Medication info

K-Duo Sustained-Release Tablet 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
Orange, biconvex, egg-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204061 · Approved 2022.11.10

Summary

Main use
Blood glucose control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is typically administered once daily with dinner. The maximum dose is 10 mg dapagliflozin and 2000 mg sustained-release metformin once daily, given as 2 tablets of 5 mg/1000 mg. If there has been no prior experience with diabetes medication, the initial therapy should be one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects associated with metformin, dosing should be adjusted gradually.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Blood glucose 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 is used to enhance blood glucose control in adults with type 2 diabetes by combining dapagliflozin and metformin. It is administered as an adjunct to diet and exercise therapy to provide more effective blood glucose management. Particularly, in patients whose blood glucose is not sufficiently controlled and who have cardiovascular disease or risk factors, reference should be made to expert guidelines regarding the cardiovascular effects of dapagliflozin. This medication aids in maintaining safe and effective blood glucose control while also supporting cardiovascular health.

How to take

Adult dose

This medication is typically administered once daily with dinner. The maximum dose is 10 mg dapagliflozin and 2000 mg sustained-release metformin once daily, given as 2 tablets of 5 mg/1000 mg. If there has been no prior experience with diabetes medication, the initial therapy should be one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects associated with metformin, dosing should be adjusted gradually.

Precautions

This medication can very rarely cause a serious metabolic complication known as lactic acidosis. Lactic acidosis is a condition where there is a high level of lactate in the blood and an increase in acidity, which can be life-threatening. Caution should be exercised when using this medication in combination with other diabetes treatments like insulin or sulfonylureas, as there is a risk of hypoglycemia. This medication should not be administered to patients with moderate to severe renal impairment, dehydration, serious infections, or cardiovascular issues. It should also be avoided in pregnant or nursing women. Patients undergoing dialysis or suspected of acute renal injury should not use this medication. Patients with decreased fluid volume or renal problems should thoroughly evaluate their condition before administering this medication, and blood pressure and renal function should be monitored periodically during treatment. Special caution is required for patients with low blood pressure, those taking diuretics, and the elderly due to the risk of hypotension or dehydration. This medication can increase the risk of genital and urinary infections, so immediate treatment is necessary if infection symptoms appear. Vitamin B12 levels may drop, therefore, patients taking this medication for long periods should have regular Vitamin B12 tests. Excessive alcohol intake can increase the risk of side effects from this medication, therefore, heavy drinking should be avoided. While taking this medication, abrupt surgery or examinations using iodinated contrast agents should be stopped for a certain period, and treatment should only resume after confirming that renal function is normal. Elderly patients are at a higher risk for reduced renal function, making dose adjustment and monitoring of renal function important. In case of overdose, appropriate symptomatic treatment is required, and for the metformin component, removal can be achieved through hemodialysis. This medication has not established safety and efficacy in children, so it should not be used in this population. Patients should be cautious, as dizziness and other symptoms may occur when driving or operating machinery. Lastly, this medication should be stored in its original container and kept in a safe place out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, diabetic ketoacidosis, ketosis, urosepsis, pyelonephritis, acute kidney injury, renal impairment, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, chest pain, acute cholecystitis, atrial fibrillation, perineal necrosis, severe allergic reactions (such as hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor), severe skin adverse reactions (with high fever and severe rash, blisters, skin peeling, pain in oral/ocular mucosa)

Mild side effects

Hypoglycemia, vulvovaginitis, balanitis and related genital infections, urinary tract infections, reduced fluid volume (dehydration, hypovolemia, hypotension), constipation, dry mouth, back pain, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, elevated blood creatinine at the beginning of treatment, increased blood urea, weight loss, headache, paresthesia, tremor, diarrhea, thirst,

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture intrusion, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing in this manner helps maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Orange, biconvex, egg-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

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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.