Medication info
Neo Empag Tablets 25 mg (Empagliflozin)

Neo Empag Tablets 25 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Pale yellow oval film-coated tablet
Packaging
30 tablets/PTP[(10 tablets/PTP X 3)], 10 tablets/PTP[(10 tablets/PTP X 1)]
Approval status
Active

MFDS item code 202105545 · Approved 2021.07.26 · Insurance code 643606150

Summary

Main use
Improvement of blood sugar control and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 10 mg once daily for monotherapy and as an adjunct to other hypoglycemic agents including insulin. If a patient tolerates 10 mg well and requires additional blood sugar control, the dosage may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablets should be swallowed whole. If a dose is missed, it should be taken as soon as remembered but not more than once per day.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Improvement of blood sugar control and prevention of cardiovascular events

View approved original text

This medication helps improve blood sugar control when used by adults with type 2 diabetes mellitus in conjunction with dietary and exercise management. It can be used alone or in combination with other medications. Care should be taken when using it, especially in patients with cardiovascular disease who do not achieve adequate blood sugar control, so it is important to refer to professional guidance. This medication is used to effectively improve blood sugar management.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and as an adjunct to other hypoglycemic agents including insulin. If a patient tolerates 10 mg well and requires additional blood sugar control, the dosage may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablets should be swallowed whole. If a dose is missed, it should be taken as soon as remembered but not more than once per day.

Precautions

This medication should not be used in patients with allergies to the active ingredients or any of the components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It is not indicated for patients with severely impaired renal function or end-stage renal disease, nor for patients on dialysis. This medication contains lactose, so it should not be used in patients with hereditary metabolic disorders such as lactose intolerance or galactose intolerance. It should be used cautiously in patients with slightly impaired renal function, and dosage adjustments or discontinuation may be necessary while regularly monitoring renal function. For patients with mild to moderate heart failure, it should be used with caution, and it is not recommended for severe cases. When used in conjunction with insulin or insulin secretagogues, there is a risk of hypoglycemia, so the insulin dosage may need to be adjusted. This medication can cause various side effects, including hypoglycemia, genital and urinary infections, increased urination, dehydration, hypotension, and liver function abnormalities, so healthcare professionals should be consulted immediately if symptoms arise. Particularly, serious metabolic abnormalities such as ketoacidosis may occur, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing appear, immediate testing and treatment are necessary. Older adults or those at risk of fluid volume depletion should be cautious of dehydration or hypotension, and treatment may be temporarily discontinued if necessary. This medication may increase the risk of genital fungal infections, so appropriate treatment should be provided in case of infection symptoms. Caution is required when driving or operating machinery due to the risk of hypoglycemia. Use of this medication during pregnancy is not recommended, and it should be discontinued if pregnancy is confirmed. For breastfeeding patients, it is safest to discontinue breastfeeding. Safety and efficacy have not been established in pediatric patients under 18 years of age. No specific toxic symptoms have been reported in case of overdose; however, appropriate treatment according to clinical condition is necessary. This medication should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angiodema
  • ketoacidosis
  • urinary sepsis and pyelonephritis
  • necrotizing fasciitis.

Mild side effects

  • Hypoglycemia
  • vulvovaginal mycotic infections
  • balanitis and other genital infections
  • increased urination
  • rash
  • itching
  • increased blood creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • thirst
Show 3 more
  • increased serum lipids
  • difficulty urinating
  • interstitial nephritis.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is preferable to maintain storage temperatures between 1°C and 30°C.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/PTP[(10 tablets/PTP X 3)], 10 tablets/PTP[(10 tablets/PTP X 1)]

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.