GC Entacavir Tablets 1 Milligram

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

No specific dosing for patients under 16 years is mentioned.

This medication may affect liver function; therefore, special caution should be taken for patients with liver disease or liver function abnormalities. Lactic acidosis and steatosis, including fatal cases, may occur, so women and obese patients, as well as patients who have been using nucleoside analogs continuously, should use it more cautiously. Abrupt discontinuation of this medication can worsen hepatitis B, and liver function should be closely monitored under physician guidance when discontinuing treatment. For patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, this medication may affect HIV treatment, so an HIV test should be taken before use. Patients with an allergy to this medication or any of its components, and those with a genetic inability to break down lactose, should not take this medication. Patients with impaired kidney function, especially those on dialysis, require dose adjustment, and liver transplant recipients should also carefully monitor their kidney function. This medication is best taken on an empty stomach, as taking it with food may reduce absorption. Side effects such as headache, fatigue, dizziness, and nausea may occur; if symptoms are severe, consult a physician. It should only be used during pregnancy if necessary due to potential risks to the fetus, and breastfeeding should be discontinued or the medication should be stopped if breastfeeding. Use is recommended only in children aged 2 years and older; safety and efficacy in children under 2 years have not been established. Elderly patients may have reduced kidney function and therefore require dose adjustment and monitoring of kidney function. Exercise caution with concurrent use of other renally excreted medications due to the risk of elevated serum concentrations and adverse reactions. There is no specific antidote for overdose; appropriate treatment should be administered according to symptoms, and some drugs may be removed by hemodialysis. This medication should be stored out of reach of children, in a tightly sealed container at room temperature, and transferring to another container should be avoided.

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

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is best to maintain a storage temperature between 15 degrees and 30 degrees Celsius.

Appearance

Pink triangular film-coated tablet

Package unit

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