Medication info
Exiglu 10 mg (Dapagliflozin)

Exiglu 10 mg (Dapagliflozin)

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

MFDS item code 202003940 · Approved 2020.05.28 · Insurance code 643308560

Summary

Main use
Treatment for type 2 diabetes blood sugar control and reduction of cardiovascular risks associated with chronic heart failure and kidney disease.
Who takes it
Adults · Children
Adult dose
Take 10 mg orally once daily as monotherapy or additional therapy. In initial combination therapy, doses of 5 mg or 10 mg can be taken once daily. The recommended dosage for chronic heart failure and chronic kidney disease patients is also 10 mg once daily, regardless of meals, taken at any time of the day, and the tablet should be swallowed whole.
Child dose
Not recommended as safety and efficacy have not been established in pediatric patients under 18 years.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Treatment for type 2 diabetes blood sugar control and reduction of cardiovascular risks associated with chronic heart failure and kidney disease.

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

This drug is used in conjunction with diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It is also effective in reducing the risk of death and hospitalization due to cardiovascular disease in patients with chronic heart failure, as well as in decreasing the risk of deterioration of kidney function and related mortality in patients with chronic kidney disease. This drug is administered in combination with standard treatments for each condition to enhance therapeutic effects. Therefore, it aids in the treatment of type 2 diabetes, chronic heart failure, and chronic kidney disease.

How to take

Adult dose

Take 10 mg orally once daily as monotherapy or additional therapy. In initial combination therapy, doses of 5 mg or 10 mg can be taken once daily. The recommended dosage for chronic heart failure and chronic kidney disease patients is also 10 mg once daily, regardless of meals, taken at any time of the day, and the tablet should be swallowed whole.

Child dose

Not recommended as safety and efficacy have not been established in pediatric patients under 18 years.

Precautions

This drug should not be used in certain patients. It is contraindicated for patients with allergies to the ingredients or additives, type 1 diabetes patients, patients with diabetic ketoacidosis, and those with genetic disorders affecting lactose breakdown. Moreover, it should not be used in patients undergoing dialysis. Precautions should be taken when administering to patients with decreased fluid volume or impaired kidney function. This drug may lower blood pressure or affect kidney function, so caution is particularly required for older patients, those with poor kidney function, and patients taking diuretics. Blood pressure and kidney function should be periodically monitored during treatment, and the effect on blood sugar control may vary depending on kidney function. Adverse effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, diabetic ketoacidosis may occur with this medication. Notably, genital infections are more common in women, and immediate treatment is required if symptoms of infection appear. If symptoms of ketoacidosis occur despite low blood sugar levels, immediate medical attention is necessary, as this drug poses a risk for ketoacidosis. This drug may affect kidney function, so any abnormal symptoms related to kidney should be discussed with a doctor. Severe skin and tissue infections such as perineal necrosis have been rarely reported, so immediate medical attention is needed if there is pain, swelling, or redness around the genital area. Women who are pregnant or planning to become pregnant should not use this medication; similarly, it should be avoided while breastfeeding. The safety and efficacy of this drug in children have not been established, thus it should not be used in this population. In the event of an overdose, as there is no specific antidote, appropriate treatment based on symptoms is necessary. Patients should be cautious of the risk of hypoglycemia when driving or operating machinery while taking this medication. Caution is warranted when using this drug concurrently with other diuretics, insulin, or sulfonylureas, as the risk of hypoglycemia or dehydration may increase, requiring dose adjustments according to physician instructions. This drug should be stored in its original container and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or breathing difficulties, asthma attacks, respiratory irregularities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis, related genital infections, urinary tract infections, hypoglycemia, dizziness, constipation, dry mouth, back pain, painful urination, polyuria, nocturia, increased hematocrit, decreased creatinine clearance during the initial treatment, dyslipidemia, increased blood urea nitrogen, weight loss, edema, fever, foreign body sensation, facial swelling, facial pain, warmth, flu-like symptoms, itching, rash, sweating, joint pain, musculoskeletal pain, limb pain, muscle

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius to ensure the medication retains its effectiveness.

Appearance and packaging

Appearance

Yellow oval 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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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.