Triexer 1

TRIEXER 1

TRIEXER 1 is a prescription medication manufactured by Cipla Health Limited, used for the management of type 2 diabetes mellitus in adults. It is prescribed when diet and exercise alone, or monotherapy with a single agent, do not provide adequate blood sugar control.

Composition Each tablet of TRIEXER 1 contains a combination of three active ingredients:

• Glimepiride: 1 mg
• Metformin Hydrochloride Extended Release: 500 mg
• Pioglitazone: 15 mg

These ingredients work synergistically to help control blood sugar levels by increasing insulin sensitivity, stimulating insulin production from the pancreas, and reducing glucose production in the liver.

Uses TRIEXER 1 is used to:

• Control blood sugar levels in adults with type 2 diabetes mellitus.
• Support dietary modifications and physical exercise to manage adult type 2 diabetes.
• Improve glycemic control when lifestyle changes alone are insufficient.
• Supplement the body's natural insulin and enhance its effectiveness.

Dosage and Administration The typical dosage guidance for TRIEXER 1 is one tablet once daily. It should be swallowed whole with a full glass of water, without breaking, crushing, or chewing the tablet. It is recommended to take this medicine during or immediately after a meal to minimize stomach upset. Your doctor will determine the correct dose and duration of therapy based on your condition.

Side Effects Common side effects associated with TRIEXER 1 may include:

• Hypoglycemia (low blood sugar levels)
• Edema (swelling)
• Weight gain
• Upper respiratory tract infection
• Diarrhea
• Headache
• Nausea
• Stomach pain/abdominal discomfort
• Metallic taste

Serious side effects, though less common, can include:

• Lactic acidosis (a rare but serious complication, especially with metformin)
• Congestive heart failure (associated with pioglitazone)

If any side effects persist or worsen, or if you experience serious symptoms, consult your doctor immediately.

Precautions

• Contraindications: TRIEXER 1 is not recommended for patients with severe renal impairment (eGFR below 30 mL/min/1.73 m2), established NYHA Class III or IV heart failure, hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic hematuria, or acute or chronic metabolic acidosis. It is also contraindicated in patients with type 1 diabetes mellitus.
• Hypoglycemia: All sulfonylureas, including glimepiride, can cause severe hypoglycemia. Patients should be educated to recognize and manage symptoms.
• Alcohol: Avoid excessive alcohol intake as it may increase the risk of lactic acidosis.
• Pregnancy and Breastfeeding: Use during pregnancy is generally not recommended, and breastfeeding is not advised while taking TRIEXER 1 due to potential harm to the infant.
• Liver and Kidney Impairment: Caution is advised in patients with liver or kidney problems, and the medication is contraindicated in severe cases. Regular monitoring of kidney and liver function may be advised.
• Drug Interactions: Inform your doctor about all other medications, including over-the-counter drugs, vitamins, and herbal supplements, as interactions can occur. Notably, NSAIDs, certain cationic medications (e.g., amiloride, digoxin, ranitidine), and strong inhibitors of CYP2C8 enzyme (e.g., gemfibrozil) can interact with the components of TRIEXER 1.
• Driving and Operating Machinery: Hypoglycemia can impair concentration and reaction, posing a risk in situations like driving or operating machinery.

Storage Store TRIEXER 1 in a cool, dry place, below 25°C. Protect it from light and moisture. Keep TRIEXER 1 and all medicines out of the reach of children.

TRIEXER 1 by CIPLA HEALTH LIMITED is a combination medication used to manage Type 2 Diabetes Mellitus. It contains three active ingredients: Glimepiride, Metformin, and Pioglitazone, which work together to help control blood sugar levels when diet and exercise alone are insufficient, or when management with a single agent does not adequately control blood sugar.

Here are some frequently asked questions about TRIEXER 1:

What is TRIEXER 1 used for?

TRIEXER 1 is used to manage Type 2 Diabetes Mellitus in adults. It is prescribed when diet, exercise, and treatment with a single antidiabetic medication do not provide adequate blood sugar control. By controlling blood sugar levels, it helps reduce the risk of long-term diabetes complications such as nerve problems, kidney problems, eye problems, and cardiovascular disease.

How does TRIEXER 1 work?

TRIEXER 1 is a combination of three antidiabetic medicines: Glimepiride, Metformin, and Pioglitazone, each with a distinct mechanism of action.

• Glimepiride (a sulfonylurea) stimulates the pancreas to secrete more insulin, a hormone that helps lower blood glucose.
• Metformin (a biguanide) works by reducing glucose production in the liver, delaying glucose absorption from the intestines, and increasing the body's sensitivity to insulin.
• Pioglitazone (a thiazolidinedione) further increases insulin sensitivity, allowing the body's cells to utilize insulin more effectively and remove glucose from the blood.

What is the usual dosage for TRIEXER 1?

The initial recommended dose is one tablet of TRIEXER 1 once daily. The dosage should be determined by your doctor based on your individual condition. It is important not to exceed three tablets per day of TRIEXER 1. Always take TRIEXER 1 preferably after meals or as advised by your physician, and swallow the tablet whole with a glass of water without crushing or chewing.

What are the possible side effects of TRIEXER 1?

Common side effects of TRIEXER 1 may include low blood sugar levels (hypoglycemia), nausea, stomach upset, diarrhea, constipation, headache, dizziness, muscle pain, sore throat, and weight gain. More serious, though less common, side effects can include lactic acidosis (a buildup of lactic acid in the blood), heart failure symptoms (such as unusual shortness of breath, rapid weight gain, or swelling), and an increased risk of bladder cancer. If you experience any severe or persistent side effects, or symptoms of lactic acidosis or heart failure, contact your doctor immediately.

Is TRIEXER 1 safe during pregnancy or breastfeeding?

TRIEXER 1 is generally not recommended for use during pregnancy as there are no adequate human data to determine its safety, and it may harm an unborn baby. Similarly, it is probably unsafe to use while breastfeeding, as it is not known if it passes into human milk and could cause adverse effects in the baby. Consult your doctor if you are pregnant, planning to conceive, or breastfeeding.

Can TRIEXER 1 be taken with other medications?

TRIEXER 1 can interact with several medications. Inform your doctor about all prescription, non-prescription, vitamins, and herbal supplements you are taking.

• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen or aspirin may increase the blood sugar-lowering effect of glimepiride.
• Cationic medications such as amiloride, digoxin, and ranitidine can interfere with metformin, potentially increasing the risk of lactic acidosis.
• Inhibitors or inducers of cytochrome P450 2C8 enzyme (e.g., gemfibrozil, rifampicin) can affect pioglitazone levels, requiring close monitoring of glycemic control.
• Concomitant use with insulin secretagogues (e.g., sulfonylureas) or insulin may increase the risk of hypoglycemia.
• Carbonic anhydrase inhibitors can increase the risk of lactic acidosis.
• Excessive alcohol intake should be avoided due to an increased risk of lactic acidosis.

What precautions should be taken while taking TRIEXER 1?

Before taking TRIEXER 1, inform your doctor if you have any kidney, liver, or heart problems, including congestive heart failure. It is contraindicated in patients with severe renal impairment (eGFR below 30 ml/min/1.73m2), established NYHA Class III or IV heart failure, active or history of bladder cancer, or diabetic ketoacidosis. Regular monitoring of kidney function and liver enzymes is advisable. Caution is also advised in elderly patients, those with hypoxic states, excessive alcohol intake, and if undergoing radiological studies with contrast or surgery.

What happens if a dose of TRIEXER 1 is missed?

If you miss a dose of TRIEXER 1, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one, as this can lead to low blood sugar (hypoglycemia).

How should TRIEXER 1 be stored?

TRIEXER 1 should be stored in its original container, ensuring it remains tightly sealed. Keep it in a cool and dry place, away from direct sunlight, and at a temperature below 30ºC (or between 10ºC to 25ºC). It should be kept out of the reach and sight of children. Do not dispose of unused medicine down the drain.