Medication info

Empagliflozin and Metformin Hydrochloride Tablets 12.5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Biconvex oval film-coated tablets with a dark brownish purple color
Packaging
60 tablets/bottle, 10 tablets/box [10 tablets/PTP X 1], 60 tablets/box [60 tablets/PTP X 6]
Approval status
Active

MFDS item code 202302639 · Approved 2023.09.05

Summary

Main use
Blood glucose 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, twice daily. The dosage should be adjusted based on the patient's condition, not exceeding a total of 25 mg of empagliflozin and 2000 mg of metformin. For those taking metformin alone or in combination with insulin and not achieving sufficient blood glucose control, the recommended dosage is 5 mg of empagliflozin twice daily and the existing dose of metformin. For patients who have good tolerance with 10 mg of empagliflozin and require further blood glucose control, the dosage may be increased to 25 mg of empagliflozin.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

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

  • Type 2 diabetes in adults
  • impaired blood glucose control
  • cardiovascular diseases
View approved original text

This medication is used to improve blood glucose control in adult patients with type 2 diabetes by combining empagliflozin and metformin. It can be administered as an adjunct to dietary and exercise therapy to effectively manage blood glucose levels. Caution is especially necessary when used in adult patients with type 2 diabetes who have cardiovascular disease and whose blood glucose is insufficiently controlled; clinical trial information should be consulted. Overall, this medication helps in blood glucose control and contributes to diabetes management.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice daily. The dosage should be adjusted based on the patient's condition, not exceeding a total of 25 mg of empagliflozin and 2000 mg of metformin. For those taking metformin alone or in combination with insulin and not achieving sufficient blood glucose control, the recommended dosage is 5 mg of empagliflozin twice daily and the existing dose of metformin. For patients who have good tolerance with 10 mg of empagliflozin and require further blood glucose control, the dosage may be increased to 25 mg of empagliflozin.

Precautions

This medication can cause a rare side effect known as severe lactic acidosis, so caution is required, particularly in patients with impaired kidney function, severe infections, dehydration, or heart disease. There is an increased risk of hypoglycemia when taken with insulin or sulfonylureas, so blood glucose levels should be closely monitored. Patients with moderate to severe renal impairment or in situations where acute kidney injury is a concern should not take this medication. When undergoing tests that use contrast agents, this medication should be temporarily discontinued, and resumed only after normal kidney function is confirmed post-test. In cases of scheduled surgery, this medication should be discontinued 48 hours prior to the procedure and restarted only after kidney function has normalized post-surgery. It is safest for pregnant or breastfeeding women to avoid this medication. This medication may increase the risk of urinary infections and genital infections; consult a healthcare provider immediately if symptoms of infection appear. Dehydration or hypotension may occur due to fluid volume loss during treatment, so special caution is required for the elderly or patients with cardiovascular disease. This medication may decrease vitamin B12 levels, so regular blood tests should be conducted during long-term use. Excessive alcohol consumption can increase the risk of side effects from this medication, so it is advisable to avoid it. Hypoglycemic symptoms may occur, so caution is necessary if meals are skipped or irregular. Regular monitoring of blood glucose levels is recommended while taking this medication, and any unusual symptoms should be discussed with a doctor immediately. Given the potential for drug interactions, inform your healthcare provider about any other medications being taken, especially those that may affect kidney function. This medication is not recommended for children under 18, and the elderly should take it with regular checks of kidney function. In cases of overdose, seek immediate medical attention, as the components of this medication can be removed through hemodialysis. Store this medication out of the reach of children, and keep it in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, angioedema, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, asthma attacks, breathing difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis, changes in urination amount

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
Show 21 more
  • abnormal liver function tests
  • hepatitis
  • taste disturbance
  • erythema
  • thirst
  • increased serum lipids
  • increased blood creatinine
  • decreased glomerular filtration rate
  • increased blood creatinine
  • interstitial nephritis
  • itching
  • rash
  • dizziness
  • headache
  • orthostatic dizziness
  • insomnia
  • anxiety
  • weight loss
  • weight gain
  • oral discomfort
  • mouth

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to keep the medication at room temperature between 1 degree Celsius and 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

Biconvex oval film-coated tablets with a dark brownish purple color

Package unit

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

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.