Medication info
Polmindapaserbangeong 10/500 mg

Polmindapaserbangeong 10/500 mg

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

MFDS item code 202300238 · Approved 2023.01.12 · Insurance code 643606490

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This drug is usually administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin per day, administered as 2 tablets of 5 mg/1000 mg. For patients without prior experience on diabetes drug treatments, the initial dosage for therapy is one tablet of either 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dosages should be adjusted stepwise.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

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

  • Type 2 diabetes
  • abnormal blood glucose control
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication is administered in combination with dapagliflozin and metformin to improve blood glucose control in adult patients with type 2 diabetes, complementing diet and exercise. In particular, it is necessary to refer to expert information regarding the impact of dapagliflozin on cardiovascular events in patients whose blood glucose is not sufficiently controlled, especially those with existing cardiovascular diseases or risk factors. This drug is effectively used in the treatment of type 2 diabetes.

How to take

Adult dose

This drug is usually administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin per day, administered as 2 tablets of 5 mg/1000 mg. For patients without prior experience on diabetes drug treatments, the initial dosage for therapy is one tablet of either 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dosages should be adjusted stepwise.

Precautions

This drug can very rarely cause a serious condition called lactic acidosis, so it should be taken cautiously following a physician's instructions before use. There is a risk of hypoglycemia when this drug is taken alongside other diabetes medications such as insulin or sulfonylureas, so caution is advised. Patients with severely impaired kidney function or acute conditions that can affect kidney function such as dehydration, severe infection, or acute myocardial infarction should not take this medication. Pregnant or breastfeeding women and those allergic to the components of this medication should also avoid taking it. Patients with decreased fluid volume or impaired kidney function should verify their fluid status and kidney function before taking this medication, and should continuously monitor for symptoms of low blood pressure and kidney function during use. This drug may increase the risk of genital infections and urinary tract infections, so if infection symptoms arise, immediate consultation with a physician is necessary. Vitamin B12 levels may decrease, so regular monitoring of vitamin B12 levels is recommended during prolonged use. Excessive alcohol consumption may increase the risk of side effects of this medication, so alcohol should be avoided while taking it. This drug has a strong effect of lowering blood sugar, so special attention should be given to hypoglycemia symptoms, especially when used with insulin or other hypoglycemic agents, and dosage adjustments may be necessary as needed. Before surgeries or radiocontrast examinations, this drug should be temporarily discontinued for a certain period of time, and it should be resumed only after confirming normal kidney function. Elderly patients may have decreased kidney function, so renal function should be frequently checked and dosages adjusted accordingly. If any abnormal symptoms or side effects occur during use, immediate notification to healthcare personnel is required, and especially if there is pain, swelling, or fever in the perineum, urgent treatment is necessary. This medication should not be used in children as its safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • acute renal failure
  • acute kidney injury
  • kidney dysfunction
  • elevated creatinine levels
  • decreased creatinine clearance
  • severe allergic reactions
  • severe skin reactions
  • respiratory problems
Show 11 more
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema or urination abnormalities
  • diabetic ketoacidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
  • acute cholecystitis
  • Guillain-Barré Syndrome
  • bacterial pneumonia
  • sialadenitis

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • lower back pain
Show 22 more
  • dysuria
  • polyuria
  • nocturia
  • genital itching
  • increased hematocrit
  • hemorrhoids
  • dyslipidemia
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased vitamin B12
  • upper abdominal pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • gastric ulcer
  • irritable bowel syndrome
  • salivary gland swelling
  • toothache
  • headache
  • altered sensation
  • insomnia

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, and the storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. By storing it this way, the efficacy of the medication can be preserved for a longer period.

Appearance and packaging

Appearance

Pink, double-sided, convex, 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.