Coport M^®

Coport M is a combination of Empagliflozin and Metformin Hydrochloride. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion. Metformin Hydrochloride is a biguanide type 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.

No Data

Coport M is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The Empagliflozin component is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

Limitation of use
Coport M is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.

Route of administration: Coport M is taken in oral route. It should be taken with meals. The starting dose of Coport M should be individualized based on the patient's current regimen:

• In patients on metformin HCI, treatment should be switched to Coport M containing empagliflozin 5 mg with a similar total daily dose of metformin HCI.
• In patients on empagliflozin, treatment should be switched to Coport M containing metformin HCI 500 mg with a similar total daily dose of empagliflozin.
• In patients already treated with empagliflozin and metformin HCI, treatment should be switched to Coport M containing the same total daily doses of each component.

Effectiveness and tolerability needs to be monitored and dosing should be adjusted as appropriate, not to exceed the maximum recommended daily dose of empagliflozin 25 mg and metformin HCI 2000 mg. Coport M should be taken twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.

Renal impairment
Initiation of Coport M is not recommended in patients with an eGFR less than 45 ml/min/l .73 m2, due to the metformin component. Coport M is contraindicated in patients with an eGFR less than 30 ml/min/l .73 m2 or in patients on dialysis.

Pregnancy: When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with this combination but insulin can be used to maintain blood glucose levels.

Lactation: There is limited information regarding the presence of this combination or its components (empagliflozin or metformin) in human milk, the effects on the breastfed infant or the effects on milk production. Use of this combination is not recommended while breastfeeding.

Use in children and adolescents
Safety and effectiveness of this combination have not been established in pediatric patients.

Renal function should be assessed before initiating this combination. In patients with volume depletion, this condition should be corrected before initiating this combination. There have been cases of metformin-associated lactic acidosis, including fatal cases. If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. Empagliflozin can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been reports of serious urinary tract infections including urosepsis and pyelonephritis in patients receiving SGLT2 inhibitors, including empagliflozin. Reports of necrotizing fasciitis of the perineum (Fournier's gangrene) have been identified in patients with diabetes mellitus receiving SGLT2 inhibitors, including empagliflozin. Empagliflozin increases the risk for genital mycotic infections. In metformin clinical trials, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in a few metformin-treated patients.

The most common side effects with empagliflozin are urinary tract infection and female genital mycotic infections. The most common side effects with metformin are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia and headache.

This combination is contraindicated in patients with known hypersensitivity to empagliflozin, metformin or any other components of this product. It is also contraindicated in acute or chronic metabolic acidosis, including diabetic ketoacidosis.

Drug interaction with medication: Concomitant use of topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) with this combination may increase the risk of lactic acidosis. Concomitant use of drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir and cimetidine) may increase the accumulation of metformin. Alcohol can potentiate the effect of metformin on lactate metabolism. Co-administration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. The risk of hypoglycemia is increased when empagliflozin is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Certain drugs (thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and isoniazid) tend to produce hyperglycemia and may lead to loss of glycemic control.

Drug interaction with food and others: Not applicable.

Lactic acidosis has been reported in approximately 32% of metformin hydrochloride overdose cases. Metformin is dialyzable with a clearance of up to 170 ml/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdose is suspected.

No Data

No Data

Coport M 5/500 tablet: Each coated tablet contains Empagliflozin INN 5 mg and Metformin Hydrochloride BP 500 mg.

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

Packing
Coport M 5/500 tablet: Carton of 30 tablets in blister pack.