Empatab Tablet 10mg

PRESENTATION

Empatab 10: Each film coated tablet contains Empagliflozin INN 10 mg.

Empatab 25: Each film coated tablet contains Empagliflozin INN 25 mg.

DESCRIPTION

Empagliflozin is an inhibitor of Sodium-glucose co-transporter 2 (SGLT2). By inhibiting SGLT2, Empagliflozin reduces renal

reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.

INDICATIONS

Empagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

DOSAGE & ADMINISTRATION

The recommended dose of Empagliflozin is 10 mg once daily in the morning, taken with or without food. In patients tolerating

Empagliflozin 10 mg, the dose may be increased to 25 mg. for additional glycemic control.

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should

not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2. Empagliflozin is limited to 10 mg once daily in patients

with an eGFR greater than or equal to 45 mL/min/1.73 m2. Empagliflozin should be discontinued if eGFR is persistently less than 45

mL/min/1.73 m2

SIDE EFFECTS

Hypotension, impairment in renal function, hypoglycemia with concomitant use with insulin and insulin secretagogues, genital

mycotic infections, urinary tract infections, increased low-density lipoprotein cholesterol (LDL-C).

PRECAUTIONS

Hypotension: Before initiating Empagliflozin, volume status should be assessed and correction on hypovolemia should be made in the

elderly, in patients with renal impairment, in patients with low systolic blood pressure and in patients on diuretics since

Empagliflozin causes intravascular volume contraction.

Impairment in Renal Function: Renal function should be evaluated prior to initiating Empagliflozin and periodically thereafter

since Empagliflozin increases serum creatinine and decreases eGFR.

Hypoglycemia: In patients taking insulin or an insulin secretagogue with Empagliflozin, a lower dose of insulin or the insulin

secretagogue is considered to reduce the risk of hypoglycemia.

Genital mycotic infections: Monitoring and treatment should be done if indicated.

Urinary Tract Infections: Monitoring and treatment should be done as appropriate.

Increased LDL-C: Monitoring and treatment should be initiated if required.

USE IN PREGNANCY & LACTATION

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if

the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Discontinue Empagliflozin or discontinue

nursing.

DRUG INTERACTION

Diuretics: Coadministration of Empagliflozin with diuretics enhances the potential for volume depletion. Insulin or Insulin

Secretagogues: Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

OVER DOSE

There were no reports of overdose during the clinical development program for Empagliflozin. Removal of Empagliflozin by

hemodialysis has not been studied.

STORAGE

Do not store above 300 C. Keep out of the reach of children.

COMMERCIAL PACK

Empatab 10: Each box contains 3 blister strip of 10 tablets.

Empatab 25: Each box contains 2 blister strip of 10 tablets.