Medication info
Empagliflozin Duo 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin Duo 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Light brownish purplish, oval, bilaterally convex film-coated tablet
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 202302608 · Approved 2023.09.01 · Insurance code 670105510

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage is 1 tablet at a time, 2 times a day. The dosage should be determined based on the patient's current therapy, efficacy, and tolerability, without exceeding the maximum recommended daily doses of 25 mg of Empagliflozin and 2000 mg of Metformin. If inadequate blood sugar control is achieved with monotherapy of metformin or in combination with other medications such as insulin, the recommended dosage is 5 mg of Empagliflozin taken 2 times daily (totaling 10 mg) along with the usual dose of Metformin.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

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

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

This medication helps adult patients with type 2 diabetes control their blood sugar levels when used in conjunction with diet and exercise. It is particularly suitable for those whose blood sugar is hard to control and can be used effectively in cases of cardiovascular disease. For more detailed information on the occurrence of cardiovascular events, please refer to professional information. This medication is used to improve blood sugar management in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage is 1 tablet at a time, 2 times a day. The dosage should be determined based on the patient's current therapy, efficacy, and tolerability, without exceeding the maximum recommended daily doses of 25 mg of Empagliflozin and 2000 mg of Metformin. If inadequate blood sugar control is achieved with monotherapy of metformin or in combination with other medications such as insulin, the recommended dosage is 5 mg of Empagliflozin taken 2 times daily (totaling 10 mg) along with the usual dose of Metformin.

Precautions

This drug can cause a rare but fatal side effect called severe lactic acidosis, so it should not be used in patients with poor renal function or in acute conditions such as severe infections, dehydration, or heart disease. Additionally, caution should be exercised when used with other diabetes medications such as insulin or sulfonylureas due to the risk of hypoglycemia. Renal function should be regularly checked to ensure it is normal, and the medication should be discontinued if renal function declines. The medication should be temporarily discontinued before and after tests involving iodine contrast media due to the risk of kidney damage and lactic acidosis. Women who are pregnant or breastfeeding should not use this medication and women of childbearing potential should avoid it as well. Elderly patients or those at risk of fluid loss should watch for dehydration or hypotension, and may need to temporarily stop taking the medication as necessary. This medication may increase urine output and thereby raise the risk of urinary tract infections or genital infections; therefore, if symptoms of infection occur, consult a doctor immediately. Gastrointestinal disturbances (such as diarrhea, nausea, vomiting) associated with the metformin component can frequently occur, and vitamin B12 levels may decrease, so regular checking is necessary. Alcohol consumption is best avoided during the course of treatment, and if symptoms such as sudden weight loss, abdominal pain, difficulty breathing, weakness appear, seek hospital care immediately. Furthermore, there may be interactions with other medications used concurrently, so always inform healthcare professionals of any medications being taken. This medication is not recommended for children, and dose adjustments are needed for the elderly based on kidney function. In the case of overdose, immediate medical attention is required as hemodialysis may be necessary. Finally, this medication should be stored out of reach of children and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • ketoacidosis
  • lactic acidosis
  • perineal necrosis
  • angioedema
  • pyelonephritis
  • urosepsis
  • acute kidney injury
  • acute cholecystitis
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  • hepatitis
  • cerebral infarction
  • myocardial infarction
  • severe allergic reactions
  • severe skin reactions
  • difficulty breathing
  • respiratory distress
  • jaundice
  • serious neurological symptoms
  • severe edema or urination abnormalities

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • taste alteration
  • itching
  • rash
  • thirst
  • increased serum creatinine
  • abnormal liver function tests
  • hepatitis
  • decreased vitamin B12
  • weight loss
  • headache
  • dizziness
  • insomnia
  • chest discomfort
  • chest pain
  • weakness
  • fever
  • hypertension
  • anxiety
  • dry mouth
  • fatigue
  • increased serum lipids
  • weight gain
  • joint pain
  • back pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to preserve the drug's effectiveness for a longer time.

Appearance and packaging

Appearance

Light brownish purplish, oval, bilaterally convex film-coated tablet

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.