Medication info
Empagliflozin/Sitagliptin/Metformin Hydrochloride Extended-Release Tablet 10/100/1000 mg (Empagliflozin, Sitagliptin, Metformin Hydrochloride)

Empagliflozin/Sitagliptin/Metformin Hydrochloride Extended-Release Tablet 10/100/1000 mg (Empagliflozin, Sitagliptin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Yellow, double convex, oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501536 · Approved 2025.06.20 · Insurance code 671808020

Summary

Main use
Improvement in blood sugar control in Type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage of this medication is determined within the range not exceeding empagliflozin 25 mg, sitagliptin 100 mg, and extended-release metformin hydrochloride 2000 mg. This medication should be taken once daily with the evening meal, with the 25/100/1000 mg or 10/100/1000 mg extended-release formulation consisting of one tablet once daily. For the 12.5/50/750 mg or 5/50/750 mg extended-release formulations

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Improvement in blood sugar control in Type 2 diabetes

View approved original text

This medication is a treatment used in conjunction with diet and exercise to help adult patients with Type 2 diabetes more effectively control their blood sugar levels by combining empagliflozin, sitagliptin, and metformin. It helps in stabilizing blood sugar levels to prevent complications associated with diabetes.

How to take

Adult dose

The recommended dosage of this medication is determined within the range not exceeding empagliflozin 25 mg, sitagliptin 100 mg, and extended-release metformin hydrochloride 2000 mg. This medication should be taken once daily with the evening meal, with the 25/100/1000 mg or 10/100/1000 mg extended-release formulation consisting of one tablet once daily. For the 12.5/50/750 mg or 5/50/750 mg extended-release formulations

Precautions

This medication contains three ingredients: sitagliptin, empagliflozin, and metformin hydrochloride. Firstly, the sitagliptin component can rarely cause severe allergic reactions; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur after taking this medication, discontinue use immediately and consult a doctor. Sitagliptin can potentially trigger pancreatitis, an inflammatory condition of the pancreas, and immediate medical attention should be sought if severe abdominal pain, vomiting, or nausea occurs. The metformin hydrochloride component can rarely cause lactic acidosis, a serious metabolic disorder that poses significant risks; if sudden difficulty in breathing, muscle pain, fatigue, or abdominal pain occurs while taking this medication, you should go to the hospital immediately. Additionally, this medication should not be used in patients with Type 1 diabetes, severe renal impairment, acute heart failure, or hepatic dysfunction. It should also be temporarily discontinued in patients scheduled for surgery or experiencing severe infections. Patients with diminished renal function should especially perform a renal function test before starting this medication, and regularly monitor their kidney status during treatment. This medication carries a risk of hypoglycemia; therefore, when used alongside other hypoglycemic agents like insulin or sulfonylureas, close observation of hypoglycemic symptoms is necessary, and adjustments to the doses of other medications may be required. Furthermore, during the use of this medication, if symptoms of dehydration, diarrhea, or vomiting occur, the risk of side effects due to fluid loss may increase, particularly in individuals aged 75 years and older, who require more vigilant monitoring of their fluid status. Genital and urinary tract infections can occur, and prompt treatment is necessary if symptoms arise. This medication should be swallowed whole without crushing or chewing tablets; occasionally, the tablet shell may appear in the stool, but this is considered normal. Caution is required when driving or operating machinery due to the risk of hypoglycemia, especially when taken with other hypoglycemic agents. Lastly, regular blood tests, renal function tests, and liver function tests are recommended during use; if any unusual symptoms arise, consult a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • rash
  • anaphylaxis
  • Stevens-Johnson syndrome
  • exfoliative skin disease
  • acute pancreatitis
  • lactic acidosis
  • acute renal failure
  • severe and disabling arthralgia
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  • bullous pemphigoid
  • ketoacidosis
  • perineal necrosis
  • pneumonia
  • metabolic acidosis
  • cardiac arrest
  • angina
  • Prinzmetal angina
  • coronary artery disease
  • deep vein thrombosis
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis
  • acute pyelonephritis

Mild side effects

  • Dyspepsia
  • abdominal pain
  • hyperglycemia
  • genital pruritus
  • vulvar pruritus
  • vaginal infection
  • weight loss
  • thirst
  • rash
  • urticaria
Show 20 more
  • angioedema
  • reduced fluid volume
  • increased urination
  • difficulty urinating
  • interstitial nephritis
  • increased serum lipids
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • hypoglycemia
  • vulvovaginitis
  • balanitis
  • urinary tract infection
  • headache
  • dizziness
  • constipation
  • diarrhea
  • nausea
  • vomiting
  • gastritis
  • gastrointestinal symptoms

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

Storage

This medication should be stored in a tightly sealed container to protect from air and moisture. The optimal storage temperature is between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, double convex, 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.