Coport L^®

Coport L is the combination of Empagliflozin and Linagliptin which are antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2), which is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate 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. Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-I (GLP-I) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation.

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

Route of administration: Coport L should be taken in oral route with or without food.

Adult
The recommended dose of Coport L is 10 mg empagliflozin / 5 mg linagliptin once daily, taken in the morning. Dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily.

Pregnancy: Empagliflozin and linagliptin is not recommended during the second and third trimesters of pregnancy.

Lactation: No information is available regarding the presence of this cnmbination or its components (empagliflozin or linagliptin) in human milk, the effects on the breastfed infant or the effects on milk production. Of the potential for serious adverse reactions in a breastfed infant including the potential for empagliflozin to affect postnatal renal development, advise patients that use of this combination is not recommended while breastfeeding.

Use in children and adolescent
Safety and effectiveness of this combination in pediatrics patients under 18 years of age have not been established.

Assessment of renal function is recommended prior to initiation and periodically thereafter of this combination and during treatment. It is also recommended that before initiating of this drug, assess and correct volume status in elderly patients, in patients with low systolic blood pressure and in patients on diuretics. This drug should be used with caution who have known risk factors for heart failure. There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue empagliflozin and linagliptin. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If acute kidney injury occurs, discontinue and promptly treat. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination. Reports of necrotizing fasciitis of the Perineum (Fournier's gangrene) have been identified. Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. If bullous pemphigoid is suspected, discontinue empagliflozin and linagliptin. If genital mycotic infections occurs monitor and treat as appropriate requirement of the patient.

The most common side effects associated with empagliflozin and linagliptin are urinary tract infections, nasopharyngitis and upper respiratory tract infections.

This combination is contraindicated in patients with hypersensitivity to empagliflozin or linagliptin or any of the components this combination. Reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria or bronchial hyperreactivity have occurred. This combination is also contraindicated in patients with severe renal impairment, end-stage renal disease or dialysis. It is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Drug interaction With medication: Coadministration Of empagliflozin With diuretics resulted in increased urine volume and frequency of voids which might enhance the for vdume depletion. Rifampin decreased linagliptin exposure, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer. Coadministration of this combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk Of hypoglycemia.

Drug interaction with food and others: Not applicable.

No overdoses has not been study. In the event of an overdose with this combination hemodialysis or peritoneal dialysis may be effective.

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Coport L 10/5 tablet: Each coated tablet contains Empagliflozin INN 10 mg and Linagliptin INN 5 mg.
Coport L 25/5 tablet: Each coated tablet contains Empagliflozin INN 25 mg and Linagliptin INN 5 mg.

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

Packing
Coport L 10/5 tablet: Each box contains 20 tablets in blister pack.
Coport L 25/5 tablet: Each box contains 20 tablets in blister pack.