Medication info
Dapagliflozin/Metformin Extended-release Tablet 10/1000 mg

Dapagliflozin/Metformin Extended-release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Yellow, oval-shaped, bilaterally convex extended-release film-coated tablet
Packaging
30 tablets/box [(6 tablets/PTP*5)], 30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202300154 · Approved 2023.01.06 · Insurance code 647805630

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
Administer once daily with the evening meal. The maximum dosage is Dapagliflozin 10 mg, extended-release Metformin 2000 mg. The initial recommended dosage is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. For patients already treated with Metformin, Dapagliflozin 10 mg is administered once daily. Tablets should be swallowed whole and not crushed, cut, or chewed. Dosage adjustments may be necessary based on kidney function.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

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

  • Difficulties in blood sugar control
  • type 2 diabetes
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication is used to effectively improve blood sugar control in adult patients with type 2 diabetes when combined with dietary and exercise therapies. It is particularly helpful for patients with type 2 diabetes who are not adequately controlled and have cardiovascular disease or risk factors. However, detailed information related to the occurrence of cardiovascular events in these patients should be referred to in professional information. Therefore, this medication provides positive assistance in blood sugar management and cardiovascular health maintenance in patients with type 2 diabetes.

How to take

Adult dose

Administer once daily with the evening meal. The maximum dosage is Dapagliflozin 10 mg, extended-release Metformin 2000 mg. The initial recommended dosage is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. For patients already treated with Metformin, Dapagliflozin 10 mg is administered once daily. Tablets should be swallowed whole and not crushed, cut, or chewed. Dosage adjustments may be necessary based on kidney function.

Precautions

This medication helps control blood sugar levels. However, it should not be used in patients with impaired kidney function, dehydration, severe infections, or acute heart diseases. Pregnant or breastfeeding women should also not take this medication. Regular kidney function tests are necessary while taking this medication, and any decrease in body fluid or symptoms of hypotension should be discussed with a physician. There is a risk of hypoglycemia when taken with insulin or sulfonylurea, so dosage adjustments may be necessary. This medication may lead to genital infections or urinary tract infections, and immediate treatment should be sought for any signs of infection. During treatment, vitamin B12 levels may decrease, so regular monitoring is advisable. Excessive alcohol consumption may increase the risk of side effects, so it should be avoided. When undergoing surgery or radiologic contrast examinations, it is necessary to suspend the use of this medication for a period of time and perform kidney function tests before resuming use. Dizziness or symptoms of hypotension may occur, so caution is needed while driving or operating machinery. This medication should be kept out of reach of children and stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • lactic acidosis
  • acute kidney injury
  • renal impairment
  • diabetic ketoacidosis
  • ketosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
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  • Guillain-Barré syndrome
  • acute cholecystitis
  • atrial fibrillation
  • severe edema or urinary abnormalities

Mild side effects

  • Vulvitis
  • balanitis and related genital infections
  • urinary tract infections
  • hypoglycemia
  • dizziness
  • constipation
  • dry mouth
  • lower back pain
  • dysuria
  • polyuria
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  • nocturia
  • vulvar pruritus
  • genital pruritus
  • increased hematocrit
  • decreased renal creatinine clearance
  • dyslipidemia
  • increased blood creatinine
  • increased blood urea
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased vitamin B12/deficiency
  • upper abdominal pain
  • dyspepsia
  • abdominal discomfort

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is essential to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Yellow, oval-shaped, bilaterally convex extended-release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP*5)], 30 tablets/bottle, 200 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.