Medication info

Il-Yang Dapagliflozin Metformin Extended-Release Tablets 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
일양약품(주)
Appearance
Deep pink, biconvex, egg-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202106877 · Approved 2021.10.12

Summary

Main use
Effect on 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/2000 mg of extended-release metformin per day, which can be taken as 2 tablets of 5 mg/1000 mg. For those with no previous experience in diabetes medication treatment, the initial therapy is one tablet daily of 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, doses should be adjusted in a stepwise manner.

Ingredients

Manufacturer
일양약품(주)

Efficacy & effects

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

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

This medication helps improve blood sugar control in adult patients with type 2 diabetes by using dapagliflozin and metformin together. It is administered as an adjunct to diet and exercise in patients whose blood sugar is not adequately controlled. It can also be used in patients with cardiovascular disease or risk factors; however, it is important to refer to expert guidance while using this medication. This medication effectively improves blood sugar control in type 2 diabetes patients.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin per day, which can be taken as 2 tablets of 5 mg/1000 mg. For those with no previous experience in diabetes medication treatment, the initial therapy is one tablet daily of 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, doses should be adjusted in a stepwise manner.

Precautions

This medication is used for the treatment of diabetes and helps to control blood sugar levels. However, this medication may rarely cause a dangerous condition called lactic acidosis, so it should not be used in cases of impaired kidney function, severe infection, or dehydration. Additionally, caution is needed when used in combination with insulin or sulfonylurea drugs, as there is a risk of hypoglycemia. Patients with moderate to severe renal impairment, acute illness, severe heart failure, acute myocardial infarction, or hepatic dysfunction should also not take this medication. Patients scheduled for surgery or radiologic contrast studies should discontinue this medication for a certain period, and patients with reduced blood volume or risk of hypotension should use it cautiously. During treatment, genital and urinary tract infections may occur, and immediate treatment is required if symptoms arise. This medication may lower vitamin B12 levels, so regular monitoring of vitamin B12 levels is recommended for long-term use. Excessive alcohol consumption can also increase the risk of side effects of this medication, so it should be avoided. Women who are pregnant or breastfeeding should not use this medication, and elderly patients should take it while regularly monitoring kidney function. In case of overdose, appropriate treatment is necessary, and prompt medical evaluation is critical. This medication does not significantly affect driving or operating machinery but may cause dizziness, so caution is advised. Finally, keep this medication out of the reach of children and store it in its original container to prevent misuse or degradation.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, chest pain, acute cholecystitis, neurological disorders (Guillain-Barré syndrome), atrial fibrillation, diabetic ketoacidosis, urinary sepsis and pyelonephritis, acute kidney injury, renal dysfunction, rash (severe skin adverse reactions), perineal necrosis, hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, shortness of breath or difficulty breathing,

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
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  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • dyslipidemia
  • elevated blood urea
  • weight loss
  • diarrhea
  • nausea/vomiting
  • vitamin B12 decrease/deficiency
  • upper abdominal pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • irritable bowel syndrome
  • salivary gland swelling
  • toothache
  • headache
  • sensory

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

Storage

This medication should be stored in a sealed container to keep out air and moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Deep pink, biconvex, 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.

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.