Medication info

Empagliflozin/Metformin Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Brown-yellow, film-coated, oval-shaped tablets with a convex surface on both sides
Packaging
10 tablets/box [(10 tablets/PTP X 1)], 60 tablets/box [(10 tablets/PTP X 6)], 60 tablets/bottle
Approval status
Active

MFDS item code 202201384 · Approved 2022.04.04

Summary

Main use
Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, twice daily. Dosage should be determined considering the patient's treatment regimen, efficacy, and tolerability, within the daily maximum recommended dose of empagliflozin 25 mg and metformin 2000 mg for each component. For patients unable to achieve sufficient blood sugar control with metformin alone or in combination with other medications such as insulin, the recommended dosage is empagliflozin 5 mg twice daily and the existing dose of metformin. Tolerability

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events

  • Type 2 diabetes
  • impaired blood sugar control
  • cardiovascular disease
View approved original text

This medication is used in conjunction with dietary and exercise therapy to assist patients with type 2 diabetes in controlling their blood sugar levels. It is particularly recommended for adults whose blood sugar control is insufficient with existing treatments. Additionally, it is important for patients with type 2 diabetes who have cardiovascular disease to refer to expert guidance when using this medication. Overall, this medication is used to effectively control blood sugar levels to aid in the management of diabetes.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice daily. Dosage should be determined considering the patient's treatment regimen, efficacy, and tolerability, within the daily maximum recommended dose of empagliflozin 25 mg and metformin 2000 mg for each component. For patients unable to achieve sufficient blood sugar control with metformin alone or in combination with other medications such as insulin, the recommended dosage is empagliflozin 5 mg twice daily and the existing dose of metformin. Tolerability

Precautions

This medication can cause a rare but serious side effect known as severe lactic acidosis, so special caution is needed for patients with impaired kidney function or heart disease. When used in conjunction with other antidiabetic agents, there may be an increased risk of hypoglycemia, so blood sugar changes should be closely monitored. Patients with moderate or severe kidney impairment or conditions that may cause acute kidney injury should not take this medication. Dosing should be temporarily suspended around surgical procedures or during serious infections or dehydration, and resumed only once the condition stabilizes. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should consult healthcare providers before use. This medication may increase the risk of urinary tract infections and genital infections, so medical attention should be sought immediately if infection symptoms appear. It is vital to monitor kidney function and vitamin B12 levels through regular blood tests during treatment, and appropriate treatment is necessary if vitamin B12 deficiency is suspected. Elderly patients or those at risk of fluid loss should pay close attention to hydration and changes in condition due to potential dehydration and low blood pressure. Alcohol consumption can increase the risk of lactic acidosis, so it is advisable to avoid drinking during treatment. Patients taking this medication should be cautious of potential interactions with other drugs, and should always consult healthcare providers before starting or stopping any new medications. Severe side effects can occur in cases of overdose, so strict adherence to the dosage is essential, and immediate medical attention should be sought at the onset of any unusual symptoms. The safety and effectiveness of this medication in children have not been established, so it is not recommended for those under 18 years of age. Store this medication out of reach of children and keep it in its original container to maintain quality. Patients taking this medication should exercise caution when driving or operating machinery, as hypoglycemic symptoms may occur and immediate action should be taken if symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, genital gangrene, ketoacidosis, lactic acidosis, pyelonephritis, urosepsis, acute kidney injury, hepatitis, cerebral infarction, myocardial infarction, sudden and severe headache, seizures, mental confusion, visual disturbances, paralysis, severe swelling, elevated blood pressure, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, skin reactions

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
Show 20 more
  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • erythema
  • hematuria
  • thirst
  • headache
  • dizziness
  • insomnia
  • weight loss
  • weight gain
  • weakness
  • chest discomfort
  • chest pain
  • fatigue
  • fever
  • chills
  • skin laceration

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Brown-yellow, film-coated, oval-shaped tablets with a convex surface on both sides

Package unit

10 tablets/box [(10 tablets/PTP X 1)], 60 tablets/box [(10 tablets/PTP X 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.