Medication info
Empamax M Tablet 12.5/500 mg (Empagliflozin, Metformin)

Empamax M Tablet 12.5/500 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin L-Proline›15.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Light brownish-purplish, oval, biconvex film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle
Approval status
Active

MFDS item code 202107452 · Approved 2021.11.12 · Insurance code 643309940

Summary

Main use
Blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet once daily, administered twice a day. The dosage should be determined considering each patient's treatment regimen, efficacy, and tolerability, without exceeding the maximum daily recommended doses of empagliflozin 25 mg and metformin 2000 mg. For patients who struggle with glycemic control using metformin alone or in combination with other medications such as insulin, the recommended dosage is empagliflozin 5 mg twice daily (total daily amount of 10 mg) along with the previously prescribed dose of metformin.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Blood sugar control for type 2 diabetes and prevention of cardiovascular events

  • Glycemic control disorders
  • type 2 diabetes
  • cardiovascular diseases
  • cardiovascular events
View approved original text

This medication is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus by combining empagliflozin and metformin. The effect of this medication on the occurrence of cardiovascular events can be obtained from clinical trial information for experts in patients with type 2 diabetes who have inadequate glycemic control and cardiovascular diseases. Therefore, this medication assists in the improvement of glycemic control and disease management in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, administered twice a day. The dosage should be determined considering each patient's treatment regimen, efficacy, and tolerability, without exceeding the maximum daily recommended doses of empagliflozin 25 mg and metformin 2000 mg. For patients who struggle with glycemic control using metformin alone or in combination with other medications such as insulin, the recommended dosage is empagliflozin 5 mg twice daily (total daily amount of 10 mg) along with the previously prescribed dose of metformin.

Precautions

This medication can cause rare side effects such as severe lactic acidosis, so if symptoms of lactic acidosis appear, immediate consultation with a physician is necessary. Be cautious as hypoglycemia may occur when taken with other diabetes medications. This medication should not be taken by patients with moderate or severe renal impairment. Patients with acute conditions such as acute renal failure, severe infections, or cardiovascular diseases should not be administered this drug. It is safest for pregnant or breastfeeding women to avoid this medication. If surgery is planned or examinations involving iodinated contrast agents are to be conducted, this medication should be discontinued for a certain period. Elderly patients or those with reduced renal function should undergo regular kidney function tests and dosage adjustments may be necessary as required. This medication can increase the risk of urinary tract infections and genital infections, so if related symptoms occur, you should immediately inform a healthcare provider. Alcohol consumption can increase the risk of side effects with this medication, so it's advisable to avoid it while taking this drug. As hypoglycemic symptoms may appear, blood glucose levels should be closely monitored, especially when used in combination with insulin or sulfonylureas. If there are symptoms of fluid loss or dehydration, this medication may be temporarily discontinued; thus, fluid status should be periodically monitored. There is a risk of vitamin B12 deficiency, so it is recommended to regularly check B12 levels during prolonged use. If any unusual symptoms such as fever, genital pain, swelling, rashes occur while taking this medication, immediate consultation with a healthcare provider is advised.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, pyelonephritis, urosepsis, acute kidney injury, acute renal failure, hepatitis, myocardial infarction, cerebral infarction, angina, acute cholecystitis, autoimmune hepatitis, cholelithiasis, concussion, intracerebral hemorrhage, heart failure, hypoglycemia (including severe hypoglycemia), significant edema, serious neurological symptoms (such as headache, confusion, seizures), respiratory distress, pneumonia, sepsis, shock, acute myocardial infarction

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • liver function test abnormalities
  • hepatitis
  • altered taste
  • itching
  • rash
  • erythema
  • increased serum lipids
  • elevated creatinine levels
  • decreased glomerular filtration rate
  • vitamin B12 decrease and deficiency
  • fluid volume reduction
  • headache
  • dizziness
  • fever
  • insomnia
  • chest discomfort
  • chest pain
  • weakness
  • weight loss
  • vulvar pruritus
  • genital pruritus

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Therefore, avoid direct sunlight and do not store it in excessively hot or cold places.

Appearance and packaging

Appearance

Light brownish-purplish, oval, biconvex film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6], 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.