Medication info

Empagliflozin/Metformin Tablets 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
Orange-yellow, biconvex, oval film-coated tablets
Packaging
10 tablets/box [10 tablets/PTP*1], 60 tablets/box [10 tablets/PTP*6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201401 · Approved 2022.04.04

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
1 tablet once, twice a day. The maximum daily doses are 25 mg of empagliflozin and 2000 mg of metformin. Patients who are currently taking metformin may combine it with empagliflozin 5 mg twice a day (total 10 mg) or increase empagliflozin to 10 mg or 25 mg if there is good tolerance. This medication is taken with meals to reduce gastrointestinal side effects related to metformin.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

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

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular diseases
View approved original text

This medication is used as an adjunct to help control blood sugar levels in adult patients with type 2 diabetes by using empagliflozin and metformin together. Administration with dietary modifications and exercise can enhance blood sugar control. Special caution is needed for patients with type 2 diabetes where blood sugar is poorly controlled and have cardiovascular diseases about the occurrence of cardiovascular events. Therefore, proper use under a healthcare professional's guidance can effectively manage blood sugar.

How to take

Adult dose

1 tablet once, twice a day. The maximum daily doses are 25 mg of empagliflozin and 2000 mg of metformin. Patients who are currently taking metformin may combine it with empagliflozin 5 mg twice a day (total 10 mg) or increase empagliflozin to 10 mg or 25 mg if there is good tolerance. This medication is taken with meals to reduce gastrointestinal side effects related to metformin.

Precautions

This medication helps in controlling blood sugar levels, acting through its two active ingredients used for diabetes treatment. It can cause a rare but very serious condition called lactic acidosis, so it should not be used by patients with impaired kidney function, severe infections, dehydration, or heart problems. Additionally, when used with insulin or other antihyperglycemic agents, there is a risk of hypoglycemia, so caution is advised. Patients with reduced kidney function, elderly patients, or those in a dehydrated state should consult with a physician before using this medication and undergo regular kidney function tests. During treatment, gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur, and there is also a risk of urinary or genital infections, so any symptoms that arise should be reported immediately to healthcare professionals. It is advisable for pregnant women or those who may become pregnant and nursing mothers to avoid using this medication. Patients scheduled for surgery should stop taking this medication 48 hours before the procedure and can resume it after confirming normal kidney function post-surgery. This medication can lead to fluid loss; hence, patients with low blood pressure or dehydration symptoms should use it cautiously, and those aged 75 and older should be particularly careful. Excessive alcohol consumption should be avoided during treatment as it may increase the risk of lactic acidosis. Regular monitoring of blood sugar and kidney function is recommended while on this medication, as well as monitoring vitamin B12 levels. If severe abdominal pain, difficulty breathing, severe fatigue, or altered consciousness occurs after taking this medication, the patient must immediately visit a healthcare facility. This medication can interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking. Lastly, this medication is not recommended for children or adolescents under 18 years of age, and it should always be taken as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), lactic acidosis, ketoacidosis, urosepsis, necrotizing perineal infection, severe allergic reactions, severe skin reactions, difficulty breathing, respiratory distress, asthma attacks, liver abnormalities (jaundice), severe neurological symptoms (stroke, headache, confusion, paralysis, etc.), severe edema, urination abnormalities, acute kidney injury, myocardial infarction, acute cholecystitis, autoimmune hepatitis, gallstones, sepsis, severe infections

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbances
  • itching
  • rash
  • erythema
  • angioedema
  • urination difficulties
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased vitamin B12 and deficiency
  • reduced fluid volume
  • taste alterations
  • dizziness
  • headache
  • anxiety
  • insomnia
  • chest discomfort
  • chest pain
  • weakness

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress, and the temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Orange-yellow, biconvex, oval film-coated tablets

Package unit

10 tablets/box [10 tablets/PTP*1], 60 tablets/box [10 tablets/PTP*6], 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.