Medication info
Empamax M Tablet 5/1000 mg (Empagliflozin, Metformin)

Empamax M Tablet 5/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin L-Proline›6.28mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Yellow, oval, bi-convex film-coated tablet with a brownish tint
Packaging
60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle
Approval status
Active

MFDS item code 202107472 · Approved 2021.11.15 · Insurance code 643309950

Summary

Main use
Blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage is 1 tablet per dose, 2 times a day. The maximum recommended daily dosage for each component is 25 mg of empagliflozin and 2000 mg of metformin. For patients whose blood sugar is not sufficiently controlled with monotherapy with metformin alone or in combination with other medications, the recommended dosage is 5 mg of empagliflozin taken twice daily (total of 10 mg) alongside the existing metformin dosage. If tolerance is good and additional blood sugar control is needed, the dosage of empagliflozin may be increased.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Blood glucose control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood glucose control
  • cardiovascular disease
  • cardiovascular events
View approved original text

This medication is used in addition to dietary and exercise therapy to improve blood glucose control in adult patients with type 2 diabetes who are suited for combined therapy with empagliflozin and metformin. Special precautions are necessary for adult patients with type 2 diabetes who do not sufficiently control their blood glucose and have cardiovascular disease due to the increased risk of cardiovascular events, so it is important to also refer to professional information. This medication effectively manages blood sugar to assist in diabetes treatment.

How to take

Adult dose

The recommended dosage is 1 tablet per dose, 2 times a day. The maximum recommended daily dosage for each component is 25 mg of empagliflozin and 2000 mg of metformin. For patients whose blood sugar is not sufficiently controlled with monotherapy with metformin alone or in combination with other medications, the recommended dosage is 5 mg of empagliflozin taken twice daily (total of 10 mg) alongside the existing metformin dosage. If tolerance is good and additional blood sugar control is needed, the dosage of empagliflozin may be increased.

Precautions

This medication is used to help control blood sugar in diabetes treatment. This medication should not be used in patients with impaired renal function. It should not be administered in cases of moderate or severe renal impairment, acute kidney problems, dehydration, or severe infections. It is safer for women who are pregnant or breastfeeding not to use this medication, and women who may become pregnant should also avoid administration. Patients with severe heart failure or cardiovascular issues such as acute myocardial infarction or shock should not use this medication. This medication may cause hypoglycemia; therefore, dosage adjustment is necessary when used in conjunction with insulin or other hypoglycemic agents. During treatment, lactic acidosis, a rare but serious side effect, may occur, so if symptoms such as vomiting, muscle pain, difficulty breathing, or weakness appear, consult a doctor immediately. Additionally, this medication can increase the risk of urinary tract infections or genital infections, so prompt treatment is necessary when any symptoms of infection occur. During treatment, it is essential to monitor renal function, blood glucose, and vitamin B12 levels regularly. If undergoing surgery or radiographic contrast examinations, this medication should be discontinued for a specific period before and after the examination, and can be resumed after normal renal function has recovered. Elderly patients or those at risk of fluid loss should be cautious of dehydration or hypotension, and may need to temporarily discontinue medication if necessary. The risk of side effects increases when this medication is taken with alcohol, so it is advisable to avoid drinking. In case of overdose, there is a risk of lactic acidosis, and hospital treatment should be sought immediately, including possible dialysis. Keep this medication out of reach of children and store it in its original packaging.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • necrotizing fasciitis
  • ketoacidosis
  • lactic acidosis
  • abnormal liver function tests
  • hepatitis

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • decreased and deficiency of vitamin B12
  • altered taste
  • itching
  • rash
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • reduced glomerular filtration rate
  • increased hematocrit

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

Storage

Store this medication in a tightly closed container to prevent air and moisture from entering, and it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Yellow, oval, bi-convex film-coated tablet with a brownish tint

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.