Cavir Tablet 1 mg (Entecavir)

Adult dose

This medicine should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Recommended dosage for adults (16 years of age and older) This medicine should be administered orally once daily at a dose of 0.5mg of entecavir. Patients with lamivudine resistance, i.e., patients 16 years of age and older who have 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 adults with renal impairment, the oral clearance of this medicine decreases as creatinine clearance decreases. In adult patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dosage as shown in Table 2. Creatinine clearance (mL/min) | Entecavir dosage | Entecavir dosage in patients with lamivudine resistance ≥ 50 | 0.5 mg once daily | 1 mg once daily 30 - <50 | 0.25 mg once daily a or 0.5 mg every 48 hours | 0.5 mg once daily or 1 mg every 48 hours 10 - <30 | 0.15 mg once daily a or 0.5 mg every 72 hours | 0.3 mg once daily a or 1 mg every 72 hours <10, hemodialysis b or CAPD | 0.05 mg once daily a or 0.5 mg every 7 days | 0.1 mg once daily a or 1 mg every 7 days a: For doses less than 0.5mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

Pediatric patients 2 years of age and older weighing at least 10kg The oral solution should be used only in patients weighing up to 30kg. Treatment-naive patients a — body weight 10 to 11 kg: recommended once-daily oral solution dose 3 mL Treatment-naive patients a — body weight over 11 to 14 kg: recommended once-daily oral solution dose 4 mL Treatment-naive patients a — body weight over 14 to 17 kg: recommended once-daily oral solution dose 5 mL Treatment-naive patients a — body weight over 17 to 20 kg: recommended once-daily oral solution dose 6 mL Treatment-naive patients a — body weight over 20 to 23 kg: recommended once-daily oral solution dose 7 mL Treatment-naive patients a — body weight over 23 to 26 kg: recommended once-daily oral solution dose 8 mL Treatment-naive patients a — body weight over 26 to 30 kg: recommended once-daily oral solution dose 9 mL Treatment-naive patients a — body weight over 30 kg: recommended once-daily oral solution dose 10 mL a Children weighing over 30kg should receive 10 mL of the oral solution or a 0.5 mg tablet once daily. There are insufficient data to recommend a specific dosage adjustment for pediatric patients with renal impairment; however, consideration should be given to reducing the dose or increasing the dosing interval, similarly to the dosage adjustment in adults.

Caution is required for patients with liver disease, pregnant women, and obese patients, as serious liver problems such as lactic acidosis and steatosis may occur. Patients with poor liver function should discontinue use immediately if liver function abnormalities develop during treatment. Sudden discontinuation of this medication may worsen hepatitis B, so liver function tests should be regularly monitored for several months after discontinuation. Patients with concurrent HIV and hepatitis B infection should undergo HIV testing before using this medication, and its use is not recommended if they are not receiving HIV treatment. Patients who are allergic to this medication or its components, or have genetic issues such as lactose intolerance, should not take it. Patients with reduced kidney function or those undergoing dialysis (hemodialysis or peritoneal dialysis) need dosage adjustments, and liver transplant recipients should be closely monitored for kidney function. Side effects such as headache, fatigue, dizziness, nausea, etc., may occur, and if symptoms persist, consultation with a doctor is advised. This medication may be less absorbed if taken with food, so it is recommended to take it on an empty stomach. During pregnancy, it should only be used when absolutely necessary, considering the risk to the fetus, and during breastfeeding, either breastfeeding should be discontinued or the medication should be stopped. Pediatric and elderly patients should also have their kidney function monitored closely while taking this medication, and its use is not recommended for children under 2 years of age. No specific harm has been reported with overdose, but if an overdose occurs, immediate medical attention should be sought, and appropriate treatment should be received. As this medication is excreted via the kidneys, caution should be taken regarding the use of other medications that may affect kidney function, observing for potential side effects.

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

This medication should be stored in a tightly sealed container to avoid exposure to air and light. It is also advisable to store it at a cool temperature between 15 and 30 degrees.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3]