Cavire 0.5mg Tablets (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 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) ≥ 50: Entecavir dosage 0.5 mg once daily; entecavir dosage in patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dosage 0.25 mg once daily a or 0.5 mg every 48 hours; entecavir dosage in patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: Entecavir dosage 0.15 mg once daily a or 0.5 mg every 72 hours; entecavir dosage in patients with lamivudine resistance 0.3 mg once daily a or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dosage 0.05 mg once daily a or 0.5 mg every 7 days; entecavir dosage in patients with lamivudine resistance 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.

This medication is used for treating liver disease, specifically prescribed for patients with hepatitis B virus infection. Patients must be careful as serious liver diseases such as lactic acidosis and fatty liver may occur during treatment; those with compromised liver function or risk factors should exercise caution. If lactic acidosis or liver function abnormalities occur during treatment, the medication should be discontinued immediately, and patients should consult healthcare professionals if liver function deterioration is suspected. Sudden discontinuation of this drug may lead to rapid deterioration of hepatitis B, so it is crucial to follow the physician's instructions during discontinuation. Use of this medication is not recommended for patients with co-infection of HIV and hepatitis B who are not undergoing HIV treatment; it is essential to undergo HIV testing before administration. Individuals with allergies to this drug or its components, or those with genetic issues such as lactose intolerance should not take this medication. Patients with severely impaired renal function or those undergoing dialysis need dosage adjustments, and patients who have undergone liver transplant should have their renal function closely monitored. Side effects such as headache, fatigue, dizziness, nausea may occur; regular check-ups, including liver function tests, are recommended. This drug should be taken on an empty stomach, as its absorption is reduced when taken with food. Additionally, since this drug is excreted through the kidneys, caution should be exercised regarding potential side effects when taken with other medications that may affect renal function. Pregnant women should consult their doctor carefully before taking this medication as there may be risks to the fetus; breastfeeding mothers should consider discontinuation of breastfeeding or the medication. This medication is prescribed for children aged 2 years and older, and its safety and effectiveness have not been established in those under 2 years. When storing this medication, keep it out of reach of children, avoid direct sunlight, and store it at room temperature. In case of overdose, there is no specific antidote, so seek appropriate treatment at a medical facility immediately.

Liver dysfunction, fatty liver, liver enlargement, liver metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reaction, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, itching, chest pain, constipation, abdominal pain, lower back pain, abdominal discomfort, runny nose, hematuria, thrombocytopenia, hyperglycemia, diabetes, liver neoplasm, intraperitoneal hemorrhage, ascites, portal hypertension-related gastric disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorder, gastric hemangioma, chronic sinusitis, abdominal pain, rash, bad taste, neutropenia

This medication should be stored in a tightly sealed container to prevent exposure to air and light, ideally kept in a cool place, at temperatures between 15 to 30 degrees Celsius, avoiding direct sunlight.

Appearance

White to light gray triangular film-coated tablets

Package unit

30 tablets/box [10 tablets/PTPX3]