Medication info

Posiplduo Sustained-release Tablet 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Pink, oval-shaped, double-convex, sustained-release film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle, 30 tablets/box [(6 tablets/PTP)*5]
Approval status
Active

MFDS item code 202301899 · Approved 2023.06.21

Summary

Main use
Effectiveness in controlling blood sugar levels in Type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once daily with dinner. The maximum dose is dapagliflozin 10 mg/sustained-release metformin 2000 mg once daily, which is administered as 2 tablets of 5 mg/1000 mg. If there has been no previous experience with diabetes medication, the initial regimen is to take one tablet daily of either 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, the dosage is progressively adjusted.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Effectiveness in controlling blood sugar levels in Type 2 diabetes and preventing cardiovascular events

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

This medication is prescribed to assist adults with Type 2 diabetes in controlling their blood sugar levels along with dietary and exercise regimens. In particular, it effectively manages blood sugar levels through combination therapy using dapagliflozin and metformin. Additionally, it may help those whose blood sugar is not adequately controlled and who have cardiovascular diseases or risk factors; further information may be needed from a healthcare professional regarding these aspects. Overall, this medication is used to improve blood sugar control.

How to take

Adult dose

This medication is generally administered once daily with dinner. The maximum dose is dapagliflozin 10 mg/sustained-release metformin 2000 mg once daily, which is administered as 2 tablets of 5 mg/1000 mg. If there has been no previous experience with diabetes medication, the initial regimen is to take one tablet daily of either 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, the dosage is progressively adjusted.

Precautions

This medication contains two active ingredients and is used for diabetes treatment. There is a very rare possibility of a serious metabolic complication called lactic acidosis occurring when taking this medication, so caution is necessary. Lactic acidosis can be life-threatening, and if symptoms appear, medical consultation should be sought immediately. Additionally, when used with insulin or sulfonylureas, hypoglycemia may occur, so blood sugar levels should be monitored closely. This medication should not be administered to patients with severely impaired kidney function, who are dehydrated, or have certain diseases such as severe infections, heart failure, or acute myocardial infarction. There may be a need to discontinue this medication for a period before and after tests or surgeries due to the risk of changes in kidney function and lactic acidosis. It is safer not to use this medication in pregnant or breastfeeding women and to consult a doctor before taking it. This medication should be administered with caution in patients at risk of decreased fluid volume or hypotension, especially in older adults or those with impaired kidney function, who should receive regular kidney function tests. During treatment, genital infections or urinary tract infections may occur, and if symptoms appear, immediate treatment is needed. Vitamin B12 levels may decrease; thus, regular blood tests are necessary for monitoring when this medication is taken over a long period. Excessive alcohol consumption should be avoided, and blood sugar control status should be checked periodically during treatment. This medication may interact with other drugs, so if you are currently taking other medications, you must inform your healthcare provider. Dizziness or hypotension may occur during treatment, so caution is needed when driving or operating dangerous machinery. Finally, keep this medication out of reach of children, and store it in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

  • Guillain-Barré syndrome
  • diabetic ketoacidosis
  • ketosis
  • lactic acidosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • kidney dysfunction
  • atrial fibrillation
  • acute cholecystitis
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  • perineal necrosis
  • chest pain
  • chest tightness

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, decreased fluid volume, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, decreased renal creatinine clearance at treatment initiation, dyslipidemia, increased blood creatinine at treatment initiation, raised blood urea, weight loss, diarrhea, nausea and vomiting, vitamin

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture exposure. It is also recommended to store it at room temperature between 1 degree Celsius and 30 degrees Celsius, away from extremely hot or cold environments.

Appearance and packaging

Appearance

Pink, oval-shaped, double-convex, sustained-release film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle, 30 tablets/box [(6 tablets/PTP)*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.