Medication info

Floqaduro Extended-Release Tablet 10/500 mg

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202204066 · Approved 2022.11.10

This product's status changed to Approval withdrawn on 2023.10.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is typically administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/metformin extended-release 2000 mg, given as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dose is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. This medication should be swallowed whole and should not be crushed, cut, or chewed.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Effect on blood sugar control in 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 adults with type 2 diabetes by combining dapagliflozin and metformin. It especially enhances effects by complementing dietary and exercise therapy. For patients whose blood sugar control is insufficient and who have cardiovascular disease or risk factors, consultation with a specialist regarding the cardiovascular events related to dapagliflozin is necessary. This medication effectively supports blood sugar control in diabetic patients.

How to take

Adult dose

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

Precautions

This medication helps in controlling blood sugar; however, it should not be used in patients with impaired kidney function or acute illness. Rarely, it can cause a serious condition called lactic acidosis, which occurs when lactic acid accumulates excessively in the body and can be very dangerous, so seek immediate medical treatment if symptoms appear. Additionally, caution is warranted when used with insulin or other diabetes medications due to the risk of hypoglycemia. Patients with reduced kidney function, dehydration, severe infections, heart problems, liver dysfunction, or women who are pregnant or breastfeeding should not take this medication. In certain situations, such as surgery or radiological examinations, the intake of this medication should be temporarily suspended, and it should be restarted only after confirming normal kidney function. While taking this medication, genital infections, urinary infections, hypoglycemia, dehydration symptoms, dizziness, etc., may occur, so consult a doctor if unusual symptoms arise. Especially in elderly patients or those with decreased kidney function, regular kidney function tests should be conducted, and dosage should be adjusted accordingly. This medication may interact with other drugs; therefore, inform your healthcare provider of any other medications you are taking. It should not be used during pregnancy or breastfeeding, and its safety and efficacy have not been established in children. In the case of overdose, seek appropriate treatment at a medical institution immediately, and keep this medication out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • acute kidney injury
  • dehydration
  • hypovolemia
  • hypotension
  • diabetic ketoacidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
Show 11 more
  • acute cholecystitis
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • atrial fibrillation
  • severe allergic reactions
  • severe skin reactions
  • respiratory issues
  • liver issues (jaundice)
  • serious neurological symptoms
  • severe edema or urinary irregularities

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), thirst, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, pruritus of the vulva, pruritus of the genitals, dyslipidemia, weight loss, headache, paresthesia, tremor, abdominal pain, indigestion, abdominal discomfort, diarrhea, salivary gland swelling, toothache, drowsiness, peripheral neuropathy, dryness

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 tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to ensure prolonged effectiveness.

Appearance and packaging

Appearance

Pink, biconvex, oval 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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.