TeraCru Tablets 0.5 mg (Entecavir)

Adult dose

Administer this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The dose is entecavir 0.5 mg orally once daily. Patients aged 16 years or older with lamivudine resistance, that is, patients who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: entecavir 1 mg once daily on an empty stomach. Patients with renal impairment: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine decreases. Adjust the dose as follows in patients with creatinine clearance below 50 mL/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 less than 0.5 mg, use of the syrup formulation is recommended. b: If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

Child dose

The dosage for patients aged 16 and older with lamivudine resistance is mentioned separately, and no specific dosage information is provided for children under 16.

This medication requires particular attention to liver health. It may lead to lactic acidosis or severe liver disease in patients with compromised liver function, therefore, individuals with poor liver function must consult with a doctor before use. Abrupt discontinuation may worsen hepatitis B, so treatment cessation should be done carefully according to a physician's instructions. It is advisable not to use this medication in patients with concurrent HIV and hepatitis B who are not receiving HIV treatment. Patients with hypersensitivity to this medication or certain genetic diseases like lactose intolerance should not take this medication. Patients with reduced kidney function may need dosage adjustment, and those undergoing dialysis (hemodialysis or peritoneal dialysis) should modify the timing of administration. Liver transplant recipients must closely monitor kidney function when using this medication alongside other drugs that may affect renal function. Symptoms such as headache, fatigue, dizziness, nausea may occur while taking this medication, and should severe symptoms arise, a doctor should be consulted. Regular liver function tests are required during treatment, and if liver enzyme levels rise sharply, drug use may need to be temporarily suspended. It is preferred to take this medication on an empty stomach as food may reduce absorption. Women who are pregnant or breastfeeding must consult a doctor before use, and if breastfeeding, consideration should be given to stopping either breastfeeding or the medication. The drug is approved for use in children aged 2 years and older, and is not to be used in children under 2 years. Elderly patients or those with decreased kidney function require dosage adjustments and monitoring of kidney function. This medication generally has few drug interactions, but caution is advised when used with medications that affect renal excretion. There is no specific antidote for overdose, so appropriate treatment must be provided based on symptoms, and some drugs may be removed via hemodialysis. This medication must be kept out of the reach of children, stored in a cool place, away from direct sunlight, at room temperature.

Liver dysfunction, steatosis, hepatomegaly, metabolic liver dysfunction, headache, fatigue, dizziness, nausea, diarrhea, indigestion, vomiting, vertigo, drowsiness, insomnia, anaphylactic reactions, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, liver neoplasm, intra-abdominal bleeding, ascites, portal hypertension gastrointestinal diseases, abdominal pain, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, septal deviation, sepsis, eyelid skin disease, gastric hemangioma, chronic sinusitis, cold, itching, chest pain, constipation, back pain, abdominal discomfort, rhinorrhea, abdominal pain, bad taste, neutropenia, hematuria

This medication should be stored in a sealed container to prevent air and moisture ingress, and it is important to maintain a storage temperature between 15 and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness and safety.

Appearance

White to off-white triangular film-coated tablet

Package unit

10 tablets/blister x 3