Medication info

K-Duo Extended-Release Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
Dark pink, double convex, egg-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202107218 · Approved 2021.10.29

Summary

Main use
Effect on blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The dosage of this medication should be individualized based on the patient's current treatment, efficacy, and tolerability, without exceeding the maximum recommended doses of dapagliflozin 10 mg and extended-release metformin 2000 mg. This medication is generally administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/extended-release metformin 2000 mg once daily, taking 2 tablets of 5 mg/1000 mg.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Effect on blood glucose control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood glucose control
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication is used to assist blood glucose control in adults with type 2 diabetes. The combination of dapagliflozin and metformin complements the effects of diet and exercise. Particularly, consultation with a specialist is necessary before use for patients whose blood glucose is insufficiently controlled and who have cardiovascular diseases or risk factors. This medication is used to improve blood glucose control and assist in diabetes management.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment, efficacy, and tolerability, without exceeding the maximum recommended doses of dapagliflozin 10 mg and extended-release metformin 2000 mg. This medication is generally administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/extended-release metformin 2000 mg once daily, taking 2 tablets of 5 mg/1000 mg.

Precautions

This medication is used for the treatment of diabetes and should not be taken if kidney function is poor or if there is an acute illness. This medication can very rarely cause severe side effects called lactic acidosis, which can be life-threatening, so immediate consultation with a doctor is required if symptoms appear. Caution is needed when taken with insulin or sulfonylureas due to the risk of hypoglycemia. This medication should not be administered to patients with decreased kidney function, dehydration, severe infections, cardiovascular problems, or liver dysfunction. It is also safe for pregnant or breastfeeding women not to take this medication. In the elderly, kidney function may decline, so kidney function should be regularly monitored before and during treatment. During treatment with this medication, symptoms of reduced fluid volume or low blood pressure may occur, thus blood pressure and fluid status should be regularly checked. This medication may increase the risk of genital infections or urinary tract infections, so immediate treatment is necessary if symptoms of infection arise. Vitamin B12 levels may decrease, so monitoring Vitamin B12 status through blood tests is advised during long-term use. Alcohol consumption may increase the risk of side effects of this medication, so excessive drinking should be avoided. In case of surgery or radioactive iodine contrast examinations, this medication should be discontinued for a certain period, and resumed only after confirming that kidney function is normal. Patients should be aware of symptoms of hypoglycemia, lactic acidosis, and ketoacidosis during treatment; any abnormal symptoms should be reported to a doctor immediately. The safety and efficacy of this medication have not been established in children, so it is not used in this population. During medication use, dizziness may occur while driving or operating machinery, so caution is advised. This medication should be stored out of the reach of children, and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis (related to metformin), severe hypoglycemia, severe allergic reactions (related to hypersensitivity), acute kidney injury and renal dysfunction, cardiovascular collapse (shock), lactic acidosis associated with sepsis, ketoacidosis, urosepsis and pyelonephritis, perineal necrosis, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, acute cholecystitis, atrial fibrillation, pain in the genitals or perineum with fever and discomfort, erosion, redness

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased initial kidney creatinine clearance, dyslipidemia, elevated creatinine levels during initial treatment, increased blood urea, weight loss, headache, sensory disturbances, tremors, upper abdominal pain, dyspepsia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is safely stored at a temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Dark pink, double convex, 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.

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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.