Coport^®

Coport^® is the preparation of Empagliflozin which is an inhibitor of sodium-glucose co-transporter 2 (SGL T2). SGL T2 is the predominant transporter responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGL T2, Coport® reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.

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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.

Route of administration: Empagliflozin should be taken in oral route.
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.

Pregnancy: 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.
Lactation: It is not known if empagliflozin is excreted in human milk. It is not recommended while breastfeeding.

Use in children and adolescents
The safety and effectiveness of empagliflozin in pediatric patients under 18 years of age have not been established.

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/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m². The risk of necrotizing fasciitis of the perineum or Fournier's gangrene is very rare. Consultation with doctor should immediately be done if any symptoms of tenderness, redness or swelling of the genital area from the genitals back to the rectum appears and there is fever above 100.4° F.

The most common side effects of empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

Empagliflozin is contraindicated in patients with known hypersensitivity to empagliflozin or any components of this product. It is also contraindicated in severe renal impairment, end-stage renal disease or dialysis.

Drug interaction with medication:

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 SGL T2 inhibitors as SGL T2 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 SGL T2 inhibitors. Use alternative methods to monitor glycemic control.

Drug interaction with food and others: Not applicable.

In the event of an overdose with empagliflozin, the usual supportive measures (e.g., removal of unabsorbed material from the gastrointestinal tract, perform clinical monitoring and institute supportive treatment) should be employed. Removal of empagliflozin by hemodialysis has not been studied.

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Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Coport^® 10 mg tablet: Each coated tablet contains Empagliflozin INN 10 mg.
Coport^® 25 mg tablet: Each coated tablet contains Empagliflozin INN 25 mg.

Coport^® 10 mg tablet: Each box contains 30 tablets in blister pack.
Coport^® 25 mg tablet: Each box contains 30 tablets in blister pack.