Medication info

Empagliflozin/Metformin Hydrochloride Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
Biconvex oval film-coated tablet with a yellowish brown color
Packaging
10 tablets/box [10 tablets/PPT X1], 60 tablets/box [10/PPT X6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201394 · 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
The recommended dosage of this medication is 1 tablet, taken twice daily. The dosage should be decided considering each patient's treatment regimen, effectiveness, and tolerability, without exceeding the limits of 25 mg of Empagliflozin and 2000 mg of Metformin. In cases where blood sugar control is inadequate with Metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of Empagliflozin twice daily and the existing dose of Metformin. Tolerability is excellent.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

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

  • Blood sugar control issues in adult patients with Type 2 diabetes
  • risk of occurrence of cardiovascular events
View approved original text

This medication is suitable as an adjunct to diet and exercise in improving blood sugar control for adult patients with Type 2 diabetes. It is particularly given to patients whose blood sugar is not sufficiently controlled, and clinical information from specialists is needed regarding the risk of cardiovascular events in patients with cardiovascular disease. This medication effectively aids in improving blood sugar control.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, taken twice daily. The dosage should be decided considering each patient's treatment regimen, effectiveness, and tolerability, without exceeding the limits of 25 mg of Empagliflozin and 2000 mg of Metformin. In cases where blood sugar control is inadequate with Metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of Empagliflozin twice daily and the existing dose of Metformin. Tolerability is excellent.

Precautions

This medication is an antidiabetic agent used to lower blood sugar. It may cause a rare but serious side effect called lactic acidosis, and should not be used in patients with impaired kidney function or liver function. Caution is also required when used with insulin or sulfonylurea medications due to the risk of hypoglycemia. It should not be administered in patients with moderate or greater impairment of kidney function or conditions that may cause acute kidney injury. This medication should be temporarily discontinued during situations such as before and after surgery, severe infections, dehydration, or acute myocardial infarction. It is safer not to use this medication during pregnancy or breastfeeding. During treatment, regular monitoring of kidney function and blood creatinine levels is necessary. Patients at risk of fluid loss should pay attention to dehydration symptoms and may need to temporarily suspend the medication if necessary. Side effects may include gastrointestinal disturbances, hypoglycemia, urinary tract infections, genital infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, taste disturbances, itching, rash, urticaria, angioedema, difficulty urinating, thirst, increased serum lipids, increased blood creatinine levels, increased hematocrit, reduced and deficiency of Vitamin B12, reduced fluid volume, headaches, dizziness, postural dizziness, memory disturbances, drowsiness, fatigue, fever. Additionally, this medication may reduce Vitamin B12 levels, so patients on long-term treatment should check their blood Vitamin B12 concentration. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided during treatment. This medication may interact with other medications, and patients should inform their healthcare provider of any other medications they are taking. Elderly patients have an increased risk of kidney function decline and fluid loss, so dosage adjustments and careful monitoring are necessary. In case of overdose, professional treatment such as hemodialysis may be required, and patients should seek medical attention immediately. This medication has not been established as safe and effective in children; therefore, it is not recommended for patients under 18 years of age. Finally, this medication should be stored out of reach of children and maintained in its original container to preserve quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, necrosis of the perineum, ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, severe allergic reactions, severe rash with high fever, blisters, peeling skin, pain in the oral/ocular mucosa, difficulty breathing, asthma attacks, shortness of breath or difficulty breathing, liver abnormalities (jaundice), yellowing of the skin or eyes, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • taste disturbances
  • itching
  • rash
  • urticaria
  • erythema
  • angioedema
  • difficulty urinating
  • thirst
  • increased serum lipids
  • increased blood creatinine
  • increased hematocrit
  • decreased and deficiency of Vitamin B12
  • decreased fluid volume
  • headache
  • dizziness
  • postural dizziness
  • memory disturbances
  • drowsiness
  • fatigue
  • fever

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Biconvex oval film-coated tablet with a yellowish brown color

Package unit

10 tablets/box [10 tablets/PPT X1], 60 tablets/box [10/PPT X6], 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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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.