Empagliflozin and Metformin Sustained-Release Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

In diabetes therapy, the dosage of this medication should be determined based on the current treatment regimen, efficacy, and tolerance of each patient, ensuring the total daily maximum recommended doses of Empagliflozin 25 mg and sustained-release Metformin Hydrochloride does not exceed 2000 mg. This medication should be taken once daily in the evening with meals to reduce gastrointestinal side effects associated with Metformin. This medication 10/1000 mg sustained-release or 25/1000 mg sustained-release should be taken once daily as 1 tablet. Patients taking this medication 5/1000 mg sustained-release or 12.5/1000 mg sustained-release should take 2 tablets simultaneously once daily. To maintain its sustained-release properties, this medication should not be split, crushed, ground, or chewed but swallowed whole. It may not completely dissolve and could be excreted in the stool. It is unknown whether the main active ingredient is present in the feces discharged. If patients repeatedly report finding this medication in their stool, healthcare professionals should assess whether blood glucose is being adequately controlled (refer to usage precautions, 5. General precautions). For patients who cannot achieve adequate blood glucose control with Metformin alone or in combination with insulin or other medications, the initial recommended dosage of this medication is a total daily amount of 10 mg Empagliflozin and the usual Metformin dose. If tolerance to 10 mg Empagliflozin is good and additional blood glucose control is needed, the dose may be increased to 25 mg Empagliflozin. Patients transitioning to this medication from combination therapy with Empagliflozin and Metformin should be dosed based on their current doses of Empagliflozin and Metformin. When switching from immediate-release Metformin to sustained-release, blood glucose control should be closely monitored and dosage adjusted as appropriate. When this medication is co-administered with sulfonylureas or insulin, consideration should be given to reducing the sulfonylureas or insulin doses to decrease the risk of hypoglycemia. (Refer to usage precautions 4. Adverse reactions and 6. Interactions). Special populations Renal impairment Dose adjustments based on renal function are necessary, so periodic assessment of kidney function before and after the initiation of this medication is recommended. In patients with mild renal impairment [creatinine clearance (CrCl) ≧ 60 mL/min or estimated glomerular filtration rate (eGFR) ≧ 60 mL/min/1.73 m²], dose adjustments are not required. In patients with moderate renal impairment [CKD stage 3A, creatinine clearance (CrCl) ≧ 45 mL/min and < 60 mL/min or estimated glomerular filtration rate (eGFR) ≧ 45 mL/min/1.73 m² and < 60 mL/min/1.73 m²] with good tolerance and no accompanying symptoms increasing the risk of lactic acidosis, the use of Metformin Hydrochloride can be adjusted in the following manner: - The starting dose of sustained-release Metformin Hydrochloride is 500 mg or 750 mg once daily, so it should not be initiated with this medication. The maximum daily dose of Metformin Hydrochloride is 1000 mg. If creatinine clearance (CrCl) drops below 45 mL/min or the estimated glomerular filtration rate (eGFR) drops below 45 mL/min/1.73 m², this medication should be discontinued immediately. Elderly patients Patients aged 75 and older should consider the risk of decreased kidney function and fluid volume loss.

This medication is used for the treatment of diabetes and helps lower blood glucose levels. However, certain precautions must be strictly followed when taking this medication. First, one of the ingredients, Metformin, can rarely cause a serious condition called lactic acidosis, which can be life-threatening, requiring utmost caution. Also, when taken with insulin or other diabetes medications, symptoms of hypoglycemia may occur, so blood glucose levels should be monitored closely. This medication should not be administered to patients with significantly decreased kidney function or severe liver dysfunction, and should be avoided in cases of acute infections, dehydration, or serious heart problems. Particularly, patients scheduled for surgery should discontinue this medication 48 hours prior to surgery and resume only after kidney function returns to normal. This medication may increase the risk of genital or urinary infections; therefore, if infection symptoms appear, prompt consultation with a physician is advised. During treatment, regular checks of serum creatinine levels are essential to monitor kidney function. Additionally, this medication may reduce Vitamin B12 levels; hence, periodic checks of Vitamin B12 levels are recommended for long-term use. Women who are pregnant or breastfeeding should avoid taking this medication, and women of childbearing potential should consult a physician before taking it. Elderly patients or those at risk of fluid loss should be cautious to avoid dehydration or hypotension, and adequate fluid intake is necessary during treatment. It is advisable to avoid excessive drinking or alcohol consumption while taking this medication. When taking the tablets, do not crush or chew them; swallow them whole, and it is normal for the tablet coating to appear in the stool. Lastly, if any adverse reactions are suspected or symptoms worsen while taking this medication, notify healthcare professionals immediately.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, shortness of breath, angioedema, urosepsis, pyelonephritis, necrosis of the perineum, lactic acidosis, ketoacidosis, acute kidney injury, acute renal failure, liver dysfunction (hepatitis, acute cholecystitis, autoimmune hepatitis), cerebral infarction, myocardial infarction, seizures, altered consciousness, vision disturbances, paralysis, severe swelling, increased blood pressure, heart failure, shock, cardiovascular collapse, sepsis, acute myocardial.

Mild side effects

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

Store this medication in a closed container to protect it from air and moisture. It is best kept at room temperature between 1 degree and 30 degrees.

Appearance

Gray, double convex, oval-shaped sustained-release film-coated tablet

Package unit

30 tablets/bottle