Medication info

Flogaduo Extended-Release Tablets 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Orange, biconvex, egg-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204065 · Approved 2022.11.10

Summary

Main use
Effects of blood glucose 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 dose is dapagliflozin 10 mg and extended-release metformin 2000 mg once daily, 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. Dosage should be gradually adjusted to minimize gastrointestinal side effects of metformin.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Effects of 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 improve blood glucose control in adult patients with type 2 diabetes when combined with dietary and exercise therapy. It is particularly effective for patients whose blood glucose is not adequately controlled by using dapagliflozin in conjunction with metformin. Furthermore, in the case of patients with cardiovascular disease or risk factors, it is important to reference expert guidelines regarding the impact of dapagliflozin on cardiovascular events and use it safely. This medication enhances blood glucose control and assists in managing type 2 diabetes.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dose is dapagliflozin 10 mg and extended-release metformin 2000 mg once daily, 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. Dosage should be gradually adjusted to minimize gastrointestinal side effects of metformin.

Precautions

This medication is used for the treatment of diabetes and helps in controlling blood glucose levels. Caution is needed as a rare side effect called severe lactic acidosis may occur while taking this medication. Lactic acidosis can lead to dangerous conditions due to excessive accumulation of lactic acid in the body. Furthermore, when taken with insulin or sulfonylureas, there is a risk of hypoglycemia, so careful monitoring of blood glucose levels is necessary. Patients with certain health conditions such as impaired kidney function, dehydration, severe infections, or weakened heart function should not take this medication. Prior to and following surgical procedures or tests using iodine-based contrast agents, this medication should be temporarily discontinued, and it should be resumed only after confirming normal kidney function. Women who are pregnant or breastfeeding should not use this medication, and safety and efficacy have not been established for children. Caution is warranted for patients at risk of decreased fluid volume or hypotension, especially in elderly patients or those with reduced kidney function, who should have their kidney function monitored regularly. During treatment, genital or urinary infections may occur, so immediate consultation with healthcare professionals is recommended if related symptoms appear. This medication can lower vitamin B12 levels, so regular checks of vitamin B12 levels are advised for prolonged usage. Excessive alcohol consumption can increase the risk of side effects of this medication, so it should be avoided. Due to the risk of hypoglycemia, any symptoms of hypoglycemia (such as dizziness, cold sweat, severe fatigue, etc.) should be addressed immediately, and dosage adjustments may be necessary when taken with insulin or other hypoglycemic agents. Symptoms of dehydration or hypotension may occur while taking this medication, so adequate fluid intake and blood pressure management are important. This medication does not significantly affect driving or the operation of machinery, but caution should be exercised due to possible dizziness. It is crucial to adhere to the prescribed methods and dosages while taking the medication and to receive regular check-ups as directed by a healthcare provider. Keep out of the reach of children and store in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • lactic acidosis
  • acute renal failure
  • diabetic ketoacidosis
  • urosepsis and pyelonephritis
  • renal impairment
  • Guillain-Barré syndrome
  • atrial fibrillation
  • acute cholecystitis
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  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory issues
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema or urinary abnormalities
  • cardiovascular collapse
  • shock
  • acute myocardial infarction
  • coma
  • diabetic pre-coma
  • severe infections

Mild side effects

  • Vulvitis
  • 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 pruritus
  • genital pruritus
  • elevated hematocrit
  • dyslipidemia
  • elevated serum creatinine
  • elevated blood urea
  • weight loss
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • tendinitis
  • chest pain
  • thermal burns
  • wrist fractures
  • gastrointestinal abnormalities

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication over time.

Appearance and packaging

Appearance

Orange, biconvex, 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.

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.