Prime Entacavir Tablet 1 mg

Adult dose

Take this drug orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The recommended dose is entecavir 0.5mg orally once daily. Patients aged 16 years or older with lamivudine resistance, i.e., patients who have experienced persistent hepatitis B virus replication despite lamivudine treatment or who have lamivudine-resistant mutations: entecavir 1mg once daily on an empty stomach Patients with renal impairment: In patients with renal impairment, the oral clearance of this drug decreases as creatinine clearance decreases. Adjust the dosage 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 Creatinine clearance (mL/min) 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 Creatinine clearance (mL/min) 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 Creatinine clearance (mL/min) <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 oral solution is recommended. b: If administered on a hemodialysis day, administer this drug after the hemodialysis session. (Pharmacokinetic properties in patients with renal impairment: See “8. Administration to patients with renal impairment” under Precautions for Use)

Child dose

Applicable to patients over 16 years who have experienced persistent replication of the hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations, therefore, there is no specific dosage for children.

This medication may cause serious side effects such as lactic acidosis and steatosis in patients with poor liver function, so caution is needed. Such side effects have been reported more frequently in women and obese patients. If this medication is suddenly discontinued, there may be a rapid deterioration of hepatitis B, so liver function should be closely monitored for several months after discontinuation. Patients who are HIV-infected but not treated should not use this medication, and it is important to undergo HIV testing before administration. This medication should not be used by patients who are allergic to it or its components, or who have lactose intolerance. Patients with reduced kidney function or those undergoing dialysis need dose adjustment, and kidney function should be carefully monitored in patients who have undergone liver transplant. This medication is recommended to be taken on an empty stomach to enhance absorption. Side effects such as headache, fatigue, dizziness, and nausea may occur during treatment, and if liver function tests worsen, medical consultation should be sought immediately. During pregnancy, it should only be used if necessary, considering the risk to the fetus, and during lactation, breastfeeding should be considered for discontinuation or drug withdrawal as this medication may be secreted in breast milk. It is approved for use only in children aged 2 years and older, and safety and efficacy have not been established in children under 2 years of age. Elderly patients may have reduced kidney function, so dose adjustment and kidney function monitoring are necessary. In case of overdose, there are no specific antidotes, so one should visit a medical institution promptly for appropriate treatment. This medication may interact with other drugs, so it is essential to inform healthcare providers, especially when taking drugs that may affect kidney function.

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

This medication should be stored in a tightly sealed container to prevent exposure to air and light. Additionally, it is advisable to keep it at room temperature between 15 to 30 degrees Celsius. This helps maintain the medication's effectiveness and prevent deterioration.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets per PTP x 3)