Medication info
Posidime Sustained-Release Tablet 10/1000 mg

Posidime Sustained-Release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Yellow, oval-shaped film-coated tablet with a convex shape on both sides
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202107224 · Approved 2021.10.29 · Insurance code 643705360

Summary

Main use
Effectiveness in blood sugar control for 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 once daily dapagliflozin 10 mg/sustained-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. If there is no previous experience with diabetes medications and adequate blood sugar control is challenging with monotherapy, the recommended starting dose for initial therapy is 5 mg/500 mg or 10 mg daily once.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

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

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

This drug helps improve blood sugar control in adult patients with type 2 diabetes through the combined administration of dapagliflozin and metformin. It is particularly effective as an adjunctive treatment in conjunction with dietary and exercise therapies. Furthermore, caution is advised when using in patients with type 2 diabetes who have cardiovascular disease or risk factors, where blood sugar is not sufficiently controlled. For related clinical trial information, please refer to guidance for healthcare professionals. This medication is used to enhance blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/sustained-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. If there is no previous experience with diabetes medications and adequate blood sugar control is challenging with monotherapy, the recommended starting dose for initial therapy is 5 mg/500 mg or 10 mg daily once.

Precautions

This medication is used for the treatment of diabetes and may rarely cause a serious metabolic complication called lactic acidosis in some patients. Lactic acidosis is a condition where acidity in the body increases abnormally, which can be life-threatening if severe. When taking this medication with insulin or sulfonylureas, there is a risk of hypoglycemia, so blood sugar levels should be closely monitored. Patients with severely impaired kidney function, dehydration, serious infections, or acute conditions that may affect kidney function, such as acute myocardial infarction, should not take this medication. In addition, pregnant or potentially pregnant women, nursing mothers, and patients undergoing dialysis should not use this medication. Patients at risk of dehydration or hypotension should evaluate their hydration status and kidney function before taking this medication and continuously monitor for symptoms of hypotension and kidney function during treatment. This medication may increase the risk of genital or urinary tract infections, so if symptoms of infection occur, immediate consultation with a healthcare professional is necessary. Vitamin B12 levels can decrease, thus it is advisable to check vitamin B12 status during long-term use. Excessive alcohol consumption may increase the risk of side effects from this medication, so it should be avoided. Patients scheduled for surgery should discontinue this medication 48 hours prior to surgery and resume once kidney function is confirmed to be normal post-surgery. If symptoms such as sudden fatigue, muscle pain, shortness of breath, or abdominal pain arise during treatment, inform the doctor immediately, as serious conditions like lactic acidosis or ketoacidosis may be suspected. Elderly patients or those with impaired kidney function should have their dosages adjusted, and regular kidney function tests are required. In the event of overdose, immediate medical attention is necessary, and prompt treatment should be undertaken. This medication does not significantly impair driving or machine operation, but caution should be exercised due to possible symptoms such as dizziness. Store this medication out of reach of children and keep it in its original container to prevent misuse and degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe dermatological reactions (severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes), respiratory issues (difficulty breathing or shortness of breath, asthma attacks, respiratory symptoms accompanied by cough and fever), liver issues (skin or eyes turning yellow, severe fatigue), significant neurological symptoms

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
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  • dysuria
  • polyuria
  • nocturia
  • vulvar pruritus
  • genital pruritus
  • elevated serum creatinine
  • dyslipidemia
  • elevated serum urea
  • weight loss
  • headache
  • paresthesia
  • tremor
  • epigastric pain
  • indigestion
  • abdominal discomfort
  • diarrhea
  • irritable bowel syndrome
  • salivary gland swelling
  • toothache
  • drowsiness
  • peripheral symptoms

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer duration.

Appearance and packaging

Appearance

Yellow, oval-shaped film-coated tablet with a convex shape on both sides

Package unit

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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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.