Medication info
Empagliflozin and Metformin Hydrochloride Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin and 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
(주)에이프로젠바이오로직스
Appearance
White, oval-shaped, double-sided convex film-coated tablet with a pink tint
Packaging
60 tablets/box [(10 tablets/PTP x 6)], 10 tablets/box [(10 tablets/PTP x 1)], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202302661 · Approved 2023.09.06 · Insurance code 645211030

Summary

Main use
Blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage is 1 tablet per dose, twice a day. The dosage should not exceed 25 mg of empagliflozin and 2000 mg of metformin, and should be determined considering each patient's current treatment regimen, efficacy, and tolerance. If sufficient blood sugar control is not achieved with metformin alone or in combination with insulin or other medication, a dose of empagliflozin 5 mg, taken twice a day (total of 10 mg daily) may be added to the existing metformin dosage.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

  • Blood sugar control issues
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication assists adult patients with type 2 diabetes in effectively improving blood sugar control while following dietary and exercise regimens. In particular, it can help manage the risk of cardiovascular events for those whose blood sugar is not adequately controlled, especially in patients with cardiovascular disease, when used cautiously under a physician's guidance. Therefore, this medication is used to enhance blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage is 1 tablet per dose, twice a day. The dosage should not exceed 25 mg of empagliflozin and 2000 mg of metformin, and should be determined considering each patient's current treatment regimen, efficacy, and tolerance. If sufficient blood sugar control is not achieved with metformin alone or in combination with insulin or other medication, a dose of empagliflozin 5 mg, taken twice a day (total of 10 mg daily) may be added to the existing metformin dosage.

Precautions

This medication can cause a rare but very serious side effect known as severe lactic acidosis, so patients at high risk for lactic acidosis should use caution. During treatment, hypoglycemia may occur if used with other diabetes medications such as insulin or sulfonylureas, thus blood sugar levels should be monitored carefully. Patients with moderate to severe renal impairment, acute kidney problems, severe infections, or cardiovascular issues should not use this medication. If undergoing surgery or tests using iodinated contrast, this medication should be discontinued for a period, and renal function should be verified as normal before resuming. This medication may cause fluid loss, so special caution is necessary for patients with dehydration symptoms or at risk for decreased fluid volume. Women who are pregnant or may become pregnant, and nursing mothers should not use this medication; especially during pregnancy, insulin therapy is recommended. Regular monitoring of liver or kidney function tests is advised during treatment to check for abnormalities. If symptoms such as fever, pain, redness, swelling in the genital or perineal area occur, immediate medical attention should be sought. This medication may reduce vitamin B12 levels, so patients on long-term treatment should periodically check their vitamin B12 levels. Alcohol can increase the risk of side effects from this medication, so excessive drinking should be avoided during treatment. Elderly patients, particularly those aged 75 and older, are at higher risk for fluid loss and should take caution, possibly requiring dose adjustments based on renal function. In the event of an overdose, immediate medical treatment is required, and if lactic acidosis is suspected, blood dialysis may be necessary. Finally, this medication should be kept out of the reach of children and safely stored in the original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, lactic acidosis, ketoacidosis, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/mucous membranes, severe skin reactions, asthma attacks, respiratory difficulties accompanied by cough and fever, shortness of breath or breathing difficulty, liver problems (symptoms of jaundice), yellowing of skin or eyes (jaundice), extreme lethargy, severe

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • hives
  • erythema
  • angioedema
  • urinary difficulties
  • thirst
  • increased serum lipid levels
  • increased blood creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • decreased fluid volume
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • insomnia
  • anxiety

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. A storage temperature between 1 and 30 degrees Celsius at room temperature is recommended. Proper storage helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

White, oval-shaped, double-sided convex film-coated tablet with a pink tint

Package unit

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

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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.