Coport M XR^®

Coport M XR is a combination of Empagliflozin and Metformin Hydrochloride. Empagliflozin is an inhibitor of the SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion. Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

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

Route of administration: Coport M XR should be taken in oral route with meal once daily.

Adults
The recommended total daily dosage of empagliflozin is 10 mg. For additional glycemic control, empagliflozin may be increased to a maximum total daily dosage of 25 mg in patients tolerating 10 mg daily and metformin may be increased to a maximum total daily dosage of 2000 mg, with gradual escalation to reduce gastrointestinal adverse reactions with metformin.
When switching to Coport® M or Coport® M XR from:
• Metformin HCl: Initiate at a similar total daily dosage and a total daily empagliflozin dosage of 10 mg.
• Empagliflozin: Initiate at the same total daily dosage and a total daily metformin HCl dosage of 1000 mg.
• Empagliflozin and metformin HCl: Initiate at the same total daily dosages of each component.
If a dose is missed, instruct patients to take the dose as soon as possible. Do not double up the next dose.

Renal Impairment
Initiation of Coport® M XR is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2. Coport® M XR is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2, ESRD or in patients on dialysis.

Pregnancy: There are no adequate and well-controlled studies in pregnant women with the combination of empagliflozin and metformin or its individual components.

Lactation: There is limited information regarding the presence of empagliflozin and metformin in human milk, the effects on the breastfed infant or the effects on milk production. The combination is not recommended during breast feeding.

Use in children and adolescents
Safety and effectiveness in children and adolescents have not been established.

All patients should be observed carefully for the signs and symptoms of metformin-associated lactic acidosis as it can result in death, hypothermia, hypotension, and resistant bradyarrhythmias. If metformin-associated lactic acidosis is suspected, immediately discontinue administration and general supportive measures should be initiated. There’s a risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus. The combination can increase the risk of volume depletion, urosepsis and pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum, genital mycotic infections and vitamin B12 deficiency. Caution should be taken.

The most common side effects are diarrhea, nausea, vomiting, fatulence, abdominal discomfort, indigestion, asthenia, headache, urinary tract infections and female genital mycotic infections.

It is contraindicated in patients with acute or chronic metabolic acidosis including diabetic ketoacidosis. It is also contraindicated in patients with serious hypersensitivity reaction to empagliflozin or metformin or any other component of this product.

Drug interaction with medication: Concomitant use of carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide or dichlorphenamide) and drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., ranolazine, vandetanib, dolutegravir and cimetidine) may increase the risk for lactic acidosis. Concomitant use of insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia. Concomitant use of diuretics may increase the risk of volume depletion and hyperglycemia. Caution should be taken.

Drug interaction with food and others: Not applicable.

In case of overdose, proper clinical monitoring and necessary general supportive measures should be employed.

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Coport M XR 5/1000 Tablet: Each extended release tablet contains Empagliflozin INN 5 mg and Metformin Hydrochloride BP 1000 mg.

Coport M XR 10/1000 Tablet: Each extended release tablet contains Empagliflozin INN 10 mg and Metformin Hydrochloride BP 1000 mg.

Coport M XR 12.5/1000 Tablet: Each extended release tablet contains Empagliflozin INN 12.5 mg and Metformin Hydrochloride BP 1000 mg.

Coport M XR 25/1000 Tablet: Each extended release tablet contains Empagliflozin INN 25 mg and Metformin Hydrochloride BP 1000 mg.

Storage
Store below 30⁰C in a dry place, protected from light. Keep away from the reach of children.

Packing
Coport M XR 5/1000 Tablet: Carton of 21 tablets in blister pack.
Coport M XR 10/1000 Tablet: Carton of 21 tablets in blister pack.
Coport M XR 12.5/1000 Tablet: Carton of 21 tablets in blister pack.
Coport M XR 25/1000 Tablet: Carton of 21 tablets in blister pack.