Jadiel Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dosage for this drug is once daily at 10 mg for monotherapy and additional combination therapy with insulin or other blood sugar-lowering medications. If tolerance is good and further blood sugar control is needed, the dose may be increased to 25 mg once daily. It can be taken irrespective of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take a double dose in one day.

This medication should not be administered to specific patients. First, it should not be used in patients with an allergic reaction to its active ingredient or excipients. Additionally, it is not indicated for type 1 diabetes patients or those experiencing diabetic ketoacidosis. Patients with significantly impaired renal function, specifically those with a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m² or those undergoing dialysis for end-stage renal disease, should not use this drug. As this medication contains lactose, it should not be used in patients with lactose intolerance, galactose intolerance, or inherited lactase deficiency. Patients with somewhat impaired renal function should be administered this drug with caution. For patients with a GFR of less than 60 mL/min/1.73m², it is advisable not to use this drug from the outset, and if already taking it, dosage adjustments or discontinuation may be necessary. This drug is not expected to be effective in patients with end-stage renal disease or on dialysis. Moreover, it should be used cautiously in patients with heart failure classified as NYHA I-II, while use is not recommended for those in NYHA III-IV stages. This medication may increase the risk of hypoglycemia when used in conjunction with insulin or sulfonylureas. Patients taking these medications should be aware of hypoglycemic symptoms and may need to reduce their insulin dosage if necessary. While taking this medication, various adverse reactions may occur. The most common adverse reaction is hypoglycemia, which occurs more frequently when combined with insulin or sulfonylureas. Other reported reactions include genital infections, urinary tract infections, increased urination, decreased fluid volume, and elevated blood creatinine levels. Additionally, this drug can induce severe ketoacidosis, particularly in patients with type 1 diabetes, those with reduced insulin dosages, or patients who are fasting for an extended period due to acute illness or post-surgery. Symptoms of ketoacidosis (nausea, vomiting, abdominal pain, difficulty breathing, etc.) should prompt immediate consultation with a healthcare professional. Elderly patients, especially those above 75 years, have a higher risk of fluid volume loss, leading to dehydration or hypotension, and should be carefully monitored in situations where fluid loss may occur, including physical examinations and blood pressure measurements. This drug may also increase the risk of serious infections such as urinary sepsis, pyelonephritis, and perineal necrosis, necessitating immediate treatment if such symptoms develop. Use of this medication is not recommended during pregnancy, and it should be discontinued if pregnancy is confirmed. Moreover, if breastfeeding, discontinuing this medication is advisable due to the potential for it to be excreted in breast milk. The safety and efficacy of this drug have not been established in children under the age of 18, so its use is not recommended. No specific toxic symptoms have been reported in the event of overdose; however, patients should be closely monitored, and appropriate treatment should be provided if an overdose occurs. Interactions with other medications may occur while taking this drug, particularly when used with diuretics, insulin, or sulfonylureas, thus consultation with healthcare professionals is necessary. Caution is advised when driving or operating machinery due to the risk of hypoglycemia. Finally, patients taking this medication should regularly undergo renal function tests and assess their fluid status.

Serious side effects

• Urticaria
• angioedema
• ketoacidosis
• urinary sepsis and pyelonephritis
• perineal necrosis

Mild side effects

• Hypoglycemia
• genital mycotic infections
• vulvovaginitis
• balanitis
• and other genital infections
• increased urination
• urination difficulties
• rash
• itching
• increased serum lipids

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablet

Package unit

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