Idian Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dose for this medicine is 10 mg once daily for monotherapy and as an adjunct to other antidiabetic medications such as insulin. If the 10 mg dose is well tolerated and additional blood sugar control is needed, the dose can be increased to 25 mg once daily. This medicine can be taken regardless of meals. The tablet should be swallowed whole. Do not take double doses in one day.

This medicine should not be administered to certain patients. First, patients with allergic reactions to the active ingredient or any components of this medicine should not use it. Second, this drug is not given to patients with type 1 diabetes or diabetic ketoacidosis. Third, patients with severely impaired renal function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m², end-stage renal disease, or those undergoing dialysis should not use this medicine. Fourth, because it contains lactose, it should not be administered to patients with genetic issues like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medicine should be used cautiously in patients with reduced renal function. Especially, patients with a glomerular filtration rate below 60 mL/min/1.73m² are recommended not to start this medicine initially, and even for those who tolerate the medicine well, dosage adjustments should be made if the filtration rate drops below 60, and it should be discontinued if it falls below 45. This medicine is not effective for patients with end-stage renal disease or those undergoing dialysis. For patients with mild to moderate heart failure, this medicine should be used cautiously, and it is not recommended for severe heart failure patients. Additionally, when used with insulin or sulfonylureas, the risk of hypoglycemia may occur, therefore the dosages of these medications may need to be reduced. During the use of this medicine, various adverse reactions may occur. The most common adverse reaction is hypoglycemia, which can occur when used in combination with insulin or sulfonylureas. Other reported problems include genital infections or urinary tract infections, increased urination, skin rash, itching, low blood pressure, dehydration, etc. Serious adverse reactions include ketoacidosis, urosepsis, pyelonephritis, and perineal necrosis (severe skin and tissue infection), so if these symptoms occur, immediate consultation with healthcare professionals is necessary. Elderly patients, particularly those over 75 years old, should take caution due to the high risk of fluid loss, and there is limited clinical experience in those over 85 years old. This medicine affects blood sugar control, so care must be taken when interpreting blood sugar test results, and accurate blood sugar control status cannot be determined with the 1,5-AG test. The use of this medicine during pregnancy is not recommended, and it should be discontinued if pregnancy is confirmed. During breastfeeding, as this drug may be excreted in breast milk, it is advisable to stop breastfeeding. For children under 18 years of age, safety and efficacy have not been established, so it is not used. No special toxicity has been reported in cases of overdose, but appropriate treatment according to clinical conditions is necessary. This medicine should be kept out of the reach of children, and care should be taken when transferring it to another container as it may affect the quality. This medicine may cause blood pressure lowering and fluid loss, so careful monitoring of the physical condition is necessary when administered to patients with cardiovascular diseases or hypotension, especially the elderly. There is a risk of hypoglycemia when driving or operating machinery, especially in patients taking insulin or sulfonylureas, so caution is essential. There may be potential interactions with other medications being taken simultaneously, so healthcare professionals should be notified of any other medications being used. During the use of this medicine, regular kidney function tests should be conducted, and immediate consultation with healthcare professionals should occur if any unusual symptoms appear.

Serious side effects

• Hives
• angioedema
• perineal necrosis
• ketoacidosis
• urosepsis and pyelonephritis
• interstitial nephritis
• liver abnormalities (jaundice)
• sudden and severe headache
• seizures
• confusion

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vulvitis
• balanitis and other genital infections
• itching
• rash
• increased urination
• increased serum lipids
• increased serum creatinine
• decreased glomerular filtration rate

This medicine may be sensitive to air or moisture, so it must be stored in a sealed container. It is best to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. By storing it this way, the efficacy of the medicine can be maintained for a longer period.

Appearance

Pale yellow, round, biconvex film-coated tablets

Package unit

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