Medication info
Empagliflozin/Metformin Tablet 5/850 mg

Empagliflozin/Metformin Tablet 5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin L-Proline›6.28mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
White film-coated tablet with a yellow tint, convex on both sides, oval-shaped
Packaging
60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle
Approval status
Active

MFDS item code 202107473 · Approved 2021.11.15 · Insurance code 643309960

Summary

Main use
Effects on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage is 1 tablet once, twice a day. Determine within the maximum daily recommended doses for each ingredient, Empagliflozin 25 mg and Metformin 2000 mg, based on each patient's current treatment regimen, efficacy, and tolerability. - If sufficient blood sugar control is not achieved through monotherapy with Metformin or in combination with insulin or other medications, the recommended dosage is Empagliflozin 5 mg once daily.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

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

  • Type 2 diabetes
  • abnormal blood sugar regulation
  • cardiovascular disease
View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes when combined with dietary and exercise regimen. It is particularly suitable for patients who are not adequately controlling their blood sugar, and should be administered cautiously in patients with a history of cardiovascular events, considering the relevant clinical trial information. This medication helps effectively control blood sugar and improves the health of patients.

How to take

Adult dose

The recommended dosage is 1 tablet once, twice a day. Determine within the maximum daily recommended doses for each ingredient, Empagliflozin 25 mg and Metformin 2000 mg, based on each patient's current treatment regimen, efficacy, and tolerability. - If sufficient blood sugar control is not achieved through monotherapy with Metformin or in combination with insulin or other medications, the recommended dosage is Empagliflozin 5 mg once daily.

Precautions

This medication is intended to help with blood sugar control; it may cause a dangerous condition called severe lactic acidosis, so caution is advised. If used in conjunction with other diabetes medications, hypoglycemia may occur, so precautions should be taken. Patients with severely impaired kidney function or those with acute infection, dehydration, or heart disease should not take this medication. It is not administered to pregnant or breastfeeding women, and patients with impaired liver function should also avoid it. This medication should be temporarily discontinued before and after surgery or before and after tests using iodinated contrast media. Kidney function should be regularly monitored during the use of this medication to ensure there are no abnormalities. Due to the risk of hypoglycemia, dose adjustments may be necessary when used with insulin or other hypoglycemic agents. Patients at risk of fluid loss, especially the elderly or those exhibiting dehydration, should be closely monitored. This medication may increase the risk of urinary or genital infections, so if related symptoms occur, consult a physician immediately. Vitamin B12 deficiency may occur, so it is advisable to check blood levels during long-term use. Excessive alcohol consumption should be avoided, and caution is also needed with sudden reductions in food intake or intense physical activities. If symptoms such as fever, pain, or swelling occur during the use of this medication, notify healthcare personnel immediately. Elderly patients face risks of impaired kidney function, so dosage adjustments and regular monitoring of their condition are necessary. In case of overdose, seek immediate medical attention for appropriate treatment, as blood dialysis may be required. This medication is not recommended for children, and those under 18 years of age should not take it.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, lactic acidosis, ketoacidosis, angioedema, perineal necrosis, severe cutaneous adverse reactions (severe rash with fever, blisters, shedding skin, pain in oral/ocular mucosa), acute kidney injury, liver abnormalities (possible symptoms of hepatitis, jaundice), severe edema, severe neurological symptoms (stroke, concussion, intracranial aneurysm, altered consciousness, seizures, vision disturbances, paralysis)

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
  • rash
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • decreased Vitamin B12
  • itching
  • rash
  • hematuria
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • fatigue
  • fever
  • facial swelling
  • edema
  • ligament injury
  • joint pain
  • back pain

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, avoid areas that are too hot or too cold, storing it at room temperature between 1 and 30 degrees Celsius is recommended.

Appearance and packaging

Appearance

White film-coated tablet with a yellow tint, convex on both sides, oval-shaped

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.

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.