Medication info
Empagrombi Tablet 5/500 mg (Empagliflozin, Metformin hydrochloride)

Empagrombi Tablet 5/500 mg (Empagliflozin, Metformin hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Orange-yellow, biconvex oval film-coated tablet
Packaging
10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201333 · Approved 2022.04.04 · Insurance code 645210980

Summary

Main use
Effective in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose is 1 tablet once, twice daily. Empagliflozin 5 mg twice a day (total daily amount of 10 mg) with the existing dose of metformin. If gastrointestinal tolerability is good and additional glycemic control is needed, empagliflozin can be increased to 25 mg (total daily amount). This medication should be taken with meals to reduce gastrointestinal side effects associated with metformin.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Effective in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events

  • Abnormal blood sugar control
  • type 2 diabetes
View approved original text

This medication is used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. It is particularly suitable for adult patients being treated with a combination of empagliflozin and metformin. Caution is needed for type 2 diabetes patients with cardiovascular disease when glycemic control is insufficient to assess the risk of cardiovascular events, and relevant clinical information should also be consulted. Overall, this medication improves blood sugar management and supports patient health care.

How to take

Adult dose

The recommended dose is 1 tablet once, twice daily. Empagliflozin 5 mg twice a day (total daily amount of 10 mg) with the existing dose of metformin. If gastrointestinal tolerability is good and additional glycemic control is needed, empagliflozin can be increased to 25 mg (total daily amount). This medication should be taken with meals to reduce gastrointestinal side effects associated with metformin.

Precautions

This medication helps lower blood sugar and is used in diabetes treatment. However, it should not be used in patients with significantly impaired kidney function, acute infections, dehydration, or severe heart disease. Women who are pregnant or breastfeeding should not take this medication. During treatment, symptoms of hypoglycemia may occur, so caution is needed when using it with insulin or other hypoglycemic agents. Additionally, this medication can cause urinary or genital infections; if such symptoms occur, consult a physician immediately. It should be used cautiously in patients with poor liver or kidney function, or in situations at risk of fluid loss, and kidney function should be regularly monitored through blood tests. Temporary suspension of this medication is required before and after surgeries or tests using iodinated contrast agents, and kidney function must be confirmed before resuming treatment. This medication can lower vitamin B12 levels, so long-term users may need to check their vitamin B12 concentrations. Alcohol may increase the risk of side effects from this medication, so excessive drinking should be avoided during treatment. Furthermore, this medication can affect body fluid levels, so caution is especially necessary for the elderly or those at risk for dehydration. During the use of this medication, if symptoms such as fever, pain, swelling, or rash around the genital or perineal areas occur, healthcare providers should be informed immediately. Finally, this medication is not recommended for children under 18 years of age, and dosages for the elderly should be adjusted based on kidney function.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), necrosis of the perineum, angioedema, lactic acidosis, ketoacidosis, liver abnormalities (jaundice), myocardial infarction, cerebral infarction, severe hypoglycemia, urosepsis, pyelonephritis, kidney and urinary disorders (acute kidney injury), severe edema or urination abnormalities, severe skin adverse reactions (severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa), breathing difficulties (shortness of breath or difficulty breathing, asthma exacerbation).

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • taste disturbances
  • itching
  • rash
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased vitamin B12 and deficiency
  • abnormal liver function tests
  • hepatitis
  • dermal cysts
  • seborrheic dermatitis
  • atopic dermatitis
  • diabetic foot
  • nummular eczema
  • heat rash
  • sebaceous gland hyperplasia
  • musculoskeletal pain
  • headache
  • dizziness.

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

Storage

This medication may be sensitive to air or humidity and must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the drug’s efficacy.

Appearance and packaging

Appearance

Orange-yellow, biconvex oval film-coated tablet

Package unit

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