Medication info
Flogaduo Extended Release Tablet 10/1000 milligrams

Flogaduo Extended Release Tablet 10/1000 milligrams

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Yellow, oval, film-coated tablet with a biconvex shape
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202107220 · Approved 2021.10.29 · Insurance code 662504680

Summary

Main use
Effect of blood glucose control and prevention of cardiovascular events in type 2 diabetes
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, not exceeding the maximum recommended doses of dapagliflozin 10mg and extended-release metformin 2000mg. Generally, it is administered once daily with the evening meal. The maximum dosage is dapagliflozin 10mg/extended-release metformin 2000mg once daily, given as two tablets of 5mg/1000mg. It is used as initial therapy.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Effect of blood glucose control and prevention of cardiovascular events in type 2 diabetes

  • Type 2 diabetes
  • poor blood glucose control
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication helps control blood sugar levels in adults with type 2 diabetes by using dapagliflozin and metformin together. It is administered to patients who are also following dietary and exercise regimens, and is particularly effective when blood sugar is not sufficiently controlled. It can also be applied to diabetes patients with cardiovascular diseases or risk factors. However, it is important to refer to professional information for detailed information regarding the occurrence of cardiovascular events. This medication aids diabetes management by improving blood glucose control.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment regimen, efficacy, and tolerability, not exceeding the maximum recommended doses of dapagliflozin 10mg and extended-release metformin 2000mg. Generally, it is administered once daily with the evening meal. The maximum dosage is dapagliflozin 10mg/extended-release metformin 2000mg once daily, given as two tablets of 5mg/1000mg. It is used as initial therapy.

Precautions

This medication is an anti-diabetic drug that helps control blood sugar levels and contains two components that work to lower blood sugar. While taking this medication, rare but serious metabolic complications known as lactic acidosis can occur, particularly in patients with poor kidney function or issues involving heart and liver function. Additionally, the risk of hypoglycemia may increase when used in conjunction with insulin or sulfonylureas, so close monitoring of blood sugar changes is necessary. This medication should not be administered to patients with moderate to severe kidney impairment, dehydration, acute infections, severe heart failure, or acute myocardial infarction. Patients scheduled for surgery or radiological contrast examinations should temporarily discontinue this medication and resume after confirming normal kidney function post-examination. Pregnant or breastfeeding women should not take this medication, and special caution is needed for children or elderly individuals aged 80 and over. This medication can cause a decrease in fluid volume or low blood pressure, so elderly patients or those on diuretics should frequently check their blood pressure and fluid status. During treatment, incidences of genital and urinary tract infections may increase, and immediate medical attention is necessary if symptoms of infection arise. Vitamin B12 levels may decrease, so regular testing of vitamin B12 levels is advisable during long-term use. Alcohol consumption can increase the risk of lactic acidosis, so it is safer to avoid drinking during treatment. Patients should be aware of symptoms related to hypoglycemia, lactic acidosis, and ketoacidosis while on this medication, and consult with medical professionals if any abnormal symptoms appear. Finally, this medication should not be used in children, pregnant women, or patients with severe kidney impairment, and because there are drug interactions, it is essential to inform healthcare providers about any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis (symptoms related to lactic acidosis: fatigue, myalgia, dyspnea, weakness, abdominal pain, hypothermia, hypotension, resistant bradyarrhythmias), severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe dermatological reactions (severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa), respiratory issues (shortness of breath or difficulty breathing, asthma attacks, cough

Mild side effects

Vulvovaginitis, balanitis, genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), decreased fluid volume, thirst, dizziness, constipation, dry mouth, lower back pain, painful urination, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, increased serum creatinine, dyslipidemia, weight loss, headache, paresthesia, tremor, upper abdominal pain, dyspepsia, abdominal discomfort, diarrhea, hypersensitivity

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 exposure to air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, oval, film-coated tablet with a biconvex shape

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.