Empazio 25mg Tab

EMPAZIO 25MG Tablets

Name

• Common Name: Empagliflozin
• Brand Name: EMPAZIO 25MG TAB by TORRENT PHARMACEUTICALS LTD

Composition

Each tablet contains Empagliflozin 25 mg as the active ingredient.

Uses

EMPAZIO 25MG Tablet is prescribed for a range of conditions, primarily focusing on managing type 2 diabetes and its associated cardiovascular and renal complications.

• Type 2 Diabetes Mellitus: Used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older.
• Cardiovascular Risk Reduction: To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.
• Heart Failure: To reduce the risk of cardiovascular death and hospitalization in adults with heart failure.
• Chronic Kidney Disease: To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Dosage and Administration

EMPAZIO is an oral tablet taken once daily.

• The recommended starting dose for type 2 diabetes is typically 10 mg once daily in the morning, taken with or without food. The dose may be increased to 25 mg once daily if tolerated and additional glycemic control is needed.
• For heart failure or chronic kidney disease, the usual dose is 10 mg once a day.
• Tablets should be swallowed whole with a drink of water and not chewed.
• For pediatric patients (10 years and older) with type 2 diabetes, the initial dose is 10 mg once daily, which a doctor may adjust up to 25 mg daily as needed. For children younger than 10 years, the use and dose must be determined by a doctor.

Side Effects

Common Side Effects:

• Urinary tract infections (UTIs)
• Genital yeast infections (vaginal in women, penile in men)
• Increased urination
• Dehydration, which may manifest as dizziness, lightheadedness, or weakness.
• Nausea
• Joint pain
• Upper respiratory tract infection

Serious Side Effects (Seek immediate medical attention if experienced):

• Diabetic ketoacidosis (DKA), a serious condition involving high ketone levels in blood or urine, potentially life-threatening, even with blood glucose levels below 250 mg/dL.
• Fournier's gangrene (necrotizing fasciitis of the perineum), a rare but serious bacterial infection causing severe pain, tenderness, redness, or swelling in the genital area.
• Severe urinary tract infections, including pyelonephritis and urosepsis.
• Acute kidney injury.
• Hypoglycemia (low blood sugar), particularly when used in combination with insulin or sulfonylureas.
• Allergic reactions, such as skin rash, itching, hives, or swelling of the face, lips, tongue, or throat.
• Lower limb amputations (a rare but serious risk).

Precautions

• EMPAZIO is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
• Before starting treatment, assess the patient's volume status and renal function, especially in those with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or individuals taking loop diuretics. Correct any volume depletion prior to initiation.
• Monitor for signs and symptoms of volume depletion and renal function during treatment.
• When used with insulin or insulin secretagogues (e.g., sulfonylureas), a lower dose of these concomitant medications may be required to reduce the risk of hypoglycemia.
• Consider factors predisposing to ketoacidosis (e.g., pancreatic insulin deficiency, caloric restriction, alcohol abuse). Temporarily discontinue EMPAZIO in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or surgery).
• EMPAZIO is not recommended for improving glycemic control in patients with type 2 diabetes and an eGFR less than 30 mL/min/1.73 m2.
• Not recommended during the second and third trimesters of pregnancy due to potential fetal risk. Limited information is available regarding its safety during breastfeeding.
• Inform your doctor about any history of kidney problems, liver problems, pancreatic disease, dehydration, low blood pressure, amputations, genital infections, or urinary tract infections.
• Concomitant use with diuretics may increase the risk of volume depletion. EMPAZIO may also decrease lithium levels.

Storage

Store EMPAZIO tablets at room temperature, between 68°F to 77°F (20°C to 25°C). Keep away from heat, moisture, and direct light. Do not freeze. Keep this medicine out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

EMPAZIO 25MG TAB, which contains empagliflozin, is a medication primarily used for the management of type 2 diabetes mellitus. It also offers significant benefits for cardiovascular and kidney health.

What is Empazio 25mg Tablet used for?

Empazio 25mg Tablet is primarily used to treat type 2 diabetes mellitus, either alone or in combination with other medicines, to help control high blood sugar levels. Additionally, it is prescribed to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to lower the risk of cardiovascular death and hospitalization in patients with heart failure. It is also indicated to reduce the risk of worsening kidney disease, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease.

How does Empazio 25mg Tablet work?

Empazio 25mg Tablet contains empagliflozin, which belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works in the kidneys by blocking the SGLT2 protein, which prevents the reabsorption of glucose (blood sugar) back into the bloodstream. This action causes excess blood sugar to be removed from the body through urine, thereby lowering blood sugar levels. This medication does not help patients with insulin-dependent or type 1 diabetes.

What is the usual dosage of Empazio 25mg Tablet?

The usual starting dose for empagliflozin in adults and children 10 years of age and older with type 2 diabetes is 10 mg once a day, taken in the morning. Your doctor may adjust the dose as needed, but it is typically not more than 25 mg per day. For lowering the risk of cardiovascular death in patients with type 2 diabetes and heart disease, or for patients with heart failure or chronic kidney disease, the usual dose is 10 mg once a day. Empazio 25mg Tablet can be taken with or without food.

What are the possible side effects of Empazio 25mg Tablet?

Common side effects include urinary tract infections (UTIs), genital yeast infections (more common in women), increased urination, and thirst.

More serious side effects can include:

• Dehydration: Symptoms may include dizziness, lightheadedness, dry mouth, and feeling weak.
• Diabetic Ketoacidosis (DKA): A serious condition where acids build up in the blood, which can be life-threatening. Symptoms include nausea, vomiting, stomach pain, increased thirst, and trouble breathing. DKA can occur even with normal blood sugar levels.
• Low Blood Sugar (Hypoglycemia): Especially when taken with other diabetes medications like insulin or sulfonylureas.
• Fournier's gangrene: A rare but serious infection of the genital area.
• Kidney problems.

Report any unusual symptoms to your healthcare provider.

Is Empazio 25mg Tablet safe during pregnancy or breastfeeding?

Empazio 25mg Tablet is not safe to take during the second and third trimesters of pregnancy as it could harm an unborn baby. There is limited information about the safety of Empazio Tablet in lactating mothers, so it is generally recommended to avoid this medicine while breastfeeding. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can Empazio 25mg Tablet be taken with other medications?

Empazio 25mg Tablet can interact with other medications. It may increase the risk of dehydration and low blood pressure when taken with diuretics (water pills). When combined with insulin or other diabetes medications (e.g., sulfonylureas), it may cause hypoglycemia (low blood sugar), so a lower dose of insulin or the insulin secretagogue may be required. Blood pressure medications may also further lower blood pressure. Always inform your doctor about all the medications, supplements, or herbs you are currently taking to avoid potential interactions.

What precautions should be taken with Empazio 25mg Tablet?

• It's important that your doctor checks your progress regularly.
• Carefully follow the special meal plan provided by your doctor, exercise regularly, and test your blood sugar as directed.
• Drink plenty of fluids to prevent dehydration, especially during exercise or in hot weather.
• Avoid excessive alcohol consumption, as it can lower blood sugar and increase the risk of ketoacidosis.
• Do not use Empazio if you have type 1 diabetes, as it increases the risk of diabetic ketoacidosis.
• Inform your doctor if you have serious kidney or liver problems, a history of urinary tract infections, or genital yeast infections.
• Empazio 25mg Tablet is generally not recommended for children and adolescents below 18 years of age.

What happens if a dose of Empazio 25mg Tablet is missed?

If you miss a dose of Empazio Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose (e.g., less than 12 hours until your next dose), skip the missed dose and continue with your regular dosing schedule. Do not double doses to compensate for a missed one.

How should Empazio 25mg Tablet be stored?

Store Empazio 25mg Tablet in a closed container at room temperature, away from heat, moisture, and direct light. Keep it from freezing and out of the reach of children. Do not keep outdated medicine or medicine no longer needed.