Empagliflozin 10 mg Tablets

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and for additional use with other antidiabetic medications such as insulin. In cases with good tolerance but requiring additional blood sugar control, the dose can be increased to 25 mg once daily. When coadministering this medication with sulfonylureas or insulin, a reduction of the sulfonylurea or insulin dosage may be considered to reduce the risk of hypoglycemia. This medication can be administered without regard to meals.

This medication should not be used in certain patients. First, it should not be administered to patients with allergies to the active ingredient or any of the components of this medication. Additionally, it may be risky for patients with type 1 diabetes or diabetic ketoacidosis to use this medication. It should not be administered to patients with severely impaired renal function, defined as a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m² or those with end-stage renal disease or on dialysis. As this medication contains lactose, it should not be used in patients with lactose intolerance, galactose intolerance, or certain genetic lactose-related disorders. Patients with moderately impaired renal function should use this medication with caution, and renal function should be monitored regularly to adjust the dosage or discontinue if necessary. In cases of mild to moderate heart failure, the medication should be used cautiously, and it is not recommended for patients with severe heart failure. When used in combination with insulin or sulfonylureas, there may be a risk of hypoglycemia, necessitating dosage adjustments. During the use of this medication, there may be instances of hypoglycemia when combined with sulfonylureas or insulin, so caution is required. There may be an increased risk of infections, such as genital fungal infections in women and urinary tract infections in both men and women, so immediate treatment is necessary when symptoms arise. This medication may increase urination frequency, which can lead to dehydration or low blood pressure, so caution is particularly required for the elderly or patients with low blood pressure. Serious metabolic disturbances known as ketoacidosis can occur; therefore, if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing appear, immediate medical attention is required. There have also been reports of liver damage, so any manifestations of abnormal liver function should be discussed with a physician. There may be limitations on methods for monitoring blood sugar control during the use of this medication, so it is essential to follow instructions from a healthcare provider. It is recommended that women who are pregnant or planning to become pregnant do not use this medication, and it should also be avoided during breastfeeding. The safety and efficacy of this medication in children under 18 years of age have not been established. No specific toxicity has been reported in cases of overdose, but appropriate treatment should be administered based on clinical symptoms. This medication should be stored out of reach of children, and transferring it to other containers is not good for maintaining its quality. Caution is required when driving or operating machinery due to the risk of hypoglycemia. Moreover, diabetic patients should ensure thorough foot care as a preventive measure, and if there is pain or any unusual symptoms in the perineal area, they must seek medical attention immediately.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• rash
• perineal necrosis
• urosepsis
• pyelonephritis

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• other genital infections
• increased urination
• urinary tract infection
• volume depletion
• increased serum creatinine
• decreased glomerular filtration rate
• headache

This medication must be stored in a tightly closed container to avoid exposure to air and moisture. It is best kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the efficacy of the medication for a longer period.

Appearance

Light yellow, biconvex, round film-coated tablets

Package unit

30 tablets/bottle