Empagliflozin/Metformin 5/500 mg Tab

Adult dose

The recommended dosage of this medication is 1 tablet once, twice daily. Empagliflozin should not exceed a maximum of 25 mg per day, and Metformin should not exceed a maximum of 2000 mg per day. If blood sugar control is insufficient with Monotherapy of Metformin or in combination with other medications, Empagliflozin 5 mg should be taken twice daily (total of 10 mg) alongside the patient's existing dose of Metformin. In cases of excellent tolerance and the need for additional blood sugar control, a dose increase to Empagliflozin 25 mg (total per day) may be indicated. In patients switching from Empagliflozin (total of 10 mg or 25 mg daily) and Metformin combination therapy, the existing dose of Empagliflozin and the existing dose of Metformin should be continued. When this medication is administered in conjunction with sulfonylureas or insulin, consideration should be given to reducing the doses of sulfonylureas or insulin to decrease the risk of hypoglycemia. This medication should be taken with meals to reduce gastrointestinal side effects related to Metformin. If a dose is missed, it should be taken as soon as remembered. However, do not take two doses at once, and in such cases, skip the missed dose. Special population: Renal impairment: Dose adjustment is not required for patients with mild renal impairment. This medication contains Metformin, so in patients with estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m² or creatinine clearance (CrCl) of 45-59 ml/min without additional symptoms that might increase the risk of lactic acidosis, it may be used with dose adjustment. In such patients, the initial dosing of Metformin could be 500 mg or 850 mg once a day, thus starting with individual single doses of Empagliflozin and Metformin. The maximum allowable daily dose of Metformin hydrochloride with this medication is 1000 mg, which can be administered as 500 mg twice daily. Kidney function should be monitored closely every 3-6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m², this medication should be discontinued immediately. Elderly: Patients over 75 years old should consider the risks of declining renal function and fluid volume.

This medication assists in blood sugar control. It may cause a rare side effect called severe lactic acidosis; therefore, patients with poor kidney function, heart disease, liver problems, etc., should not use it. Care should be taken as hypoglycemic symptoms may occur when taken with other diabetes medications. Patients with decreased kidney function, dehydration, severe infections, acute heart issues should avoid this medication. Women who are pregnant or breastfeeding should avoid using this medication as well. During the period of taking this medication, regular monitoring of kidney function and blood sugar levels is necessary, and in case of unusual symptoms, medical personnel should be informed immediately. There is a possibility of urinary tract infections or genital infections; fast treatment should be sought if such symptoms occur. This drug can cause fluid loss, hence patients with dehydration symptoms or elderly individuals should exercise special caution. Due to the risk of hypoglycemia, meals should not be skipped, and dosage adjustments may be necessary when used with other hypoglycemic agents. Consumption of alcohol should be avoided as it can increase the risk of lactic acidosis. This medication should be temporarily stopped before and after surgery or examinations using iodine contrast agents, and reinstated after normal kidney function is confirmed. During the use of this medication, vitamin B12 levels may decrease, hence regular testing may be required. This medication is not recommended for children under 18 years old, and elderly patients should be closely monitored for kidney function. In case of overdose, immediate medical attention should be sought as appropriate treatment may be necessary and blood dialysis could be required. Store this medication out of reach of children and preferably in its original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling of skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough + fever, jaundice indicated by yellowing of skin or eyes, extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, visual disturbances, paralysis, urination

Mild side effects

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

Store this medication in a tightly closed container to protect it from air and moisture. Also, it is recommended to keep the medication at room temperature between 1°C and 30°C. Avoid places that are too hot or too cold, and store in a cool place away from direct sunlight.

Appearance

Orange-yellow, biconvex oval film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 60 tablets/bottle, 30 tablets/bottle