Envir Tablet 1.0 mg (Entacapivir)

Adult dose

Administer this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer 0.5mg of entecavir orally once daily. Patients 16 years of age and older with lamivudine resistance, that is, patients who experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir once daily on an empty stomach Patients with renal impairment: In patients with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily; entecavir dose in patients with lamivudine resistance 1 mg once daily 30 - <50: Entecavir dose 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dose in patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours 10 - <30: Entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose in patients with lamivudine resistance 0.3 mg a once daily or 1 mg every 72 hours <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose in patients with lamivudine resistance 0.1 mg a once daily or 1 mg every 7 days a: For doses below 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

This medication is a nucleoside analogue and can cause severe liver-related side effects such as severe hepatic enlargement, lactic acidosis, and steatosis, whether used alone or in combination with other antiretroviral agents. The risk is especially high in women and obese patients, so patients at risk of liver disease should take extra caution. If symptoms of lactic acidosis or liver function abnormalities occur while using this medication, it should be discontinued immediately. Furthermore, discontinuing this medication can lead to acute exacerbation of hepatitis B, so liver function and status must be thoroughly monitored for several months after discontinuation. This medication is not recommended for untreated patients with HIV infection, and an HIV antibody test must be performed before use. This medication should not be administered to patients with hypersensitivity to its components or those with specific genetic lactose intolerance. In certain patient groups, such as those with renal failure or liver transplant recipients, dose adjustment or kidney function monitoring is required. It is best taken on an empty stomach, as taking it with food may decrease the absorption of the medication. Common side effects include headache, fatigue, dizziness, nausea, and regular monitoring is required since liver function test results may increase. There is no specific antidote in case of overdose, so appropriate supportive care is necessary according to symptoms, and it may be partially removed through hemodialysis. During pregnancy, the risks and benefits to the fetus should be carefully considered before use. In breastfeeding cases, it is recommended to either stop breastfeeding or discontinue the medication. This medication is excreted through the kidneys, hence dose adjustment is necessary for patients with impaired kidney function, and caution is required when used in combination with other renal-excreted drugs as the risk of side effects may increase. Finally, this medication should be kept out of reach of children, stored in a cool place away from direct sunlight, and syrup forms should only be used within the validity period after opening.

• Lactic acidosis
• steatosis
• hepatomegaly
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is important to maintain the storage temperature between 15 degrees and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness and safety over a long period.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/AluAlu pack x 3)