Product Description

Indications: Emazid L is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Pharmacology: Emazid L contains Linagliptin and Empagliflozin. Linagliptin is a DPP-4 inhibitor that increases incretin hormones (GLP-1 and GIP), enhancing glucose-dependent insulin secretion and reducing glucagon levels, thereby lowering blood glucose. Empagliflozin is an SGLT2 inhibitor that reduces renal glucose reabsorption, increases urinary glucose excretion, and lowers blood glucose levels. Together, they provide complementary mechanisms for improved glycemic control.

Dosage & Administration: The recommended dose is Empagliflozin 10 mg and Linagliptin 5 mg once daily, taken in the morning with or without food. If additional glycemic control is required, the dose may be increased to Empagliflozin 25 mg with Linagliptin 5 mg once daily. Renal function should be assessed before initiation; do not start if eGFR is below 45 mL/min/1.73 m² and discontinue if it falls below this level during treatment.

Interaction: Concomitant use with diuretics may increase urine output and risk of volume depletion. Use with insulin or insulin secretagogues may increase the risk of hypoglycemia. Strong P-glycoprotein or CYP3A4 inducers such as rifampin may reduce the effectiveness of Linagliptin. SGLT2 inhibitors may cause positive urine glucose tests and interfere with 1,5-anhydroglucitol (1,5-AG) assays, making them unreliable for glycemic monitoring.

Contraindications: Contraindicated in patients with severe renal impairment, end-stage renal disease, or those on dialysis. Also contraindicated in patients with a history of hypersensitivity reactions to Linagliptin or Empagliflozin, including anaphylaxis, angioedema, or severe skin reactions.

Side Effects: Important adverse effects include pancreatitis, ketoacidosis, volume depletion, urinary tract infections including urosepsis and pyelonephritis, hypoglycemia (especially with insulin), genital fungal infections, hypersensitivity reactions, severe joint pain, bullous pemphigoid, and rare cases of Fournier’s gangrene.

Pregnancy & Lactation: Not recommended during the second and third trimesters of pregnancy due to potential risk to the fetus. Available data are insufficient to determine safety. Risks associated with uncontrolled diabetes should also be considered. Use during breastfeeding is not recommended due to lack of safety data.

Precautions & Warnings: Use with caution in patients with a history of pancreatitis, hypotension, renal impairment, or ketoacidosis. Empagliflozin may cause volume depletion leading to hypotension or acute kidney injury. Increased risk of serious urinary tract infections and genital infections has been reported. Monitor for hypoglycemia when used with insulin or insulin secretagogues. Rare but serious conditions such as necrotizing fasciitis of the perineum (Fournier’s gangrene) have been reported. Monitor patients for signs of heart failure when using DPP-4 inhibitors.

Overdose Effects: In case of overdose, supportive and symptomatic treatment should be provided. Removal of unabsorbed drug and clinical monitoring are recommended. Empagliflozin is not effectively removed by hemodialysis, and Linagliptin is unlikely to be removed by dialysis.

Therapeutic Class: Sodium-glucose cotransporter-2 (SGLT2) inhibitors combination

Storage Conditions: Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.