Medication info

Dapagli glyflozin Duo Sustained Release Tablet 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Pink, bilaterally convex, oval-shaped sustained-release film-coated tablet
Packaging
30 tablets/box [6 tablets/PTP*5], 30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202301898 · Approved 2023.06.21

Summary

Main use
Blood glucose 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 dose is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, administered as two tablets of 5 mg/1000 mg. The recommended starting dose for initial therapy is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted incrementally.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Blood glucose control in Type 2 diabetes and prevention of cardiovascular events

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

This medication helps improve blood glucose control in adults with Type 2 diabetes when used in combination with dapagliflozin and metformin. It is administered as an adjunct therapy alongside dietary and exercise regimens for more effective blood glucose management. It is especially suitable for patients whose blood glucose is not adequately controlled, and special attention should be given to the effects of dapagliflozin on cardiovascular events for patients with cardiovascular diseases or risk factors based on expert guidelines. This drug is used to effectively control the patient's blood glucose.

How to take

Adult dose

This medication is typically administered once daily with the evening meal. The maximum dose is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, administered as two tablets of 5 mg/1000 mg. The recommended starting dose for initial therapy is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted incrementally.

Precautions

This medication can rarely cause a serious metabolic complication known as lactic acidosis, so it should not be used in patients with impaired kidney function or those with severe infections or dehydration. Additionally, caution is necessary when taken with insulin or sulfonylurea medications due to the risk of hypoglycemia. It should not be administered to patients with moderate or severe impairment of kidney function or those with acute heart disease or liver dysfunction. Before surgery or radiologic contrast examinations, this medication should be discontinued for a period and re-evaluated based on renal function before re-administration. Women who are pregnant or breastfeeding should not take this medication, and it should also not be administered to patients with lactose intolerance. Elderly patients or those with decreased kidney function should be carefully treated with this medication due to the increased risk of decreased fluid volume and hypotension, and renal function should be monitored regularly. During the use of this medication, infections such as genital, urinary tract infections, and ketoacidosis may occur, so it is important to consult a doctor immediately if symptoms arise. Vitamin B12 deficiency may occur; therefore, it is advisable to monitor serum vitamin B12 levels during prolonged use. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. This medication can cause hypoglycemia, so immediate appropriate action should be taken if signs of hypoglycemia appear, especially when used in combination with insulin or sulfonylurea, which may require dosage adjustments. Dehydration, hypotension, and changes in renal function as measured by blood tests may occur; therefore, regular monitoring is needed. This medication has not been established for safety and efficacy in children, so it should not be used in that population. In case of overdose, appropriate treatment should be undertaken based on symptoms, and for metformin, dialysis may be beneficial. This drug should be stored out of reach of children, and it should be kept in its original container to prevent degradation in quality and misuse.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe edema (generalized swelling), acute kidney injury, renal dysfunction, ketoacidosis, urosepsis and pyelonephritis, necrotizing fasciitis, acute cholecystitis, Guillain-Barré syndrome, bacterial pneumonia, neurological disorders (headache, facial paralysis, Guillain-Barré syndrome, peripheral neuropathy, paresthesia, tremors), atrial fibrillation, chest pain, urticaria, severe swelling (edema), chest tightness, dyspnea, cold sweat, pallor, high

Mild side effects

Vulvovaginitis, balanitis, and related genital infections, urinary tract infection, fungal infections, hypoglycemia (when used with insulin or sulfonylurea), decreased fluid volume, dry mouth, dizziness, constipation, oral dryness, low back pain, dysuria, polyuria, nocturia, vulvar pruritus, genital pruritus, increased hematocrit, initial renal creatinine clearance reduction, dyslipidemia, initial serum creatinine elevation, increased blood urea, body

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. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to preserve its effectiveness.

Appearance and packaging

Appearance

Pink, bilaterally convex, oval-shaped sustained-release film-coated tablet

Package unit

30 tablets/box [6 tablets/PTP*5], 30 tablets/bottle, 200 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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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.