Medication info
Dapeldm Met Extended-Release Tablet 10/1000 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Dapeldm Met Extended-Release Tablet 10/1000 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Yellow, biconvex, oval, extended-release film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP (Alu-Alu)x3]
Approval status
Active

MFDS item code 202300431 · Approved 2023.01.31 · Insurance code 642707410

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is usually administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg / extended release metformin 2000 mg once daily, taking 2 tablets of 5 mg / 1000 mg. The recommended starting dose when used as initial therapy is 1 tablet of 5 mg / 500 mg or 10 mg / 500 mg once daily. To reduce gastrointestinal side effects of metformin, adjust the dose gradually.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

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

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

This medication helps improve blood sugar control in adults with type 2 diabetes who are suitable for combination therapy with dapagliflozin and metformin, used alongside dietary and exercise therapies. Particularly in patients whose blood sugar is insufficiently controlled and who have cardiovascular disease or risk factors, this medication should be used with caution, considering the impact on the occurrence of cardiovascular events. Therefore, this medication is used to improve blood sugar control and cardiovascular health management in patients with type 2 diabetes.

How to take

Adult dose

This medication is usually administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg / extended release metformin 2000 mg once daily, taking 2 tablets of 5 mg / 1000 mg. The recommended starting dose when used as initial therapy is 1 tablet of 5 mg / 500 mg or 10 mg / 500 mg once daily. To reduce gastrointestinal side effects of metformin, adjust the dose gradually.

Precautions

This medication is used for the treatment of diabetes and should not be used in patients with impaired kidney function or certain serious diseases. This medication may rarely cause a serious metabolic complication called lactic acidosis, and if symptoms occur, medical assistance should be sought immediately. Also, caution is required when taken with insulin or sulfonylurea medications, as there is a risk of hypoglycemia. Patients with impaired kidney function or reduced fluid volume must have their kidney function and fluid status checked before administration, and regular monitoring is required afterward. This medication may increase the risk of genital infections and urinary tract infections, so treatment should be sought promptly if infection symptoms appear. Patients with specific health conditions such as liver dysfunction, dehydration, severe infections, or acute myocardial infarction should not use this medication. Women who are pregnant or breastfeeding should not take this medication, and those who plan to become pregnant should consult a doctor. In the elderly, since reduced kidney function is common, careful dosage adjustments and kidney function evaluations are important. This medication may interact with other drugs, so it is essential to inform your healthcare provider about any other medications you are taking. In case of overdose, seek medical attention immediately for appropriate treatment, and dialysis may be necessary depending on the symptoms. While taking this medication, be cautious of symptoms of dehydration or hypotension, and consult with healthcare providers if symptoms arise. Additionally, since this medication affects blood sugar control, regular monitoring of blood sugar and kidney function is important. Finally, this medication should be kept out of reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, cardiovascular collapse (shock), acute myocardial infarction, sepsis, ketoacidosis, severe allergic reactions, severe skin reactions, respiratory issues (breathlessness or difficulty breathing, asthma attacks, cough with fever accompanying breathing issues), liver abnormalities (jaundice), severe neurological symptoms (sudden and severe headache, lightning headache, seizures, consciousness confusion, visual disturbances, paralysis), severe edema

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 pruritus, genital pruritus, increased hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, increased serum creatinine at the beginning of treatment, 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 or moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius. This will help maintain the effectiveness and safety of the medication over time.

Appearance and packaging

Appearance

Yellow, biconvex, oval, extended-release film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP (Alu-Alu)x3]

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.