Medication info
Dapagliflozin Extended-Release Tablets 10/1000 Milligrams

Dapagliflozin Extended-Release Tablets 10/1000 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Yellow to deep yellow, oval, biconvex extended-release film-coated tablets
Packaging
30 tablets/box [6 tablets/PTP (Alu-Alu) × 5]
Approval status
Active

MFDS item code 202300347 · Approved 2023.01.27 · Insurance code 669908330

Summary

Main use
Blood sugar control for 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 dosage is dapagliflozin 10mg/extended-release metformin 2000mg once daily, taken as 2 tablets of 5mg/1000mg. When used as initial therapy, the recommended starting dose is one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Blood sugar control for type 2 diabetes and prevention of cardiovascular events

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

This medication is used together with diet and exercise to improve blood glucose control in adults with type 2 diabetes. In particular, it enhances glycemic control effects by using dapagliflozin in combination with metformin. Additionally, it is recommended to consult with a specialist regarding the effects of dapagliflozin on the occurrence of cardiovascular events in patients with insufficient glycemic control who have cardiovascular disease or risk factors. This medication helps manage type 2 diabetes and improve blood glucose control.

How to take

Adult dose

This medication is typically administered once daily with the evening meal. The maximum dosage is dapagliflozin 10mg/extended-release metformin 2000mg once daily, taken as 2 tablets of 5mg/1000mg. When used as initial therapy, the recommended starting dose is one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

Precautions

This medication is used for the treatment of diabetes and can rarely cause a serious metabolic complication known as lactic acidosis. Lactic acidosis can be life-threatening, so if symptoms appear, you must inform your doctor immediately. Also, when taken with insulin or sulfonylurea medications, the risk of hypoglycemia may increase, so caution is needed. Symptoms of hypoglycemia can include dizziness, cold sweat, and tremors, and you should respond immediately if these symptoms occur. Patients with poor kidney function, especially those with moderately or severely impaired kidney function, should not use this medication, and it should be administered cautiously in states where there is a risk of declining kidney function. This medication should be avoided in the presence of acute conditions that can affect kidney function, such as dehydration, severe infections, cardiovascular issues, acute myocardial infarction, or sepsis. It is safest for women who are pregnant or potentially pregnant, and nursing mothers not to use this medication. Additionally, patients who are allergic to any component of this drug should not be administered this medication. This drug increases urine output which can lower blood pressure, so patients at risk of hypotension or reduced fluid volume should be careful. Elderly patients or those taking diuretics need to be particularly cautious. During treatment, there can be occurrences of genital infections or urinary tract infections, so you should consult your doctor immediately if related symptoms appear. Vitamin B12 deficiency may occur, so it is advisable to check blood levels of vitamin B12 during long-term treatment. Excessive alcohol consumption should be avoided while taking this medication, and it should be suspended for a period before undergoing surgery or iodine contrast imaging tests. In case of overdose, you must visit a healthcare facility immediately for appropriate treatment, and this medication’s safety and efficacy have not been established in children or adolescents. Finally, while this medication generally does not significantly affect driving or machine operation, caution is necessary due to possible dizziness.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, acute kidney injury, diabetic ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, acute cholecystitis, Guillain-Barré syndrome, atrial fibrillation, chest tightness, severe swelling (edema), difficulty breathing, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, jaundice indicating yellowing of skin or eyes, generalized malaise, sudden and severe headache, lightning headache, vomiting

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylurea or insulin), decreased fluid volume, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, initial treatment-related decrease in renal creatinine clearance, dyslipidemia, increased serum creatinine, elevated blood urea, weight

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow to deep yellow, oval, biconvex extended-release film-coated tablets

Package unit

30 tablets/box [6 tablets/PTP (Alu-Alu) × 5]

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.

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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.