Medication info

Il Yang Dapagliflozin Extended Release Tablets 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
일양약품(주)
Appearance
Orange-colored, double-convex, egg-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204067 · Approved 2022.11.10

Summary

Main use
Effectiveness in controlling blood sugar for type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
This medication is usually administered once daily with the evening meal. The maximum dose is 10 mg of dapagliflozin/2000 mg of extended-release metformin daily, administered as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. For patients already being treated with metformin, the recommended dose of dapagliflozin is once daily at 10 mg.

Ingredients

Manufacturer
일양약품(주)

Efficacy & effects

Effectiveness in controlling blood sugar for type 2 diabetes and preventing cardiovascular events

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

This medication is used to improve blood sugar control in patients with type 2 diabetes by combining dapagliflozin and metformin. It is administered to adult patients whose blood sugar is not sufficiently controlled in conjunction with dietary and exercise therapies. Additionally, caution is warranted for patients with cardiovascular disease or risk factors for cardiovascular events. Using this medication with appropriate management can effectively improve blood sugar control.

How to take

Adult dose

This medication is usually administered once daily with the evening meal. The maximum dose is 10 mg of dapagliflozin/2000 mg of extended-release metformin daily, administered as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. For patients already being treated with metformin, the recommended dose of dapagliflozin is once daily at 10 mg.

Precautions

This medication is used for diabetes treatment and should not be administered to patients with impaired kidney function. It may cause a rare side effect known as severe lactic acidosis, so it is important to regularly monitor kidney function and overall health. There is a risk of hypoglycemia when used in combination with insulin or sulfonylureas, so blood sugar changes should be carefully observed when these medications are used together. This medication should not be used in situations that may affect kidney function, such as dehydration, severe infections, cardiovascular issues, or acute myocardial infarction. In cases involving surgical procedures or radiological examinations that may burden the kidneys, the medication should be temporarily discontinued and resumed only after kidney function has normalized. Women who are pregnant or breastfeeding should not use this medication, and it should be administered to children and the elderly with caution. This medication can cause decreases in blood volume, hypotension, and changes in kidney function, so regular monitoring is necessary, especially for elderly patients or those with weakened kidney function. While taking this medication, there may be an increased risk of genital and urinary tract infections, and any signs of infection should be immediately discussed with healthcare professionals. This medication can lower vitamin B12 levels; therefore, it's advisable to monitor vitamin B12 concentrations during long-term use. Excessive alcohol consumption can increase the risk of side effects associated with this medication, so alcohol should be avoided while taking it. When using this medication with others, be cautious of the potential for drug interactions and inform healthcare providers about all medications being taken. This medication does not significantly affect driving or operating machinery, but caution is needed as dizziness may occur. Store out of reach of children, and keep it in its original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • severe edema
  • diabetic ketoacidosis
  • urosepsis and pyelonephritis
  • acute kidney injury
  • kidney dysfunction
  • acute cholecystitis
  • Guillain-Barré syndrome
  • atrial fibrillation
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  • perineal necrosis
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory problems
  • liver abnormalities (jaundice)
  • severe neurological symptoms

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, genital itching, elevated hematocrit, reduced initial renal creatinine clearance during treatment, dyslipidemia, elevated blood creatinine at the beginning of treatment, elevated blood urea, weight loss, diarrhea, nausea/vomiting, decreased vitamin B12/deficiency, upper abdominal pain, digestion

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

Storage

This medication may be sensitive to air and moisture and should be stored in a sealed container. To maintain the drug's efficacy, it is best to store it at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Orange-colored, double-convex, egg-shaped film-coated tablet

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.

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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.