Medication info
Polmindapaserbongjeong 10/1000 milligrams

Polmindapaserbongjeong 10/1000 milligrams

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Yellow, biconvex, oval, sustained-release film-coated tablet
Packaging
30 tablets/box [(6 tablets/PTP x 5)]
Approval status
Active

MFDS item code 202300239 · Approved 2023.01.12 · Insurance code 643606500

Summary

Main use
Effectiveness in blood sugar control and prevention of cardiovascular events in type 2 diabetes.
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg/sustained-release metformin 2000mg, which is taken as 2 tablets of 5mg/1000mg. For patients with no previous experience of diabetes medication therapy, the initial regimen is to take 1 tablet once daily of 5mg/500mg or 10mg/500mg. To reduce gastrointestinal side effects of metformin, the dosage should be gradually increased.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

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

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

This medication is used to improve blood sugar control in adults with type 2 diabetes when used in conjunction with dietary and exercise therapy. In particular, combining dapagliflozin and metformin can provide more effective blood sugar management. Additionally, caution is required when using this medication in patients with existing cardiovascular disease or risk factors who do not achieve adequate blood sugar control, and it is important to refer to relevant clinical trial information. This medication can assist in managing both blood sugar control and cardiovascular health simultaneously.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg/sustained-release metformin 2000mg, which is taken as 2 tablets of 5mg/1000mg. For patients with no previous experience of diabetes medication therapy, the initial regimen is to take 1 tablet once daily of 5mg/500mg or 10mg/500mg. To reduce gastrointestinal side effects of metformin, the dosage should be gradually increased.

Precautions

This medication can very rarely cause a serious condition called lactic acidosis, so caution is required regarding this. When used with other diabetes medications, there is a risk of hypoglycemia, so caution is advised. It should not be administered to patients with moderate to severe renal impairment or those with dehydration, severe infections, or cardiovascular issues. Pregnant or nursing women and patients with genetic issues such as lactose intolerance should not use this medication. Patients with reduced fluid volume or renal impairment should exercise caution when using this medication, as there may be a risk of blood pressure reduction or deterioration of kidney function, requiring regular monitoring. During treatment with this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, renal dysfunction, etc., may occur, so if symptoms arise, it is crucial to consult healthcare professionals immediately. Furthermore, this medication can lower vitamin B12 levels, so checking vitamin B12 status during long-term use is advised. Excessive alcohol consumption may increase the risk of side effects from this medication. Before surgery or diagnostic tests using iodinated contrast media, this medication should be stopped for a certain period, and it should be resumed only after confirming normal kidney function. Elderly patients are at increased risk of kidney function deterioration and reduced fluid volume, thus requiring dosage adjustments and regular kidney function assessments when using this medication. Caution is also advised for dizziness when operating vehicles or machinery during treatment with this medication. Finally, this medication should be kept out of reach of children and stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • severe skin reactions
  • respiratory distress
  • ketoacidosis
  • urinary sepsis
  • pyelonephritis
  • acute kidney injury
  • renal dysfunction
  • severe edema
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  • Guillain-Barre syndrome
  • acute cholecystitis
  • atrial fibrillation
  • perineal necrosis
  • severe allergic reactions

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, reduced renal creatinine clearance at the start of treatment, dyslipidemia, elevated serum creatinine at the start of treatment, elevated blood urea, weight loss, diarrhea, nausea/vomiting, vitamin B

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to ensure the medication's effectiveness.

Appearance and packaging

Appearance

Yellow, biconvex, oval, sustained-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.