Medication info

Empagliflozin/Metformin Hydrochloride Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
Pinkish white, bilaterally convex oval film-coated tablets
Packaging
60 tablets/box [10 tablets/PTP X 6], 10 tablets/box [10 tablets/PTP X 1], 60 tablets/bottle
Approval status
Active

MFDS item code 202302607 · Approved 2023.09.01

Summary

Main use
Blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once, twice a day. The dosage should be determined within the limits of the maximum daily recommended dose of 25 mg empagliflozin and 2000 mg metformin, taking into account each patient's current therapy, efficacy, and tolerability. For those who cannot achieve sufficient blood glucose control with metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of empagliflozin twice a day (10 mg total per day).

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

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

  • Type 2 diabetes with inadequate blood glucose control
  • cardiovascular disease
View approved original text

This medication contains both empagliflozin and metformin and is used to improve blood glucose control in adults with type 2 diabetes. It is especially effective when combined with diet and exercise regimens. Additionally, for patients with type 2 diabetes who are not sufficiently controlled and have cardiovascular diseases, careful consideration is needed regarding the risk of cardiovascular events. This medication plays an important role in managing blood glucose levels in diabetic patients.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once, twice a day. The dosage should be determined within the limits of the maximum daily recommended dose of 25 mg empagliflozin and 2000 mg metformin, taking into account each patient's current therapy, efficacy, and tolerability. For those who cannot achieve sufficient blood glucose control with metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of empagliflozin twice a day (10 mg total per day).

Precautions

This medication is used for the treatment of diabetes and helps to control blood glucose levels. This medication should not be administered to patients with impaired kidney function, severe infections, dehydration, or acute heart diseases. It is advisable for women who are pregnant or breastfeeding to avoid using this medication for safety reasons. During the use of this medication, symptoms of hypoglycemia may occur, so caution is necessary when using it with insulin or other blood glucose-lowering agents. Regular kidney function tests should be conducted before and during treatment, and if kidney function worsens, the use of this medication should be discontinued. This medication may have side effects such as gastrointestinal disturbances, urinary tract infections, genital infections, and increased urination, so if symptoms are severe, consult a physician. Consumption of alcohol may increase the risk of lactic acidosis, so it is recommended to avoid it during treatment. If surgery is planned or if you are undergoing tests with iodinated contrast agents, it is necessary to temporarily discontinue the medication and consult a physician. During the use of this medication, if symptoms of dehydration or severe vomiting or diarrhea occur, notify medical personnel immediately. Elderly patients are at higher risk of fluid loss, so greater caution should be taken when using this medication, and dosage adjustments may be necessary. In case of overdose, professional treatments such as blood dialysis may be necessary, so seek emergency treatment immediately. It is important to monitor for potential side effects through regular blood tests and physical examinations during the use of this medication.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, hives, angioedema, erythema, perineal necrosis, ketoacidosis, lactic acidosis, urinary sepsis, pyelonephritis, severe allergic reactions, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, taste alterations, itching, rash, hives, erythema, angioedema, increased urination, difficulty urinating, thirst, increased serum lipids, increased serum creatinine, increased hematocrit, decreased vitamin B12 absorption, hypoglycemia, vaginal candidiasis, vulvovaginitis, balanitis, genital infections, decreased fluid volume (low blood pressure during activities, dehydration, hypotension, reduced blood volume, orthostatic hypotension,

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It should be stored at room temperature, ideally between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pinkish white, bilaterally convex oval film-coated tablets

Package unit

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

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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.