Medication info

Fosidicm Extended Release Tablet 10/500 mg

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202204069 · Approved 2022.11.10

This product's status changed to Approval withdrawn on 2023.10.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 typically administered once daily with the evening meal. The maximum dosage is once daily at dapagliflozin 10 mg / extended release metformin 2000 mg, administered as two tablets of 5 mg / 1000 mg. In the case of no previous diabetes medication treatment experience, the initial therapy is one tablet of 5 mg / 500 mg or 10 mg / 500 mg taken once daily. To reduce gastrointestinal side effects of metformin, dosing should be stepwise.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Effectiveness in blood sugar control for Type 2 Diabetes and prevention of cardiovascular events

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

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar levels in adult patients with Type 2 diabetes. The combination of dapagliflozin and metformin effectively manages blood sugar levels. Attention should be paid to the impact on the occurrence of cardiovascular events, particularly in patients whose blood sugar is not adequately controlled and who have cardiovascular disease or risk factors. This medication is used to improve blood sugar control in diabetes patients.

How to take

Adult dose

This medication is typically administered once daily with the evening meal. The maximum dosage is once daily at dapagliflozin 10 mg / extended release metformin 2000 mg, administered as two tablets of 5 mg / 1000 mg. In the case of no previous diabetes medication treatment experience, the initial therapy is one tablet of 5 mg / 500 mg or 10 mg / 500 mg taken once daily. To reduce gastrointestinal side effects of metformin, dosing should be stepwise.

Precautions

This medication is used to control blood sugar levels and should not be administered to patients with poor kidney function. While rare, serious lactic acidosis can occur while on this medication. If symptoms such as malaise, muscle pain, difficulty breathing, or abdominal pain appear, it is important to consult a doctor immediately. Hypoglycemia may occur when used with other diabetes medications, so careful monitoring of blood sugar levels is required. It is advisable not to take this medication if you are experiencing acute infections, dehydration, heart disease, or liver dysfunction. When undergoing examinations using iodine-based contrast agents, you should discontinue this medication at least 48 hours before the test and resume only after confirming that kidney function is normal. Pregnant or breastfeeding women should not use this medication, and women who may become pregnant should also avoid it. Elderly patients are at higher risk for decreased kidney function, so kidney function tests should be performed prior to administration, and regular monitoring should continue during treatment. Excessive alcohol consumption should be avoided while taking this medication, as alcohol can increase the risk of lactic acidosis. Patients with a risk of decreased fluid volume or low blood pressure should carefully monitor blood pressure and fluid status while on this medication. This medication may increase the risk of genital infections and urinary tract infections, so if any infection symptoms appear, prompt treatment should be sought. If blood sugar control fails or abnormal symptoms develop, consult healthcare professionals immediately for appropriate action. Regular blood tests and monitoring of vitamin B12 levels should be performed while taking this medication to check for abnormalities. Caution is advised while driving or operating machinery due to possible dizziness. This medication should be kept out of reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • severe edema
  • severe allergic reactions
  • severe skin reactions
  • respiratory problems
  • liver issues (jaundice)
  • severe neurological symptoms
  • ketoacidosis
  • urosepsis
Show 8 more
  • pyelonephritis
  • acute kidney injury
  • renal dysfunction
  • perineal necrosis
  • acute cholecystitis
  • atrial fibrillation
  • Guillain-Barré syndrome
  • bacterial pneumonia.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), fluid volume depletion, thirst, diabetic ketoacidosis, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, dyslipidemia, elevated blood urea, weight loss, rash, diarrhea, nausea/vomiting, upper abdominal pain, indigestion, abdominal discomfort.

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

Storage

This medication must be stored in a tightly closed container to protect it from exposure to air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps preserve the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pink, bilaterally convex, egg-shaped film-coated tablets

Package unit

30 tablets per 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.

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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.