Medication info
Empagliflozin 25 mg Tablet (Empagliflozin)

Empagliflozin 25 mg Tablet (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Pale yellow, bi-convex, oval-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102080 · Approved 2021.03.05 · Insurance code 646005270

Summary

Main use
Improvement of blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this drug is 10 mg once daily for monotherapy and additional combination therapy with other glucose-lowering agents such as insulin. If this 10 mg dose is well tolerated but additional blood sugar control is necessary, the dose may be increased to 25 mg once daily. The drug can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, without doubling the dose for the day.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement of blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • difficulty in blood sugar control
  • cardiovascular disease
View approved original text

This drug is used in conjunction with diet and exercise to help control blood sugar in adults with type 2 diabetes. It can be administered alone, but in cases where blood sugar control is difficult, it is used in combination with metformin, pioglitazone, sulfonylureas, insulin, or the DPP-4 inhibitor linagliptin. It should be used cautiously in patients with type 2 diabetes who have cardiovascular disease, according to professional guidelines. This drug effectively improves blood sugar levels and is used in diabetes treatment.

How to take

Adult dose

The recommended dosage for this drug is 10 mg once daily for monotherapy and additional combination therapy with other glucose-lowering agents such as insulin. If this 10 mg dose is well tolerated but additional blood sugar control is necessary, the dose may be increased to 25 mg once daily. The drug can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, without doubling the dose for the day.

Precautions

This drug should not be used in patients with allergies to the active ingredient or other components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This drug is not used in patients with severely impaired renal function, end-stage renal disease, or those undergoing dialysis. Since this drug contains lactose, it should not be given to patients with lactose intolerance or related genetic disorders. Patients with mildly impaired renal function may require dosage adjustments, and if function worsens, administration should be discontinued. This drug is not expected to be effective in patients with end-stage renal disease or those undergoing dialysis. Caution should be exercised in patients with mild to moderate heart failure, and it is not recommended for patients with severe heart failure. There may be a risk of hypoglycemia when used in conjunction with insulin or sulfonylureas, necessitating dosage adjustments. When taking this drug, it is important to be aware of potential side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, liver dysfunction, etc. The risk of hypoglycemia may be increased, especially when used alongside insulin or sulfonylureas. Moreover, serious adverse reactions such as ketoacidosis or perineal necrosis have been reported; if symptoms appear, immediate medical consultation is necessary. Since this drug carries a risk of ketoacidosis, any metabolic acidosis symptoms should prompt immediate testing and treatment. Elderly patients or those with low blood pressure should be cautious about dehydration and hypotension. Rapid treatment is advised for any signs of urinary and genital infections. When used with other diuretics, there may be an increased risk of dehydration and hypotension. There is a potential for hypoglycemia when combined with insulin secretagogues, requiring dosage adjustments. The 1,5-AG test for evaluating blood sugar control is unreliable, and alternative methods should be used. Use of this drug during pregnancy is not recommended, and administration should be discontinued upon confirmation of pregnancy. During lactation, as this drug may be secreted in breast milk and affect the newborn, breastfeeding should be stopped. Safety and efficacy in children under 18 years have not been established. No specific toxicity has been reported in cases of overdose, but appropriate treatment based on clinical conditions is necessary. This drug should be stored out of reach of children, and transferring it to another container is not recommended. Caution is necessary when driving or operating machinery due to the risk of hypoglycemia, especially when taken alongside insulin or sulfonylureas. Diabetic patients should pay attention to regular foot care and infection prevention, and if any pain or abnormal symptoms around the perineum occur, they should immediately inform medical personnel.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, perineal necrosis, ketoacidosis, urinary sepsis and pyelonephritis, severe allergic reactions, renal and urinary disorders (acute kidney injury, acute pyelonephritis), severe skin reactions (severe rash, blisters, skin peeling, pain in oral/ocular mucosa), liver abnormalities (jaundice), serious neurological symptoms (headache, cerebrovascular accident, intracranial aneurysm), severe edema or urinary abnormalities (significant reduction in urine volume, systemic severe

Mild side effects

Hypoglycemia, genital mycotic infection, vulvovaginitis, glans inflammation and other genital infections, increased urination, rash, itching, decreased fluid volume, increased serum lipids, elevated blood creatinine, decreased glomerular filtration rate, decreased blood pressure, dehydration, decreased blood volume, orthostatic hypotension, syncope, thirst, headache, dizziness, drowsiness, fever, fatigue, peripheral edema, facial edema, swelling, pain, abnormal blood tests, weight gain and loss, urine

Not everyone experiences these, and they can vary from person to person.

Storage

This drug must be stored in a tightly closed container to protect it from air and moisture. It is also important to store it at room temperature between 1 and 30 degrees Celsius to maintain the drug's efficacy.

Appearance and packaging

Appearance

Pale yellow, bi-convex, oval-shaped film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.