Medication info
Dapagliflozin and Metformin Extended-Release Tablets 10/1000 mg

Dapagliflozin and Metformin Extended-Release Tablets 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›Strength being verifiedDapagliflozin Propanediol Hydrate›Strength being verified
Manufacturer / importer
동아에스티(주)
Appearance
Yellow to dark yellow oval film-coated double-layer tablet consisting of immediate-release and extended-release layers
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202300348 · Approved 2023.01.27 · Insurance code 642507720

Summary

Main use
Effect for blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dose is Dapagliflozin 10mg/extended-release Metformin 2000mg once daily, administered as 2 tablets of 5mg/1000mg. When used as initial therapy, the recommended starting dose is one tablet of 5mg/500mg or 10mg/500mg once daily. For patients already on metformin, the recommended dose of dapagliflozin is 10 mg once daily.

Ingredients

Manufacturer
동아에스티(주)

Efficacy & effects

Effect for blood sugar control and prevention of cardiovascular events in type 2 diabetes

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

This medication is used as a combination therapy of dapagliflozin and metformin to assist in controlling blood sugar levels in adult patients with type 2 diabetes, in conjunction with diet and exercise therapy. It can also be used in patients with type 2 diabetes who have insufficient blood sugar control and cardiovascular disease or risk factors. However, caution is necessary regarding the risk of cardiovascular events during the use of this medication, and detailed clinical information should be referenced in professional materials. This medication is used to improve blood sugar control and assist in the management of cardiovascular complication risks.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dose is Dapagliflozin 10mg/extended-release Metformin 2000mg once daily, administered as 2 tablets of 5mg/1000mg. When used as initial therapy, the recommended starting dose is one tablet of 5mg/500mg or 10mg/500mg once daily. For patients already on metformin, the recommended dose of dapagliflozin is 10 mg once daily.

Precautions

This medication is used for the treatment of diabetes and helps to control blood sugar levels. It should not be used in cases where kidney function is impaired or specific health conditions exist. For example, patients with severe renal impairment, serious infections, dehydration, or heart problems may be at risk if they take this medication. Additionally, caution is needed if used with insulin or other diabetes medications as hypoglycemia (a state of excessively low blood sugar) may occur. Pregnant or breastfeeding women should not take this medication, and the safety for children has not been established. This medication can cause a rare but serious side effect called lactic acidosis in some patients. Symptoms include muscle pain, difficulty breathing, weakness, and abdominal pain. If these symptoms occur, consult a doctor immediately. It is recommended to avoid alcohol consumption during treatment with this medication, and to discontinue use for a period before surgery or tests involving iodinated contrast agents. This medication may increase the risk of infections such as genital infections or urinary tract infections; therefore, prompt treatment is required if signs of infection occur. Elderly patients or those with decreased kidney function should use this medication with particular caution, and regular kidney function tests are important. This medication may lower vitamin B12 levels, so blood tests may be needed to check and supplement if necessary. In case of overdose, appropriate treatment is necessary, and since this medication lowers blood sugar, attention should be paid to symptoms of hypoglycemia. Finally, 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

  • Lactic acidosis
  • severe allergic reaction
  • severe skin reactions
  • respiratory issues
  • liver abnormalities (jaundice)
  • serious neurological symptoms
  • severe edema or urinary abnormalities
  • diabetic ketoacidosis
  • urosepsis and pyelonephritis
  • acute kidney injury and renal impairment
Show 4 more
  • Guillain-Barré syndrome
  • acute cholecystitis
  • atrial fibrillation
  • perineal necrosis

Mild side effects

Hypoglycemia, vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, decreased fluid volume, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, initial decrease in renal creatinine clearance, dyslipidemia, increased serum creatinine, increased blood urea, weight loss, rash, diarrhea, nausea, vomiting, vitamin B1

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. This way, the effectiveness of the medication can be maintained for a long time.

Appearance and packaging

Appearance

Yellow to dark yellow oval film-coated double-layer tablet consisting of immediate-release and extended-release layers

Package unit

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.