Medication info
DapaPlus Extended Release Tablet 10/500 Milligrams

DapaPlus Extended Release Tablet 10/500 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pink biconvex oval extended-release film-coated tablet
Packaging
30 tablets/box [6 tablets/PTP x 5]
Approval status
Active

MFDS item code 202300242 · Approved 2023.01.12 · Insurance code 648604490

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 one daily dose of 10 mg dapagliflozin / 2000 mg extended-release metformin, and the administration is two tablets of 5 mg/1000 mg. In cases of initial therapy, one tablet of 5 mg/500 mg or 10 mg/500 mg is taken once daily. To alleviate gastrointestinal side effects of metformin, the dosage is adjusted gradually. Metformin

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

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

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

This medication is used in adults with type 2 diabetes to assist dietary and exercise regimens in controlling blood sugar levels. In particular, it is important to carefully consider the cardiovascular event prevention effect of dapagliflozin in patients whose blood sugar is not adequately controlled and who have cardiovascular diseases or risk factors. Therefore, this medication is administered to contribute to diabetes management and the reduction of cardiovascular risk.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is one daily dose of 10 mg dapagliflozin / 2000 mg extended-release metformin, and the administration is two tablets of 5 mg/1000 mg. In cases of initial therapy, one tablet of 5 mg/500 mg or 10 mg/500 mg is taken once daily. To alleviate gastrointestinal side effects of metformin, the dosage is adjusted gradually. Metformin

Precautions

This medication is used for diabetes treatment and helps to control blood sugar. Before taking this medication, it is essential to verify that kidney function is normal. This medication should not be used in patients with significantly impaired kidney function, and caution is required in cases of reduced kidney function. This medication can rarely cause serious metabolic complications, such as lactic acidosis, so immediate consultation with a doctor is advised if symptoms like sudden fatigue, muscle pain, difficulty breathing, or abdominal pain occur. Additionally, the risk of hypoglycemia may increase when used in conjunction with insulin or sulfonylureas, necessitating close monitoring of blood sugar changes and dosage adjustments as needed. This medication should not be administered to patients with acute conditions that may affect kidney function, such as dehydration, severe infections, or acute myocardial infarction. Before and after examinations using radiological iodine contrast agents, the administration of this medication should be temporarily suspended, and it should only be restarted once normal kidney function is confirmed. Pregnant or potentially pregnant women and nursing mothers should not take this medication and should discontinue it immediately if they are currently taking it. This medication contains lactose, so patients with certain genetic disorders should not take it. In elderly patients, kidney function decline is common, so kidney function should be regularly monitored and treatment should start at a minimum dose. While taking this medication, there is a risk of genital and urinary tract infections, so immediate treatment is required if symptoms of infection appear. Fluid volume reduction or symptoms of low blood pressure may occur, so it is essential for elderly patients or those taking diuretics to closely monitor blood pressure and fluid status. Vitamin B12 levels may decrease, so regular checks of vitamin B12 levels are recommended for long-term usage. Excessive alcohol intake may increase the risk of side effects from this medication, so alcohol should be avoided while taking it. This medication should be temporarily suspended for a certain period before and after surgery, and it should be resumed only after confirming that kidney function is normal post-surgery. During the administration of this medication, there may be failures in blood sugar control or abnormal symptoms, so regular blood sugar checks and consultations with a doctor are important. In the case of overdose, medical assistance should be sought immediately, and while the toxicity of this medication is generally mild, the risk may vary depending on kidney function. While taking this medication, dizziness and other symptoms may occur during driving or operating machinery, so caution is necessary. Finally, this medication should be stored out of reach of children and kept in its original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe edema, fluid volume depletion, low blood pressure, diabetic ketoacidosis, ketosis, urosepsis, pyelonephritis, acute kidney injury, kidney dysfunction, severe allergic reactions, severe skin reactions, severe neurological symptoms, liver abnormalities (jaundice), perineal necrosis, Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, neurological impairment (Guillain-Barré syndrome, facial paralysis), atrial fibrillation, acute cholecystitis, severe rash

Mild side effects

  • Vulvovaginitis
  • balanitis
  • genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • dry mouth
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  • back pain
  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • increased hematocrit
  • elevated serum creatinine
  • increased serum urea
  • dyslipidemia
  • weight loss
  • diarrhea
  • nausea
  • vomiting
  • decreased vitamin B12
  • upper abdominal pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • gastric ulcer
  • irritable bowel syndrome

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 storage temperature should be maintained between 1 and 30 degrees Celsius. This helps preserve the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

Pink biconvex oval extended-release film-coated tablet

Package unit

30 tablets/box [6 tablets/PTP x 5]

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.