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

Empaganduo Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Biconvex oval film-coated tablets with a light 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 202302304 · Approved 2023.07.31 · Insurance code 657309120

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 1 tablet once in the morning and once in the evening. Dosage is determined considering each patient's current treatment regimen, efficacy, and tolerability within the maximum recommended daily doses of 25 mg of Empagliflozin and 2000 mg of Metformin. - For patients unable to achieve adequate blood sugar control with Metformin alone or in combination with insulin or other medications, the recommended dosage is 5 mg of Empagliflozin twice a day.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

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

  • Type 2 diabetes with difficult blood sugar control
  • cardiovascular diseases
View approved original text

This medication helps manage blood sugar levels in adult patients with type 2 diabetes who have inadequate blood sugar control using Empagliflozin and Metformin together. It is more effective when combined with diet and exercise, especially in patients with cardiovascular diseases, and should be used cautiously considering its impact on cardiovascular events. This medication improves blood sugar control and aids in diabetes management.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once in the morning and once in the evening. Dosage is determined considering each patient's current treatment regimen, efficacy, and tolerability within the maximum recommended daily doses of 25 mg of Empagliflozin and 2000 mg of Metformin. - For patients unable to achieve adequate blood sugar control with Metformin alone or in combination with insulin or other medications, the recommended dosage is 5 mg of Empagliflozin twice a day.

Precautions

This medication may cause severe lactic acidosis; therefore, it should not be used by patients with renal impairment, severe infections, dehydration, or acute cardiac conditions. Additionally, it is not recommended for type 1 diabetes patients or those with a history of lactic acidosis. Care should be taken as hypoglycemia may occur when used with insulin or sulfonylureas. This medication should be temporarily discontinued before and after tests involving iodinated contrast agents, and should only be resumed once renal function is confirmed normal. It is safest for pregnant or breastfeeding women not to take this medication. Elderly patients or those with renal impairment should have regular monitoring of renal function and dosage adjustments if needed. If dehydration or gastrointestinal disturbances occur during treatment, immediate consultation with a healthcare provider is necessary, and in cases of severe fluid loss, temporary cessation of medication may be needed. There is a risk of vitamin B12 deficiency, so monitoring serum vitamin B12 levels during prolonged use is advised. Hypoglycemia symptoms may appear, so do not skip meals and monitor blood sugar levels closely after vigorous exercise. This medication may increase the risk of genital and urinary tract infections, so prompt treatment is required if related symptoms occur. If pain, swelling, or redness around the genital area occurs during medication, inform the healthcare provider immediately. In cases where food intake is not possible for a long period due to surgery or significant illness, temporary discontinuation of this medication may be necessary. In case of overdose, treatments like dialysis may be required, making adherence to the prescribed dosage important. It is advised to avoid alcohol while taking this medication, and consult with healthcare providers if taking other medications that may interact.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • necrosis of the perineum
  • ketoacidosis
  • lactic acidosis
  • severe rash with high fever
  • blistering
  • peeling skin
  • pain in the mouth/eyes
  • severe swelling
Show 15 more
  • difficulty breathing
  • asthma attacks
  • respiratory distress
  • liver abnormalities (jaundice)
  • liver dysfunction
  • sudden and severe headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • significant decrease in urine output
  • severe swelling
  • edema with elevated blood pressure
  • pyelonephritis
  • urosepsis

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • altered taste
  • itching
  • rash
  • erythema
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  • hypoglycemia
  • decrease and deficiency of vitamin B12
  • thirst
  • increased serum lipids
  • increased urination
  • difficulty urinating
  • weakness
  • headache
  • dizziness
  • drowsiness
  • weight loss
  • insomnia
  • anxiety
  • vulvar pruritus
  • genital pruritus
  • fever
  • elevated blood pressure
  • fatigue

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature to ensure prolonged safety and effectiveness.

Appearance and packaging

Appearance

Biconvex oval film-coated tablets with a light 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.