Medication info
Empagliflozin/Metformin Hydrochloride Tablets 12.5/1000 mg

Empagliflozin/Metformin Hydrochloride Tablets 12.5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Biconvex, oval, film-coated tablet with a dark brownish-purple color.
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 202302659 · Approved 2023.09.06 · Insurance code 645211010

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 at a time, twice a day. The dosage should be determined based on each patient's condition within the limits of not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, the dose of 5 mg of empagliflozin twice daily (total daily amount 10 mg) along with the existing metformin dosage should be used. If tolerance is good, the empagliflozin can be increased to 25 mg (total daily amount).

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

  • Poor blood sugar control
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication improves blood sugar control in adults with type 2 diabetes when used alongside diet and exercise therapy, combining empagliflozin and metformin. It is especially effective when blood sugar is inadequately controlled, and caution is recommended for use in type 2 diabetes patients with cardiovascular disease. This medication aids in stable blood sugar management and benefits diabetes treatment.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet at a time, twice a day. The dosage should be determined based on each patient's condition within the limits of not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, the dose of 5 mg of empagliflozin twice daily (total daily amount 10 mg) along with the existing metformin dosage should be used. If tolerance is good, the empagliflozin can be increased to 25 mg (total daily amount).

Precautions

This medication is used for treating diabetes and helps regulate blood sugar levels. However, there are several important precautions to take: First, this medication can cause a rare side effect called severe lactic acidosis, which can be life-threatening and requires special attention. Second, when taken with insulin or other diabetes medications, hypoglycemia may occur, so blood sugar changes should be closely monitored. Third, patients with poor kidney function or conditions such as severe infection, dehydration, or acute myocardial infarction should not take this medication. Fourth, it is safer for women who are pregnant or breastfeeding to avoid using this medication. Fifth, during treatment, regular checks of kidney function, blood sugar, and lactate levels should be conducted to ensure there are no abnormal signs. Sixth, if examinations involve iodine contrast agents, this medication should be temporarily stopped, and resumed only after kidney function is confirmed to be normal. Seventh, this medication can cause dehydration or low blood pressure, so elderly patients or those with cardiovascular disease should carefully manage their fluid status. Eighth, genital or urinary tract infections may occur, so immediate consultation with a doctor is necessary if symptoms appear. Ninth, this medication can lower vitamin B12 levels, so monitoring vitamin B12 levels during long-term use is necessary. Finally, excessive alcohol consumption should be avoided while taking this medication, and any signs of hypoglycemia or lactic acidosis should be reported immediately to healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, severe allergic reactions, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with coughing and fever, jaundice (yellowing of skin or eyes), extreme fatigue, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures

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
  • taste disturbance
  • itching
  • rash
  • erythema
  • angioedema
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • musculoskeletal pain
  • headache
  • dizziness
  • insomnia
  • weight loss
  • weight gain
  • fever
  • chest pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Biconvex, oval, film-coated tablet with a dark brownish-purple color.

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.

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.