Medication info
Dapagluem Sustained Release Tablet 10/500 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Dapagluem Sustained Release Tablet 10/500 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
Pink, convex, oval-shaped sustained-release film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP (Alu-Alu) x 3)]
Approval status
Active

MFDS item code 202300432 · Approved 2023.01.31 · Insurance code 640904460

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The dosage of this medication should be individualized based on the patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended dosage of 10 mg Dapagliflozin and 2000 mg sustained-release Metformin. This medication is generally administered once daily with the evening meal. The maximum dosage of this medication is 10 mg Dapagliflozin/2000 mg sustained-release Metformin taken once daily, typically as 2 tablets of 5 mg/1000 mg.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

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

View approved original text

This medication is administered in combination with dietary and exercise therapy to improve blood sugar control in adult patients with type 2 diabetes using Dapagliflozin and Metformin. It can be used in patients with insufficient blood sugar control, particularly those with cardiovascular disease or risk factors. However, in such cases, the effects of Dapagliflozin on the occurrence of cardiovascular events should refer to expert clinical trial information. This drug aids in safe blood sugar management and is effectively used in the treatment of diabetes.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended dosage of 10 mg Dapagliflozin and 2000 mg sustained-release Metformin. This medication is generally administered once daily with the evening meal. The maximum dosage of this medication is 10 mg Dapagliflozin/2000 mg sustained-release Metformin taken once daily, typically as 2 tablets of 5 mg/1000 mg.

Precautions

This medication is used for the treatment of diabetes and should not be used in patients with poor kidney function or specific health conditions. It can rarely cause a dangerous condition called lactic acidosis, so immediate consultation with healthcare professionals is needed if symptoms appear. When used with insulin or other diabetes medications, hypoglycemia may occur, thus careful monitoring of blood sugar levels is necessary. Patients with reduced kidney function, those who are dehydrated, or those with low blood pressure should be particularly cautious when using this medication, and regular checks on kidney function and blood pressure are required. Genital or urinary tract infections may occur, and prompt treatment is necessary if such symptoms arise. This medication is not recommended for use in pregnant or nursing women, and its use should cease if pregnancy is confirmed. Elderly patients have an increased risk of reduced kidney function and fluid volume depletion, requiring careful monitoring and dosage adjustment. Excessive alcohol consumption should be avoided during treatment, and potential interactions with other drugs should be discussed with healthcare professionals. In case of overdose, appropriate medical treatment should be sought immediately. While taking this medication, caution is advised when driving or operating machinery due to possible dizziness. Lastly, this medication should be kept out of the reach of children and stored in its original container.

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
  • pain in mucous membranes of mouth/eyes
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  • difficulty or wheezing
  • asthma attack
  • abnormal breathing with cough and fever
  • yellowing of skin or eyes (jaundice)
  • extreme lethargy
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • confusion
  • visual abnormalities
  • paralysis
  • urination

Mild side effects

Dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, reduced creatinine clearance at the beginning of treatment, dyslipidemia, elevated serum creatinine at the beginning of treatment, increased blood urea, weight loss, hypoglycemia, polydipsia, neurological disorders (headache, facial paralysis, Guillain-Barré syndrome, peripheral neuropathy, sensory abnormalities, drowsiness, tremors), upper abdominal pain, dyspepsia,

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink, convex, oval-shaped sustained-release film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP (Alu-Alu) x 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.