MELLITOFIX TRIO

Empagliflozin / Linagliptin / Metformin HCl Extended-Release — 30 Film-Coated Tablets

Product Description

Mellitofix Trio is a combination oral antidiabetic medicine containing empagliflozin, linagliptin, and metformin hydrochloride extended-release. It is intended to improve blood glucose control in adults with type 2 diabetes mellitus when used alongside a healthy diet and regular physical activity.

The three active ingredients work through complementary mechanisms: empagliflozin increases glucose elimination through the urine, linagliptin enhances glucose-dependent insulin release and reduces glucagon secretion, and metformin decreases glucose production in the liver while improving insulin sensitivity.

Available Strengths

Indications and Potential Benefits

• Type 2 diabetes management: Helps improve blood glucose control in combination with diet and exercise.
• Complementary glucose-lowering action: Combines three different mechanisms to help manage blood glucose throughout the day.
• Insulin regulation: Linagliptin helps enhance insulin secretion and suppress glucagon release in a glucose-dependent manner.
• Reduced hepatic glucose production: Metformin helps decrease glucose production in the liver.
• Increased urinary glucose excretion: Empagliflozin reduces glucose reabsorption in the kidneys.
• Potential cardiovascular benefit: Empagliflozin may reduce cardiovascular death in eligible adults with type 2 diabetes and established cardiovascular disease, according to its approved indication.

Recommended Use and Dosage

• Take exactly as prescribed by the treating physician.
• The combination is generally taken once daily in the morning with a meal, according to the prescribed strength and the patient's previous treatment.
• Swallow the extended-release tablet whole. Do not crush, chew, split, or dissolve it.
• Kidney function, blood glucose control, and tolerability should be assessed before and during treatment.
• Do not change the dose or discontinue treatment without medical advice.

Warnings and Precautions

• Lactic acidosis: Metformin may rarely cause a serious, potentially life-threatening condition, particularly in patients with impaired kidney function or other risk factors.
• Diabetic ketoacidosis: Seek urgent medical attention for nausea, vomiting, abdominal pain, unusual fatigue, or difficulty breathing, even if blood glucose is not markedly elevated.
• Dehydration and low blood pressure: Empagliflozin increases urinary fluid loss and may cause dizziness or dehydration.
• Genital and urinary infections: Seek medical advice if symptoms of infection develop.
• Hypoglycemia: The risk may increase when used with insulin or sulfonylureas.
• Pancreatitis: Seek urgent medical assessment for persistent, severe abdominal pain, particularly if it radiates to the back.
• Kidney impairment: Renal function must be assessed. This fixed-dose combination is contraindicated in severe renal impairment and may be unsuitable at higher levels of impairment.
• Surgery and prolonged fasting: Treatment may need to be temporarily interrupted under medical supervision.
• Pregnancy and breastfeeding: Consult a physician to determine the appropriate diabetes treatment.
• Type 1 diabetes: This medicine is not recommended for routine glycemic control in type 1 diabetes because of the risk of diabetic ketoacidosis.

Storage

Store according to the manufacturer's instructions, protected from excessive heat and moisture. Keep out of reach of children.

Patient Disclaimer

This information is provided for educational purposes only and is not intended to diagnose, treat, cure, or prevent any disease. Mellitofix Trio is a prescription medicine that must be used under the supervision of a qualified healthcare professional. The appropriate treatment depends on the patient's medical condition, kidney function, current medications, and blood glucose control. Consult your physician or pharmacist before starting treatment, and do not change or discontinue medication without professional advice.

References

1. U.S. National Library of Medicine — DailyMed (.gov): TRIJARDY XR: Empagliflozin, Linagliptin and Metformin Extended-Release Prescribing Information.
2. U.S. National Library of Medicine — DailyMed (.gov): SYNJARDY XR: Empagliflozin and Metformin Extended-Release Prescribing Information.