Finished product reference
Empagliflozin / Linagliptin / Metformin Hydrochloride
Tablet, Extended Release · Oral · 12.5 mg/2.5 mg/1000 mg
- List code
- 52841
- Pharmacologic class
- Dipeptidyl Peptidase 4 Inhibitor · Sodium-Glucose Cotransporter 2 Inhibitor
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain.
What it is and how it works
Mechanism of Action TRIJARDY XR TRIJARDY XR contains: empagliflozin, a SGLT2 inhibitor, linagliptin, a DPP-4 inhibitor, and metformin HCl, a biguanide. Empagliflozin Empagliflozin is an inhibitor of SGLT2, 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 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).
Mechanism class: Dipeptidyl Peptidase 4 Inhibitors · Sodium-Glucose Transporter 2 Inhibitors
Indications
is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) 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 (CV) death in adults with type 2 diabetes mellitus and established CV disease . TRIJARDY XR is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, 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 (CV) death in adults with type 2 diabetes mellitus and established CV disease. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. Has not been studied in patients with a history of pancreatitis.
Dosage and administration (summary)
Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. Individualize the starting dosage based on the patient's current regimen and renal function. ( 2.2 , 2.3 ) Initiation is not recommended in patients with an eGFR less than 45 mL/min/1.73 m 2 , due to the metformin HCl component. The maximum recommended dosage of TRIJARDY XR is 25 mg empagliflozin, 5 mg linagliptin and 2,000 mg metformin HCl. Take once daily with a meal in the morning. Swallow whole; do not split, crush, dissolve, or chew. TRIJARDY XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.
Contraindications
is contraindicated in patients with: severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) . acute or chronic metabolic acidosis, including diabetic ketoacidosis . hypersensitivity to empagliflozin, linagliptin, metformin HCl or any of the excipients in TRIJARDY XR, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred . Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ).
Warnings and precautions
Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk of ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue TRIJARDY XR if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue TRIJARDY XR.
Pregnancy
Pregnancy Risk Summary Based on animal data showing adverse renal effects from empagliflozin, TRIJARDY XR is not recommended during the second and third trimesters of pregnancy.
Storage and supply
Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Protect from exposure to high humidity.
Source: Empagliflozin, Linagliptin, Metformin Hydrochloride (Trijardy Xr) — US FDA prescribing information, 2026-08-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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