Medication info
Daidian Tablet 10 mg (Empagliflozin)

Daidian Tablet 10 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Pale yellow, biconvex, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102107 · Approved 2021.03.05 · Insurance code 649105200

Summary

Main use
Improvement of blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication for monotherapy and additional combination therapy with insulin and other antidiabetic agents is 10 mg once daily. For cases where tolerance to this 10 mg dose is good but additional blood sugar control is needed, the dose may be increased to 25 mg once daily. When this medication is administered with sulfonylureas or insulin, dosage reductions of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improvement of blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events

  • Difficulty controlling blood sugar in patients with type 2 diabetes
  • inability to control blood sugar
  • cardiovascular disease
  • occurrence of cardiovascular events
View approved original text

This medication is used in conjunction with diet and exercise to help control blood sugar levels in adult patients with type 2 diabetes. It can be administered as monotherapy, and if adequate blood sugar control is difficult at the initial treatment stage, it can be combined with metformin. Additionally, this drug can be added to enhance treatment efficacy in patients who struggle to control blood sugar with metformin alone or other combination therapies. It may be used with various combination therapies such as insulin therapy or DPP-4 inhibitors. It is particularly important for patients with type 2 diabetes who have cardiovascular disease to consult a specialist regarding additional precautions. This medication helps improve blood sugar control and aids in diabetes management.

How to take

Adult dose

The recommended dosage of this medication for monotherapy and additional combination therapy with insulin and other antidiabetic agents is 10 mg once daily. For cases where tolerance to this 10 mg dose is good but additional blood sugar control is needed, the dose may be increased to 25 mg once daily. When this medication is administered with sulfonylureas or insulin, dosage reductions of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia.

Precautions

This medication should not be used in patients who are allergic to the active ingredient or any of its components. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely reduced kidney function, specifically those with a glomerular filtration rate of less than 30 mL/min/1.73m2 or those with end-stage renal disease or those on dialysis should not use this medication. This drug contains lactose, so it should not be given to patients with genetic issues such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. It should be used with caution in patients with mild kidney impairment, and it is recommended not to initiate treatment if the glomerular filtration rate is below 60 mL/min/1.73m2. If kidney function continues to decline and falls below 45 mL/min/1.73m2, this medication should be discontinued. Caution should be exercised in patients with mild heart failure, and it is not recommended for severe heart failure patients. This drug may increase the risk of hypoglycemia when used with insulin or sulfonylureas, so dosage adjustments may be necessary when combined. While taking this medication, be alert for hypoglycemic symptoms, especially when used with insulin or sulfonylureas. Adverse effects such as genital infections, urinary tract infections, and increased urination may occur, so consult a healthcare provider immediately if symptoms arise. There may be a risk of lowered blood pressure or dehydration due to reduced fluid volume, so elderly patients or those taking blood pressure medications should be cautious. Severe metabolic disturbances such as ketoacidosis may occur rarely, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing arise, visit a hospital immediately. Pregnant women should avoid taking this medication, and if pregnancy is confirmed, they should discontinue use immediately. Breastfeeding women are also recommended to stop breastfeeding while taking this medication. Children under 18 years old should not use this medication as its safety and efficacy have not been established. No special toxicity has been reported in the case of overdose, but appropriate treatment based on clinical conditions is necessary. This medication should be kept out of reach of children and not transferred to another container as a safety measure. Caution is needed when driving or operating machinery due to the risk of hypoglycemia, especially when taken in conjunction with insulin or sulfonylureas. Patients with diabetes should pay attention to routine foot care, and since serious side effects such as limb amputation have been reported rarely, regular foot checks are advised. If there is pain, soreness, swelling, or fever in the perineal area, it may indicate the possibility of perineal necrosis, so inform a healthcare provider immediately and seek treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema (severe swelling), ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, rash (severe skin adverse reactions), headache (including sudden and very severe headache), cerebrovascular accident, intracranial aneurysm, liver damage (including yellowing of the skin or eyes), acute cholecystitis, autoimmune hepatitis, cholelithiasis, acute kidney injury, severe edema associated with high blood pressure and urinary abnormalities, heart failure, deep venous thrombosis,

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • balanitis and other genital infections
  • increased urination
  • urinary tract infections
  • fluid volume loss
  • increased serum creatinine
  • decreased glomerular filtration rate
  • rash
  • itching
Show 19 more
  • headache
  • dizziness
  • abdominal pain
  • nausea
  • diarrhea
  • dyspepsia
  • vomiting
  • fatigue
  • peripheral edema
  • facial swelling
  • edema
  • chest pain
  • palpitations
  • anxiety
  • insomnia
  • drowsiness
  • blurred vision
  • coughing
  • nasal bleeding

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow, biconvex, round film-coated tablet

Package unit

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.