Empazio M Xr 25/1000mg Tab

EMPAZIO M XR 25/1000MG Tablet is a combination medication used for the management of type 2 diabetes mellitus. It helps to control blood sugar levels when diet and exercise alone are not sufficient.

Name

• Brand Name: EMPAZIO M XR 25/1000MG Tablet
• Manufacturer: Torrent Pharmaceuticals Ltd.

Composition

EMPAZIO M XR 25/1000MG Tablet contains two active ingredients:

• Empagliflozin (25 mg)
• Metformin Hydrochloride (1000 mg), in an extended-release (XR) formulation.

Uses

EMPAZIO M XR 25/1000MG Tablet is prescribed for:

• Managing blood sugar levels in adults with type 2 diabetes mellitus.
• Improving insulin sensitivity and lowering high blood sugar.
• It may also offer cardiovascular benefits by reducing the risk of heart attacks, heart failure, or other cardiovascular events in patients with type 2 diabetes and existing cardiovascular disease.
• Helps to prevent serious complications of diabetes such as kidney damage, blindness, and nerve damage.

Dosage and Administration

• Typically, the starting dose is one tablet taken once daily.
• It should be taken preferably with a meal, particularly the evening meal, to minimize gastrointestinal side effects associated with Metformin.
• The tablet should be swallowed whole with a full glass of water. Do not crush, chew, or break the extended-release tablet to ensure slow and consistent release of the medication.
• It is crucial to follow the dosage and duration advised by your doctor and not to discontinue the medicine without consultation.

Side Effects

Common side effects may include:

• Nausea, vomiting, diarrhea, stomach pain, and loss of appetite.
• Metallic taste.
• Hypoglycemia (low blood sugar), especially when used with other antidiabetic medicines, alcohol, or if meals are missed.
• Headache, dizziness, weakness, fatigue, constipation.
• Frequent urination, mild skin rash, or itchy skin.
• Urinary tract infection and genital fungal infection.
• Joint pain.

Serious but rare side effects can include:

• Lactic acidosis (a build-up of lactic acid in the body).
• Vitamin B12 deficiency.
• Liver problems.
• Pancreatitis.

Precautions

• Allergies: Do not take if allergic to Empagliflozin, Metformin, or any other ingredients.
• Alcohol Consumption: Avoid excessive alcohol intake as it can interfere with blood sugar control, increase the risk of lactic acidosis, and lower blood sugar levels.
• Kidney and Liver Issues: Unsafe for patients with severe kidney disease; use with caution in patients with liver disease.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding. Consult a doctor as it may harm an unborn baby or pass into breast milk.
• Diabetic Ketoacidosis/Lactic Acidosis: Contraindicated in conditions like metabolic acidosis, diabetic ketoacidosis, or if there is a risk of lactic acidosis.
• Hydration: Stay hydrated by drinking plenty of water to prevent dehydration, as the medication increases glucose excretion through urine.
• Other Conditions: Inform your doctor if you have Type 1 diabetes, severe infection, dehydration, or are taking diuretics.

Storage

• Store in a cool, dry place away from direct sunlight and moisture.
• Keep out of reach of children and pets.

Frequently Asked Questions about EMPAZIO M XR 25/1000MG Tablet

EMPAZIO M XR 25/1000MG Tablet is a prescription medication used to manage Type 2 Diabetes Mellitus. It combines two active ingredients, empagliflozin and metformin hydrochloride (extended-release), to help control blood sugar levels.

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What is EMPAZIO M XR 25/1000MG Tablet used for?

EMPAZIO M XR 25/1000MG Tablet is primarily used in adults with Type 2 Diabetes Mellitus as an adjunct to diet and exercise to improve glycemic control. Additionally, empagliflozin, one of its components, is indicated to reduce the risk of cardiovascular death in adults with Type 2 Diabetes Mellitus and established cardiovascular disease. It is also used to lower the risk of cardiovascular death, hospitalization for heart failure, and the worsening of kidney disease in patients with chronic kidney disease.

How does EMPAZIO M XR work?

EMPAZIO M XR combines two different medications with complementary actions. Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, works by blocking the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine and thus lowering blood sugar levels. Metformin, a biguanide, primarily decreases glucose production in the liver, reduces intestinal absorption of glucose, and improves the body's sensitivity to insulin, allowing it to use sugar more effectively. The extended-release (XR) formulation of metformin ensures a steady release of the medication over time.

What is the usual dosage of EMPAZIO M XR?

EMPAZIO M XR 25/1000MG tablets should be taken as a single tablet once daily with a meal, preferably in the morning, to minimize gastrointestinal side effects. The dosage is individualized by your doctor based on your current treatment regimen and renal function. The maximum recommended daily dose of empagliflozin is typically 25 mg, and metformin is 2000 mg. It is important to swallow the tablets whole and not to crush, break, dissolve, or chew them.

What are the possible side effects of EMPAZIO M XR?

Common side effects of EMPAZIO M XR include urinary tract infections, genital yeast infections, nausea, vomiting, diarrhea, headache, stomach pain, gas, and indigestion. More serious but less common side effects can include lactic acidosis (a rare but severe buildup of lactic acid in the blood), dehydration, ketoacidosis, and kidney problems. If you experience symptoms like muscle pain, unusual weakness, severe stomach pain, trouble breathing, or unusual drowsiness, seek immediate medical attention.

Is EMPAZIO M XR safe during pregnancy or breastfeeding?

EMPAZIO M XR is generally not recommended during the second and third trimesters of pregnancy due to potential harm to the unborn baby. If you are pregnant or planning to become pregnant, discuss this with your doctor, as they may recommend alternative diabetes treatments. Similarly, it is not recommended while breastfeeding because it is not known how much empagliflozin passes into breast milk and its potential effects on the infant's blood sugar and kidney development.

Can EMPAZIO M XR be taken with other medications?

Yes, EMPAZIO M XR can interact with other medications. Concomitant use with insulin or insulin secretagogues (like sulfonylureas) may increase the risk of hypoglycemia, and a dose adjustment of these medications might be necessary. Drugs that impair renal function, interfere with acid-base balance, or increase metformin accumulation (e.g., carbonic anhydrase inhibitors, certain antiviral drugs) can increase the risk of lactic acidosis. Diuretics may enhance the potential for volume depletion. Always inform your doctor about all other medicines, supplements, and herbal products you are taking.

What precautions should be taken while using EMPAZIO M XR?

Before starting EMPAZIO M XR, your doctor will assess your kidney function, and it will be monitored periodically thereafter. Avoid excessive alcohol intake, as it can increase the risk of lactic acidosis. Inform your doctor if you are going to have surgery or a radiological procedure involving iodinated contrast, as the medication may need to be temporarily discontinued. EMPAZIO M XR is not recommended for patients with Type 1 diabetes or diabetic ketoacidosis. It's also important to stay well-hydrated to reduce the risk of dehydration.

What happens if a dose of EMPAZIO M XR is missed?

If you miss a dose of EMPAZIO M XR, take it as soon as you remember, unless it is only a few hours until your next scheduled dose. In that case, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed one.

How should EMPAZIO M XR be stored?

EMPAZIO M XR should be stored in a closed container at room temperature, typically between 68°F to 77°F (20°C to 25°C), away from heat, moisture, and direct light. Keep it out of the reach of children.