Green Cross Entecavir Tablets 0.5 mg

Adult dose

This drug should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer entecavir 0.5mg orally once daily. 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 substitutions: Administer 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 declines. In patients with creatinine clearance less than 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), adjust the dose as follows. 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 less than 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 Precautions for Use, “8. Administration to Patients with Renal Impairment”)

Child dose

There are no specified dosages for children.

This medication can potentially cause severe liver problems such as lactic acidosis and steatosis in patients with liver disease, particularly in women and obese patients, thus caution is needed. Patients with impaired liver function have a higher risk of lactic acidosis when using this medication, so regular monitoring of liver function tests during treatment is necessary. Abrupt discontinuation of this medication can lead to a rapid exacerbation of hepatitis B, so patient monitoring should closely follow physician instructions during discontinuation. Usage of this medication is not recommended in patients co-infected with HIV and hepatitis B who are not receiving treatment for HIV, and an HIV test is required before treatment. Patients with an allergy to this medication or its components, and those with hereditary lactose intolerance should not use it. Patients with renal impairment, especially those undergoing hemodialysis or peritoneal dialysis, require dosage adjustments, and liver transplant recipients should carefully monitor renal function. Common side effects include headaches, fatigue, dizziness, nausea, and so forth; if any abnormal symptoms occur, consultation with a healthcare professional is advised. Food intake can reduce the absorption of this medication, so it is advisable to take it on an empty stomach. As this medication is excreted through the kidneys, caution should be exercised regarding potential side effects when used concurrently with other medications that affect renal function. During pregnancy, this medication should only be used if absolutely necessary due to risks to the fetus, and breastfeeding should be discontinued or the medication halted while nursing. Use in children and elderly patients is permissible, but particularly for the elderly, dosage adjustments may be needed considering renal function deterioration. No special harmful reactions have been reported with overdose, but patients should visit a medical facility immediately if necessary as some can be removed via hemodialysis. This medication must be stored out of reach of children, kept away from direct sunlight, and stored at room temperature.

Lactic acidosis, steatosis, hepatomegaly, hepatic metabolic dysfunction, headache, fatigue, dizziness, nausea, diarrhea, dyspepsia, vomiting, vertigo, drowsiness, insomnia, anaphylactic reaction, increase in aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, cold, cough, pruritus, constipation, abdominal pain, low back pain, abdominal discomfort, runny nose, hematuria, thrombocytopenia, hyperglycemia, diabetes, hepatic neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension-related gastric disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disorders, gastric angioedema, chronic sinusitis, abdominal pain, rash, unpleasant taste, nausea, diarrhea, vomiting

This medication should be stored in a tightly sealed container to prevent air exposure, ideally at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x 3)]