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

Adult dose

The recommended dosage of this medication is 1 tablet once, 2 times a day. Dosage should be determined based on each patient's current treatment regimen, efficacy, and tolerability without exceeding the maximum daily doses of empagliflozin 25 mg and metformin 2000 mg. For patients with insufficient blood glucose control, the dosage is empagliflozin 5 mg taken twice daily (totaling 10 mg), and if tolerated well, empagliflozin may be increased to 10 mg or 25 mg.

This medication can cause a rare side effect known as severe lactic acidosis, which may pose a life-threatening risk, so caution is advised. When used in conjunction with other diabetes treatments such as insulin or sulfonylureas, hypoglycemia may occur, necessitating careful monitoring. This medication should not be used in patients with moderate to severe renal impairment, acute kidney issues, heart problems, or severe infections. It is also advisable that pregnant women, women who might become pregnant, and lactating women do not take this medication. Before undergoing surgery or tests involving radiopaque iodine contrast, this medication should be temporarily discontinued, and can be resumed once renal function is confirmed to be normal. This medication may increase the risk of urinary infections and genital infections, so immediate consultation with a physician is required if symptoms of infection appear. While taking this medication, there is a risk of dehydration or hypotension due to fluid loss, especially in elderly patients or those with cardiovascular diseases, necessitating careful monitoring of blood pressure and hydration status. This medication can lower vitamin B12 levels, so regular blood tests to check vitamin B12 levels are recommended during prolonged use. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided during treatment. Additionally, when taken with other blood glucose-lowering medications, there may be a risk of hypoglycemia, which may require dosage adjustments of other medications as needed. During treatment, kidney function should be monitored regularly to ensure there are no abnormalities, and if renal function deteriorates rapidly, treatment should be stopped immediately. Rarely, allergic reactions such as skin rash, itching, hives, or severe infections like severe perineal necrosis may occur, so if abnormal symptoms develop in the skin or genital area, immediate notification to medical personnel is essential. Elderly patients are at higher risk for renal function decline and fluid loss, requiring more caution when taking this medication, and it is generally recommended not to administer the maximum dose. In case of overdose, serious side effects such as lactic acidosis may occur, so the dosage should be strictly adhered to, and immediate medical attention should be sought if abnormal symptoms appear. The safety and efficacy of this medication have not been established in children, so it is not recommended for patients under 18 years of age.

Serious side effects

• Hives
• angioedema
• perineal necrosis
• lactic acidosis
• severe allergic reactions
• ketoacidosis
• urosepsis
• pyelonephritis
• cerebral infarction
• myocardial infarction

Mild side effects

• Nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation
• taste alteration
• itching
• rash
• increased urination

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius to preserve the medication's effectiveness and safety for a long time.

Appearance

Orange-yellow, biconvex, oval film-coated tablet

Package unit

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