Medication info
DapaM Duo Sustained Release Tablet 5/500 mg

DapaM Duo Sustained Release Tablet 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Orange rectangular sustained-release film-coated tablet
Packaging
28 tablets/box [7 tablets/PTP x 4]
Approval status
Active

MFDS item code 202302655 · Approved 2023.09.06 · Insurance code 645210860

Summary

Main use
Effect of 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 dosages are 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, dosed as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dose is 5 mg/500 mg or 10 mg/500 mg once daily. To minimize gastrointestinal side effects of metformin, doses should be adjusted gradually.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Effect of controlling blood sugar in type 2 diabetes and preventing cardiovascular events

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

This drug is used in combination with diet and exercise to help control blood sugar in adults with type 2 diabetes, using dapagliflozin and metformin. It should be administered with caution according to expert guidelines, especially in patients with cardiovascular disease or risk factors whose blood sugar is not sufficiently controlled. This drug is effectively used to improve blood sugar management in diabetic patients.

How to take

Adult dose

This drug is generally administered once daily with the evening meal. The maximum dosages are 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, dosed as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dose is 5 mg/500 mg or 10 mg/500 mg once daily. To minimize gastrointestinal side effects of metformin, doses should be adjusted gradually.

Precautions

This drug is an antidiabetic medication that helps in controlling blood sugar. It may very rarely cause a serious metabolic disorder called lactic acidosis, which can be life-threatening; therefore, caution is needed. When used in combination with other antidiabetic drugs, there is a risk of hypoglycemia, so blood sugar levels should be closely monitored. This drug should not be used in patients with significantly impaired kidney function, serious infection or dehydration, type 1 diabetes patients, pregnant or nursing women, etc. Patients undergoing surgery or those undergoing tests using iodine contrast agents should temporarily discontinue this drug and restart it after confirming normal kidney function. Elderly patients or those with compromised kidney function should regularly check kidney function and fluid status before and after taking this drug, and carefully observe for any symptoms of hypotension or dehydration. This drug may increase the risk of genital and urinary tract infections, so if infection symptoms appear, medical consultation should be sought immediately. The metformin component may lower vitamin B12 levels, thus checking vitamin B12 levels regularly during long-term use is advisable. Excessive alcohol consumption should be avoided, and it is preferable to limit alcohol intake during treatment. This drug may need to be temporarily discontinued in situations of difficult blood sugar control, and dosage adjustments of insulin or other antidiabetic agents may be required to prevent hypoglycemia. Pregnant women or women who may become pregnant should avoid taking this drug, and it is also best for nursing mothers not to use it. There may be risks of dizziness or hypoglycemia when driving or operating machinery while taking this drug, so caution is advised. Keep out of reach of children and store in the 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, renal dysfunction, acute kidney injury, lactic acidosis-related hepatic abnormalities, ketoacidosis, urosepsis, pyelonephritis, severe allergic reactions, severe edema, perineal necrosis

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar pruritus, genital pruritus, dyslipidemia, increase in serum creatinine, increase in serum urea, weight loss, chest pain, weakness, fatigue, peripheral edema, swelling, pain, hyperglycemia, urethral syndrome,

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

Storage

This drug should be stored in a tightly closed container to avoid exposure to air or moisture. Additionally, it is advisable to store the medication at room temperature between 1 degree and 30 degrees Celsius, avoiding very hot or very cold places.

Appearance and packaging

Appearance

Orange rectangular sustained-release film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP x 4]

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.