Medication info

Empagliflozin/Metformin Tablets 5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
White, biconvex, oval film-coated tablets with a yellowish hue
Packaging
10 tablets/box[(10 tablets/PTP)×1], 60 tablets/box[(10 tablets/PTP)×6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201377 · Approved 2022.04.04

Summary

Main use
Effectiveness in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet, twice daily. It should be determined based on each patient's current therapeutic regimen, efficacy, and tolerability, not exceeding empagliflozin 25 mg and metformin 2000 mg. For patients who find it difficult to achieve sufficient blood sugar control with metformin alone or in conjunction with insulin or other medications, the recommended dose is empagliflozin 5 mg twice daily (total 10 mg) combined with their existing dose of metformin.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Effectiveness in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events

  • Blood sugar control issues in adults with type 2 diabetes
  • cardiovascular diseases
View approved original text

This medication is used to improve blood sugar control in adults with type 2 diabetes by assisting with dietary and exercise regimens. It is particularly administered to patients whose blood sugar is not adequately controlled, and may also be applicable to patients with cardiovascular diseases. The effectiveness and safety of the drug should be used in accordance with professional guidelines. Therefore, this medication effectively controls blood sugar and aids in the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 1 tablet, twice daily. It should be determined based on each patient's current therapeutic regimen, efficacy, and tolerability, not exceeding empagliflozin 25 mg and metformin 2000 mg. For patients who find it difficult to achieve sufficient blood sugar control with metformin alone or in conjunction with insulin or other medications, the recommended dose is empagliflozin 5 mg twice daily (total 10 mg) combined with their existing dose of metformin.

Precautions

This medication is used to manage diabetes and helps with blood sugar control. This drug may cause a rare side effect called severe lactic acidosis, therefore, patients with poor kidney function or those experiencing severe infections, shock, or acute myocardial infarction should not use it. Additionally, caution is needed as hypoglycemia may occur when used alongside insulin or sulfonylureas. This medication is contraindicated in patients with moderate to severe kidney impairment, liver dysfunction, and in women who are pregnant or breastfeeding. Before and after undergoing tests using iodine contrast agents, this medication should be temporarily discontinued, and it should only be resumed once kidney function has been confirmed to be normal. Discontinue this medication within 48 hours before surgery, and resume once kidney function has returned to normal post-surgery. This medication may cause decreased fluid volume, so those in a dehydrated state or with gastrointestinal disorders should take special care. It may reduce vitamin B12 levels, hence it's advisable to routinely monitor vitamin B12 levels during long-term use. Alcohol intake may increase the risk of lactic acidosis, so excessive drinking should be avoided during treatment. This medication may increase the risk of urinary and genital infections, so immediate consultation with a physician is required upon the appearance of such symptoms. Hypoglycemic symptoms may occur, so especially if taken with insulin or sulfonylureas, blood sugar changes should be closely monitored. Elderly patients or those with impaired kidney function should regularly undergo kidney function tests, and dosage adjustments may be necessary. In the event of overdose, serious side effects like lactic acidosis may occur, hence strict adherence to dosage is necessary, and if unusual symptoms arise, immediate medical attention should be sought. Keep this medication out of reach of children and store it in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, pyelonephritis, urosepsis, acute kidney injury, liver abnormalities (hepatitis, acute cholecystitis, autoimmune hepatitis), myocardial infarction, cerebral infarction, cerebral hemorrhage, intracranial aneurysm, acute cholecystitis, shock, dyspnea, asthma attacks, severe allergic reactions (urticaria, severe swelling, chest tightness, breathing difficulties, cold sweat, pallor), severe

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
  • hepatitis
  • taste disturbances
  • itching
  • rash
  • increased serum lipids
  • elevated serum creatinine
  • headache
  • dizziness
  • orthostatic dizziness
  • insomnia
  • anxiety
  • chest discomfort
  • chest pain
  • weakness
  • weight loss
  • vulvar pruritus
  • genital pruritus
  • cough
  • dyspnea
  • hypertension
  • musculoskeletal pain

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and maintained at room temperature between 1 to 30 degrees Celsius. This is to preserve the drug's efficacy and ensure safe usage.

Appearance and packaging

Appearance

White, biconvex, oval film-coated tablets with a yellowish hue

Package unit

10 tablets/box[(10 tablets/PTP)×1], 60 tablets/box[(10 tablets/PTP)×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.