Medication info
Dapalil Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Dapalil Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
Yellow, bi-convex, diamond-shaped film-coated tablet
Packaging
PTP - 28 tablets/box [28 tablets (7 tablets/PTP x 4)], bottle - 30 tablets/bottle, bottle - 300 tablets/bottle
Approval status
Active

MFDS item code 202201843 · Approved 2022.05.04 · Insurance code 654005900

Summary

Main use
Treatment for glycemic control in type 2 diabetes and reduction of cardiovascular risk in chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication is 10 mg once daily. It can be taken orally at any time of day, regardless of food intake. The tablet should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

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

  • Type 2 diabetes
  • glycemic control disorders
  • cardiovascular diseases
  • cardiovascular risk factors
  • chronic heart failure
  • heart failure
  • chronic kidney disease
  • reduced glomerular filtration rate
  • end-stage kidney disease
View approved original text

This medication is used together with diet and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. Additionally, it helps reduce the risk of death and hospitalization due to cardiovascular disease in patients with chronic heart failure. It also plays a role in reducing the decline in kidney function and the risk of cardiovascular death in patients with chronic kidney disease. This drug is used in combination with standard treatments appropriate for each condition, making it effective for comprehensive management of the patient's status. Therefore, it is used in the treatment of type 2 diabetes, chronic heart failure, and chronic kidney disease.

How to take

Adult dose

The recommended dose for this medication is 10 mg once daily. It can be taken orally at any time of day, regardless of food intake. The tablet should be swallowed whole.

Child dose

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

Precautions

This medication should not be administered to certain patients. For example, it should not be used in individuals who are allergic to the active ingredient or excipients, patients with type 1 diabetes or diabetic ketoacidosis, individuals with lactose intolerance or certain genetic metabolic disorders, and patients undergoing dialysis. Caution should be exercised when administering this medication to patients with reduced fluid volume or impaired renal function. This drug can lower blood pressure or affect renal function, so elderly patients or those taking diuretics need to be monitored more closely. Evaluate fluid status and renal function thoroughly before administration, and continuously monitor blood pressure and renal function during treatment. This medication may cause various side effects including genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis. Genital infections may occur more frequently in women, so immediate treatment should be sought if symptoms arise. The risk of hypoglycemia may be increased when used in conjunction with insulin or sulfonylureas, so dosage adjustments may be necessary when using these agents together. Pregnant and breastfeeding women are advised not to use this medication. If pregnancy is confirmed, treatment should be discontinued immediately, and it is safe to avoid this medication during breastfeeding. Elderly patients or those with impaired renal function are at higher risk of side effects from this drug and should be more cautious. Additionally, this medication may yield a positive result in urine glucose tests, so take this into account during blood glucose monitoring. This drug may interact with other medications, so especially when taking diuretics, insulin, or sulfonylureas, consultation with a physician or pharmacist is necessary. Patients taking lithium should have their blood lithium levels checked more frequently. In case of overdose, there are no specific antidotes, so appropriate treatment based on the patient's condition is essential. Finally, the safety and efficacy of this medication in children have not been established, so it is preferable not to use it in this population. When storing the drug, keep it out of reach of children and store it in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination

Mild side effects

  • Vulvitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dizziness
  • constipation
  • dry mouth
  • back pain
  • painful urination
Show 25 more
  • polyuria
  • nocturia
  • dyslipidemia
  • weight loss
  • itching
  • sweating
  • hives
  • vomiting
  • dyspepsia
  • diarrhea
  • gastrointestinal disturbances
  • abdominal discomfort
  • vaginal discharge
  • headache
  • cough
  • dyspnea
  • palpitations
  • insomnia
  • tinnitus
  • weakness
  • chest pain
  • fatigue
  • chest discomfort
  • pain
  • peripheral edema

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 it from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and ensure safe use.

Appearance and packaging

Appearance

Yellow, bi-convex, diamond-shaped film-coated tablet

Package unit

PTP - 28 tablets/box [28 tablets (7 tablets/PTP x 4)], bottle - 30 tablets/bottle, bottle - 300 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.