Medication info
Flogaduo Extended Release Tablet 5/1000 mg

Flogaduo Extended Release Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Biconvex, egg-shaped film-coated tablets in dark pink color.
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202107219 · Approved 2021.10.29 · Insurance code 662504690

Summary

Main use
Blood glucose control in type 2 diabetes and prevention of cardiovascular events.
Who takes it
Adults
Adult dose
The dosage of this medication should be individualized based on the patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended dose of 10 mg of dapagliflozin and 2000 mg of extended-release metformin. Generally, it is administered once daily with dinner. The maximum dosage is 10 mg dapagliflozin/2000 mg extended-release metformin once daily, which is 2 tablets at the dosage of 5 mg/1000 mg. For patients with previous diabetes medication treatment

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Blood glucose control in type 2 diabetes and prevention of cardiovascular events.

  • Type 2 diabetes
  • abnormal blood glucose control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication helps control blood glucose levels in adults with type 2 diabetes by utilizing both dapagliflozin and metformin. It is prescribed as an adjunct to dietary and exercise therapy for patients. Additionally, in type 2 diabetes patients with cardiovascular disease or risk factors where blood glucose is poorly controlled, the impact of dapagliflozin on cardiovascular events can be verified in expert information. This medication is effectively used to improve blood glucose control and treat diabetes.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended dose of 10 mg of dapagliflozin and 2000 mg of extended-release metformin. Generally, it is administered once daily with dinner. The maximum dosage is 10 mg dapagliflozin/2000 mg extended-release metformin once daily, which is 2 tablets at the dosage of 5 mg/1000 mg. For patients with previous diabetes medication treatment

Precautions

This medication may rarely cause a serious metabolic complication known as lactic acidosis, so kidney function and overall health status should be thoroughly assessed before use. During the use of this medication, caution should be taken, as the risk of hypoglycemia may increase when used with insulin or sulfonylurea drugs, and blood glucose changes should be closely monitored. It is safer not to use this medication in patients with moderate to severe renal impairment, dehydration, serious infections, or cardiovascular problems. Patients scheduled to undergo tests using iodinated contrast agents should discontinue this medication 48 hours prior to the test and only resume after normal kidney function is confirmed post-testing. Patients scheduled for surgery should also temporarily discontinue this medication 48 hours before surgery and resume after confirming normal kidney function post-surgery. Pregnant or breastfeeding women should not take this medication, and it should be discontinued immediately upon confirmation of pregnancy. Elderly patients and those with decreased kidney function should carefully adjust the dosage and regularly monitor kidney function. This medication may increase the risk of genital and urinary infections, so immediate consultation with a physician is necessary if infection symptoms arise. Symptoms of decreased fluid volume or hypotension may occur, so especially in patients at risk of dehydration or hypotension, monitoring of blood pressure and fluid status should be performed periodically. Vitamin B12 levels may decrease, so checking serum vitamin B12 levels is advisable with long-term use. Alcohol may increase the risk of side effects from this medication, so excessive drinking should be avoided during treatment. Hypoglycemic symptoms may occur during the administration of this medication, so patients at risk for hypoglycemia should closely monitor their blood glucose levels. This medication may interact with other drugs, so any other medications being taken must be disclosed to healthcare providers. In case of overdose, immediate medical attention is required, and dialysis treatment may be beneficial if necessary. The safety and efficacy of this medication in children have not been established, so it should not be used in this population. This medication should be kept out of reach of children and stored in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain of oral/ocular mucosa, difficulty or shortness of breath, asthma attack, respiratory abnormality with cough + fever, jaundice (yellowing of skin or eyes), severe lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Hypoglycemia
  • dry mouth
  • constipation
  • back pain
  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • increased hematocrit
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  • dyslipidemia
  • elevated serum creatinine
  • elevated urea levels
  • weight loss
  • dizziness
  • diarrhea
  • nausea/vomiting
  • decreased/deficiency of vitamin B12
  • abdominal pain
  • dyspepsia
  • abdominal discomfort
  • irritable bowel syndrome
  • salivary gland swelling
  • dental pain
  • headache
  • sensory disturbances
  • tremor
  • nasopharyngitis
  • pharyngitis

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best to store it in a place at room temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Biconvex, egg-shaped film-coated tablets in dark pink color.

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.