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Empagreat 25mg Tab

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10TABProduct code 268401

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Product information

Manufacturer
Mankind Pharma Ltd.
Category
Other
Composition
Not provided
Packaging
10TAB
Box / case pack
1 / —
Description

Name

  • Brand Name: EMPAGREAT 25MG TAB
  • Common Name: Empagliflozin

Composition

  • Active Ingredient: Empagliflozin 25mg

Uses EMPAGREAT 25MG Tablet is prescribed for:

  • Type 2 Diabetes Mellitus: 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 adults with type 2 diabetes mellitus and established cardiovascular disease.
  • Heart Failure: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults when the heart cannot pump enough blood to the rest of the body.
  • Chronic Kidney Disease (CKD): To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.

Dosage and Administration

  • The usual recommended starting dose for type 2 diabetes is 10 mg once daily in the morning, taken with or without food.
  • The dose may be increased to 25 mg once daily if needed and tolerated, particularly for additional glycemic control in adults with Type 2 Diabetes.
  • For heart failure or chronic kidney disease, the usual dose is 10 mg once a day.
  • Swallow tablets whole with a drink of water; do not crush or chew.
  • It is important to take it at approximately the same time each day.

Side Effects

  • Common Side Effects: Frequent urination, increased thirst, urinary tract infections (UTIs), genital yeast infections (in both males and females), dehydration, nausea, and joint pain.
  • Serious Side Effects: Diabetic ketoacidosis (DKA), severe urinary tract infections (urosepsis, pyelonephritis), Fournier's gangrene (a serious bacterial infection in the genital area), low blood sugar (hypoglycemia, especially when used with insulin or sulfonylureas), acute kidney injury, and serious allergic reactions. Lower limb amputations have also been reported.

Precautions

  • EMPAGREAT is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • Assess volume status and renal function before initiating treatment, especially in elderly patients, those with impaired renal function, or those on loop diuretics. Correct any volume depletion prior to starting.
  • This medicine may increase the risk of hypotension (low blood pressure), particularly in patients with kidney disease, low blood pressure, or those taking diuretics.
  • Monitor for signs of ketoacidosis and temporarily discontinue in clinical situations known to predispose to it (e.g., prolonged fasting due to acute illness or surgery).
  • The risk of hypoglycemia is increased when used in combination with insulin or insulin secretagogues (e.g., sulfonylureas), and a lower dose of these concomitant medications may be required.
  • Not recommended during the second and third trimesters of pregnancy due to potential fetal risk.
  • Exercise caution in patients with a history of alcohol abuse, congestive heart failure, hypovolemia, or pancreatic insulin deficiency.

Storage

  • Store EMPAGREAT tablets in the original container, tightly closed, at room temperature (between 68°F to 77°F or 20°C to 25°C).
  • Keep away from excess heat, moisture, and direct light.
  • Keep this medication out of sight and reach of children.
Frequently asked questions

Here are some frequently asked questions about EMPAGREAT 25MG TAB:

What is EMPAGREAT 25MG TAB used for?

EMPAGREAT 25MG TAB is primarily used to treat type 2 diabetes mellitus in adults when diet and exercise alone are insufficient to control blood sugar levels. It is also used to treat heart failure and chronic kidney disease, helping to reduce hospitalizations and slow disease progression in these conditions. Additionally, it helps lower the risk of cardiovascular death in patients with type 2 diabetes and heart disease.

How does EMPAGREAT 25MG TAB work?

EMPAGREAT 25MG TAB contains empagliflozin, which belongs to a class of medicines called SGLT2 inhibitors. It works by blocking the sodium-glucose co-transporter 2 (SGLT2) protein in the kidneys. This action prevents the reabsorption of glucose back into the bloodstream, leading to an increased removal of excess blood sugar through the urine. This process also results in mild salt and water loss, which can help reduce the workload on the heart and protect kidney function.

What is the usual dosage for EMPAGREAT 25MG TAB?

The usual starting dose for adults and children 10 years and older for type 2 diabetes is 10 milligrams (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. The tablet can be taken with or without food, as directed by your doctor.

What are the possible side effects of EMPAGREAT 25MG TAB?

Common side effects can include urinary tract infections (UTIs), female genital yeast infections, increased urination, and increased thirst. Other possible side effects include low blood sugar (hypoglycemia), especially when taken with other anti-diabetic medications like insulin or sulfonylureas, and dehydration. You might also experience bladder pain, cloudy urine, changes in vaginal discharge, or painful urination.

Is EMPAGREAT 25MG TAB safe during pregnancy or breastfeeding?

There is limited information regarding the safety of EMPAGREAT 25MG TAB during pregnancy, and it is generally not recommended as animal studies have shown potential harmful effects on the developing baby. Similarly, it is probably unsafe to use while breastfeeding, as it is not known if the medicine passes into breast milk and could harm the baby. Always consult your doctor for advice if you are pregnant, planning a pregnancy, or breastfeeding.

Can EMPAGREAT 25MG TAB be taken with other medications?

EMPAGREAT 25MG TAB can interact with other medications. For example, taking it with diuretics (water pills) may increase the risk of dehydration. When used with other antidiabetic medicines, such as insulin or sulfonylureas, it can increase the risk of low blood sugar, and dose adjustments may be necessary. It may also increase lithium levels if taken concurrently. It is crucial to inform your doctor about all medicines, supplements, or herbal products you are currently taking to avoid potential interactions.

What precautions should be taken while taking EMPAGREAT 25MG TAB?

EMPAGREAT 25MG TAB is not recommended for individuals with type 1 diabetes. Use with caution if you have kidney or liver problems, are elderly, or have a history of dehydration, low blood pressure, or urinary infections. It's important to stay well-hydrated, especially during hot weather or physical activity, and maintain good personal hygiene to reduce the risk of urinary and genital infections. Avoid consuming alcohol, as it can increase the risk of dizziness and hypoglycemia. Regular monitoring of blood sugar levels is advised.

What happens if a dose of EMPAGREAT 25MG TAB is missed?

If you miss a dose of EMPAGREAT 25MG TAB, 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 take a double dose to compensate for the missed one.

How should EMPAGREAT 25MG TAB be stored?

EMPAGREAT 25MG TAB should be stored below 30°C in a cool, dry place. Keep it away from heat, moisture, and direct light, and out of the sight and reach of children and pets. Do not use the medicine after its expiry date.