Medication info
Excigluem Sustained-release Tablet 5/500 mg

Excigluem Sustained-release Tablet 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tabletDapagliflozin›5mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Orange, double convex, rectangular 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 202107478 · Approved 2021.11.15 · Insurance code 643309200

Summary

Main use
Effect on blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is typically taken once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, which can be administered as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects associated with metformin, the dosage should be adjusted gradually.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Effect on blood sugar control and prevention of cardiovascular events in type 2 diabetes

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

This medication is used to help control blood sugar levels in adults with type 2 diabetes by combining dapagliflozin and metformin. It can effectively manage blood sugar levels when administered alongside dietary and exercise therapies. It is particularly important for patients who have difficulty controlling their blood sugar and have cardiovascular disease or risk factors to consult with a healthcare professional regarding the potential impacts on cardiovascular events. This medication contributes to the improvement of patients’ health by aiding in safe and systematic blood sugar management.

How to take

Adult dose

This medication is typically taken once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of sustained-release metformin once daily, which can be administered as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects associated with metformin, the dosage should be adjusted gradually.

Precautions

This medication helps control blood sugar levels. However, it may rarely cause a serious condition known as lactic acidosis, so caution is warranted. When using this medication, there is a risk of hypoglycemia when taken with insulin or sulfonylureas, so care should be taken. This medication should not be used in patients with severely reduced kidney function, dehydration, serious infections, cardiovascular issues, or acute myocardial infarction. Additionally, pregnant or nursing women, patients with lactose intolerance, and those undergoing dialysis should not take this medication. Before taking the medication, it is essential to check fluid volume and kidney function, especially in elderly patients or those with compromised kidney function. This medication may increase the risk of genital infections or urinary tract infections; hence, if symptoms of infection appear, prompt consultation with a physician is necessary. Hypoglycemic symptoms may occur, so dosage adjustment may be needed when used in combination with insulin or other hypoglycemic agents. While taking this medication, there may be rare side effects such as dizziness, dry mouth, constipation, and back pain; if any unusual symptoms occur, they should be reported. This medication should not be administered to patients with impaired liver function, and alcohol consumption should be avoided due to an increased risk of lactic acidosis. Before surgery or radiologic examinations, this medication should be stopped for a certain period, and only resumed once normal kidney function is confirmed. Vitamin B12 deficiency may occur, so regular monitoring of serum vitamin B12 levels is advisable. In cases of overdose, immediate medical attention should be sought, and this medication should not be used by children or pregnant women. During treatment, caution should be exercised about dizziness when driving or operating machinery, and it should be stored in its original container out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever, changes in skin or eye color, extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Hypoglycemia
  • dizziness
  • constipation
  • dry mouth
  • back pain
  • dysuria
  • polyuria
  • nocturia
  • itching of the genital area
  • itching of the external genitalia
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  • increased hematocrit
  • dyslipidemia
  • elevated serum creatinine
  • elevated blood urea
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased vitamin B12/deficiency
  • epigastric pain
  • dyspepsia
  • abdominal discomfort
  • abdominal pain
  • gastric ulcer
  • irritable bowel syndrome
  • salivary gland hypertrophy
  • toothache
  • headache
  • sensory disturbances
  • tremor
  • nasopharyngitis

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and kept at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Orange, double convex, rectangular 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.