR less than 30 mL/min/1.73m2) or ESRD: Use is contraindicated
-eGFR less than 45 mL/min/1.73 m2: Do not initiate therapy.
-eGFR 45 mL/min/1.73 m2 or greater: No adjustment recommended.
-If eGFR become persistently less than 45 mL/min/1.73 m2 during therapy, this drug should be discontinued.

-Monitor renal function at baseline, and periodically thereafter; monitor more frequently in those with an eGFR below 60 mL/min/1.73 m2
-Monitor for signs and symptoms of AKI, if AKI develops discontinue therapy.
-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).

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

Use is contraindicated

Other Comments

Administration advice:
-Take once daily 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.

General:
-Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-This drug has not been studied in patients with a history of pancreatitis.
-Correct any volume depletion prior to initiating therapy.

Monitoring:
-Monitor for signs and symptoms of hypotension; increase monitoring where volume contraction is expected.
-Monitor volume status and electrolytes during treatment, especially in those with conditions that may lead to fluid loss
-Monitor renal function prior to initiating therapy, at least yearly after initiation, and prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
-Monitor for signs and symptoms of pancreatitis
-Monitor glycemic control
-Evaluate for the presence ketoacidosis in symptomatic patients, regardless of presenting blood glucose levels.

Patient advice:
-Patients should be instructed to maintain adequate fluid intake to avoid adverse reactions related to volume depletion.
-This drug will cause the urine to test positive for glucose.
-Inform patient 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 experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to seek immediate medical attention.
-Instruct patients to contact their health care provider if they develop severe and persistent joint pain or blisters or erosions of the skin.

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