Medication info

Emplom Tablets 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Biconvex oval film-coated tablets in orange-yellow color
Packaging
10 tablets/box [(10 tablets/PTP)×1], 60 tablets/box [(10 tablets/PTP)×6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201378 · Approved 2022.04.04

Summary

Main use
Effectiveness in controlling blood sugar levels in Type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet per administration, twice daily. The dosing should be determined based on each patient’s treatment regimen, efficacy, and tolerance, without exceeding a total of 25 mg of empagliflozin and 2000 mg of metformin. For patients receiving metformin alone or in combination with insulin or other drugs, the recommended dose is empagliflozin 5 mg taken twice daily and the patient’s existing metformin dosage. If the patient shows good tolerance and needs additional blood glucose control, the dose of empagliflozin could be increased to 25 mg daily.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Effectiveness in controlling blood sugar levels in Type 2 diabetes and prevention of cardiovascular events

  • Adult Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
View approved original text

This medication is used in conjunction with diet and exercise to help control blood sugar levels in adults with Type 2 diabetes. Specifically, the combination of empagliflozin and metformin can effectively manage blood sugar levels. Additionally, it may affect the reduction of cardiovascular event risk in patients with established cardiovascular disease, so it must be used carefully under the guidance of a healthcare professional. This medication helps improve blood sugar control, aiding in diabetes management.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet per administration, twice daily. The dosing should be determined based on each patient’s treatment regimen, efficacy, and tolerance, without exceeding a total of 25 mg of empagliflozin and 2000 mg of metformin. For patients receiving metformin alone or in combination with insulin or other drugs, the recommended dose is empagliflozin 5 mg taken twice daily and the patient’s existing metformin dosage. If the patient shows good tolerance and needs additional blood glucose control, the dose of empagliflozin could be increased to 25 mg daily.

Precautions

This medication can potentially cause a rare but life-threatening condition known as severe lactic acidosis, so caution is required. When used in conjunction with other diabetes medications, hypoglycemia may occur, so blood sugar levels must be monitored closely. It should not be used in patients with moderate to severe renal impairment or in situations suspecting acute kidney injury. In cases of severe infections, dehydration, or serious health conditions such as heart failure, the administration of this medication should be avoided. Prior to and after undergoing examinations using iodine-based contrast agents, this medication should be temporarily discontinued, and should only be resumed after normal kidney function is confirmed. It is advised that this medication not be used by pregnant or potentially pregnant women and nursing mothers. Since this medication is affected by kidney function, regular kidney function testing is necessary, especially for elderly patients or those with reduced kidney function. Caution is necessary for patients at risk of decreased fluid volume, such as those experiencing dehydration, vomiting, or diarrhea when taking this medication. While taking this medication, be vigilant for symptoms of hypoglycemia, and dose adjustments may be necessary when used in combination with insulin or sulfonylureas due to an increased risk of hypoglycemia. Urinary or genital infections may occur, so consult a physician immediately if related symptoms appear. Long-term use may lower vitamin B12 levels, so it is advisable to monitor through blood tests. Alcohol intake can increase the risk of lactic acidosis, so it is important to avoid excessive drinking while on this medication. If food intake is not possible for a prolonged period due to surgery or significant illness, the use of this medication should be temporarily stopped. Immediate treatment should be sought if symptoms of fever, pain or swelling in the genital area, or perineal necrotic symptoms appear, and medication should be discontinued in such cases. This medication is not recommended for children under 18 years, and patients over 75 years should be cautious due to the risk of fluid loss. In the event of an overdose, seek medical attention promptly, as this medication can be removed through hemodialysis.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucous membranes, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), liver abnormalities, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis

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 changes
  • itching
  • rash
  • urticaria
  • erythema
  • angioedema
  • difficulty urinating
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of vitamin B12
  • decreased fluid volume
  • headache
  • dizziness
  • insomnia
  • cough
  • shortness of breath
  • fatigue
  • chest pain
  • rash

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

Storage

This medication should be stored in a tightly sealed container to prevent the entry of air or moisture, and it is recommended to be kept at a room temperature of 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness safely.

Appearance and packaging

Appearance

Biconvex oval film-coated tablets in orange-yellow color

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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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.