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Empaglibet® (EMPAGLIFLOZIN)

Empaglibet® (EMPAGLIFLOZIN)

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10,25  mg film coated tablets

 

Empagliflozin is an inhibitor of Sodium-glucose co-transporter 2 (SGLT2). By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and thereby increases urinary glucose excretion.




INDICATIONS
Empaglibet® is indicated:

To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes  mellitus.

Limitations of Use:

Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2.


It is not known if Empaglibet® is safe and effective in children.

DOSAGE AND ADMINISTRATION
  • Assess volume status and correct volume depletion before initiating.
  • Recommended dose is 10 mg once daily in the morning, taken with or without food.
  • For additional glycemic control, dose may be increased to 25 mg in patients tolerating Empaglibet®.
WARNINGS AND PRECAUTIONS

Empaglibet® may cause serious side effects including:

 

Ketoacidosis (increased ketones in your blood or urine). 
•Dehydration
Serious urinary tract infections.
Low blood sugar (hypoglycemia).
A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). 
• Vaginal yeast infection. 
• Yeast infection of the penis (balanitis or balanoposthitis). 
• Allergic (hypersensitivity) reactions. 

DRUG INTERACTIONS

Diuretics
Coadministration of Empaglibet® with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Before initiating Empaglibet®, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating Empaglibet®. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.

Insulin or Insulin Secretagogues
The risk of hypoglycemia is increased when Empaglibet® is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Coadministration of Empaglibet® with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Lithium
Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during Empaglibet® initiation and dosage changes.

Positive Urine Glucose Test
SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.

Inducers of UGT enzymes 

Co-treatment with known inducers of UGT enzymes is not recommended due to a potential risk of decreased efficacy. If an inducer of these UGT enzymes (e.g. Rifampicin, phenobarbital, phenytoin, and carbamazepine, …) must be co-administered, monitoring of glycemic control to assess response to Empaglibet® is appropriate.

 Brochure download

 Brochure download