Medication info
Exiglu Tablet 5mg (Dapagliflozin)

Exiglu Tablet 5mg (Dapagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin›5mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Yellow round film-coated tablet
Packaging
10 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202003939 · Approved 2020.05.28 · Insurance code 643308580

Summary

Main use
Management of blood sugar in type 2 diabetes and reduction of cardiovascular risks associated with chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10mg once daily. It can be taken orally at any time of the day without regard to food. The tablet should be swallowed whole.
Child dose
Efficacy and safety of dapagliflozin for children under 18 years have not been established. There are no related materials.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Management of blood sugar in type 2 diabetes and reduction of cardiovascular risks associated with chronic heart failure and kidney disease

  • Type 2 diabetes
  • blood sugar control disorders
  • cardiovascular disease
  • cardiovascular risk factors
  • chronic heart failure
  • cardiovascular diseases
  • heart failure
  • chronic kidney disease
  • decreased glomerular filtration rate
  • end-stage renal disease
View approved original text

This medication is used in conjunction with dietary and exercise therapy to improve blood sugar control in patients with type 2 diabetes. Additionally, it helps reduce the risk of cardiovascular disease-related mortality and hospitalization due to heart failure in chronic heart failure patients. It is also effective in patients with chronic kidney disease by lowering the risks of declining kidney function and cardiovascular disease-related mortality. This medication can be safely used alone or in combination with other standard treatments. It can be used cautiously in diabetic patients with cardiovascular risks, contributing to overall improvements in blood sugar control, cardiovascular, and kidney health.

How to take

Adult dose

The recommended dose of this medication is 10mg once daily. It can be taken orally at any time of the day without regard to food. The tablet should be swallowed whole.

Child dose

Efficacy and safety of dapagliflozin for children under 18 years have not been established. There are no related materials.

Precautions

This medication should not be used in certain patients. Patients with allergies to the active ingredient or excipients of this medication, patients with type 1 diabetes or diabetic ketoacidosis, and those with lactose intolerance or specific genetic problems should not be administered this medication. Additionally, patients undergoing dialysis should not use this medication. It should be used cautiously in patients with decreased fluid volume or kidney function issues. This medication may lower blood pressure or reduce blood volume, which can lead to symptomatic hypotension or rapid changes in kidney function. This risk may be higher in patients with decreased kidney function, the elderly, and those taking diuretics, thus careful monitoring is necessary before and during administration. Adverse effects of this medication may include genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis. Genital infections are more common in women, usually with mild symptoms that respond well to treatment, but in rare cases, treatment discontinuation may be necessary. Hypoglycemia is more likely to occur when this medication is used with insulin or blood glucose-lowering agents like sulfonylureas, requiring careful attention. This medication is not recommended for patients with severely impaired liver function, and the elderly may be more susceptible to reduced fluid volume and changes in kidney function, necessitating caution. Also, glucose may be detected in urine tests while taking this medication. Pregnant women should not use this medication, and it should be discontinued immediately upon confirmation of pregnancy. Furthermore, breastfeeding women should also not take this medication. This medication may interact with other drugs; therefore, especially in cases where diuretics, insulin, or blood glucose-lowering agents are used together, dosage adjustments and caution are required. Patients taking lithium should frequently monitor serum lithium levels. In case of overdose, there is no specific antidote, so symptomatic treatment should be given, and medical assistance should be sought if necessary. Finally, this medication does not significantly affect the ability to drive or operate machinery, but when taken with other blood glucose-lowering agents, the risk of hypoglycemia should be acknowledged and precautions taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), severe rash with high fever, blisters, epidermal peeling, pain in oral/ocular mucosa (severe skin reaction), difficulty or shortness of breath, asthma attack, respiratory distress associated with cough and fever (respiratory problems), yellowing of skin or eyes (jaundice), extreme fatigue (liver issues), sudden and severe

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infection, fungal infection, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, elevated serum creatinine, dyslipidemia, weight loss, dehydration, thirst, gastrointestinal disorders (dyspepsia, nausea, diarrhea, vomiting, etc.), urinary retention, edema, itching, hives, cold sweat, headache, cough, shortness of breath,

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Maintaining a storage temperature between 1 and 30 degrees Celsius at room temperature is important. This will help safely preserve the drug's effectiveness.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

10 tablets/bottle, 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.