Medication info
N-Pyang Tablet 10 mg (Empagliflozin)

N-Pyang Tablet 10 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Light yellow, round, biconvex film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102114 · Approved 2021.03.05 · Insurance code 669908490

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 10 mg once daily. If tolerance is good and additional blood sugar control is needed, the dosage can be increased to 25 mg once daily. This medication can be taken without regard to meals, and tablets should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, and do not double doses in one day.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

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

  • Type 2 diabetes
  • difficulties in blood sugar control
  • cardiovascular disease
  • failure in blood sugar control
View approved original text

This medication is used to help control blood sugar levels in adult patients with type 2 diabetes mellitus. Initially, it is administered as monotherapy, but in cases where blood sugar control is difficult, it can be used in combination therapy with other antidiabetic agents such as metformin. Particularly, additional administration of this drug improves blood sugar control in patients who do not achieve adequate control with metformin monotherapy or other combination therapies. Furthermore, caution is needed when using this medication in patients with type 2 diabetes who have cardiovascular disease, and it is important to refer to related clinical trial information, etc. This medication aids in comprehensive diabetes management, improving blood sugar control.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily. If tolerance is good and additional blood sugar control is needed, the dosage can be increased to 25 mg once daily. This medication can be taken without regard to meals, and tablets should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, and do not double doses in one day.

Precautions

This medication should not be administered to patients who have allergic reactions to the active ingredient or any of its components. Additionally, it should not be used in patients with type 1 diabetes or diabetic ketoacidosis. It should not be given to patients with severely impaired renal function, specifically those with a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m2 or who have end-stage renal disease or are undergoing dialysis. Due to the presence of lactose, it should not be given to patients with lactose intolerance or related genetic disorders. Caution is required when using this medication in patients with impaired renal function, and treatment should be avoided in patients with a GFR of less than 60 mL/min/1.73m2. If the GFR continues to drop below 45 mL/min/1.73m2, the medication should be discontinued. The use of this medication is not recommended in heart failure patients classified as NYHA class III-IV, and caution should be exercised in class I-II patients. When used in combination with insulin or sulfonylureas, there is an increased risk of hypoglycemia; therefore, dosage adjustments for insulin or secretagogues may be necessary. While taking this medication, side effects such as hypoglycemia, urinary tract infections, genital infections, increased urination, and depletion of fluid volume may occur, so symptoms should be monitored closely. There is a risk of serious metabolic disturbances such as ketoacidosis, so immediate consultation with healthcare providers is needed if related symptoms (nausea, vomiting, abdominal pain, difficulty breathing, etc.) appear. Elderly patients over 75 years of age have a higher risk of fluid volume loss and require caution, and the use is not recommended in patients over 85 years of age. Additionally, this medication may reduce lithium levels in the blood, so patients undergoing lithium treatment need monitoring of blood levels. It should not be administered to pregnant women, and breastfeeding women should discontinue breastfeeding when taking this medication. The safety and effectiveness in children under 18 years of age have not been established. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment is necessary depending on the clinical condition. This medication should be kept out of reach of children, and transferring it to another container should be avoided. Caution is needed when driving or operating machinery due to the risk of hypoglycemia. Diabetic patients should take care of regular foot care and genital hygiene and should inform healthcare providers immediately if they experience pain or swelling in the perineum.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (angioedema), ketoacidosis, perineal necrosis, urosepsis, pyelonephritis, acute kidney injury, liver abnormalities (possible jaundice), severe skin adverse reactions (severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes), severe allergic reactions, serious neurological symptoms (headache, cerebral infarction, intracranial aneurysm, seizures, confusion, visual disturbances, paralysis), breathing difficulties (shortness of breath or difficulty breathing)

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • vulvitis
  • balanitis and other genital infections
  • increased urination
  • urinary tract infections
  • fluid volume loss
  • increased serum creatinine
  • decreased GFR
  • rash
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  • itching
  • increased serum lipids
  • decreased blood pressure
  • dehydration
  • hypotension
  • reduced blood volume
  • orthostatic hypotension
  • syncope
  • headache
  • dizziness
  • drowsiness
  • fatigue
  • peripheral edema
  • facial edema
  • vascular stent narrowing
  • vascular stent thrombosis
  • abnormal urination

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

Storage

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

Appearance and packaging

Appearance

Light yellow, round, biconvex 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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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.