Medication info
Empagliflozin/Metformin Hydrochloride Tablets 5/1000 mg

Empagliflozin/Metformin Hydrochloride Tablets 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Brownish yellow, biconvex, oval film-coated tablet
Packaging
10 tablets/box [(10 tablets/PTP X 1)], 60 tablets/box [(10 tablets/PTP X 6)], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201379 · Approved 2022.04.04 · Insurance code 669908420

Summary

Main use
Effectiveness in glycemic control of type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this drug is 1 tablet, twice a day. It is determined within the range not exceeding 25 mg of Empagliflozin and 2000 mg of Metformin, considering each patient's therapy, efficacy, and tolerability. - For patients using Metformin alone or in combination with other drugs such as insulin, the recommended dose is Empagliflozin 5 mg twice daily (total daily dose of 10 mg) and the existing dose of Metformin. - Empa

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Effectiveness in glycemic control of type 2 diabetes and prevention of cardiovascular events

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

This drug is a treatment that helps control blood sugar levels in adults with type 2 diabetes by using Empagliflozin and Metformin together. It is primarily administered to patients whose blood sugar is not sufficiently controlled with diet and exercise alone. Moreover, in patients with type 2 diabetes accompanied by cardiovascular disease, caution is necessary regarding the occurrence of cardiovascular events, so it should be used with information from professional clinical trials. This drug improves glycemic control and is effectively used in the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dosage of this drug is 1 tablet, twice a day. It is determined within the range not exceeding 25 mg of Empagliflozin and 2000 mg of Metformin, considering each patient's therapy, efficacy, and tolerability. - For patients using Metformin alone or in combination with other drugs such as insulin, the recommended dose is Empagliflozin 5 mg twice daily (total daily dose of 10 mg) and the existing dose of Metformin. - Empa

Precautions

This drug is a medication that helps control blood sugar and is used in diabetes treatment. Caution is needed when taking this medication as there may be rare side effects such as severe lactic acidosis. Lactic acidosis could accumulate excess lactic acid in the body, leading to dangerous conditions. Additionally, if taken with insulin or sulfonylurea drugs, hypoglycemia can occur, so blood sugar changes should be closely monitored. Patients with severely impaired kidney function or certain acute illnesses should not use this medication. For instance, cases of dehydration, severe infections, shock, acute myocardial infarction fall under this category. If surgery is planned, or if undergoing tests with iodine contrast agents, this medication should be discontinued for a certain period before and after the test, and should only be resumed after confirming normal kidney function. It is advisable for women who are pregnant or may become pregnant, and nursing mothers not to take this drug. During the use of this medication, kidney function and blood creatinine levels should be regularly monitored to check kidney status. Irregular eating habits or poor nutritional status, as well as vigorous exercise may increase the risk of hypoglycemia or lactic acidosis, therefore caution is necessary. This drug may cause gastrointestinal disturbances (diarrhea, vomiting, abdominal pain, etc.), urinary tract infections, genital infections, increased urination, hypoglycemia, decreased fluid volume, and other side effects. In particular, genital or urinary tract infections may occur frequently, so if symptoms arise, consult a doctor immediately. During the use of this drug, it is best to avoid alcohol consumption, as alcohol may increase the risk of lactic acidosis. Additionally, there may be interactions with other medications, so it is essential to inform a doctor or pharmacist if you are taking other medications. Elderly patients or those with reduced kidney function should adjust the dose of this drug and monitor kidney function more frequently. In case of overdose, serious side effects may occur, and immediate medical attention should be sought. This medication is not recommended for children and should be stored safely out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, breathing abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, markedly reduced urine output

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
  • altered taste
  • itching
  • rash
  • thirst
  • increased serum lipids
  • increased blood creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • reduced vitamin B12 and deficiency
  • decreased fluid volume
  • weight loss
  • headache
  • dizziness
  • insomnia
  • fatigue
  • peripheral edema
  • facial swelling
  • weight gain

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

Storage

This drug may be sensitive to air or moisture, so it must be stored in a tightly closed container. It's best to keep the storage temperature between 1 to 30 degrees Celsius at room temperature to maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

Brownish yellow, biconvex, oval film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP X 1)], 60 tablets/box [(10 tablets/PTP X 6)], 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.