Medication info
Dapagluem Sustained Release Tablet 10/1000 mg

Dapagluem Sustained Release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Yellow, biconvex, oval-shaped sustained-release film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle [(bottle: HDPE, cap: LDPE)], bottle packaging - 100 tablets/bottle [(bottle: HDPE, cap: LDPE)]
Approval status
Active

MFDS item code 202300275 · Approved 2023.01.17 · Insurance code 644004690

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 dapagliflozin 10 mg and sustained-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. If the patient has no prior experience with diabetes medication, the initial therapy consists of taking 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

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

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

This medication helps control blood sugar in adult patients with type 2 diabetes who are using dapagliflozin and metformin in conjunction with diet and exercise therapy. The efficacy on the occurrence of cardiovascular events is also considered, particularly in patients with cardiovascular disease or risk factors where blood sugar control is insufficient. For more details, please refer to professional clinical trial information. This medication is used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg and sustained-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. If the patient has no prior experience with diabetes medication, the initial therapy consists of taking 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily.

Precautions

This medication is used to help control blood sugar and is mainly used in patients with diabetes. However, it should not be administered to patients with poor kidney function or those with severe infections or dehydration. This medication can rarely cause a serious metabolic complication called lactic acidosis, so patients and healthcare providers should be well aware of the symptoms of lactic acidosis. Also, there is a risk of hypoglycemia when used in combination with insulin or sulfonylureas, so caution is needed. This medication is not recommended for patients with moderate to severe impaired kidney function, and kidney function should be regularly monitored before and during treatment. Elderly patients or those with reduced fluid volume are at higher risk of dehydration or hypotension, so blood pressure and fluid status should be closely monitored. Additionally, this medication may increase the risk of genital and urinary tract infections, and immediate treatment should be sought if symptoms of infection appear. Women who are pregnant or breastfeeding should not use this medication, and treatment should be discontinued immediately if pregnancy is confirmed. Excessive alcohol consumption may increase the risk of lactic acidosis when taking this medication, so it should be avoided. If surgery or contrast agent examination is planned during the treatment period, it is necessary to consult the healthcare provider to consider discontinuation for a period. Also, this medication can cause vitamin B12 deficiency in some patients, so regular blood tests are recommended. Hypoglycemia symptoms may occur, so patients should pay attention to symptoms such as dizziness or lightheadedness, and consult a physician immediately if symptoms occur. This medication is not established for safety and efficacy in children, so it should not be used. Finally, this medication should be stored out of reach of children and kept in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • dehydration
  • hypovolemia
  • hypotension
  • diabetic ketoacidosis
  • ketosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
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  • renal impairment
  • rash
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • chest pain
  • thermal burns
  • wrist fractures
  • gastrointestinal stromal tumors
  • malignant neoplasm of the lung
  • uterine fibroids
  • atrial fibrillation
  • acute cholecystitis
  • headache
  • facial paralysis
  • Guillain-Barré syndrome
  • peripheral neuropathy
  • paresthesia
  • drowsiness
  • tremor
  • Guillain-Barré

Mild side effects

Hypoglycemia, dry mouth, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, elevated serum creatinine at the beginning of treatment, elevated blood urea, weight loss, tendinitis, joint pain, muscle pain, myofascial pain syndrome, osteoarthritis, osteochondrosis, limb pain, periarticular inflammation, tendinitis, headache, paresthesia, tremor, epigastric pain, indigestion, abdominal discomfort, diarrhea, abdominal pain

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

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering. It is recommended to maintain storage temperatures between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

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

Package unit

Bottle packaging - 30 tablets/bottle [(bottle: HDPE, cap: LDPE)], bottle packaging - 100 tablets/bottle [(bottle: HDPE, cap: LDPE)]

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.