Medication info
Dapagliflozin Metformin Sustained-release Tablet 10/500 mg

Dapagliflozin Metformin Sustained-release Tablet 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›505mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Pink, double-sided convex oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204358 · Approved 2022.12.05 · Insurance code 657308860

Summary

Main use
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 dose is once daily dapagliflozin 10 mg/sustained-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dose should be adjusted gradually.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

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

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

This medication is used to assist in blood sugar control for adult patients with type 2 diabetes who take dapagliflozin and metformin together. It is effective as an adjunct to dietary and exercise therapy, particularly suitable for patients whose blood sugar is not adequately controlled. However, patients with cardiovascular diseases or risks should use it cautiously after consulting a specialist. Overall, this medication helps improve blood sugar management in type 2 diabetes.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dose is once daily dapagliflozin 10 mg/sustained-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dose should be adjusted gradually.

Precautions

This medication contains metformin and dapagliflozin, which are diabetes treatments. Though rare, a serious condition called lactic acidosis can occur while taking this medication, so it should not be used in cases of impaired kidney function or severe infections, or dehydration. Furthermore, caution is necessary when used in conjunction with insulin or sulfonylureas, as hypoglycemia may occur. Patients with moderate or severe impaired kidney function, heart failure, acute myocardial infarction, sepsis, or acute diseases with cardiovascular collapse should also avoid this medication. Patients scheduled for tests using iodine contrast agents should stop taking this medication 48 hours prior to the test and begin again only after ensuring normal kidney function post-test. Pregnant or breastfeeding women should not use this medication, and patients with genetic issues such as lactose intolerance should also refrain from using it. Elderly patients or those with decreased kidney function should have their kidney function closely evaluated before taking this medication, and kidney function, blood pressure, and fluid status should be monitored regularly during treatment. This medication may cause reduced fluid volume or low blood pressure due to increased urination, so caution is advised for patients with symptoms of dehydration or low blood pressure. Genital infections or urinary infections may occur during treatment; if related symptoms arise, consult a doctor immediately. The metformin component can cause vitamin B12 deficiency, so blood serum vitamin B12 levels should be checked during prolonged use. Excessive alcohol consumption may elevate the risk of side effects from this medication, so avoiding alcohol during treatment is recommended. This medication may interact with other drugs, so dosage adjustments and monitoring are necessary according to medical advice, especially when used with diuretics, antihypertensives, insulin, etc. In case of overdose, immediate medical attention should be sought, and patients with impaired kidney function may require dialysis treatment. Finally, the safety of this medication has not been established in children, and caution is needed as dizziness may occur when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe edema or urination abnormalities, severe skin reactions (severe rash with fever, blisters, skin peeling, oral/eye mucous membrane pain), severe allergic reactions (hives, severe swelling, chest tightness, breathing difficulties, cold sweat, pallor), respiratory problems (difficulty breathing or shortness of breath, asthma attacks, cough accompanied by fever along with respiratory abnormalities), liver abnormalities (yellowing of the skin or eyes, etc.)

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, fungal infection, hypoglycemia (when used with sulfonylureas or insulin), dry mouth, dizziness, constipation, low back pain, dysuria, polyuria, nocturia, pruritus of the vulva, pruritus of the genital area, elevated hematocrit, initial decreased renal creatinine clearance, dyslipidemia, elevated serum creatinine at the start of treatment, elevated blood urea, weight loss

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

Storage

This medication may be sensitive to air or humidity, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

Pink, double-sided convex oval 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.

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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.