Medication info
Dapaon Tablet 5mg (Dapagliflozin bis L-Proline)

Dapaon Tablet 5mg (Dapagliflozin bis L-Proline)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Bis L-proline›7.8mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Yellow, bilaterally convex, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202003734 · Approved 2020.05.22 · Insurance code 643508260

Summary

Main use
Treatment for blood sugar control in type 2 diabetes and reduction of cardiovascular risk in chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
This medication can be taken orally once daily at any time, regardless of food intake. The tablet should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin have not been established in children under 18 years of age. No relevant data is available.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Treatment for blood sugar control in type 2 diabetes and reduction of cardiovascular risk in chronic heart failure and kidney disease

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
  • chronic heart failure
  • heart failure
  • chronic kidney disease
  • decreased estimated glomerular filtration rate
  • end-stage kidney disease
View approved original text

This medication helps improve blood sugar control in patients with type 2 diabetes and can be used alone or in combination with other medications. It also plays a role in reducing the risk of death from cardiovascular disease and hospitalizations due to heart failure in patients with chronic heart failure. In patients with chronic kidney disease, it helps delay the decline in glomerular filtration rate and reduces the risk of death from end-stage kidney disease and cardiovascular disease. This drug is effective in treating diabetes, heart failure, and kidney disease and is used in combination with standard treatments for each condition.

How to take

Adult dose

This medication can be taken orally once daily at any time, regardless of food intake. The tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin have not been established in children under 18 years of age. No relevant data is available.

Precautions

This drug should not be administered to certain patients. For example, it should not be given to patients with allergies to the active ingredient or excipients, patients with type 1 diabetes, patients with diabetic ketoacidosis, and patients with certain genetic lactose intolerance issues. Additionally, it should not be taken by patients undergoing dialysis. This drug should be used cautiously in patients with decreased fluid volume or impaired kidney function. It can lower blood pressure or reduce intravascular volume, which may lead to symptomatic hypotension or acute kidney injury. Special care should be taken in patients with reduced kidney function, elderly patients, and those taking diuretics to carefully evaluate fluid status and kidney function before administration, as well as monitor for signs of hypotension and changes in kidney function during administration. Adverse effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis may occur. Women and patients with a history of infections may be at higher risk for genital infections. Diabetic ketoacidosis can occur even without high blood sugar, so if symptoms like nausea, vomiting, abdominal pain, or difficulty breathing arise, immediate medical attention is necessary. Monitoring blood ketone levels during medication use is recommended. Furthermore, this medication may have a weight loss effect, increasing the risk of decreased fluid volume and hypotension in elderly patients or those with impaired kidney function, requiring special care. Pregnant or breastfeeding women are advised not to use this drug, and if pregnancy is confirmed, administration should be discontinued. When taken in conjunction with insulin or sulfonylureas, the risk of hypoglycemia may increase, necessitating potential dose adjustments for these medications. Finally, while this drug does not significantly affect driving or operating machinery, caution is advised due to the potential for hypoglycemic symptoms.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis,

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, increased hematocrit, decreased initial treatment kidney creatinine clearance, dyslipidemia, increased initial treatment blood creatinine, elevated blood urea, weight loss, hives, itching, cold sweat, indigestion, nausea, diarrhea, vomiting, weakness, hunger,

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

Storage

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

Appearance and packaging

Appearance

Yellow, bilaterally convex, round 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.