sodium-glucose co-transporter 2 (SGLT2) inhibitors
- Adjunct to diet and exercise in the management of type 2 diabetes.
- To reduce risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.
Inhibits proximal renal tubular sodium-glucose co-transporter 2 (SGLT2) which determines reabsorption of glucose from the tubular lumen. Inhibits reabsorption of glucose, lowers renal threshold for glucose and increases excretion of glucose in urine.
- Improved glycemic control.
- Reduced death due to cardiovascular causes.
Absorption: Well absorbed following oral administration.
Distribution: Enters red blood cells, remainder of distribution unknown.
Metabolism and Excretion: Minimally metabolized; excreted in feces (41.2% mostly as unchanged drug) and urine (54.4% half as unchanged drug, half as metabolites).
Half-life: 12.4 hr.
TIME/ACTION PROFILE (↓ in A1c)
|PO||within 6 wk||12 wk||unknown|
- Severe renal impairment (eGFR <30 mL/min/1.73 m2 /end-stage renal disease/dialysis);
- Type 1 diabetes;
- Diabetic ketoacidosis;
- Lactation: Avoid use, discontinue breast feeding or discontinue empagliflozin.
Use Cautiously in:
- Moderate renal impairment (eGFR 30–<45 mL/min/1.73 m2 ); use not recommended;
- Hypotension (correct prior to treatment, especially in renal impairment, age >65 yr, or concurrent use of loop diuretics, ACE inhibitors, or ARBs;
- History of bladder cancer;
- History of pancreatitis, pancreatic surgery, reduced caloric intake due to illness or surgery, or alcohol abuse (↑ risk of ketoacidosis);
- Hypovolemia, chronic kidney disease, HF (↑ risk of acute kidney injury);
- OB: Use only if potential maternal benefit justifies potential fetal risk;
- Pedi: Safety and effectiveness not established;
- Geri: ↑ risk of adverse reactions related to ↓ intravascular volume.
Adverse Reactions/Side Effects
CV: hypotension, volume depletion
Endo: hypoglycemia (↑ with other medications)
F and E: KETOACIDOSIS, hyperphosphatemia
GU: NECROTIZING FASCIITIS OF PERINEUM (FOURNIER'S GANGRENE), UROSEPSIS, acute kidney injury, genital mycotic infections, ↑ urination, urinary tract infection (including pyelonephritis), renal impairment
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA)
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
PO (Adults) 10 mg once daily, may be ↑ to 25 mg once daily.
Tablets: 10 mg, 25 mg
In Combination with: linagliptin (Glyxambi); metformin (Synjardy); metformin XR (Synjardy XR). See combination drugs.
- Observe patient for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, confusion, headache, tremor, tachycardia, irritability, drowsiness).
- Monitor for signs and symptoms of volume depletion (dizziness, feeling faint, weakness, orthostatic hypotension) after initiating therapy, especially in elderly patients and patients with renal impairment, low systolic BP, or on diuretics.
- Monitor for signs and symptoms of urinary tract infection during therapy. Treat promptly.
- Monitor for infection, new pain, tenderness, erythema, swelling, sores, or ulcers involving lower limbs, with fever or malaise; discontinue empagliflozin if these occur.
- Assess for ketoacidosis in patients presenting with signs and symptoms of dehydration and metabolic acidosis (nausea, vomiting, abdominal pain, malaise, shortness of breath), regardless of blood glucose level. Discontinue empagliflozin and treat promptly (insulin, fluid and caloric replacement) if suspected. Consider risk factors for ketoacidosis (pancreatic insulin deficiency, caloric restriction, alcohol abuse) before starting empagliflozin.
Lab Test Considerations: Monitor hemoglobin A1C prior to and periodically during therapy.
- May ↑ serum creatinine and ↓ eGFR. Monitor renal function prior to starting and periodically during therapy. Do not begin therapy if eGFR <45 mL/min/1.73 m2 . Discontinue therapy if eGFR is persistently <45 mL/min/1.73 m2 .
- May cause ↑ serum phosphate levels. Monitor electrolytes periodically during therapy.
- May cause ↑ LDL-C. Monitor serum lipid levels periodically during therapy.
- May cause ↑ hematocrit.
- Monitor for ketoacidosis, especially during prolonged fasting for illness or surgery. May require temporary discontinuation of therapy.
- Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
- Correct volume depletion prior to beginning therapy with empagliflozin.
- PO Administer once daily in the morning with or without food.
- Instruct patient to take empagliflozin as directed. Take missed doses as soon as remembered, unless it is almost time for next dose; do not double doses. Advise patient to read the Medication Guide before starting and with each Rx refill in case of changes.
- Explain to patient that empagliflozin helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
- Instruct patient not to share this medication with others, even if they have the same symptoms; it may harm them.
- Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
- Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water, and notify health care professional.
- Instruct patient in proper testing of serum glucose and ketones, especially during periods of stress or illness. Inform patient that empagliflozin will cause a positive test result when testing for urine glucose. Notify health care professional if significant changes occur.
- Advise patient to notify health care professional if new pain or tenderness, sores or ulcers, or infections involving the leg or foot occur and to immediately seek care if pain or tenderness, redness, or swelling of the genitals or area from the genitals back to the rectum, along with a fever above 100.4°F or malaise occur.
- Advise patient to notify health care professional if signs and symptoms of hypotension occur and to maintain adequate hydration as dehydration may increase risk of hypotension.
- Inform patient that empagliflozin may cause mycotic (yeast) infections. Women may have signs and symptoms of a vaginal yeast infection (vaginal odor, white or yellow vaginal discharge [may be lumpy or look like cottage cheese], vaginal itching). Men may have signs and symptoms of a yeast infection of the penis (redness, itching or swelling of penis; rash on penis; foul smelling discharge from penis; pain in skin around penis). Advise patient to notify health care professional if yeast infection occurs.
- Advise patient to notify health care professional if signs and symptoms of urinary tract infection (burning feeling when passing urine, cloudy urine, pain in pelvis or back) occur.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially other oral hypoglycemic medications.
- Advise patient to notify health care professional promptly if signs and symptoms of hypersensitivity reactions (rash; raised red patches on skin; swelling of face, lips, tongue, throat; difficulty breathing or swallowing) occur.
- Advise patient to notify health care professional if pregnancy is planned or suspected and to avoid breast feeding during therapy.
- Encourage patient to follow up with routine lab tests for blood glucose and renal function.
Improved hemoglobin A1C and glycemic control in adults with Type 2 diabetes.
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