Medication info
Exiglumem Sustained Release Tablet 10/500 mg

Exiglumem Sustained Release Tablet 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tabletDapagliflozin›10mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Pink, convex on both sides, oblong sustained-release film-coated tablet
Packaging
10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202107476 · Approved 2021.11.15 · Insurance code 643309180

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once daily with dinner. The maximum dosage is once daily dapagliflozin 10mg/sustained-release metformin 2000mg, taking 2 tablets of 5mg/1000mg. If there is no previous experience with diabetes drug therapy, the initial regimen should be one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce gastrointestinal side effects from metformin, dosages should be adjusted gradually.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication helps to control blood sugar levels in adults with type 2 diabetes when used in conjunction with dapagliflozin and metformin. It can effectively manage blood sugar when used with dietary and exercise therapy. It is particularly suitable for type 2 diabetes patients whose blood sugar is not adequately controlled and who have cardiovascular disease or risk factors. This medication may aid not only in blood sugar control but also in managing the risk of cardiovascular events, so precautions should be checked before use. Overall, it is used for controlling blood sugar levels and managing cardiovascular health.

How to take

Adult dose

This medication is generally administered once daily with dinner. The maximum dosage is once daily dapagliflozin 10mg/sustained-release metformin 2000mg, taking 2 tablets of 5mg/1000mg. If there is no previous experience with diabetes drug therapy, the initial regimen should be one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce gastrointestinal side effects from metformin, dosages should be adjusted gradually.

Precautions

This medication may very rarely cause a serious condition known as lactic acidosis. Lactic acidosis occurs when there is an excessive buildup of lactic acid in the body, and this condition can be fatal, so caution is needed. If taken with other diabetes medications, hypoglycemia may occur, so blood sugar levels should be closely monitored. This medication should not be used in patients with severely compromised kidney function, dehydration, severe infections, or acute heart issues. Pregnant or breastfeeding women should not take this medication. Furthermore, patients with specific genetic issues like lactose intolerance should also refrain from using this medication. Elderly patients or those with diminished kidney function must check their fluid status and renal function prior to taking this medication and monitor regularly during treatment. This medication may increase the risk of infections such as genital infections or urinary tract infections, so if symptoms of infection develop, consult a doctor promptly. During treatment, be vigilant for signs of dehydration or low blood pressure; if these symptoms occur, notify medical personnel. This medication may lower vitamin B12 levels, so monitoring blood vitamin B12 concentrations is advised during long-term treatment. Excessive alcohol consumption may enhance the risk of side effects, so it should be avoided. If planning surgery or radiocontrast examinations, this medication should be discontinued for a period, and kidney function testing is required before resuming. Immediate consultation with medical staff is required if severe abdominal pain, difficulty breathing, or profound lethargy occurs while taking this medication. Finally, this medication is not recommended for children or pregnant women, and storage must ensure it is kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • severe allergic reactions
  • severe edema or urination abnormalities
  • acute renal failure
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • diabetic ketoacidosis
  • urosepsis and pyelonephritis
  • acute kidney injury
Show 7 more
  • atrial fibrillation
  • acute cholecystitis
  • Guillain-Barré syndrome
  • perineal necrosis (Fournier gangrene)
  • chest pain
  • headache (including severe headache)
  • wrist fractures

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • back pain
  • dysuria
Show 17 more
  • polyuria
  • nocturia
  • vulvar pruritus
  • genital pruritus
  • elevated hematocrit
  • increased serum creatinine
  • elevated blood urea
  • dyslipidemia
  • weight loss
  • diarrhea
  • nausea/vomiting
  • vitamin B12 reduction/deficiency
  • upper abdominal pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • gastric ulcer

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

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

Pink, convex on both sides, oblong sustained-release film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 30 tablets/box [10 tablets/PTP x 3]

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.