Medication info
Empagliflozin/Metformin Hydrochloride Tablets 12.5/1000 milligrams

Empagliflozin/Metformin Hydrochloride Tablets 12.5/1000 milligrams

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Biconvex oval film-coated tablet with dark brownish purple color
Packaging
60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202302698 · Approved 2023.09.11 · Insurance code 647805810

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is one tablet at a time, twice a day. The maximum recommended daily dosage for each ingredient should not exceed 25 mg of empagliflozin and 2000 mg of metformin. For patients who cannot achieve adequate blood sugar control with metformin alone or as part of combination therapy with insulin or other medications, the recommended dosage is 5 mg of empagliflozin taken twice a day (total daily dose of 10 mg) along with the existing dose of metformin.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

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

  • Poor blood sugar control in patients with type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used to help control blood sugar in adult patients with type 2 diabetes. It is particularly effective for those who are also following dietary and exercise regimens, providing additional blood sugar management benefits. It can be administered even when blood sugar is not adequately controlled, and is suitable for patients with cardiovascular disease. However, the risk of cardiovascular events should be referred to a specialist’s guidance. Overall, this drug effectively improves blood sugar control in adult patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage for this medication is one tablet at a time, twice a day. The maximum recommended daily dosage for each ingredient should not exceed 25 mg of empagliflozin and 2000 mg of metformin. For patients who cannot achieve adequate blood sugar control with metformin alone or as part of combination therapy with insulin or other medications, the recommended dosage is 5 mg of empagliflozin taken twice a day (total daily dose of 10 mg) along with the existing dose of metformin.

Precautions

This medication is used for the treatment of diabetes and works by combining two main ingredients to control blood sugar. It should not be administered to patients with impaired renal function or certain severe diseases. During treatment, there is a risk of rare complications known as lactic acidosis, so any symptoms that arise should be promptly discussed with a doctor. This medication can cause hypoglycemia, especially when taken with insulin or other hypoglycemic agents, requiring careful monitoring. Urinary tract infections or genital infections may occur, and any signs of infection should be treated quickly. Care should be taken to avoid dehydration due to fluid loss, especially in the elderly or those with cardiovascular diseases. It is advisable for pregnant women or those who may become pregnant, as well as nursing mothers, not to take this medication. It is better to avoid alcohol consumption during treatment, and liver and kidney functions should be regularly checked. Medication administration may need to be temporarily suspended before or after surgeries or tests utilizing radiocontrast agents containing iodine. Common side effects may include nausea, diarrhea, abdominal pain, headache, and dizziness; if symptoms are severe, the doctor should be notified. This medication is not recommended for children under 18 years of age, and the elderly may require dose adjustments due to reduced kidney function. In cases of overdose, immediate medical attention is necessary, and dialysis may be required. It is important to keep this medication out of reach of children and to store it in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • severe swelling
  • difficulty breathing
  • ketoacidosis
  • lactic acidosis
  • severe rash with fever
  • blisters
  • skin peeling
  • pain in oral/eye mucosa
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  • perineal necrosis (Fournier's gangrene)
  • urosepsis
  • pyelonephritis
  • liver abnormalities (jaundice)
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • confusion
  • vision disturbances
  • paralysis
  • marked reduction in urine output
  • elevated blood pressure
  • severe swelling
  • heart failure
  • heart

Mild side effects

Hypoglycemia, urinary tract infections, genital infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, hepatitis, altered taste, itching, rash, hives, erythema, angioedema, increased serum creatinine, decreased glomerular filtration rate, thirst, abnormal diagnostic tests (such as increased serum lipids), vitamin B12 reduction and deficiency, reduced fluid volume, musculoskeletal pain, headache, dizziness, insomnia, chest discomfort,

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, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Biconvex oval film-coated tablet with dark brownish purple color

Package unit

60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 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.