Liglimet 2.5/850 mg Tablet, 1 strip

Overview

Liglimet Tablet (2.5 mg + 850 mg) is a fixed-dose combination of Linagliptin and Metformin Hydrochloride, manufactured by Square Pharmaceuticals PLC. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both components is appropriate. Linagliptin inhibits DPP-4 to increase active incretin hormone levels, while Metformin reduces hepatic glucose production and improves peripheral insulin sensitivity.

Dosage and Administration

Dosage should be individualized based on effectiveness and tolerability. The maximum recommended dose is 2.5 mg Linagliptin + 1000 mg Metformin twice daily with meals. For patients not currently on Metformin, initiate with 2.5 mg Linagliptin + 500 mg Metformin twice daily, then up-titrate as needed. For patients already on Metformin 850 mg, the 2.5 mg + 850 mg combination is a convenient starting option. Dose escalation should be gradual to reduce gastrointestinal side effects. Always administer with food.

Interaction

Cationic drugs eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, trimethoprim, vancomycin) may interact with Metformin. Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide) may increase the risk of lactic acidosis. Strong P-gp or CYP3A4 inducers (e.g., rifampin) may reduce Linagliptin efficacy; alternative treatments not containing Linagliptin are strongly recommended in such cases. Drugs that cause hyperglycemia (thiazide diuretics, corticosteroids, estrogens, phenytoin, sympathomimetics) may impair glycemic control.

Contraindications

Liglimet is contraindicated in patients with renal impairment due to the risk of Metformin accumulation and lactic acidosis. It is also contraindicated in acute or chronic metabolic acidosis (including diabetic ketoacidosis) and in patients with known hypersensitivity to Linagliptin or Metformin Hydrochloride.

Side Effects

The most common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more likely when Liglimet is combined with sulfonylureas. Prolonged use of Metformin may reduce Vitamin B12 levels. Rare but serious adverse effects include lactic acidosis and acute pancreatitis.

Pregnancy and Lactation

There are no adequate and well-controlled studies in pregnant women with Liglimet or its individual components. Use during pregnancy only if clearly needed. Caution is advised during lactation, as it is not established whether the combination is safe for nursing infants.

Precautions and Warnings

Discontinue Liglimet immediately if lactic acidosis is suspected and initiate supportive therapy. Temporarily withhold before radiologic procedures using iodinated contrast agents and before major surgery. If pancreatitis is suspected, discontinue promptly. Monitor hematologic parameters annually for Vitamin B12 deficiency. Avoid excessive alcohol. Patients should carry medical identification indicating their diabetes status and current medications.

Storage Conditions

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

Frequently Asked Questions

Q: How does Liglimet 2.5 mg + 850 mg differ from the 2.5 mg + 500 mg strength?
A: The 850 mg strength of Metformin is suitable for patients who require a higher Metformin dose for glycemic control, particularly those being transitioned from standalone Metformin 850 mg twice daily. The choice of strength should be guided by the treating physician.

Q: Should Liglimet be taken with or without food?
A: Liglimet should always be taken with meals to reduce the risk of gastrointestinal side effects such as nausea and diarrhea, which are common during the initial period of Metformin use.