Medication info
Flogam Duo Extended-Release Tablets 10/500 mg (Dapagliflozin, Metformin)

Flogam Duo Extended-Release Tablets 10/500 mg (Dapagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Pink oval extended-release film-coated tablets
Packaging
28 tablets/box [7 tablets/PTP x 4]
Approval status
Active

MFDS item code 202400167 · Approved 2024.01.23 · Insurance code 662504980

Summary

Main use
Efficacy in blood sugar control for 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, efficacy, and tolerance, without exceeding the maximum recommended dose of dapagliflozin 10 mg and extended-release metformin 2000 mg. Generally, it is administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/extended-release metformin 2000 mg once daily, given as 2 tablets of 5 mg/1000 mg. For those without prior experience of diabetes medication,

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Efficacy in blood sugar control for type 2 diabetes and prevention of cardiovascular events

  • Blood sugar control in patients with type 2 diabetes
  • poorly controlled type 2 diabetes
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used in combination with dapagliflozin and metformin to assist in blood sugar control for adults with type 2 diabetes. It can effectively manage blood sugar levels as an adjunct to dietary and exercise therapy. Especially for patients with type 2 diabetes whose blood sugar is not adequately controlled, it is important to refer to additional information from professionals regarding the impact of dapagliflozin on the occurrence of cardiovascular events, particularly in those with cardiovascular disease or risk factors. This medication is used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment, efficacy, and tolerance, without exceeding the maximum recommended dose of dapagliflozin 10 mg and extended-release metformin 2000 mg. Generally, it is administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/extended-release metformin 2000 mg once daily, given as 2 tablets of 5 mg/1000 mg. For those without prior experience of diabetes medication,

Precautions

This medication may rarely cause a serious condition called lactic acidosis, so patients with reduced kidney function or problems with heart, liver, or lung function should be especially cautious. This medication can cause hypoglycemia when used in combination with other diabetes medications, so dosage adjustments may be necessary when used concurrently with insulin or sulfonylureas. Patients with moderate or severe renal impairment, dehydration, serious infections, or cardiovascular issues should not take this medication. If undergoing imaging tests using iodinated contrast agents, this medication should be discontinued 48 hours before the test and resumed only after kidney function is confirmed to be normal. Pregnant or potentially pregnant women and nursing mothers should not use this medication, and its safety and efficacy in children have not been established. This medication can cause depletion of fluid volume and low blood pressure, so elderly patients or those on diuretics or with low blood pressure should be cautious while taking it. There may be an increased risk of genital and urinary tract infections during use, so any related symptoms should be reported to healthcare professionals immediately. Vitamin B12 levels may decrease, so patients taking it long-term should have regular blood tests to monitor this. Excessive alcohol consumption may heighten the risk of side effects with this medication; therefore, it is advisable to avoid alcohol while taking it. Patients scheduled for surgery should discontinue this medication 48 hours before the procedure and can resume it after kidney function has been restored post-surgery. During treatment, dizziness or symptoms of hypoglycemia may occur, requiring caution while driving or operating machinery. Store this medication away from the reach of children and keep it in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • acute renal failure
  • renal impairment
  • diabetic ketoacidosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • worsening renal function
  • necrotizing fasciitis
Show 11 more
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • atrial fibrillation
  • acute cholecystitis
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory issues
  • liver abnormalities (jaundice)
  • serious neurological symptoms
  • severe edema or urination abnormalities

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • back pain
  • dysuria
Show 16 more
  • polyuria
  • nocturia
  • genital itching
  • and hyperlipidemia
  • elevated blood creatinine
  • increased blood urea
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased/deficiency of vitamin B12
  • abdominal pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • gastric ulcers
  • irritable bowel syndrome

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness.

Appearance and packaging

Appearance

Pink oval extended-release film-coated tablets

Package unit

28 tablets/box [7 tablets/PTP x 4]

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.