Flogam Duo Extended-Release Tablets 5/500 mg (Dapagliflozin, Metformin)

Adult dose

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

This medication consists of two components that help control blood sugar. First, it acts by causing glucose to be excreted through the urine in the kidneys, thus lowering blood sugar levels. However, it should not be administered to patients with impaired kidney function, and kidney function must be checked before and after administration. Secondly, it assists in blood sugar control by inhibiting glucose production in the liver and reducing glucose absorption in the intestines. However, this component can very rarely cause a serious side effect called lactic acidosis, so caution is required for patients with poor kidney function or liver dysfunction. If conditions that may affect kidney function arise during treatment, such as dehydration, severe infection, or acute myocardial infarction, treatment should be immediately discontinued. Furthermore, this medication should be temporarily halted before surgeries or tests involving iodine contrast agents, and resuming only after confirming normal kidney function. This medication may increase the risk of hypoglycemia when used in combination with other diabetes medications, such as insulin or sulfonylureas; therefore, dosage adjustments may be necessary for those medications. During treatment, genital infections or urinary tract infections may occur, and if related symptoms arise, consult a doctor immediately. Moreover, due to reduced fluid volume, this medication may cause low blood pressure or dizziness, necessitating caution, particularly in the elderly or patients taking diuretics. Pregnant or nursing women should not take this medication, and it should be discontinued upon confirmation of pregnancy. This medication can lower vitamin B12 levels, so it is advisable to regularly check vitamin B12 status during long-term use. Excessive alcohol consumption may increase the risk of side effects with this medication; hence it should be avoided. Lastly, the safety and efficacy of this medication have not been established in children, and in elderly patients, kidney function should be monitored more closely during use.

Serious side effects

Lactic acidosis, severe hypoglycemia, severe edema and increased blood pressure, acute renal impairment, cardiovascular collapse (shock), acute myocardial infarction, liver abnormalities associated with lactic acidosis, severe allergic reactions, severe dermatological adverse reactions, serious neurological symptoms (headache, seizures, confusion, etc.), ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, acute cholecystitis, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, atrial fibrillation, acute cholecystitis

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, itching of the vulva, itching of the genitalia, increased hematocrit, elevated serum creatinine at treatment initiation, dyslipidemia, increased serum urea, weight loss, headache, paresthesia, tremors, upper abdominal pain, dyspepsia, abdominal discomfort, diarrhea, abdominal pain, gastric ulcer, excessive

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. Additionally, it is advisable to store it at room temperature between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance

Orange oval extended-release film-coated tablet

Package unit

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