Medication info

K-Duo Sustained-release Tablets 10/500 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
Pink, oval-shaped, double-coated film tablets
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202204062 · Approved 2022.11.10

This product's status changed to Approval withdrawn on 2023.10.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 administered once daily with the evening meal. The maximum dosage is one daily dose of dapagliflozin 10 mg/sustained-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. The recommended starting dose when used as initial therapy is one tablet of 5 mg/500 mg or 10 mg/500 mg taken once daily. This medication should be swallowed whole and should not be crushed, cut, or chewed.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

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

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

This medication is used to improve blood sugar control in adult patients with type 2 diabetes who are not adequately controlled with diet and exercise alone, through the combined administration of dapagliflozin and metformin. Patients with cardiovascular disease or risk factors for cardiovascular disease should consult a healthcare professional before use. This medication assists in blood sugar control and effectively contributes to diabetes management.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is one daily dose of dapagliflozin 10 mg/sustained-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. The recommended starting dose when used as initial therapy is one tablet of 5 mg/500 mg or 10 mg/500 mg taken once daily. This medication should be swallowed whole and should not be crushed, cut, or chewed.

Precautions

This medication is used for the treatment of diabetes and should not be used in patients with decreased kidney function, serious infections, dehydration, acute myocardial infarction, or other such conditions. During the course of treatment, there is a rare but serious risk of lactic acidosis, so if symptoms such as difficulty breathing, muscle pain, or fatigue occur, contact a doctor immediately. The risk of hypoglycemia may be present when used in conjunction with insulin or other diabetic medications; therefore, blood sugar levels should be monitored regularly, and medication dosages adjusted if necessary. Women who are pregnant or breastfeeding should not use this medication, and it should be discontinued immediately if pregnancy is confirmed. Elderly patients with decreased kidney function or reduced fluid volume should use this medication with caution, and regular kidney function tests and fluid status checks are recommended. It is advisable to avoid alcohol while using this medication, and gastrointestinal disturbances or infection symptoms may occur; thus, informing healthcare personnel of any onset of symptoms is important. Additionally, this medication contains certain dyes, so use with caution if allergic to any of these ingredients, and exercise caution while driving or operating machinery during treatment. In case of overdose, seek medical attention immediately and keep the medication in its original container out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, acute cholecystitis, ketoacidosis, urosepsis, pyelonephritis, acute kidney injury, renal impairment, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, severe swelling, elevated blood pressure, severe allergic reactions, hives, significant swelling, chest tightness, difficulty breathing, cold sweats, pallor, shortness of breath or difficulty breathing, asthma

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • hypoglycemia
  • reduced fluid volume
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • low back pain
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  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • dyslipidemia
  • increased blood creatinine
  • increased blood urea
  • weight loss
  • rash
  • diarrhea
  • nausea/vomiting
  • upper abdominal pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • irritable bowel syndrome
  • salivary gland swelling
  • toothache
  • headache

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the drug's effectiveness.

Appearance and packaging

Appearance

Pink, oval-shaped, double-coated film 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.