Medication info
Dapagliflozin Metformin Extended-Release Tablets 10/500 mg

Dapagliflozin Metformin Extended-Release Tablets 10/500 mg

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

MFDS item code 202204037 · Approved 2022.11.08 · Insurance code 640007830

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 dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin taken once daily, administered as two tablets of 5 mg/1000 mg. For patients who have no previous experience with diabetes medications and have difficulty achieving adequate blood sugar control with monotherapy, the initial regimen involves taking one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. This

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

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

  • Type 2 diabetes
  • blood sugar control abnormalities
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication is used to enhance blood sugar control in adult patients with type 2 diabetes by complementing diet and exercise therapy. In particular, effective blood sugar management can be achieved through the combination of dapagliflozin and metformin. For patients with cardiovascular diseases or risk factors, it is important to refer to additional information provided by a specialist regarding the impact of this medication on the occurrence of cardiovascular events. Overall, this medication plays an important role in assisting blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin taken once daily, administered as two tablets of 5 mg/1000 mg. For patients who have no previous experience with diabetes medications and have difficulty achieving adequate blood sugar control with monotherapy, the initial regimen involves taking one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. This

Precautions

This medication is used for the treatment of diabetes and helps in controlling blood sugar levels. However, it may rarely cause a serious side effect called lactic acidosis, so caution is needed. When used in combination with other diabetes medications, there may be an increased risk of hypoglycemia, requiring dosage adjustments. Patients with impaired kidney function, dehydration, severe infections, or weak heart function should not use this medication. It should also be discontinued for a certain period before and after surgeries or diagnostic tests involving radiopaque agents, and it should be resumed only after confirming normal kidney function. Pregnant or lactating women should not use this medication, and careful use is advised in children and elderly patients. While taking this medication, regular checks of blood sugar and kidney function are necessary, and patients should be vigilant for symptoms of hypoglycemia or dehydration. Additionally, genital or urinary infections may occur, so medical consultation is required immediately if such symptoms arise. This medication may lower vitamin B12 levels, so it is advisable to check vitamin B12 status during long-term use. Excessive alcohol should be avoided, and there is potential for drug interactions with other medications, so consultation with healthcare professionals is essential regarding co-medication. While taking this medication, fluid volume status and blood pressure should be periodically monitored, and caution should be exercised if dizziness or hypotensive symptoms occur. In case of overdose, immediate medical attention should be sought, and this medication should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe allergic reactions, acute kidney injury, renal dysfunction, heart failure, diabetic ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, acute cholecystitis, atrial fibrillation, severe skin adverse reactions (severe rash with fever, blisters, skin peeling, pain in mucosal membranes of mouth/eyes), respiratory problems (shortness of breath or difficulty breathing, asthma attacks, cough and fever).

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • back pain
  • dysuria
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  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • dyslipidemia
  • increased serum creatinine
  • elevated blood urea
  • weight loss
  • rash
  • diarrhea
  • nausea/vomiting
  • decreased vitamin B12
  • upper abdominal pain
  • indigestion
  • abdominal discomfort
  • diarrhea
  • abdominal pain
  • gastric ulcers
  • hypersensitivity.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid extremely hot or cold places, and store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink, biconvex, oval-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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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.