EMLIN
Therapeutic Class
Antidiabetic Agents
Indications
Emlin combines 2 anti-hyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes: Linagliptin, a DPP-4 inhibitor and Empagliflozin, a SGLT2 inhibitor. Emlin 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 while Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones, glucagon-like peptide-1(GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Chemical Composition
Emlin 10/5 Tablet: Each film coated tablet contains Empagliflozin INN 10 mg & Linagliptin INN 5 mg./Emlin 25/5 Tablet: Each film coated tablet contains Empagliflozin INN 25 mg & Linagliptin INN 5 mg.
Packaging
Emlin 10/5 Tablett: Each box contains 30 tablets in alu-alu blister pack./Emlin 25/5 Tablet: Each box contains 30 tablets in alu-alu blister pack.
Dosage & Administration
The recommended dose is Emlin 10/5 Tablet once daily in the morning taken orally with or without food. In patients tolerating Emlin 10/5, the dose may be increased to Emlin 25/5 Tablet once daily.
Contraindications
Combination of Linagliptin & Empagliflozin is contraindicated in patients on dialysis. It is also contraindicated in patients with a history of hypersensitivity reaction to Linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, bronchial hyper reactivity, or a history of serious hypersensitivity reaction to Empagliflozin.
Side Effects
The most common adverse reactions (≥5%) associated with combination of Empagliflozin & Linagliptin (10/5 mg, 25/5 mg) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections.
Drug Interaction
Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which cause volume depletion. Linagliptin or Empagliflozin in combination with an insulin secretagogue (e.g., Sulfonylurea) or insulin was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial. Rifampin decreased Linagliptin exposure & efficacy may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer.