Medication info
Dapaone M Extended Release Tablet 5/500 mg

Dapaone M Extended Release Tablet 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›505mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Orange-colored, biconvex, oval-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204141 · Approved 2022.11.18 · Insurance code 671807580

Summary

Main use
Blood sugar control and prevention of cardiovascular events in Type 2 diabetes
Who takes it
Adults
Adult dose
This medication is typically administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg / extended-release metformin 2000mg, given as 2 tablets of 5mg/1000mg. If there is no prior experience with diabetes medication treatment, the initial regimen is one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce metformin-related gastrointestinal side effects, the dosage should be adjusted gradually.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

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

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

This medication functions as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes through the combination therapy of dapagliflozin and metformin. It is particularly used in patients with cardiovascular disease or risk factors where blood sugar control is insufficient. However, detailed information regarding cardiovascular event occurrence should refer to professional clinical trial data. This medication is effective in improving blood sugar control in patients with Type 2 diabetes.

How to take

Adult dose

This medication is typically administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg / extended-release metformin 2000mg, given as 2 tablets of 5mg/1000mg. If there is no prior experience with diabetes medication treatment, the initial regimen is one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce metformin-related gastrointestinal side effects, the dosage should be adjusted gradually.

Precautions

This medication assists in controlling blood sugar levels. However, it may rarely cause a serious side effect called lactic acidosis, which results from excessive lactate accumulation in the blood, so caution is needed. Additionally, when used with insulin or sulfonylurea medications, there is a risk of hypoglycemia, thus extreme care is necessary. This medication should not be administered to certain patients. For example, patients with allergies to this drug or severely impaired kidney function, those in a dehydrated state, or patients with severe infections, heart issues, or acute myocardial infarction should not take this medication. Women who are pregnant or breastfeeding, as well as patients with genetic lactose intolerance, should also avoid using this drug. Caution is required when this medication is administered to patients with mildly impaired kidney function or dehydration. Particularly, elderly patients or those on diuretics may experience blood pressure drops or worsening kidney function, thus their condition should be closely monitored before and after administration. During the use of this medication, genital infections or urinary tract infections may occur, which are more common in females. Various side effects such as dizziness, constipation, dry mouth, and lower back pain have also been reported, so consultation with healthcare professionals is necessary if symptoms occur. This medication is not recommended for patients with impaired liver function, and alcohol intake should be avoided as it may increase the risk of lactic acidosis. Also, it should be temporarily discontinued around certain examinations or surgeries involving radiological contrast agents, and it should only be resumed after confirming normal kidney function. This drug may interact with other medications, so if currently taking any, it is critical to inform healthcare providers. When used with diuretics, antihypertensive medications, insulin, or insulin secretagogues, the risk of hypoglycemia or hypotension may increase. Pregnant women or women who may become pregnant, as well as breastfeeding women, should not use this medication, and its safety in children has not yet been established. In case of overdose, appropriate treatment is necessary, and this medication should be kept out of the reach of children. Finally, during the use of this medication, dizziness may occur, necessitating caution while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • acute kidney injury
  • renal impairment
  • diabetic ketoacidosis
  • urosepsis
  • pyelonephritis
  • severe allergic reactions
  • severe edema
  • liver abnormality (jaundice)
Show 2 more
  • severe neurological symptoms
  • perineal necrosis

Mild side effects

  • Hypoglycemia
  • vulvovaginal infection
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • dizziness
  • constipation
  • dry mouth
  • lower back pain
  • urinary pain
Show 16 more
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • increased hematocrit
  • decreased renal creatinine clearance
  • dyslipidemia
  • elevated serum creatinine
  • increased blood urea
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased vitamin B12
  • abdominal pain
  • indigestion
  • abdominal discomfort

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. It is best to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Orange-colored, biconvex, oval-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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.