Medication info
TruDapa PM Extended-Release Tablet 10/1000 mg (Dapagliflozin, Metformin)

TruDapa PM Extended-Release Tablet 10/1000 mg (Dapagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Bis L-proline›15.63mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
Yellow to deep yellow, double convex oval-shaped film-coated tablets
Packaging
30 tablets/box [(6 tablets (Alu-Alu) × 5)], 30 tablets/bottle
Approval status
Active

MFDS item code 202108080 · Approved 2021.12.23 · Insurance code 641908060

Summary

Main use
Effectiveness in blood glucose control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is individualized not to exceed dapagliflozin 10 mg and extended-release metformin 2000 mg. Generally administered once daily with the evening meal. For initial therapy, take one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To minimize gastrointestinal side effects of metformin, the dosage should be titrated gradually. Patients currently on metformin therapy should have their dapagliflozin dose adjusted accordingly.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Effectiveness in blood glucose control for type 2 diabetes and prevention of cardiovascular events

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

This medication helps improve blood glucose control in adult patients with type 2 diabetes through the combination of dapagliflozin and metformin. It is used as an adjunct to diet and exercise in patients whose blood glucose is not adequately controlled. For patients with cardiovascular disease or risk factors, it is important to refer to expert information regarding the effects of dapagliflozin on the occurrence of cardiovascular events. This medication improves glycemic control in patients with type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is individualized not to exceed dapagliflozin 10 mg and extended-release metformin 2000 mg. Generally administered once daily with the evening meal. For initial therapy, take one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To minimize gastrointestinal side effects of metformin, the dosage should be titrated gradually. Patients currently on metformin therapy should have their dapagliflozin dose adjusted accordingly.

Precautions

This medication is used to treat diabetes and contains two components. Firstly, this medication helps lower blood glucose by blocking the reabsorption of glucose in the kidneys, allowing for glucose to be excreted in urine. Additionally, it helps with blood glucose control by reducing glucose production in the liver and absorption in the intestines. However, there are several precautions to consider when taking this medication. This medication can rarely cause a serious condition known as lactic acidosis, so individuals with impaired kidney function or heart and liver disease should be particularly cautious. Moreover, when taken with insulin or other diabetes medications, hypoglycemia may occur, so it is important to monitor blood glucose levels closely. Patients with moderate to severe renal impairment, dehydration, serious infection, heart attack, shock, etc. should not take this medication. This medication should also be temporarily halted before and after dialysis imaging tests using contrast agents, and it is advisable to stop taking it for a period before and after surgery. Women who are pregnant or breastfeeding, as well as individuals with certain genetic metabolic disorders, should not use this medication. During treatment, genital infections and urinary tract infections may occur, so any signs of infection should be reported to healthcare providers immediately. This medication can cause dehydration or hypotension, so regular checks of fluid status and blood pressure are necessary, especially for the elderly or those taking diuretics. Long-term use may lower vitamin B12 levels, so blood tests may be needed to check and supplement if necessary. Excessive alcohol consumption can increase the risk of adverse effects from this medication, so it should be avoided. In case of overdose, the patient should seek medical attention immediately for appropriate treatment. Finally, the safety and efficacy of this medication have not been established in children, and elderly patients should have their kidney function evaluated to adjust the dosage appropriately. During the course of treatment, it is critical to regularly monitor renal function and blood glucose status following the physician's guidance.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, diabetic ketoacidosis, urosepsis and pyelonephritis, acute kidney injury and renal dysfunction, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, acute cholecystitis, atrial fibrillation, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, difficulty breathing, metabolic acidosis related to ketoacidosis, severe allergic reactions, perineal necrosis, severe edema associated with elevated blood pressure, urticaria, severe

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, reduced fluid volume (including dehydration, hypovolemia, hypotension), dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, genital itching, itching of reproductive organs, increased hematocrit, elevated blood creatinine, increased blood urea, weight loss, diarrhea, nausea/vomiting, decrease/deficiency of vitamin B12, abdominal pain, dyspepsia, abdominal discomfort,

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1 degree and 30 degrees Celsius. This way, the effectiveness of the medication can be preserved for a longer duration and used safely.

Appearance and packaging

Appearance

Yellow to deep yellow, double convex oval-shaped film-coated tablets

Package unit

30 tablets/box [(6 tablets (Alu-Alu) × 5)], 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

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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.