Medication info
Daprodia Tablets 10 mg (Dapagliflozin Propanediol Hydrate)

Daprodia Tablets 10 mg (Dapagliflozin Propanediol Hydrate)

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

MFDS item code 202202180 · Approved 2022.05.23 · Insurance code 641807180

Summary

Main use
Blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults · Children
Adult dose
For monotherapy and adjunctive therapy in type 2 diabetes, take 10 mg once daily. During initial combination therapy with metformin, take 5 mg or 10 mg once daily. Administration may occur at any time of the day regardless of food intake, and the tablet should be swallowed whole.
Child dose
The efficacy and safety of this medication in children under 18 years have not been established and should not be administered.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • blood sugar control disorders
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used alone or in combination with dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It may also be given to patients with insufficient blood sugar control and existing cardiovascular disease or risk factors, however, careful use must be followed according to relevant clinical trial information. This medication assists in diabetes management by improving blood sugar control.

How to take

Adult dose

For monotherapy and adjunctive therapy in type 2 diabetes, take 10 mg once daily. During initial combination therapy with metformin, take 5 mg or 10 mg once daily. Administration may occur at any time of the day regardless of food intake, and the tablet should be swallowed whole.

Child dose

The efficacy and safety of this medication in children under 18 years have not been established and should not be administered.

Precautions

This medication should not be used in patients with allergies to the main ingredient or excipients, or in patients with type 1 diabetes or diabetic ketoacidosis. Moreover, patients with lactose intolerance or specific genetic issues and patients undergoing dialysis should not take this medication. Caution is required for patients with reduced fluid volume or renal dysfunction, and blood pressure and kidney function should be closely monitored before and after administration. This medication may have reduced blood sugar control efficacy in patients with severely impaired kidney function. There is a risk of genital and urinary tract infections during treatment, and immediate treatment is necessary if symptoms develop. Due to the risk of hypoglycemia, dosage adjustments may be needed when taken alongside insulin or sulfonylureas. Watch for dehydration or hypotension symptoms due to reduced fluid volume, and temporarily discontinue use if symptoms are severe. There is a risk of diabetic ketoacidosis, so immediate hospital visit is required if symptoms such as vomiting, abdominal pain, or shortness of breath occur. Serious infection symptoms like necrotizing fasciitis are rarely reported, so consult a doctor if there is pain or redness around the genital area. Elderly patients or those with renal dysfunction should use this medication with extra caution, and regular kidney function tests are recommended. Pregnant or breastfeeding women should not take this medication and should discontinue use upon confirmation of pregnancy. There is no specific antidote for overdose; appropriate treatment should be administered according to symptoms. This medication does not significantly affect driving or machinery operation, but caution is needed due to potential hypoglycemia symptoms. Safety and efficacy in children under 18 years have not yet been established, and its use is not recommended. This medication must be stored in its original container and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, mucous membrane pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory disturbances with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision disturbances, paralysis,

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, elevated hematocrit, increased serum creatinine, elevated blood urea, weight loss, rash, angioedema, gastrointestinal disorders (gastroesophageal reflux disease, upper abdominal pain, diverticulitis, intestinal perforation, acute pancreatitis, chronic pancreatitis, dyspepsia, nausea, diarrhea, vomiting, etc.),

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is best stored at a cool room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, convex, diamond-shaped film-coated tablet

Package unit

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