EMPACOZA TRIO XR 25/5/1000MG 30TAB 6224002652010

EMPACOZA TRIO XR 25/5/1000MG 30TAB 6224002652010

Description:

EMPACOZA TRIO XR 25/5/1000 mg is a prescription oral antidiabetic medicine in extended-release film-coated tablets, combining three active ingredients: empagliflozin, linagliptin, and metformin. Manufactured by ZETA PHARMA, this triple therapy is designed to improve glycemic control in adults with type 2 diabetes mellitus when diet, exercise, and previous monotherapy or dual therapy are insufficient. It targets multiple mechanisms of glucose regulation, helping to lower fasting and postprandial blood glucose levels and support long-term diabetes management under medical supervision.

Indications:

• Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• For patients insufficiently controlled on metformin alone or in combination with other oral antidiabetic agents (such as SGLT2 inhibitors or DPP-4 inhibitors), as decided by the treating physician.
• May be used in patients requiring triple oral therapy (SGLT2 inhibitor + DPP-4 inhibitor + metformin) to achieve individualized HbA1c targets.
• Helps reduce elevated fasting and postprandial blood glucose levels and improve overall glycemic profile.
• Not indicated for type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Active Ingredients / Key Components:

• Empagliflozin – 25 mg per extended-release film-coated tablet (sodium-glucose co-transporter 2 (SGLT2) inhibitor).
• Linagliptin – 5 mg per extended-release film-coated tablet (dipeptidyl peptidase-4 (DPP-4) inhibitor).
• Metformin hydrochloride – 1000 mg per extended-release film-coated tablet (biguanide class, extended-release formulation).
• Other excipients: film-coating and tablet core ingredients (fillers, binders, disintegrants, colorants, and stabilizers) – specific excipient list and concentrations , please check the product leaflet or the manufacturer’s official website; please refer to the official package leaflet.

Dosage & Administration / How to Use:

• EMPACOZA TRIO XR 25/5/1000 mg must be used exactly as prescribed by a physician experienced in the management of type 2 diabetes.
• Typical dosing: 1 tablet once daily, preferably with the evening meal, or as directed by your doctor. The exact dose and timing depend on prior diabetes therapy, kidney function, and individual response.
• Swallow the tablet whole with a glass of water. Do not crush, split, or chew the extended-release tablet, as this may alter the controlled-release properties and increase side effects.
• Take with food to help reduce gastrointestinal side effects associated with metformin (such as nausea or abdominal discomfort).
• If a dose is missed, take it as soon as you remember on the same day. If it is almost time for the next dose, skip the missed dose and resume your regular schedule. Do not take a double dose to make up for a missed one.
• Regular monitoring of blood glucose and HbA1c is recommended to assess treatment response and adjust therapy.
• Renal function (kidney function), liver function, and volume status should be assessed before starting therapy and periodically thereafter.
• Do not start or stop this medication, or change the dose, without consulting your healthcare provider.

Clinical Benefits:

• Provides triple mechanism of action for improved glycemic control: reduces renal glucose reabsorption (empagliflozin), enhances incretin effect (linagliptin), and decreases hepatic glucose production while improving insulin sensitivity (metformin).
• Helps lower both fasting and postprandial blood glucose levels, contributing to better HbA1c reduction in adults with type 2 diabetes.
• Empagliflozin increases urinary glucose excretion by inhibiting SGLT2 in the proximal renal tubules, lowering the renal threshold for glucose and reducing plasma glucose levels.
• Linagliptin inhibits the DPP-4 enzyme, prolonging the activity of incretin hormones, which increases glucose-dependent insulin secretion and decreases glucagon secretion, improving glucose homeostasis.
• Metformin decreases endogenous hepatic glucose production, reduces intestinal absorption of glucose, and improves peripheral insulin sensitivity, enhancing glucose uptake and utilization.
• Extended-release formulation of metformin may improve gastrointestinal tolerability and provide more stable plasma levels over 24 hours.
• Convenient once-daily tablet may support better adherence compared to multiple separate antidiabetic medications.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to empagliflozin, linagliptin, metformin, or any of the excipients.
• Contraindicated in patients with severe renal impairment, end-stage renal disease, or on dialysis (metformin- and SGLT2-related risks); renal function must be assessed before initiation and regularly thereafter.
• Contraindicated in acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma (primarily due to metformin-related risk of lactic acidosis).
• Use with caution in patients with conditions that may predispose to volume depletion or hypotension (e.g., elderly, diuretic use, low blood pressure, dehydration, acute illness).
• Empagliflozin may increase the risk of genital mycotic infections and urinary tract infections; counsel patients on genital hygiene and to report symptoms promptly.
• Metformin is associated with a rare but serious risk of lactic acidosis, particularly in patients with significant renal impairment, liver disease, uncontrolled heart failure, severe infection, dehydration, or excessive alcohol intake.
• Use with caution in patients with a history of pancreatitis (DPP-4 inhibitors have been associated rarely with pancreatitis); advise patients to seek medical attention if they develop severe, persistent abdominal pain.
• May cause hypoglycemia when used in combination with insulin or insulin secretagogues (e.g., sulfonylureas); dose adjustment of concomitant therapy may be required.
• Not recommended during pregnancy or breastfeeding unless clearly needed and prescribed by a specialist; insulin is generally preferred for glycemic control in pregnancy.
• Discontinue temporarily in situations associated with reduced kidney function or hypoxia (e.g., severe infection, dehydration, surgery, contrast imaging with iodinated contrast media), as advised by your doctor.
• Consult your doctor before use if pregnant, nursing, taking other medications, or have medical conditions such as kidney disease, liver disease, heart failure, hypotension, recurrent urinary or genital infections, or history of pancreatitis.
• Not intended to diagnose, treat, cure, or prevent any disease without medical supervision; it is a prescription medicine and must be used under doctor guidance.
• Keep out of reach of children.

Side Effects:

• Common side effects may include urinary tract infections, genital fungal infections (e.g., vulvovaginal candidiasis, balanitis), increased urination, thirst, nausea, vomiting, diarrhea, abdominal discomfort, and mild gastrointestinal upset (often related to metformin, especially at treatment initiation).
• Other possible side effects: headache, nasopharyngitis, cough, joint pain, or rash (associated with DPP-4 inhibitors like linagliptin in some patients).
• Hypoglycemia is more likely when this medicine is used with insulin or sulfonylureas; symptoms include sweating, tremor, palpitations, hunger, confusion, or dizziness.
• Serious but rare side effects: lactic acidosis (metformin), characterized by muscle pain, difficulty breathing, abdominal pain, severe weakness, and feeling cold; acute pancreatitis (severe abdominal pain radiating to the back, nausea, vomiting); severe allergic reactions or angioedema (swelling of face, lips, tongue, or throat, difficulty breathing); and severe dehydration or hypotension.
• Seek immediate medical attention if you experience signs of lactic acidosis, severe abdominal pain, signs of severe infection, difficulty breathing, chest pain, or symptoms of a severe allergic reaction.
• Report any persistent, unusual, or bothersome side effects to your healthcare provider.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date stated on the pack. Store at or below the temperature indicated on the package insert (specific temperature range is not available in the provided information; refer to the official packaging).

Specifications:

• Product type: Prescription oral antidiabetic medicine.
• Form: Extended-release film-coated tablets.
• Strength per tablet: empagliflozin 25 mg + linagliptin 5 mg + metformin hcl 1000 mg (xr).
• Pack size: 30 tablets per pack.
• Intended use: Adults with type 2 diabetes mellitus, as prescribed by a physician.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.