Medication info
Dapagliflozin and Metformin Extended-Release Tablets 10/1000 mg

Dapagliflozin and Metformin Extended-Release Tablets 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Bis L-proline›15.63mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Yellow to deep yellow, biconvex, oval, film-coated tablet
Packaging
30 tablets/box [6 tablets (Alu-Alu) X 5], 30 tablets/bottle
Approval status
Active

MFDS item code 202108084 · Approved 2021.12.23

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is usually administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/metformin extended-release 2000 mg once daily, taken as 2 tablets of 5 mg/1000 mg. If there has been no previous experience in diabetes pharmacotherapy, the initial therapy is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. For patients already on metformin therapy, the recommended dose of dapagliflozin is 10 mg once daily.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • blood sugar level abnormalities
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication acts by combining dapagliflozin and metformin to help control blood sugar levels in adults with type 2 diabetes. It can be used in conjunction with meal plans and physical exercise for more effective blood sugar management. It is also safe to use in patients with cardiovascular disease or risk factors, but detailed information should be referenced from a specialist's guidance. This medication aids in improving blood sugar management in diabetic patients.

How to take

Adult dose

This medication is usually administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/metformin extended-release 2000 mg once daily, taken as 2 tablets of 5 mg/1000 mg. If there has been no previous experience in diabetes pharmacotherapy, the initial therapy is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. For patients already on metformin therapy, the recommended dose of dapagliflozin is 10 mg once daily.

Precautions

This medication is used for the treatment of type 2 diabetes and helps control blood sugar levels. While taking this medication, caution is required as a rare but serious side effect called lactic acidosis may occur. Lactic acidosis is a state where excessive lactic acid accumulates in the body, leading to symptoms such as difficulty breathing, muscle pain, lethargy, abdominal pain, and if any of these symptoms appear, consult a doctor immediately. Additionally, when taken with other diabetes medications such as insulin or sulfonylureas, hypoglycemia can occur, so blood sugar levels should be frequently monitored. Patients with impaired kidney function, dehydration, serious infections, heart problems, or liver dysfunction should not take this medication. Especially, patients with moderate to severe renal impairment should be very cautious or strictly contraindicated from taking this medication. Those scheduled for surgery or undergoing tests using iodinated contrast media should temporarily discontinue this medication before and after the procedure, resuming only after normal kidney function has been restored. Pregnant or breastfeeding women should not take this medication, and its safety and efficacy in children have not been established. This medication should be used with caution in patients at risk for decreased fluid volume or hypotension, especially the elderly or those on diuretics, and blood pressure and kidney function should be periodically monitored. During treatment, genital infections or urinary tract infections may occur, so prompt treatment should be sought if infection symptoms appear. Vitamin B12 levels may decrease, so it is advisable to check vitamin B12 levels with blood tests during prolonged use. Excessive alcohol consumption should be avoided as alcohol can increase the risk of side effects from this medication. While taking this medication, there may be interactions with other drugs, so it is important to inform your doctor or pharmacist of any other medications you are taking. In case of overdose, seek medical attention immediately, as this medication can typically be removed through dialysis. Finally, this medication should be kept out of the reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, serious lactic acidosis (reported fatalities), severe allergic reactions (history of hypersensitivity), acute kidney injury, renal impairment, cardiovascular collapse (shock), acute myocardial infarction, sepsis, acute or chronic metabolic acidosis, diabetic precoma, congestive heart failure, acute cholecystitis, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, atrial fibrillation, ketoacidosis, urosepsis, pyelonephritis, rash, perineal necrosis,

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • fluid volume reduction
  • dry mouth
  • dizziness
  • constipation
  • back pain
Show 19 more
  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • increased hematocrit
  • elevated serum creatinine
  • elevated serum urea
  • dyslipidemia
  • weight loss
  • headache
  • paresthesia
  • tremor
  • upper abdominal pain
  • indigestion
  • abdominal discomfort
  • diarrhea
  • abdominal pain
  • gastric ulcer

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. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Proper storage ensures the safety and efficacy of the medication.

Appearance and packaging

Appearance

Yellow to deep yellow, biconvex, oval, film-coated tablet

Package unit

30 tablets/box [6 tablets (Alu-Alu) X 5], 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.