Medication info
Empagliflozin Metformin Duo Tablet 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin Metformin Duo Tablet 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

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

MFDS item code 202302610 · Approved 2023.09.01 · Insurance code 670105530

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 of this medication is 1 tablet once, 2 times a day. The dosage should be determined considering each patient’s current treatment regimen, efficacy, and tolerability, not exceeding empagliflozin 25 mg and metformin 2000 mg. Patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin should take empagliflozin 5 mg twice a day (total daily dose of 10 mg) together with their usual metformin dose.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

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

  • Abnormal blood sugar control
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication contains empagliflozin and metformin and is primarily used to assist in blood sugar control for adult patients with type 2 diabetes. It is more effective when accompanied by dietary and exercise therapies and is suitable for those whose blood sugar is not adequately controlled. It should be used cautiously in adult patients with a history of cardiovascular disease, therefore it is important to follow the instructions of the healthcare provider. This medication effectively improves blood sugar levels and aids in diabetes management.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once, 2 times a day. The dosage should be determined considering each patient’s current treatment regimen, efficacy, and tolerability, not exceeding empagliflozin 25 mg and metformin 2000 mg. Patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin should take empagliflozin 5 mg twice a day (total daily dose of 10 mg) together with their usual metformin dose.

Precautions

This medication helps control blood sugar by combining two active ingredients that lower blood sugar levels. Caution should be exercised as there is a risk of severe lactic acidosis, a rare side effect that can occur while taking this medication. Lactic acidosis can lead to serious conditions due to the accumulation of lactic acid in the body. Additionally, if used in combination with insulin or other diabetes medications, there may be symptoms of hypoglycemia, so blood sugar changes should be monitored closely. Patients with moderate to severe renal impairment, acute kidney issues, severe infections, or heart problems should not take this medication for safety reasons. If an iodine contrast agent examination is planned, it is necessary to discontinue medication for a certain period before and after the exam and resume only after renal function has been confirmed. Pregnant or breastfeeding women should avoid using this medication. This medication can cause fluid volume loss, so patients with dehydration or low blood pressure should be cautious. During treatment, urinary or genital infections may occur, and symptoms should be reported to healthcare providers immediately. Long-term use may lower vitamin B12 levels; therefore, regular blood tests are recommended. In case of an overdose, blood dialysis may be required, so the dosage must be strictly adhered to. Finally, this medication is not recommended for children, and elderly patients should have their renal function monitored regularly during treatment.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • lactic acidosis
  • perineal necrosis
  • cerebral infarction
  • myocardial infarction
  • acute kidney injury
  • pyelonephritis
  • urosepsis
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  • hepatitis
  • liver damage
  • acute cholecystitis
  • gallstones
  • pneumonia
  • sepsis
  • asthma
  • difficulty breathing
  • severe swelling (edema)
  • severe allergic reactions
  • severe skin adverse reactions
  • severe neurological symptoms
  • severe edema or urination abnormalities
  • acute and unstable heart failure
  • cerebral infarction

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
  • altered taste
  • itching
  • rash
  • angioedema
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • decreased fluid volume
  • headache
  • dizziness
  • insomnia
  • anxiety
  • general weakness
  • chest discomfort
  • chest pain
  • weight loss
  • vulvar pruritus

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This will help preserve the medication's effectiveness for a long time and ensure safe use.

Appearance and packaging

Appearance

Biconvex oval film-coated tablet with a dark brownish purple color

Package unit

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