Medication info
Empahuna Tablet 25 mg (Empagliflozin)

Empahuna Tablet 25 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Light yellow, double-convex oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102374 · Approved 2021.03.16 · Insurance code 645210970

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this drug is 10 mg once daily for monotherapy and as an adjunct to other blood glucose-lowering agents like insulin. If tolerance is excellent and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. When given in combination with sulfonylureas or insulin, consider a reduction in the dosage of those medications to reduce the risk of hypoglycemia. Administration can be done regardless of meals.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • poor blood sugar control
  • cardiovascular disease
  • cardiovascular events
View approved original text

This drug is used as an adjunct to diet and exercise to help control blood sugar in adults with type 2 diabetes and is administered alone, or in combination therapy in various cases. It improves blood sugar control when used in combination with metformin when monotherapy is insufficient, or with metformin and pioglitazone, sulfonylureas, insulin, and the DPP-4 inhibitor linagliptin. It effectively manages blood sugar, especially in patients with difficult blood sugar control, and precautions should be noted for patients with cardiovascular disease. This drug is used for the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dose of this drug is 10 mg once daily for monotherapy and as an adjunct to other blood glucose-lowering agents like insulin. If tolerance is excellent and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. When given in combination with sulfonylureas or insulin, consider a reduction in the dosage of those medications to reduce the risk of hypoglycemia. Administration can be done regardless of meals.

Precautions

This drug should not be administered to patients with allergies to the active ingredient or its components. This drug is not used in patients with type 1 diabetes or diabetic ketoacidosis. It is safe not to use this drug in patients with severely impaired kidney function, end-stage kidney disease, or those undergoing dialysis. This drug contains lactose and should not be given to patients with lactose intolerance, galactose intolerance, or hereditary lactase deficiency. In patients with mildly impaired kidney function, cautious use is required as this drug's dosage may need adjustment or discontinuation. Use is not recommended in patients with moderate or severe heart failure, and caution is needed in mild cases. When used with medications like insulin or sulfonylureas, dosage adjustments may be necessary due to the risk of hypoglycemia. This drug helps with blood sugar control, but hypoglycemic symptoms may occur, so symptoms should be monitored. The risk of genital infections or urinary tract infections may increase, so immediate consultation with a doctor is necessary if infection symptoms occur. This drug increases urine output, which may lead to more frequent urination, requiring preparation for this effect. There may be risks of hypotension or dehydration due to reduced fluid volume, particularly caution is needed for elderly patients or those with low blood pressure. Serious metabolic abnormalities like ketoacidosis may occur, so immediate treatment is necessary if symptoms appear. There is a possibility of liver damage, so inform medical personnel immediately if symptoms of liver dysfunction appear. This drug may pose a risk of hypoglycemia while driving or operating machinery, so caution is warranted. It is advisable to avoid using this drug during pregnancy or when planning to become pregnant, and it is also safe not to use it while breastfeeding. It is not used in children under 18 years of age as safety and efficacy have not been established. No specific toxic symptoms have been reported in case of overdose, but appropriate treatment should be received immediately if overdose occurs. This drug may interact with other medications, so inform medical personnel if you are currently taking any medications. When storing, keep it out of reach of children and do not transfer it to other containers. During treatment with this drug, regular checks of kidney function and blood sugar status should be conducted to monitor for abnormalities.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, ketoacidosis, urosepsis and pyelonephritis, necrotizing fasciitis, kidney and urinary tract disorders (acute kidney injury, acute pyelonephritis), liver damage (liver abnormalities, although symptoms of jaundice are not specified, caution regarding liver damage), severe neurological symptoms (headache, cerebral infarction, intracranial aneurysm, etc.), severe edema or urination abnormality (generalized severe edema, marked decrease in urine output), severe allergic reactions (urticaria,

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • balanitis and other genital infections
  • increased urination
  • rash
  • itching
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased fluid volume
  • headache
Show 21 more
  • dizziness
  • fatigue
  • edema
  • fever
  • chest pain
  • vulvar pruritus
  • genital pruritus
  • cough
  • nasal bleeding
  • anxiety
  • insomnia
  • constipation
  • diarrhea
  • dyspepsia
  • abdominal pain
  • nausea
  • gastritis
  • drowsiness
  • weight loss
  • lumbar pain
  • musculoskeletal pain.

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

Storage

This drug may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is best kept at room temperature between 1 and 30 degrees Celsius. Avoid extremely hot or cold places for safe storage.

Appearance and packaging

Appearance

Light yellow, double-convex oval film-coated tablet

Package unit

30 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.