Entacavir 1 mg Tablets

Adult dose

This medicine should be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The recommended dose is 0.5mg of entecavir once daily by mouth. Patients with lamivudine resistance, i.e., patients aged 16 years or 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: Oral clearance of this medicine decreases as creatinine clearance decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) Entecavir dose Entecavir dose 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 below 0.5mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medicine 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

The dosage is specified only for patients aged 16 and older, and there are no separate dosing instructions for children.

This medication is used for the treatment of liver disease and there are several precautions to be aware of when using it. First, using this drug alone or in combination with other antiretroviral agents can rarely lead to serious liver problems or lactic acidosis. This is particularly important for women, obese patients, and those already at risk for liver disease. Second, abruptly stopping this medication can lead to a rapid deterioration of hepatitis B, so liver function should be closely monitored for several months after discontinuation. Third, this medication is not recommended for patients infected with HIV who are not receiving treatment, and it is important to be tested for HIV before starting this medication. Fourth, patients allergic to this medication or its components, or those with certain genetic lactose intolerance disorders, should not take this medication. Fifth, patients with impaired kidney function, especially those on dialysis, require dose adjustments, and liver transplant recipients should also carefully monitor their kidney function. Sixth, this medication is better absorbed when taken on an empty stomach, as food can reduce absorption. Seventh, since this medication is excreted through the kidneys, it is important to carefully monitor for adverse reactions when taken with other medications that can affect kidney function. Eighth, during pregnancy, there may be risks to the fetus, so it should only be used when deemed necessary by a physician, and nursing mothers should carefully consider whether to continue breastfeeding while taking this medication. Ninth, for pediatric patients, safety and efficacy have only been established in those aged 2 years and older, and its use is not recommended in children under 2 years of age. Finally, if this medication is taken in excess, consult healthcare professionals immediately and obtain appropriate treatment if necessary. Regular monitoring of liver and kidney functions should be conducted during treatment, and any abnormal symptoms should be reported to healthcare professionals immediately.

• Lactic acidosis
• lipidosis
• hepatomegaly
• impaired liver metabolism
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

Store this medication in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is in a cool place between 15 and 30 degrees.

Appearance

Pink triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP×3)