Empagliflozin 10 mg Tablets

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy or in combination therapy with insulin or other blood glucose-lowering agents. If 10 mg of this medication is well tolerated and additional blood glucose control is needed, the dosage can be increased to 25 mg once daily. This medication can be taken regardless of meals. The tablets should be swallowed whole. If a dose is missed, take it as soon as remembered.

This medication should not be administered to certain patients. Firstly, patients with allergic reactions to the ingredients of this medication should not take it. Secondly, this medication is not suitable for patients with type 1 diabetes or diabetic ketoacidosis. Thirdly, patients with severely impaired kidney function, that is, with a glomerular filtration rate of less than 30 mL/min/1.73m2, or those with end-stage kidney disease or on dialysis should avoid using it. Fourthly, since this medication contains lactose, it should not be administered to patients with genetic metabolic abnormalities such as lactose intolerance or galactose intolerance. In patients with mild impairment of kidney function, it should be administered with caution. For patients with a glomerular filtration rate of less than 60 mL/min/1.73m2, dosage adjustment or discontinuation might be required. This medication is not used for patients with end-stage renal disease or those on dialysis due to lack of expected effectiveness. Additionally, it is important to monitor kidney function regularly. In patients with congestive heart failure of NYHA class I-II, caution is required while use is not recommended for those in NYHA class III-IV. If this medication is taken in conjunction with insulin or insulin secretagogues such as sulfonylureas, there may be a risk of hypoglycemia, hence dosage adjustments may be necessary. During the course of treatment, there may be side effects such as hypoglycemia, infections, increased urination, urinary tract infections, and reduced fluid volume; therefore, vigilance is necessary. Particularly in women, genital infections may occur more frequently, so symptoms should be closely monitored. Ketoacidosis, a serious metabolic abnormality, may occur rarely. If symptoms such as vomiting, abdominal pain, difficulty in breathing, or malaise arise, immediate consultation with healthcare professionals is necessary. In elderly patients, especially those over 75 years, the risk of fluid loss should be carefully monitored regarding blood pressure and fluid status. This medication has been reported to cause serious side effects including dehydration, hypotension, urosepsis, pyelonephritis, and perineal necrosis; immediate treatment is necessary if any abnormal symptoms occur. Use of this medication during pregnancy is not recommended; it should be discontinued upon confirmation of pregnancy. During breastfeeding, this medication may be excreted in breast milk, hence it is advisable to stop breastfeeding. Children under 18 years should not use this medication as safety and efficacy have not been established. No specific toxic symptoms have been reported in cases of overdose; however, appropriate treatment might be necessary depending on a clinical situation. This medication should be stored out of the reach of children and should not be transferred to other containers. During treatment, blood glucose levels and kidney function should be checked regularly, and if symptoms of hypoglycemia or infection occur, immediate consultation with healthcare professionals is necessary. Caution is required when driving or operating machinery, especially if taken with insulin or sulfonylureas due to the risk of hypoglycemia.

Serious side effects

• Urticaria
• angioedema
• perineal necrosis
• ketoacidosis
• urosepsis
• pyelonephritis
• severe allergic reactions
• severe skin reactions
• liver abnormalities (jaundice)
• serious neurological symptoms

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• other genital infections
• increased urination
• urinary tract infections
• fluid volume loss
• increased serum creatinine
• decreased glomerular filtration rate
• rash

This medication should be stored in a sealed container to prevent exposure to air or humidity. Also, it is important to store it at a temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance

Light yellow, biconvex, round film-coated tablets

Package unit

10 tablets/box [10 tablets/PTPX1], 30 tablets/box [10 tablets/PTPX3], 30 tablets/bottle