Description
Empacoza Trio XR 10 mg/5 mg/1000 mg 30 Modified Release Tablets
Composition
Each modified release tablet contains:
Empagliflozin 10 mg (SGLT2 inhibitor)
Linagliptin 5 mg (DPP-4 inhibitor)
Metformin hydrochloride 1000 mg (biguanide)
Description
Empacoza Trio XR is a once-daily, fixed-dose combination of three oral antihyperglycemic agents—empagliflozin, linagliptin, and metformin—designed to target multiple pathophysiological defects of type 2 diabetes mellitus (T2DM).
Empagliflozin reduces renal glucose reabsorption, promoting glucose excretion in urine.
Linagliptin increases levels of incretin hormones, leading to glucose-dependent insulin secretion and suppression of glucagon.
Metformin decreases hepatic glucose production and improves peripheral insulin sensitivity.
This triple therapy provides complementary mechanisms of action to improve glycemic control in adult patients with T2DM who are inadequately managed on dual or triple therapy with the same components.
The extended-release formulation allows once-daily dosing while minimizing gastrointestinal side effects, particularly from metformin.
Indications for Use
-Empacoza Trio XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus:
-Who are inadequately controlled on a combination of empagliflozin, linagliptin, and metformin
-As a substitute for the individually titrated components
-Not indicated for type 1 diabetes or diabetic ketoacidosis
Dosage and Administration
Recommended dose: One tablet once daily with food.
Should be individualized based on current treatment regimen and tolerability.
Dose of metformin should not exceed the maximum recommended daily dose (2000 mg).
Tablets must be swallowed whole with a glass of water; do not chew, split, or crush.
Renal function must be assessed prior to initiation and periodically thereafter.
Missed Dose: If a dose is missed, take as soon as remembered unless it is close to the next dose. Do not double dose.
Contraindications
Hypersensitivity to empagliflozin, linagliptin, metformin, or any excipients
Severe renal impairment (eGFR <30 mL/min/1.73 m²)
Acute metabolic acidosis, including diabetic ketoacidosis or lactic acidosis
Acute conditions with potential for renal function deterioration (e.g. dehydration, infection, shock)
History of lactic acidosis
Precautions
Renal function: Assess before initiation and monitor regularly
Risk of lactic acidosis: Especially in patients with renal impairment, alcoholism, or hepatic insufficiency
Risk of volume depletion: Monitor elderly and those on diuretics or low blood pressure
Cardiovascular safety: Empagliflozin has demonstrated cardiovascular benefits, but caution is needed in patients with hypotension
Pancreatitis: Rare cases reported with DPP-4 inhibitors like linagliptin
Hypoglycemia: Especially when combined with insulin or sulfonylureas
Vitamin B12 levels: May decrease with long-term metformin use—monitor periodically
Pregnancy and Lactation
Pregnancy: There are insufficient data on the use of empagliflozin and linagliptin in pregnant women. Use is not recommended.
Lactation: Data on excretion in human milk are unavailable. Due to potential risk to the infant, breastfeeding should be avoided during therapy.
Side Effects
Common side effects:
Empagliflozin: Urinary tract infections, increased urination, genital mycotic infections
Linagliptin: Nasopharyngitis, cough, arthralgia
Metformin: Nausea, diarrhea, abdominal discomfort, metallic taste
Uncommon or serious side effects:
Lactic acidosis: A rare but life-threatening complication associated with metformin
Diabetic ketoacidosis (euglycemic)
Pancreatitis, hypersensitivity reactions, volume depletion, urinary tract infections, increased LDL cholesterol
Bullous pemphigoid (reported with DPP-4 inhibitors)
Storage Conditions
Store below 30°C. Keep tablets in original packaging to protect from moisture and light.
Packaging
a carton box containing: 30 tablets and insert leaflet.
