Medication info

Empagliflozin/Metformin Film-Coated Tablets 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
Biconvex oval film-coated tablet, yellow with a brown tint
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 202201339 · Approved 2022.04.04

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this drug is one tablet, twice a day. Dosage is determined based on the patient's condition, within the maximum recommended dose of empagliflozin of 25 mg and metformin of 2000 mg. In cases where blood sugar control is difficult with metformin alone or in combination with other medications like insulin, empagliflozin 5 mg twice a day and the existing dose of metformin is recommended. If there is good tolerance and additional blood sugar control is required, dosage may be increased to empagliflozin 25 mg daily.

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

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

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

This medication contains both empagliflozin and metformin, effectively assisting adults with type 2 diabetes in controlling their blood sugar when combined with diet and exercise. It is particularly suitable for those whose blood sugar is not sufficiently controlled, and those with cardiovascular disease should use it according to a specialist's guidance. This medication is used to improve blood sugar management and support diabetes treatment.

How to take

Adult dose

The recommended dosage for this drug is one tablet, twice a day. Dosage is determined based on the patient's condition, within the maximum recommended dose of empagliflozin of 25 mg and metformin of 2000 mg. In cases where blood sugar control is difficult with metformin alone or in combination with other medications like insulin, empagliflozin 5 mg twice a day and the existing dose of metformin is recommended. If there is good tolerance and additional blood sugar control is required, dosage may be increased to empagliflozin 25 mg daily.

Precautions

This medication is used to help lower blood sugar levels in diabetic patients. When taking this medication, there is a risk of rare side effects such as serious lactic acidosis, so caution is necessary. In addition, using this medication with other diabetes drugs like insulin or sulfonylureas may increase the risk of hypoglycemia, so care is needed. This medication should not be used in patients with significant renal impairment, acute renal issues, severe infections, heart failure, or type 1 diabetes. If an iodinated contrast agent for radiological examinations is planned, temporarily discontinue this medication before and after the test. Patients about to undergo surgery should also stop taking this medication 48 hours prior and resume only when their kidney function returns to normal. Patients with poor liver function, severe pulmonary diseases, or excessive alcohol consumption should avoid this medication. Pregnant or breastfeeding women should not take this medication, and those breastfeeding are advised to discontinue use. Regular monitoring of kidney function and serum creatinine levels is necessary during treatment. This medication may increase urination, and the risk of urinary tract infections or genital infections may climb, so consult a doctor immediately if symptoms of infection appear. Hypotension or dehydration due to fluid loss can occur, hence caution is needed in cases of dehydration symptoms or reduced fluid volume risk. Vitamin B12 levels may decrease, so patients taking this medication long-term should regularly check their Vitamin B12 levels. Hypoglycemia symptoms may occur, so especially when taken with other hypoglycemic agents, blood sugar changes should be carefully monitored. Alcohol can increase the risk of lactic acidosis, hence excess drinking should be avoided while on this medication. If pain, swelling, or redness occurs around the genital area during the course of treatment, inform healthcare providers immediately as there may be a serious infection like perineal necrosis. Elderly patients or those with poor kidney function may need dose adjustments and regular testing; it is safe to stay within the maximum prescribed dose. In case of an overdose, serious side effects may appear, so take the exact dose as prescribed by a physician and receive appropriate treatment at a hospital if necessary. This medication is not recommended for children and it is advisable not to use it for individuals under 18 years old.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • lactic acidosis
  • perineal necrosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • acute pyelonephritis
  • renal function impairment
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  • severe edema
  • heart failure
  • acute myocardial infarction
  • myocardial infarction
  • cerebral infarction
  • acute cholecystitis
  • autoimmune hepatitis
  • gallstones
  • hepatitis
  • headache
  • confusion
  • visual disturbances
  • paralysis
  • seizures
  • severe allergic reactions
  • cold sweat
  • pallor
  • breathing difficulties
  • chest tightness
  • high fever and

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • dysgeusia
  • itching
  • rash
  • hives
  • erythema
  • angioedema
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • decreased and deficiency of Vitamin B12
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • facial swelling

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 at room temperature between 1 to 30 degrees Celsius. This will help retain the medication's effectiveness and safety.

Appearance and packaging

Appearance

Biconvex oval film-coated tablet, yellow with a brown tint

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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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.