Medication info
Dapagliflozin/Metformin Extended-Release Tablet 5/1000 mg

Dapagliflozin/Metformin Extended-Release Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletDapagliflozin Bis L-proline›7.8mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
A pink, oval, biconvex extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202202498 · Approved 2022.06.15 · Insurance code 643508570

Summary

Main use
Effect of blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, and 2 tablets of 5 mg/1000 mg are taken. If there is no previous experience with diabetes medication, initial therapy is to take once daily 1 tablet of either 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, dosage should be escalated gradually.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

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

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes, along with dietary and exercise therapy. It is particularly important to consult additional expert information regarding the safety and efficacy of dapagliflozin in patients with cardiovascular disease or risk factors who are not adequately controlled. This medication effectively aids in blood sugar management and is used in the treatment of type 2 diabetes.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, and 2 tablets of 5 mg/1000 mg are taken. If there is no previous experience with diabetes medication, initial therapy is to take once daily 1 tablet of either 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, dosage should be escalated gradually.

Precautions

This medication is used for the treatment of diabetes and helps control blood sugar. It should not be administered to patients with impaired renal function, severe infections, dehydration, or cardiovascular diseases at the time of prescription. It is also safer for pregnant or breastfeeding women not to use this medication. This medication can rarely cause serious metabolic complications known as lactic acidosis, so it is important to consult a doctor immediately if symptoms occur. Additionally, when taken with insulin or sulfonylureas, there is a risk of hypoglycemia, so care is needed. This medication may increase the risk of infections such as genital infections or urinary tract infections, so treatment should be sought promptly if symptoms of infection appear. Patients with reduced fluid volume or at risk of hypotension should carefully monitor blood pressure and renal function before and after taking this medication. Alcohol consumption should be avoided while taking this medication, and regular testing is recommended as vitamin B12 levels may decrease. If you are undergoing surgery or radiation tests which may affect renal function, this medication should be temporarily suspended and resumed only after checking renal function. Elderly patients or those with diminished renal function need to adjust dosages and regularly monitor kidney function. In case of overdose, prompt assessment and appropriate treatment by medical personnel are necessary, as this medication can be removed through dialysis. Lastly, this medication must be kept out of the reach of children and stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe edema, severe liver abnormalities (jaundice), acute kidney injury, increased blood pressure, diabetic ketoacidosis, perineal necrosis, urosepsis, pyelonephritis, severe allergic reactions (urticaria, severe swelling, chest tightness, breathing difficulties, cold sweats, pallor), severe skin reactions (severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes), respiratory issues (shortness of breath or difficulty breathing).

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, painful urination, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased early treatment creatinine clearance, dyslipidemia, elevated serum creatinine early in treatment, elevated blood urea, weight loss, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, tendonitis, and others.

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 to 30 degrees Celsius. This storage method helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

A pink, oval, biconvex extended-release film-coated tablet

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.