Medication info
Hudian Tablets 10 mg (Empagliflozin)

Hudian Tablets 10 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Pale yellow round film-coated tablets
Packaging
PTP packaging - 30 tablets/PTP[10 tablets/PTPX3], PTP packaging - 10 tablets/PTP[10 tablets/PTPX1]
Approval status
Active

MFDS item code 202105425 · Approved 2021.07.16 · Insurance code 670609480

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 in combination therapy with other antihyperglycemic agents. If excellent tolerance is observed and additional blood sugar control is required, the dosage may be increased to 25 mg once daily. This drug can be taken regardless of meals and should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not double the dose on the same day. Specific Groups

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Improvement of blood sugar control and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular diseases
View approved original text

This medication helps effectively control blood sugar levels in adults with type 2 diabetes. It is used alone or in combination with other medications, alongside dietary and exercise therapy. Special caution is required when used in patients with cardiovascular diseases whose blood sugar is not adequately controlled, and further information from relevant clinical trials can enhance safety in its use. This drug is used to improve blood sugar control and for the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and in combination therapy with other antihyperglycemic agents. If excellent tolerance is observed and additional blood sugar control is required, the dosage may be increased to 25 mg once daily. This drug can be taken regardless of meals and should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not double the dose on the same day. Specific Groups

Precautions

This medication should not be used in patients with an allergic reaction to the active ingredient or any component thereof. It is not to be administered to patients with Type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired renal function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m2 or those undergoing dialysis due to end-stage renal disease should not take this medication. Since this drug contains lactose, patients with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not receive it. Caution should be exercised when administering this medication to patients with impaired renal function, and those with a glomerular filtration rate below 60 mL/min/1.73m2 should have their dosage adjusted or should discontinue use. The medication will not be expected to have efficacy in patients with end-stage renal disease or on dialysis. In patients with heart failure in NYHA class I-II, it should be used cautiously, and it is not recommended for those in classes III-IV. When used in conjunction with insulin or sulfonylureas, the risk of hypoglycemia exists; therefore, the dosage of these medications may need to be reduced. This medication can cause various adverse reactions, including hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, and interstitial nephritis. Ketoacidosis may occur, so if metabolic acidosis symptoms appear regardless of blood glucose levels, immediate testing and treatment are warranted. Elderly patients or those at risk of fluid loss should monitor for signs of dehydration or hypotension, and discontinuation of treatment may be necessary. Severe infection symptoms, such as urosepsis, pyelonephritis, and genital fungal infections, require immediate treatment. Rare but serious infections, such as necrotizing fasciitis, have been reported, necessitating prompt diagnosis and treatment if related symptoms occur. This medication may increase the risk of dehydration and hypotension when used in combination with other diuretics, thus caution is advised. Use during pregnancy should be avoided, and if pregnancy is confirmed, the medication should be discontinued immediately. During breastfeeding, there is a potential for this drug to be excreted in breast milk, hence discontinuing breastfeeding is recommended. Safety and efficacy in pediatric patients under the age of 18 have not been established. No specific toxicity has been reported in cases of overdose, but treatment appropriate to the clinical condition is necessary. This medication should be kept out of reach of children and should not be transferred to other containers. There is a risk of hypoglycemia when driving or operating machinery, so caution is necessary.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • necrotizing fasciitis

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • balanitis
  • other genital infections
  • itching
  • rash
  • increased urination
  • urination difficulties
  • interstitial nephritis
  • thirst
Show 4 more
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow round film-coated tablets

Package unit

PTP packaging - 30 tablets/PTP[10 tablets/PTPX3], PTP packaging - 10 tablets/PTP[10 tablets/PTPX1]

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.