Empacoza Trio XR 25/5/1000 mg 30 tablets

Empacoza Trio XR 25/5/1000 mg 30 tablets

Composition:
Each prolonged-release tablet contains:
Empagliflozin 25 mg
Linagliptin 5 mg
Metformin hydrochloride 1000 mg.
Description:
Empacoza Trio XR 25/5/1000 is a fixed-dose combination medication containing empagliflozin, linagliptin, and metformin hydrochloride. It is formulated as a once-daily, prolonged-release tablet for the treatment of adults with type 2 diabetes mellitus. This combination provides complementary mechanisms to effectively lower blood glucose levels by reducing hepatic glucose production, improving insulin sensitivity, enhancing glucose-dependent insulin secretion, and promoting glucose excretion via the urine.
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 metformin and/or other antidiabetic agents.
It may also be used to reduce the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.
Dosage and Administration:
The recommended dose is one tablet once daily with food to reduce gastrointestinal side effects associated with metformin.
Dose should be individualized based on the patient’s current regimen, effectiveness, and tolerability.
Do not exceed the maximum recommended dose of empagliflozin 25 mg, linagliptin 5 mg, and metformin 2000 mg per day.
Tablets must be swallowed whole and not crushed, split, or chewed.
Contraindications:
Hypersensitivity to empagliflozin, linagliptin, metformin, or any excipients
Severe renal impairment (eGFR <30 mL/min/1.73 m²)
Acute or chronic metabolic acidosis, including diabetic ketoacidosis
Conditions associated with an increased risk of lactic acidosis (e.g., severe dehydration, shock, or severe infection).
Precautions:
Monitor renal function before initiation and periodically during treatment.
Assess for signs of lactic acidosis and discontinue if suspected.
Use with caution in elderly patients, particularly those at risk of volume depletion or renal impairment.
Increased risk of genital mycotic infections due to empagliflozin.
May cause hypoglycemia when used with insulin or insulin secretagogues.
Pregnancy and Lactation:
Not recommended during pregnancy due to potential risks to the fetus.
Breastfeeding is not advised during treatment due to the unknown safety profile of the combination in lactating women.
Side Effects:
Common side effects may include:
Genital yeast infections
Urinary tract infections
Increased urination
Gastrointestinal disturbances (nausea, vomiting, diarrhea)
Headache
Hypoglycemia (especially when combined with insulin or sulfonylureas)
Rare but serious side effects:
Lactic acidosis
Acute kidney injury
Pancreatitis
Hypersensitivity reactions.
Storage Conditions:
Store below 30°C in the original package to protect from moisture and light. Keep out of reach of children.
Packaging:
A carton box contains 30 tablets in total, and a package insert.