Medication info
Dapagliflozin Metformin Extended-release Tablets 10/1000 Milligrams

Dapagliflozin Metformin Extended-release Tablets 10/1000 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Yellow or dark yellow, biconvex oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204359 · Approved 2022.12.05 · Insurance code 657308870

Summary

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

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

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

  • Type 2 diabetes
  • blood sugar control disorder
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication is prescribed to aid in blood sugar control for patients with type 2 diabetes who are using dapagliflozin and metformin together. It helps to effectively manage blood sugar when used in conjunction with basic treatment methods such as diet and exercise. It is particularly used in patients whose blood sugar is not well controlled and who have cardiovascular disease or risk factors. However, it is important to follow the guidance of a healthcare professional regarding the impact on cardiovascular health. This medication is used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

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

Precautions

This medication may very rarely cause a serious side effect known as lactic acidosis, which can lead to death. When used in conjunction with other diabetes medications, serious hypoglycemia may occur, so caution is advised. Patients who are allergic to any component of this medication or who have severely impaired kidney function, dehydration, or serious infections should not use it. Additionally, patients with acute myocardial infarction or sepsis, type 1 diabetes patients, and women who are pregnant or breastfeeding should not take this medication. Prior to and after procedures involving contrast media, this medication should be temporarily discontinued, and it should be resumed only after confirming normal kidney function. Patients with low fluid volume or poor kidney function should carefully assess their condition before using this medication, and should periodically check blood pressure and kidney function during treatment. Patients who have low blood pressure or are taking diuretics need to be cautious due to the risk of dehydration or hypotension. This medication may increase the risk of genital infections and urinary tract infections, and treatment should be sought immediately if symptoms of infection appear. During the use of this medication, vitamin B12 levels may decrease, so regular testing should be conducted if necessary. Excessive alcohol should be avoided, as it may increase the risk of side effects associated with this medication. When used alongside insulin or sulfonylureas, the risk of hypoglycemia may require dose adjustments. Women who are pregnant or may become pregnant should not use this medication, and breastfeeding mothers should avoid it as well. Elderly patients may have decreased kidney function, so kidney function should be frequently monitored and dosing should be carefully adjusted when using this medication. In case of overdose, seek medical attention immediately for appropriate treatment, and dialysis may be beneficial if needed. Keep this medication out of the reach of children, and store it in its original container to prevent quality degradation or misuse. Caution is needed when driving or operating machinery because dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, acute kidney injury and renal dysfunction, severe edema or urinary abnormalities, severe allergic reactions (hives, severe swelling, tightness in chest, difficulty breathing, cold sweat, paleness), severe skin reactions (severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa), respiratory issues (shortness of breath or difficulty in breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever), and liver issues.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, initial decrease in renal creatinine clearance, dyslipidemia, initial increase in serum creatinine, elevated blood urea, weight loss, diarrhea, nausea/vomiting, decreased/deficiency of vitamin B12

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness and safety for a longer period.

Appearance and packaging

Appearance

Yellow or dark yellow, biconvex oval film-coated tablets

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.

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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.