Jepazine Duo Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is 1 tablet at a time, twice a day. Dosing should be determined based on the current treatment regimen, efficacy, and tolerability considering the maximum recommended daily doses of the components, which is 25 mg of empagliflozin and 2000 mg of metformin. For patients unable to achieve sufficient blood sugar control with metformin alone or other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice daily (total daily amount 10 mg) along with the existing dose of metformin. If patients demonstrate good tolerability for a total daily amount of 10 mg of empagliflozin and additional blood sugar control is needed, the dose may be increased to 25 mg (total daily amount). Patients switching to this medication from a combination of empagliflozin (total daily amount 10 mg or 25 mg) and metformin will use their existing doses of empagliflozin and metformin. Consider reducing the dose of sulfonylureas or insulin when this medication is co-administered to decrease the risk of hypoglycemia (see precautions regarding side effects 4 and interactions 6). This medication should be taken with food to minimize gastrointestinal side effects associated with metformin. If you miss a dose of this medication, take it as soon as you remember. However, do not take two doses at once, and in such cases, skip the missed dose. Special populations Patients with renal impairment Dose adjustment is not necessary for patients with mild renal impairment. This medication contains metformin, and can thus be used for patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or a CrCl of 45-59 ml/min, provided they do not have any additional symptoms associated with an increased risk for lactic acidosis. In such patients, the starting dose of metformin is 500 mg or 850 mg once daily, requiring that treatment with empagliflozin and metformin as individual monotherapy be initiated. The maximum daily dose of metformin hydrochloride that can be administered with this medication is 1000 mg, given as 500 mg twice daily. Renal function should be monitored closely every 3-6 months (see precautions regarding careful administration to specific patients). Should renal function decline (CrCl <45 ml/min or eGFR <45 ml/min/1.73m2), this medication should be discontinued immediately (see precautions regarding contraindications). Elderly patients Patients aged 75 years or older should consider the risk of decreased kidney function and fluid volume.

This medication contains two components that help control blood sugar. However, there are several points to be cautious about while taking this medication. First, it may be dangerous for individuals with poor kidney function, so it is essential to confirm that kidney function is normal. Additionally, it is not advisable to use this medication in patients with severe infections, dehydration, or heart and kidney issues such as heart failure. This medication can cause hypoglycemia, especially when taken with insulin or other blood sugar-lowering agents; hence, caution is advised. If symptoms of too low blood sugar appear, consult a doctor immediately. Furthermore, it may not be suitable for patients with impaired liver function. Excessive alcohol intake can also increase the risk of side effects, so it should be avoided. Pregnant or potentially pregnant women and those who are breastfeeding should not take this medication. During the use of this medication, urinary tract infections or genital infections may occur; therefore, if related symptoms arise, prompt treatment is essential. This medication may lower Vitamin B12 levels; regular checking of Vitamin B12 levels is advisable for those on long-term use. If undergoing surgery or tests involving iodine contrast agents, the use of this medication should be temporarily suspended and restarted only after kidney function has returned to normal. Elderly patients or those at risk of fluid loss should be cautious of dehydration or low blood pressure, and regular monitoring of kidney function and fluid status is important. Finally, consult healthcare professionals promptly if you notice any changes in symptoms or unusual reactions during the intake of this medication.

Serious side effects

• Urticaria
• angioedema
• perineal necrosis
• ketoacidosis
• lactic acidosis
• acute kidney injury
• pyelonephritis
• urosepsis
• severe edema
• myocardial infarction

Mild side effects

• Hypoglycemia
• urinary tract infection
• genital infection
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Maintaining the storage temperature between 1 degree and 30 degrees Celsius at room temperature is crucial. Proper storage will ensure the medication's efficacy is safely preserved.

Appearance

Biconvex oval film-coated tablet with a light brownish purple color.

Package unit

Bottle - 60 tablets/bottle, PTP - 60 tablets/box [(10 tablets/PTP x 6)]