Medication info
Dapldm Met Extended-Release Tablet 10/500 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Dapldm Met Extended-Release Tablet 10/500 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Pink, biconvex, oval-shaped extended-release film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP (Alu-Alu) x 3]
Approval status
Active

MFDS item code 202300430 · Approved 2023.01.31 · Insurance code 642707380

Summary

Main use
Effect of 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 once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dose is 5 mg/500 mg or 10 mg/500 mg of 1 tablet once daily. This medication should be swallowed whole and must not be crushed, cut, or chewed.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

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

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

This medication contains dapagliflozin and metformin, which effectively help control blood sugar levels in adult patients with type 2 diabetes. When used in conjunction with diet and exercise, it greatly aids in blood sugar management. It can be used in patients who have cardiovascular diseases or risk factors, particularly those with poorly controlled blood sugar. However, it is advisable to refer to information intended for professionals regarding matters related to cardiovascular events. This medication improves 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 once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dose is 5 mg/500 mg or 10 mg/500 mg of 1 tablet once daily. This medication should be swallowed whole and must not be crushed, cut, or chewed.

Precautions

This medication helps control blood sugar levels. However, it can rarely cause a condition called lactic acidosis, and should not be administered to patients with impaired kidney function or specific health conditions. Additionally, caution should be exercised when used with insulin or other diabetes treatments, as hypoglycemic symptoms may occur. Patients with decreased kidney function or low fluid volume should periodically check kidney function and blood pressure while using this medication. This medication may increase the risk of genital infections and urinary tract infections, so if any infection symptoms occur, immediate consultation with healthcare professionals is necessary. The metformin component should not be used in patients with impaired liver function or those experiencing dehydration or severe infections. Women who are pregnant or breastfeeding should not take this medication, and it should be discontinued if pregnancy is planned or confirmed. It is advisable to avoid alcohol consumption while taking this medication, and to refrain from skipping meals or overexercising to prevent hypoglycemic symptoms. When administering this medication to elderly patients, dosage adjustment and careful monitoring should be considered due to the possibility of reduced kidney function. In case of overdose, immediate medical attention should be sought, and dialysis treatment may be beneficial if necessary. Lastly, caution should be taken as symptoms like dizziness may occur while driving or operating machinery during the course of this medication.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, diabetic ketoacidosis, acute kidney injury, renal dysfunction, perineal necrosis, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe dermatological reactions (severe rash with fever, blistering, skin peeling, oral/ocular mucosal pain), respiratory issues (shortness of breath or difficulty breathing, asthma attack)

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, external genital itching, genital itching, increased hematocrit, reduced renal creatinine clearance at the beginning of treatment, dyslipidemia, increased serum creatinine at the beginning of treatment, increased blood urea, weight reduction, diarrhea, nausea/vomiting, reduced/deficiency of vitamin B12

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 exposure to air or moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink, biconvex, oval-shaped extended-release film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP (Alu-Alu) x 3]

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.