Medication info
Dapa Tablets (Dapagliflozin Propanediol Hydrate)

Dapa Tablets (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
Yellow, biconvex, diamond-shaped film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP×3)]
Approval status
Active

MFDS item code 202203322 · Approved 2022.08.19 · Insurance code 644309700

Summary

Main use
Treatment for type 2 diabetes blood sugar control and reduction of cardiovascular risk in chronic heart failure and chronic kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy. In initial combination therapy, 5 mg or 10 mg once daily is recommended. For patients with chronic heart failure and chronic kidney disease, 10 mg once daily is also recommended. This medication can be taken orally once daily at any time regardless of food intake, and the tablet should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in patients under 18 years of age have not been established.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • blood sugar control disorders
  • chronic heart failure
  • cardiovascular diseases
  • chronic kidney disease
  • presumed decreased glomerular filtration rate
  • end-stage kidney disease
View approved original text

This medication is used in conjunction with diet and exercise to improve blood sugar control in patients with type 2 diabetes. Additionally, for patients with chronic heart failure, it helps reduce the risks of death, hospitalization due to cardiovascular disease, and emergency hospital visits. In patients with chronic kidney disease, it is used in combination with other treatments to reduce the risk of kidney function decline and cardiovascular-related mortality. Thus, this medication improves various risks associated with diabetes, heart failure, and kidney disease.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy. In initial combination therapy, 5 mg or 10 mg once daily is recommended. For patients with chronic heart failure and chronic kidney disease, 10 mg once daily is also recommended. This medication can be taken orally once daily at any time regardless of food intake, and the tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in patients under 18 years of age have not been established.

Precautions

This medication should not be used in patients with known allergies to the active ingredient or excipients, or in those with type 1 diabetes or diabetic ketoacidosis. It also contains anhydrous lactose, which is contraindicated in patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndromes. Use in patients undergoing dialysis is also not recommended. This drug should be used with caution in patients with reduced fluid volume or impaired kidney function, and fluid status and renal function should be assessed before administration. Caution is particularly necessary for older adults or patients on diuretics, as they may be at higher risk of hypotension or decreased intravascular volume. In patients with moderate or severe renal impairment, blood sugar control effects may be diminished, and administration is not recommended for those with severely impaired kidney function. During treatment, genital infections and urinary tract infections may occur; immediate treatment should be sought if symptoms arise. There is a risk of hypoglycemia, so dosage adjustments may be necessary when used concomitantly with insulin or sulfonylureas. Symptoms of dehydration or hypotension can occur due to fluid volume reduction, so medical advice should be sought if symptoms appear. Diabetic ketoacidosis can rarely occur, so patients should immediately notify healthcare providers if they experience symptoms such as vomiting, abdominal pain, or breathlessness. This medication should be used cautiously in patients with severely impaired liver function and is not recommended for use in pregnant or breastfeeding women. Elderly patients are at increased risk for decreased renal function and fluid volume reduction, so extra caution is necessary. Glucose may be detected in urine tests while taking this medication, but this is a normal response. In the case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms. Care should be taken when driving or operating machinery considering the risk of hypoglycemia. This medication should be stored out of reach of children and kept in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, difficulty or shortness of breath, asthma attacks, cough accompanied by fever-related respiratory distress, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary

Mild side effects

Vulvar vaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, reduced fluid volume (dehydration, hypovolemia, hypotension), thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, initial treatment decrease in renal creatinine clearance, dyslipidemia, initial treatment increase in serum creatinine, elevated blood urea, weight

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

Storage

This medication should be stored in a tightly closed container to protect against air and moisture, and it is safe to store at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy for a longer duration.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP×3)]

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.