Drug Detail:Empagliflozin (Empagliflozin [ em-pa-gli-floe-zin ])
Drug Class: SGLT-2 inhibitors
Usual Adult Dose for Diabetes Type 2
10 mg orally once a day in the morning
- For additional glycemic control in patients tolerating this drug: May increase to 25 mg orally once a day
Uses:
- To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease
- As an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus
Usual Adult Dose for Cardiovascular Risk Reduction
10 mg orally once a day in the morning
- For additional glycemic control in patients tolerating this drug: May increase to 25 mg orally once a day
Uses:
- To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease
- As an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus
Usual Adult Dose for Heart Failure
10 mg orally once a day in the morning
Use: To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure
Renal Dose Adjustments
Estimated GFR less than 30 mL/min/1.73 m2:
- For glycemic control in patients without established cardiovascular disease or cardiovascular risk factors: Not recommended
- In patients with type 2 diabetes and established cardiovascular disease: Data not available
Estimated GFR less than 20 mL/min/1.73 m2:
- In patients with heart failure: Data not available
Liver Dose Adjustments
Liver dysfunction: 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:
- Hypersensitivity to the active component or any of the ingredients
- 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:
- Assess renal function before starting this drug and as clinically indicated.
- Correct volume depletion before starting this drug.
- Administer with or without food.
General:
- Limitations of Use:
- This drug is not recommended in patients with type 1 diabetes mellitus; it may increase the risk of diabetic ketoacidosis in these patients.
- This drug is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an estimated GFR less than 30 mL/min/1.73 m2; based on the mechanism of action, it is likely to be ineffective.
Monitoring:
- Infections/Infestations: For signs/symptoms of urinary tract infections (during therapy); patients with history of chronic/recurrent genital mycotic infections
- Metabolic: Volume status (before starting therapy); for signs/symptoms of volume depletion (during therapy); for ketoacidosis (in clinical situations known to predispose ketoacidosis)
- Renal: Renal function (before starting therapy and as clinically indicated)
Patient advice:
- Read the US FDA-approved patient labeling (Medication Guide).
- Check ketones (when possible) if symptoms consistent with ketoacidosis occur, even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, labored breathing) occur, discontinue this drug and seek medical attention immediately.
- Contact health care provider if symptomatic hypotension occurs. Maintain adequate fluid intake; dehydration may increase the risk for hypotension.
- Seek medical advice if symptoms of urinary tract infection occur.
- Promptly seek medical attention if you develop pain/tenderness, redness, or swelling of the genitals/area from genitals back to rectum, as well as a fever above 100.4F or malaise.
- Immediately report any skin reaction or angioedema and discontinue this drug until you have consulted prescribing health care provider.
- Report pregnancy to health care provider as soon as possible.
- Do not breastfeed during therapy.
- Take this drug only as prescribed. If a dose is missed, take it as soon as you remember; do not double your next dose.
Frequently asked questions
- How long does it take for Jardiance to work?