Medication info

Daprodyl 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
광동제약(주)
Appearance
Yellow, double-convex, round film-coated tablet
Packaging
28 tablets/box [(7 tablets/PTP x 4)]
Approval status
Active

MFDS item code 202204370 · Approved 2022.12.05

Summary

Main use
Blood sugar control in type 2 diabetes and reduction of cardiovascular risk
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 safety and efficacy of dapagliflozin in children under 18 years have not been established. No relevant data is available.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Blood sugar control in type 2 diabetes and reduction of cardiovascular risk

  • Blood sugar control issues in patients with type 2 diabetes
  • failure in blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used in combination with dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It can be administered alone or in combination with other medications. It is particularly applicable in patients who have difficulty controlling blood sugar and have existing cardiovascular diseases or risk factors. This medication helps to stabilize blood sugar levels and reduces cardiovascular risk. Therefore, it is effectively used in the treatment of type 2 diabetes.

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

Precautions

This medication should not be used in patients with allergies to the active ingredient or additives, patients with type 1 diabetes, patients with diabetic ketoacidosis, or patients with genetic issues such as lactose intolerance. Additionally, it should not be administered to patients undergoing dialysis. Caution should be exercised in patients with fluid volume deficiency or impaired kidney function when using this medication. This medication can cause decreases in blood pressure or sudden changes in kidney function, so fluid status and kidney function should be thoroughly checked before administration, and blood pressure and kidney function should be continuously monitored after administration. This medication can lead to various side effects, such as genital infections, urinary tract infections, hypoglycemia, fluid volume depletion, and diabetic ketoacidosis. Particularly, genital infections may occur more frequently in women and patients with a history of infections. It is not recommended for use in pregnant women, and if pregnancy is confirmed, the medication should be discontinued immediately. It is also safe not to use this medication during breastfeeding. When used in combination with other diuretics, insulin, or sulfonylureas, the risk of hypoglycemia, dehydration, and hypotension may increase, so careful dosage adjustment and attention are needed. During the course of treatment, blood sugar levels should be regularly checked, and if any abnormal symptoms occur, immediate consultation with healthcare professionals is necessary. The safety and efficacy of this medication have not been established in children, so it should not be used in pediatrics. In cases of overdose, there is no specific antidote, so appropriate treatment should be provided according to symptoms, and if necessary, follow the directions of healthcare professionals. Finally, this medication should be kept out of reach of children and stored in its original container.

Side effects and when to seek care immediately

Serious side effects

Decreased fluid volume (including dehydration, hypovolemia, hypotension), diabetic ketoacidosis, perineal necrosis (Fournier's gangrene), acute kidney injury, renal impairment, urinary sepsis, pyelonephritis, angioedema, anaphylaxis, severe swelling (edema), chest tightness, difficulty breathing, sweating, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • back pain
  • dysuria
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  • polyuria
  • nocturia
  • increased hematocrit
  • elevated creatinine
  • dyslipidemia
  • weight loss
  • chest pain
  • weakness
  • pain
  • edema
  • foreign body sensation
  • facial swelling
  • facial pain
  • warmth
  • flu-like symptoms
  • itching
  • urticaria
  • sweating
  • chest pain
  • fatigue
  • hunger
  • vaginal discharge
  • menstrual disturbances

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This helps ensure the medication's efficacy is well maintained and prevents deterioration.

Appearance and packaging

Appearance

Yellow, double-convex, round film-coated tablet

Package unit

28 tablets/box [(7 tablets/PTP x 4)]

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.