Medication info

DuoRich Sustained Release Tablets 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
풍림무약(주)
Appearance
Pink, double convex, egg-shaped film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204058 · Approved 2022.11.10

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally taken as 1 tablet once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/metformin sustained release 2000 mg once daily, administered as 2 tablets of 5 mg/1000 mg. If there is no prior experience with diabetes medication therapy, the initial therapy consists of taking 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, doses should be incrementally adjusted.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events

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

This medication assists adults with type 2 diabetes in controlling blood glucose levels through dietary and exercise therapy, by administering dapagliflozin and metformin together. In particular, for patients with cardiovascular disease or risk factors among those whose blood sugar is not adequately controlled, it is important to refer to specialist information regarding the impact of dapagliflozin on cardiovascular event occurrence. This medication aids in diabetes management by improving blood sugar control.

How to take

Adult dose

This medication is generally taken as 1 tablet once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/metformin sustained release 2000 mg once daily, administered as 2 tablets of 5 mg/1000 mg. If there is no prior experience with diabetes medication therapy, the initial therapy consists of taking 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, doses should be incrementally adjusted.

Precautions

This medication is used for the treatment of diabetes, and one of its active ingredients, metformin hydrochloride, is excreted by the kidneys, so it should not be administered to patients with impaired kidney function. This medication can very rarely cause a serious condition known as lactic acidosis, which is characterized by increased levels of lactic acid in the blood and increased acidity, potentially fatal without appropriate treatment. Additionally, caution is required when taken with insulin or sulfonylureas as hypoglycemia may occur. Patients with moderate or severe renal impairment, dehydration, severe infections, cardiovascular problems, or acute diseases such as acute myocardial infarction should not be administered this medication. Before procedures that use iodinated radiocontrast agents, this medication should be stopped at least 48 hours prior and should not be resumed until renal function is confirmed as normal after the procedure. Prior to surgery, except for minor surgeries with no restrictions on food and fluid intake, this medication should be temporarily stopped 48 hours prior to surgery, and resumed only after normal renal function is confirmed post-surgery. It is not recommended to use this medication in pregnant or breastfeeding women. In elderly patients, because renal function deterioration is common, dose adjustments may be necessary, and regular monitoring of renal function is advised. During treatment with this medication, there may be a risk of dehydration or low blood pressure, so careful monitoring of fluid status and blood pressure is required, particularly if diuretics are being taken concurrently. This medication may increase the risk of genital and urinary tract infections, so if related symptoms develop, prompt consultation with healthcare personnel is necessary. Vitamin B12 levels may decrease, so long-term users should regularly check their vitamin B12 levels. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided during treatment. This medication may induce hypoglycemic symptoms, so caution is needed regarding hypoglycemic symptoms when combined with blood sugar-lowering agents, and adjustments to the doses of these agents may be necessary. In the event of an overdose, contact healthcare personnel immediately for appropriate treatment; the component metformin can be removed through dialysis, which may assist in cases of acute toxicity. During treatment, caution should be exercised while driving or operating machinery due to the risk of dizziness. Finally, this medication should be kept out of the reach of children and stored in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, ketoacidosis, urosepsis, pyelonephritis, acute kidney injury, renal impairment, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash with fever, blisters, peeling skin, pain of oral/ocular mucosa), respiratory issues (shortness of breath or difficulty breathing, asthma attacks, coughing with fever accompanied respiratory abnormalities).

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infection, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased initial kidney creatinine clearance, dyslipidemia, initial increase in serum creatinine, elevated blood urea, weight loss, upper abdominal pain, indigestion, abdominal discomfort, diarrhea, abdominal pain.

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to keep storage temperatures between 1 to 30 degrees Celsius at room temperature. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink, double convex, egg-shaped film-coated tablets

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.