Medication info

Duo-extended-release 5/500 milligrams

Prescription medicationTablet경구Expired
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tabletDapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
한국아스트라제네카(주)
Appearance
Orange, biconvex, rectangular film-coated tablet
Packaging
30 tablets (6 tablets x 5) / box
Approval status
Expired

MFDS item code 201503636 · Approved 2015.06.08

This product's status changed to Expired on 2024.11.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
This drug is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg/extended-release metformin 2000mg, taken as 2 tablets of 5mg/1000mg. If there has been no prior experience with diabetes medication treatments, the recommended starting dose when used as initial therapy is 1 tablet of 5mg/500mg or 10mg/500mg, administered once daily. Regarding gastrointestinal side effects of metformin.

Ingredients

Importer
한국아스트라제네카(주)

Efficacy & effects

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

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

This drug is used to improve blood sugar control in adult patients with type 2 diabetes, in combination with dapagliflozin and metformin, along with diet and exercise therapy. It may also be applicable in patients with cardiovascular disease or risk factors among those whose blood sugar is not well controlled; however, the effects of dapagliflozin on these patients should be referenced in professional information. This drug aids in blood sugar management and enhances the effectiveness of diabetes treatment.

How to take

Adult dose

This drug is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg/extended-release metformin 2000mg, taken as 2 tablets of 5mg/1000mg. If there has been no prior experience with diabetes medication treatments, the recommended starting dose when used as initial therapy is 1 tablet of 5mg/500mg or 10mg/500mg, administered once daily. Regarding gastrointestinal side effects of metformin.

Precautions

This drug is used for diabetes treatment and helps control blood sugar. Although very rare, this drug can cause a serious metabolic complication known as lactic acidosis. Lactic acidosis is a condition in which the level of lactic acid in the blood rises and acidity increases, which can be life-threatening if not treated. Therefore, patients with poor kidney function or those with heart or liver issues should be especially cautious. Additionally, the risk of hypoglycemia may increase when this drug is used with insulin or sulfonylureas, so hypoglycemic symptoms should be closely monitored during co-administration. Patients with severely impaired kidney function, dehydration, acute infections, severe heart failure, or acute myocardial infarction should not use this drug, and it should be temporarily discontinued before and after tests using radiographic contrast agents. Patients with decreased fluid volume or low blood pressure, the elderly, and those on diuretics should be closely monitored for the risk of hypotension or deterioration of kidney function before and after administering this drug. This drug can cause genital and urinary tract infections, and if symptoms of infection appear, medical personnel should be notified immediately. There may be a deficiency in vitamin B12, so if taken for a long time, it is advisable to regularly check vitamin B12 levels in the blood. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not use this drug, and use in children and those over 80 years old should be with caution. In case of overdose, appropriate treatment is necessary, and especially in patients with reduced kidney function, there is a risk of drug accumulation in the body, so caution is advised. Alcohol consumption should be avoided while taking this drug, and care should be taken to ensure that there are no symptoms of hypoglycemia or dehydration by monitoring meals and fluid intake. Finally, this drug should be stored out of reach of children, and kept in its original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • kidney dysfunction
  • necrotizing fasciitis
  • acute cholecystitis
  • Guillain-Barré syndrome
Show 9 more
  • bacterial pneumonia
  • sialadenitis
  • atrial fibrillation
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory issues
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema or urination abnormalities

Mild side effects

  • Genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • back pain
  • dysuria
  • polyuria
Show 19 more
  • nocturia
  • pruritus of the vulva
  • pruritus of the genitals
  • increased hematocrit
  • elevated blood creatinine
  • elevated blood urea
  • dyslipidemia
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased vitamin B12
  • upper abdominal pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • irritable bowel syndrome
  • salivary gland mass
  • dental pain
  • headache

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

Storage

This drug should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This helps to preserve the effectiveness and safety of the drug for a long time.

Appearance and packaging

Appearance

Orange, biconvex, rectangular film-coated tablet

Package unit

30 tablets (6 tablets x 5) / box

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.