Medication info
Empagliflozin/Metformin Extended-Release Tablets 12.5/1000 mg (Empagliflozin, Metformin)

Empagliflozin/Metformin Extended-Release Tablets 12.5/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pale pink oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202502003 · Approved 2025.07.31 · Insurance code 647805910

Summary

Main use
Efficacy in glycemic control for adult type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
In diabetes therapy, the recommended dose of this medication is determined based on each ingredient's maximum recommended daily dose, which is empagliflozin 25 mg and extended-release metformin hydrochloride 2000 mg, considering the patient's current treatment, efficacy, and tolerability. This medication should be taken once daily with the evening meal to reduce gastrointestinal adverse reactions associated with metformin. This medication should be taken as 10/1000 mg.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Efficacy in glycemic control for adult type 2 diabetes and prevention of cardiovascular events

  • Glycemic control issues in adult patients with type 2 diabetes
  • cardiovascular disease
View approved original text

This medication helps improve glycemic control in adult patients with type 2 diabetes in conjunction with dietary and physical exercise. It is particularly suitable for those with insufficient glycemic control and should be used with caution in patients with established cardiovascular disease regarding the occurrence of cardiovascular events. Therefore, this drug is used to enhance glycemic management in type 2 diabetes.

How to take

Adult dose

In diabetes therapy, the recommended dose of this medication is determined based on each ingredient's maximum recommended daily dose, which is empagliflozin 25 mg and extended-release metformin hydrochloride 2000 mg, considering the patient's current treatment, efficacy, and tolerability. This medication should be taken once daily with the evening meal to reduce gastrointestinal adverse reactions associated with metformin. This medication should be taken as 10/1000 mg.

Precautions

This medication is used for the treatment of type 2 diabetes and contains two active ingredients: empagliflozin and metformin. Before taking this drug, it is crucial to verify that kidney function is normal. It should not be used in patients with significantly reduced kidney function, and regular tests should be conducted to monitor changes in kidney function. This medication can cause a rare but serious side effect known as lactic acidosis. Lactic acidosis is a condition characterized by excessive accumulation of lactic acid in the body, which can lead to symptoms such as malaise, muscle pain, shortness of breath, and abdominal pain. If any of these symptoms occur, you should immediately inform your healthcare provider. Additionally, this drug can increase the risk of hypoglycemia when used in conjunction with insulin or sulfonylureas; therefore, it is important to monitor for hypoglycemic symptoms and adjust insulin doses if necessary. Care should be taken to monitor for infections while taking this medication. Urinary tract infections or genital infections may occur, so any signs of infection should be addressed promptly. If surgery is planned or if undergoing tests involving contrast agents, this medication should be discontinued 48 hours prior to surgery or testing, and can be resumed after confirming normal kidney function. Pregnant women or those with a possibility of pregnancy are advised against using this medication, and breastfeeding should be discontinued while taking this medication. Elderly patients or those at risk of fluid loss, patients with impaired liver or heart function, and those who consume alcohol excessively should use this medication with caution, and regular health check-ups and evaluations are necessary. This medication should be swallowed whole without crushing or chewing, and the coating may be eliminated in the stool, which is a normal occurrence. Lastly, there may be potential interactions with other medications taken simultaneously, so it is important to inform your healthcare provider about any other drugs being used, and it is advisable to avoid alcohol consumption.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, ketoacidosis, lactic acidosis, necrotizing fasciitis, urosepsis, pyelonephritis, abnormal liver function tests, hepatitis, liver abnormalities (including jaundice), cerebral infarction, neurological disorders due to cerebral infarction, acute kidney injury, acute renal failure, myocardial infarction, high fever with severe rash, blisters, skin peeling, mucosal pain in mouth/eyes, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions

Mild side effects

Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, altered taste, itching, rash, erythema, urticaria, angioedema, increased urination, urination difficulty, decreased vitamin B12 levels and deficiency in diagnostic tests, increased serum lipids, elevated creatinine levels, increased hematocrit, thirst, headache, dizziness, insomnia, malaise, fatigue, musculoskeletal pain, facial swelling, edema, chest pain, cough, nosebleed, allergic rhinitis, postural changes

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to prolong its effectiveness.

Appearance and packaging

Appearance

Pale pink oval extended-release 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.