Medication info
Enpian Duo Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Enpian Duo Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Pink-tinted white, oval, biconvex film-coated tablet
Packaging
10 tablets/box [(10 tablets/PTP × 1)], 60 tablets/box [(10 tablets/PTP × 6)], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202302663 · Approved 2023.09.06 · Insurance code 669908450

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet once, 2 times a day. The dosage is determined within the range not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, 5 mg of empagliflozin should be administered twice daily (10 mg per day total) along with the patient's current dose of metformin. If tolerance is good, the dosage may be increased to 25 mg of empagliflozin (total daily dose). This medication should be taken with meals.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes with difficult blood sugar control
  • cardiovascular disease
View approved original text

This medication is used in adults with type 2 diabetes to improve blood sugar control as an adjunct to diet and exercise. It is particularly suitable for patients whose blood sugar control is insufficient with metformin and empagliflozin combination therapy. Furthermore, in adults with type 2 diabetes who have cardiovascular disease, it is essential to consider the impact on cardiovascular events under the guidance of a healthcare professional. Thus, this medication helps manage blood sugar in diabetic patients and protects cardiovascular health.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once, 2 times a day. The dosage is determined within the range not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, 5 mg of empagliflozin should be administered twice daily (10 mg per day total) along with the patient's current dose of metformin. If tolerance is good, the dosage may be increased to 25 mg of empagliflozin (total daily dose). This medication should be taken with meals.

Precautions

This medication consists of two components that help lower blood sugar. However, it may lead to a rare side effect known as serious lactic acidosis, so caution is required. When used with other diabetes medications, there may be a risk of hypoglycemia. Patients with significantly impaired kidney function, acute kidney problems, severe infections, heart failure, or acute myocardial infarction should not use this medication. Additionally, pregnant or breastfeeding women should avoid its use. If you are scheduled for surgery or an examination using iodinated contrast agents, you must temporarily suspend this medication before and after the test, and resume it only after confirming normal kidney function. This medication may be affected by kidney function, so regular blood tests should be conducted to monitor kidney health. Elders or patients with impaired kidney function should be particularly cautious. While taking this medication, if symptoms such as dehydration, vomiting, or diarrhea occur, you should consult a doctor immediately. Patients at high risk of fluid loss should also be cautious. Some patients may experience urinary or genital infections, so immediate treatment is necessary if there are symptoms of infection. Additionally, vitamin B12 deficiency may occur; therefore, it is advisable to regularly check vitamin B12 levels if used long-term. When taking this medication alongside insulin or sulfonylurea drugs, the risk of hypoglycemia may increase, necessitating dose adjustments. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. This medication is not recommended for children, and caution is advised when administered to the elderly. In the event of overdose, serious side effects such as lactic acidosis can occur, requiring immediate medical attention. Finally, this medication should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, severe allergic reactions (hives, angioedema), ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, acute kidney injury, liver abnormalities (hepatitis, autoimmune hepatitis, cholelithiasis), hypertension, myocardial infarction, heart failure, cerebral infarction, headache, seizures, confusion, visual disturbances, paralysis, acute cholecystitis, unstable angina, deep vein thrombosis, cardiovascular collapse,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • taste disturbances
  • itching
  • rash
  • hives
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  • erythema
  • angioedema
  • increased urination
  • urination difficulties
  • increased serum lipids
  • elevated serum creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • thirst
  • dizziness
  • headache
  • weight loss
  • insomnia
  • fatigue
  • chest discomfort
  • chest pain
  • weakness
  • weight gain
  • facial swelling
  • peripheral edema
  • joint pain

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pink-tinted white, oval, biconvex film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP × 1)], 60 tablets/box [(10 tablets/PTP × 6)], 30 tablets/bottle, 60 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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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.