Barcavir 0.5

Indications for Use

Barcavir is indicated for treating chronic hepatitis B virus infection in adults and children aged 2 years and older who show signs of active viral replication. This includes those with persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Always consult a registered healthcare professional before use.

Pharmacological Action

Entecavir, the active ingredient in Barcavir, inhibits all three activities of the HBV polymerase (reverse transcriptase) by competing with deoxyguanosine triphosphate, leading to:

• Base priming
• Reverse transcription of the negative strand from pregenomic mRNA
• Synthesis of the positive strand of HBV DNA

Once activated by kinases, the drug can be incorporated into viral DNA, effectively inhibiting HBV polymerase activity.

Dosage & Administration

For chronic hepatitis B in treatment-naive adults and adolescents aged 16 and older, the recommended dosage is 0.5 mg once daily. For patients with Lamivudine-resistant strains or known mutations, the dose increases to 1 mg daily. Adults with decompensated liver disease should also take 1 mg once daily. Barcavir should be taken on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it’s nearly time for the next dose, skip the missed dose and take the next one at the scheduled time. Do not double up on doses.
Always follow the advice of a registered healthcare professional when using this medication.

Drug Interactions

Co-administration of Barcavir with Lamivudine or Adefovir dipivoxil has shown no significant drug interactions. However, the effects of Barcavir combined with other renal-eliminated drugs are not well-studied, so patients should be closely monitored for adverse events.

Contraindications

Barcavir is contraindicated for individuals with a known hypersensitivity to Entecavir or any of its components.

Side Effects

Common side effects include headache, fatigue, dizziness, and nausea.

Pregnancy & Lactation

Data regarding Entecavir’s impact on the transmission of HBV from mother to infant is lacking. Caution is advised, and breastfeeding is not recommended for mothers taking Entecavir.

Precautions & Warnings

• Lactic Acidosis: There have been reports of lactic acidosis and severe hepatomegaly with steatosis, which can be fatal, associated with nucleoside analogues.
• Hepatitis Exacerbation: Patients who discontinue anti-hepatitis B therapy, including Barcavir, may experience severe acute exacerbations of hepatitis.

Use in Special Populations

• Pediatric Patients: The safety and effectiveness of Barcavir in children under 2 years old have not been established.
• Geriatric Patients: Limited data on patients aged 65 and older suggests that careful dose selection is necessary, with monitoring of renal function advised.

Dose Adjustment in Renal Impairment:

Dose adjustments for patients with creatinine clearance (CrCl) <50 ml/min are as follows:

• CrCl ≥50 ml/min: 0.5 mg every 24 hours
• CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
• CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
• CrCl <10 ml/min or patients on hemodialysis/CAPD: 0.5 mg every 7 days

Overdose Effects

No cases of Barcavir overdose have been reported. Healthy individuals taking doses up to 20 mg daily for 14 days or single doses up to 40 mg experienced no unexpected adverse effects. In case of overdose, monitor the patient for toxicity and provide standard supportive care as needed.

Therapeutic Class

Barcavir is classified under medications for hepatic viral infections, specifically for hepatitis B.

Storage Conditions

Store in a dry place below 30°C, away from light, and keep out of reach of children.