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

Dapagliflozin Metformin Extended-Release Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Pink or dark pink biconvex oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204357 · Approved 2022.12.05 · Insurance code 657308850

Summary

Main use
Effect on blood glucose control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication should be individualized based on the patient's current treatment regimen, 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 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, which is taken as 2 tablets of 5 mg/1000 mg. In cases of prior diabetes medication treatment,

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

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

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

This medication is an adjunctive treatment for adults with type 2 diabetes, assisting in blood glucose control by combining dapagliflozin and metformin. It is used in conjunction with diet and exercise to enhance blood glucose management and is particularly suitable for patients with type 2 diabetes whose blood glucose is not adequately controlled. Careful monitoring is required regarding the effects of dapagliflozin in patients with cardiovascular disease or risk factors. This medication is effectively used for managing type 2 diabetes.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment regimen, 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 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, which is taken as 2 tablets of 5 mg/1000 mg. In cases of prior diabetes medication treatment,

Precautions

This medication is used to help manage diabetes and control blood sugar levels. However, it should not be administered to patients with poor kidney function, severe infections, or dehydration. Caution is needed particularly in patients with moderate to severe kidney impairment, as taking this medication may pose a risk. Rarely, it can cause serious metabolic complications called lactic acidosis, which can be life-threatening; immediate medical attention should be sought if symptoms occur. Additionally, when taken with insulin or sulfonylureas, there is a risk of hypoglycemia, so blood glucose levels should be carefully monitored. During the course of treatment, urinary and genital infections may occur, so prompt treatment is necessary if infection symptoms arise. Pregnant or breastfeeding women should not take this medication and must discontinue it immediately if pregnancy is confirmed. Elderly patients or those with impaired kidney function should have their renal function regularly monitored before and during treatment, and dosage adjustment may be necessary. This medication should be temporarily discontinued before and after surgery or tests using iodinated contrast agents and restarted only after confirming normal kidney function. It may cause dehydration, hypotension, or reduced fluid volume, so special monitoring is required for elderly patients or those on diuretics. There are no specific antidotes for overdose, so appropriate treatment should be administered based on symptoms, and the metformin component can be removed via dialysis. It is advisable to avoid alcohol consumption during treatment, and regular monitoring may be necessary as vitamin B12 levels can decrease. Caution is advised as dizziness may occur when driving or operating machinery, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe kidney injury, acute kidney injury and dysfunction, severe edema or hypotension, diabetic ketoacidosis, urosepsis and pyelonephritis, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes), respiratory issues (shortness of breath or difficulty breathing)

Mild side effects

Vulvovaginitis, glans inflammation and related genital infections, urinary tract infection, fungal infection, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, initial increase in serum creatinine, elevated blood urea, dyslipidemia, weight loss, headaches, sensory disturbances, tremors, upper abdominal pain, dyspepsia, abdominal discomfort, diarrhea, abdominal pain, irritable bowel syndrome

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the medicinal effect for a longer duration.

Appearance and packaging

Appearance

Pink or dark pink 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.