Medication info

Posimet Extended Release Tablet 10/500 Milligrams

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pink, double convex, oval, film-coated tablet
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202204064 · Approved 2022.11.10

This product's status changed to Approval withdrawn on 2023.10.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in blood glucose 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 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily. For patients who have not previously received diabetes medication, the initial dosage is one tablet of 5 mg/500 mg or 10 mg/500 mg, taken once daily. Dosage adjustments should be made gradually to minimize gastrointestinal adverse effects from metformin. Tablets should be swallowed whole.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

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

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

This medication is administered as an adjunct to improve blood glucose control in adults with type 2 diabetes using dapagliflozin and metformin in combination. It is used in conjunction with dietary and exercise therapies and is suitable when blood glucose is not adequately controlled. Special caution is required for type 2 diabetes patients with concomitant cardiovascular diseases or risk factors regarding the risk of cardiovascular events. Please refer to the clinical trial information for healthcare professionals for more details. This medication effectively aids in treating diabetes and controlling blood glucose.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily. For patients who have not previously received diabetes medication, the initial dosage is one tablet of 5 mg/500 mg or 10 mg/500 mg, taken once daily. Dosage adjustments should be made gradually to minimize gastrointestinal adverse effects from metformin. Tablets should be swallowed whole.

Precautions

This medication is a diabetes treatment that helps control blood glucose. When taking this medication, kidney function is very important, so it should not be used in patients with reduced kidney function or kidney impairment. Additionally, it should be avoided in cases of severe infections, dehydration, cardiovascular issues, or acute illnesses. Pregnant or nursing women should not use this medication, and caution is especially needed during the 2nd and 3rd trimesters due to potential effects on kidney development. This medication may increase the risk of hypoglycemia when used with other diabetes medications, so dosage adjustments may be necessary when used with insulin or sulfonylureas. This medication can rarely induce life-threatening lactic acidosis or ketoacidosis, so if symptoms such as fatigue, muscle pain, difficulty breathing, abdominal pain, or vomiting occur, consult a doctor immediately. Furthermore, this medication may increase the risk of genital and urinary tract infections, and prompt treatment is necessary if infection symptoms occur. Patients with risks of reduced fluid volume or hypotension should periodically monitor blood pressure and fluid status, and temporarily discontinue the medication if dehydration symptoms occur. This medication is not recommended for patients with liver function impairment, and excessive alcohol consumption should also be avoided. Patients scheduled for surgery should stop taking this medication 48 hours before surgery and should resume after surgical renal function is confirmed to be normal. Elderly individuals often experience decreased kidney function, thus dosage adjustments and kidney function monitoring are necessary, particularly for those aged 80 and over, who should use this medication cautiously. In case of overdose, immediate medical attention is required, as this medication can be removed through dialysis, making rapid intervention essential. Caution should be exercised regarding dizziness while driving or operating machinery during the medication period, and it should be stored out of children’s reach.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (skin or eyes turning yellow), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, urination

Mild side effects

Headache, dizziness, constipation, dry mouth, back pain, nocturia, dysuria, polyuria, vulvar pruritus, genital pruritus, hypoglycemia (mild cases), fluid volume reduction (including dehydration, hypovolemia, hypotension), thirst, rash, diarrhea, nausea/vomiting, upper abdominal pain, indigestion, abdominal discomfort, abdominal pain, irritable bowel syndrome, salivary gland swelling, toothache, facial paralysis, peripheral neuropathy, sensory abnormalities, drowsiness, tremor, tendinitis, joint pain, muscle pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperature between 1 and 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Pink, double convex, oval, film-coated tablet

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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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.