Medication info
Empagliflozin/Metformin Duo Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin/Metformin Duo Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Yellow oval film-coated tablet with a brownish hue, biconvex on both sides
Packaging
10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 60 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202201345 · Approved 2022.04.04 · Insurance code 670105330

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, taken twice daily. The dosage should be determined based on each patient's current therapy regimen, efficacy, and tolerability, without exceeding a total of 25 mg of Empagliflozin and 2000 mg of Metformin. For patients who find adequate blood sugar control difficult with Metformin alone or other medications such as insulin, it is recommended to take 5 mg of Empagliflozin twice daily (total 10 mg) along with their current dosage of Metformin.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

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

  • Type 2 diabetes with difficulty in blood sugar control
  • cardiovascular disease
View approved original text

This medication is used to assist in blood sugar control for adult patients with type 2 diabetes who find it difficult to manage blood sugar levels through diet and exercise alone. It can also be administered to patients with a history of cardiovascular disease; however, in such cases, a specialist's guidance must be followed. Empagliflozin and Metformin work together to effectively improve blood sugar levels.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, taken twice daily. The dosage should be determined based on each patient's current therapy regimen, efficacy, and tolerability, without exceeding a total of 25 mg of Empagliflozin and 2000 mg of Metformin. For patients who find adequate blood sugar control difficult with Metformin alone or other medications such as insulin, it is recommended to take 5 mg of Empagliflozin twice daily (total 10 mg) along with their current dosage of Metformin.

Precautions

This medication is utilized for the treatment of type 2 diabetes and aids in blood sugar regulation. One of the main components of this medication is Metformin, which is excreted by the kidneys and should not be administered to patients with impaired kidney function. Additionally, Metformin can cause a rare side effect known as lactic acidosis, which can be life-threatening, so caution is necessary. During the administration of this medication, hypoglycemic symptoms may occur if used with insulin or sulfonylurea medications, and extra vigilance is required. Patients with moderate to severe renal impairment, those at risk for acute kidney injury, or patients with unstable health conditions such as severe infection, dehydration, or heart failure should not take this medication. Administration of this medication should be temporarily halted before and after using iodinated contrast agents, and can only be resumed after kidney function has recovered to normal. It is recommended that pregnant or breastfeeding women avoid this medication for safety. This medication may lead to fluid loss, especially in elderly patients or those with low blood pressure; therefore, caution is necessary during use. There may be an increased risk of urinary and genital infections, so individuals should consult healthcare professionals immediately if related symptoms occur. Vitamin B12 deficiency may occur; hence, regular monitoring of Vitamin B12 levels is advisable for prolonged use. Alcohol consumption should preferably be avoided while taking this medication, as excessive drinking may increase the risk of lactic acidosis. Hypoglycemic symptoms may emerge, so particular caution should be taken if meals are skipped or irregular. For patients scheduled for surgery, this medication should be discontinued 48 hours prior to the procedure and can be resumed after kidney function normalizes post-surgery. This medication is not recommended for children under the age of 18, as safety and efficacy have not been established. In case of overdose, serious side effects such as lactic acidosis may occur, thus it should be taken strictly according to the physician's instructions. This medication should be kept out of reach of children and should be stored in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, increased serum creatinine and decreased glomerular filtration rate, liver abnormalities (including hepatitis), cerebral infarction, stroke, myocardial infarction, acute kidney injury, urosepsis, pyelonephritis, acute cholecystitis, autoimmune hepatitis, cholelithiasis, severe allergic reactions (chest tightness, difficulty breathing, cold sweat, pallor), severe skin adverse reactions (severe rash with fever, blistering)

Mild side effects

Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, altered taste, itching, rash, thirst, abnormal diagnostic tests (increased serum lipids, increased serum creatinine, increased hematocrit), decreased and deficiency of Vitamin B12, increased urination, difficulty urinating, abnormal liver function tests, hepatitis, urinary tract infection, genital infection, headache, dizziness, insomnia, fatigue, weakness, weight loss, weight gain, elevated blood pressure, chest discomfort, chest pain

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the effectiveness and safety of the medication for a longer period.

Appearance and packaging

Appearance

Yellow oval film-coated tablet with a brownish hue, biconvex on both sides

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 60 tablets/bottle, 30 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.