Medication info

Empagliflozin/Metformin Tablets 12.5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Thin brownish purple, biconvex, oval film-coated tablet
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 202302733 · Approved 2023.09.12

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet at a time, twice a day. The maximum daily recommended dosages for each ingredient should not exceed 25 mg of empagliflozin and 2000 mg of metformin. For patients who struggle to control blood sugar with metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice a day (total 10 mg) along with the usual dosing of metformin. If tolerance is good and additional blood sugar control is needed,

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events

View approved original text

This medication contains a combination of empagliflozin and metformin, which helps effectively improve blood sugar control in adult patients with type 2 diabetes. Particularly, better effects can be expected when combined with diet and exercise management. Additionally, it is recommended to use this medication carefully, referring to clinical trial information, for patients with cardiovascular diseases among those whose blood sugar is poorly controlled. It is an overall blood sugar control medication that aids in diabetes management.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet at a time, twice a day. The maximum daily recommended dosages for each ingredient should not exceed 25 mg of empagliflozin and 2000 mg of metformin. For patients who struggle to control blood sugar with metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice a day (total 10 mg) along with the usual dosing of metformin. If tolerance is good and additional blood sugar control is needed,

Precautions

This medication may cause severe lactic acidosis and should not be used in patients with impaired kidney function or those with serious infections, dehydration, heart problems, etc. Caution should be taken as there is a risk of hypoglycemia when used together with other diabetes medications such as insulin or sulfonylureas. Patients with moderate to severe decreased kidney function, acute kidney issues, severe heart failure, or those scheduled for surgery should not take this medication. This medication should not be administered to pregnant or breastfeeding women, nor to patients with impaired liver function. There may be side effects associated with decreased fluid volume, so patients in a dehydrated state or who are at risk of fluid loss should be cautious. Regular kidney function tests should be performed before and during treatment, and careful management is particularly needed for elderly patients or those with diminished kidney function. Urinary tract infections or reproductive infections may occur, so patients should consult their healthcare provider immediately if infection symptoms develop. Vitamin B12 deficiency may occur, thus regular blood tests are recommended for long-term users. Alcohol intake may increase the risk of lactic acidosis, hence excessive drinking should be avoided while taking this medication. While taking this medication, it is important to maintain a regular diet and exercise regimen for blood sugar control, and to respond immediately to hypoglycemic symptoms. If surgery or contrast examinations are planned, this medication should be discontinued for a period and resumed only after kidney function recovery. This medication is not recommended for children under 18 years old, and elderly patients should adjust dosages based on kidney function. Adverse reactions reported include hypoglycemia, gastrointestinal disturbances, urinary and reproductive infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, hepatitis, altered taste, rashes, erythema, itching, increased serum lipids, increased serum creatinine, reduced glomerular filtration rate, increased serum creatinine, increased serum creatinine, increased serum creatinine, increased serum creatinine, headache, dizziness, insomnia, constipation, dyspepsia, anxiety,

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling, perineal necrosis, ketoacidosis, lactic acidosis, severe allergic reactions, severe skin adverse reactions, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), serious neurological symptoms (headaches, lightning headaches, seizures, altered consciousness, visual disturbances, paralysis), significantly reduced urine output, severe swelling or urinary abnormalities, cerebral infarction, myocardial infarction.

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • reproductive infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • altered taste
  • rash
  • erythema
  • itching
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased serum creatinine
  • increased serum creatinine
  • increased serum creatinine
  • increased serum creatinine
  • headache
  • dizziness
  • insomnia
  • constipation
  • dyspepsia
  • anxiety

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, the storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Thin brownish purple, biconvex, oval film-coated tablet

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

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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.