Empagliflozin/Metformin Hydrochloride Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dose of this medication is 1 tablet per dose, taken twice daily. The dosage should be determined based on the current treatment regimen, effectiveness, and tolerability of each patient, without exceeding the maximum recommended daily doses of 25 mg empagliflozin and 2000 mg metformin. For patients who are inadequately controlled with monotherapy of metformin or other drugs like insulin, the recommended starting dosage is 5 mg of empagliflozin taken twice daily (total daily dosage of 10 mg) along with the existing dosage of metformin.

This medication is designed to help lower blood sugar levels. However, it should not be administered to patients with poor kidney function or those with acute infections, heart failure, or liver dysfunction. It is also advised that pregnant or breastfeeding women avoid this medication. This drug can rarely cause severe lactic acidosis, so if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, medical advice should be sought immediately. Additionally, care is needed when using this drug with other diabetes medications due to the risk of hypoglycemia. Urinary or genital infections may occur, so patients should inform their healthcare provider if any symptoms arise. This medication may cause a decrease in fluid volume, so it should be used cautiously in patients who are dehydrated or elderly. If surgery is planned, discontinue this medication 48 hours before surgery and resume it only after kidney function has returned to normal. Regular blood tests to monitor kidney function and vitamin B12 levels are recommended. Avoiding alcohol is advisable as it may increase the risks of side effects from this medication. During treatment, if sudden weight loss, severe fatigue, or dizziness occurs, consult a healthcare provider immediately. Safety in children has not been established; hence, it is not used in this population. This medication must be taken exactly as prescribed, and patients should not discontinue or increase the dosage arbitrarily.

Serious side effects

Hives, severe swelling (edema), urosepsis, pyelonephritis, perineal necrosis, ketoacidosis, lactic acidosis, liver abnormalities (abnormal liver function tests, hepatitis), myocardial infarction, cerebral infarction, acute kidney injury, acute pyelonephritis, acute cholecystitis, autoimmune hepatitis, gallstones, severe allergic reactions, severe skin adverse reactions, respiratory issues, serious neurological symptoms, severe edema or urinary abnormalities

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 closed container to prevent exposure to air or moisture. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness for a longer period.

Appearance

Orange-yellow, oval, biconvex, film-coated tablet

Package unit

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