Medication info

Dapduo Sustained Release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Yellow, biconvex, oval-shaped sustained-release film-coated tablet
Packaging
30 tablets/box [(6 tablets/PTP*5)], 200 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202300151 · Approved 2023.01.06

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, which can be taken as two tablets of 5 mg/1000 mg. For patients without prior experience with diabetes medication treatment and having difficulty with blood glucose control alone, the initial dosage for therapy is one tablet of 5 mg/500 mg or 10 mg/500 mg taken once daily.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication helps control blood sugar levels in adult patients with type 2 diabetes by using dapagliflozin and metformin together. It assists in effectively managing blood sugar in conjunction with dietary and exercise therapy. In particular, caution must be exercised based on expert guidelines regarding the cardiovascular effects of dapagliflozin in patients who have insufficient blood sugar control and have cardiovascular disease or risk factors.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, which can be taken as two tablets of 5 mg/1000 mg. For patients without prior experience with diabetes medication treatment and having difficulty with blood glucose control alone, the initial dosage for therapy is one tablet of 5 mg/500 mg or 10 mg/500 mg taken once daily.

Precautions

This medication is used for diabetes treatment and helps manage blood sugar levels. When taking this medicine, one should be cautious of rare side effects such as severe lactic acidosis. Lactic acidosis is a potentially dangerous condition where lactic acid accumulates excessively in the body. Additionally, careful monitoring is required when used in conjunction with insulin or sulfonylurea medications, as it may cause severe hypoglycemia. Patients with poor kidney function, dehydration, severe infections, or heart issues should not take this medication. Before and after surgeries or tests using radioactive iodine contrast agents, the use of this medication should be temporarily discontinued, and it should only be resumed after confirming normal renal function. Pregnant or breastfeeding women should not use this medication, and patients with specific genetic disorders such as lactose intolerance should also avoid it. Elderly patients or those with diminished kidney function should undergo kidney function tests before taking this medication, and regular monitoring of kidney function should continue during treatment. This medication can cause a decrease in fluid volume or low blood pressure, so patients with low blood pressure or those taking diuretics should be especially cautious. Genital infections and urinary tract infections may occur frequently, so patients should consult a healthcare professional immediately if infection symptoms appear. Vitamin B12 levels may decrease, so it's advisable to check vitamin B12 levels during long-term use. Excessive alcohol consumption can increase the risk of side effects associated with this medication, so it should be avoided. This medication may cause hypoglycemia, and dosage adjustments may be necessary when taken with insulin or other hypoglycemic agents. In case of overdose, seek immediate medical attention for appropriate treatment. During treatment, dizziness may occur while driving or operating machinery, so caution is advised. Lastly, this medication should be stored out of reach of children and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • chest pain
  • heat burns
  • wrist fractures
  • gastrointestinal stromal tumors
  • malignant lung neoplasms
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  • uterine fibroids
  • atrial fibrillation
  • acute cholecystitis
  • diabetic ketoacidosis
  • urosepsis
  • pyelonephritis
  • acute kidney damage
  • renal impairment
  • rash
  • severe allergic reactions
  • severe skin abnormalities
  • respiratory issues
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema

Mild side effects

Hypoglycemia, dry mouth, constipation, low back pain, dysuria, polyuria, nocturia, pruritus of the external genitalia, genital itching, increased hematocrit, early treatment renal creatinine clearance decline, dyslipidemia, early treatment blood creatinine increase, blood urea increase, weight loss, dizziness, fungal infections, urinary tract infections, pruritus, headache, paresthesia, tremors, weakness, fatigue, edema, hyperglycemia, benign prostatic hyperplasia,

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Moreover, it is best stored at room temperature, which is neither too hot nor too cold, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, biconvex, oval-shaped sustained-release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP*5)], 200 tablets/bottle, 30 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.