Glifo 25 mg Tablet

Glifo 25 mg Tablet

DESCRIPTION

Empagliflozin is an inhibitor of Sodium-glucose co-transporter-2 (SGLT2). SGLT2 is the predominant transporter responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

COMPOSITION

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

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

INDICATIONS

Empagliflozin is indicated

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

• to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease

DOSAGE AND ADMINISTRATION

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

SIDE EFFECT

The common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. The risk of necrotizing fasciitis of the perineum/ Fournier’s gangrene. Others side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

PRECAUTION

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 mL/min/1.73m2

No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73m2

CONTRAINDICATION

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

DRUG INTERACTION

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

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

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT-2 inhibitors. Use alternative methods to monitor glycemic control.

USE IN PREGNANCY AND LACTATION

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

STORAGE CONDITION

Store below 300 C, protected from light. Keep out of the reach of children.

SUPPLY

Glifo 10 : Each box contains 2 x10 tablets in Alu-Alu Blister pack.

Glifo 25 : Each box contains 1x10 tablets in Alu-Alu Blister pack.