Medication info
Empagliflozin/Metformin Hydrochloride Tablets 12.5/1000 mg

Empagliflozin/Metformin Hydrochloride Tablets 12.5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Biconvex oval film-coated tablets with a dark brown tint and purple color.
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 202302635 · Approved 2023.09.05 · Insurance code 642707490

Summary

Main use
Efficacy in blood glucose control for type 2 diabetes and prevention of cardiovascular events.
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once, twice a day. The daily maximum recommended doses for each ingredient, not exceeding empagliflozin 25 mg and metformin 2000 mg, should be considered based on the patient's current treatment regimen, efficacy, and tolerability. For patients not achieving sufficient blood glucose control with metformin alone or combination therapy with other medications such as insulin, the recommended dosage is to take empagliflozin 5 mg twice daily.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Efficacy in blood glucose control for type 2 diabetes and prevention of cardiovascular events.

  • Difficulty controlling blood glucose
  • type 2 diabetes
  • cardiovascular diseases
  • cardiovascular events
View approved original text

This medication is used to improve blood glucose control in adult patients with type 2 diabetes, in conjunction with diet and exercise. It is particularly suitable for patients whose blood glucose levels are not adequately controlled and should be used with caution in patients with accompanying cardiovascular diseases. In short, this drug aids in improving blood glucose levels and maintaining cardiovascular health.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once, twice a day. The daily maximum recommended doses for each ingredient, not exceeding empagliflozin 25 mg and metformin 2000 mg, should be considered based on the patient's current treatment regimen, efficacy, and tolerability. For patients not achieving sufficient blood glucose control with metformin alone or combination therapy with other medications such as insulin, the recommended dosage is to take empagliflozin 5 mg twice daily.

Precautions

This medication is used for the treatment of diabetes and helps control blood glucose levels. However, it can cause a rare side effect called severe lactic acidosis, so it should not be used in patients with poor heart or kidney function. Additionally, there is a risk of hypoglycemia when used with insulin or other diabetes medications, so caution is needed. Patients with moderate to severe kidney function impairment, acute kidney problems, severe infections, heart failure, and other specific conditions should not take this medication. This medication should be temporarily discontinued before and after using iodine contrast agents for examinations, and can be resumed once kidney function has recovered. Pregnant or breastfeeding women should not take this medication, and it is also not recommended for children or adolescents under 18 years of age. Elderly patients should regularly monitor their kidney function, and dosage adjustments may be necessary. Patients taking this medication should carefully observe their hydration status in case of dehydration or gastrointestinal disturbances (nausea, vomiting, etc.), and may need to temporarily stop the medication if needed. This drug may increase the risk of urinary and genital infections, so if any symptoms of infection appear, consult a doctor immediately. Vitamin B12 levels may decrease, so regular checks may be necessary for those taking it long term. Alcohol may increase the risk of side effects of this medication, so avoid excessive drinking during treatment. Also, this medication may interact with other drugs, so inform your doctor or pharmacist if you are taking other medications. If symptoms of hypoglycemia (dizziness, cold sweat, severe fatigue, etc.) occur while taking this medication, check your blood glucose level immediately and take appropriate measures. Before surgery, discontinue this medication at least 48 hours prior, and can resume once kidney function returns to normal thereafter. Regular blood tests and kidney function monitoring are important during the use of this medication to check for any abnormalities.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • perineal necrosis
  • ketoacidosis
  • lactic acidosis
  • severe allergic reactions
  • severe skin adverse reactions
  • urticaria
  • erythema angioedema
  • angioedema
Show 18 more
  • perineal necrosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis
  • myocardial infarction
  • cerebral infarction
  • headache
  • consciousness disorder
  • vision abnormalities
  • paralysis
  • systemic infections
  • sepsis
  • acute pyelonephritis
  • sepsis
  • hypoglycemia

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
Show 21 more
  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • increased serum creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • decreased fluid volume
  • headache
  • dizziness
  • insomnia
  • chest discomfort
  • chest pain
  • weakness
  • fever
  • edema
  • weight loss
  • weight gain
  • vulvar itching
  • allergic rhinitis

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 to 30 degrees Celsius to safely preserve its efficacy.

Appearance and packaging

Appearance

Biconvex oval film-coated tablets with a dark brown tint and purple color.

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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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.