Baraclude (Entecavir) 0.5mg & 1mg Tablets
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What is Baraclude used to treat?
Baraclude (entecavir) is an oral antiviral medication used to treat chronic hepatitis B infection in adults and children over 2 years. It works by inhibiting HBV DNA polymerase, preventing the virus from multiplying and reducing liver damage.
Generic Name: Entecavir

Strengths Available: 0.5 mg and 1 mg tablets

Form: Oral tablet

Route: Oral administration
Indication: Chronic Hepatitis B Virus (HBV) infection
Prescription Required: Yes
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Entecavir monohydrate, equivalent to entecavir 0.5mg or 1mg

Classified as a nucleoside analogue reverse transcriptase inhibitor (NRTI)

Other Popular and Common Names
Entecavir

Generic Baraclude

Entecavir monohydrate

Baraclude HBV Tablets

HBV Nucleoside Analogue
Baraclude is a guanosine nucleoside analogue that:

Selectively inhibits HBV DNA polymerase activity

Blocks three stages of viral replication: base priming, reverse transcription, and DNA synthesis

Results in suppression of viral load and improvement in liver histology
Adults and children ≥2 years with chronic hepatitis B virus (HBV) infection

Patients with compensated or decompensated liver disease
Treatment-naive patients or those resistant to lamivudine
Patient Type Recommended Dosage
Treatment-naive adults 0.5 mg once daily on empty stomach
Lamivudine-resistant patients 1 mg once daily on empty stomach
Pediatric patients (≥2 years) 0.015 mg/kg up to max 0.5 mg once daily
Take on an empty stomach (at least 2 hours before or after meals)

Dosage should be adjusted in renal impairment based on creatinine clearance
Formulation: Film-coated tablet
Bioavailability: ~100%
Onset of Action: Viral load suppression within 2–4 weeks

Half-life: ~128–149 hours (steady-state)

Metabolism: Minimal hepatic metabolism; excreted via kidneys
Headache

Dizziness
Nause
Fatigue
Lactic acidosis and severe hepatomegaly with steatosis (rare)
Exacerbation of hepatitis after discontinuation
Renal impairment (requires dose adjustment)
Discontinue only under medical supervision to avoid acute hepatitis flares

Use with caution in patients with renal or hepatic impairment
Avoid concurrent use with other nephrotoxic drugs
Pregnancy Category C – Use only if benefits outweigh potential fetal risks
Not for use in patients co-infected with HIV not on HAART (may induce resistance)
Class: Nucleoside analogue reverse transcriptase inhibitor (NRTI)
ATC Code: J05AF10
Schedule: Schedule H (India – Prescription only)
Baraclude has a low potential for drug interactions, but caution should be used with:
Tenofovir or Adefovir Increased risk of nephrotoxicity
Nephrotoxic agents May worsen renal function
HIV antivirals Risk of HIV resistance development if HIV not treated concurrently
NEJM, 2006 (Chang et al.): Baraclude more effective than lamivudine in HBV DNA suppression and histologic improvement.
Pediatric Study (J Hepatol, 2011): Safe and effective in children aged 2–17 years.
Resistance Profile: Low resistance rates in treatment-naive patients over 5 years.
FAQs – Frequently Asked Questions
Q1: What is Baraclude used for?
Baraclude is used for long-term treatment of chronic hepatitis B to reduce viral replication and prevent liver damage.

Q2: Is Baraclude a cure for hepatitis B?
No, it is not a cure. It controls HBV replication and helps prevent liver complications but requires long-term treatment.

Q3: Can I stop taking Baraclude if I feel better?
No. Stopping Baraclude suddenly may cause severe worsening of hepatitis. Discontinuation should only be done by a healthcare provider.

Q4: How long do I need to take Baraclude?
Treatment duration varies; some may need lifelong therapy, especially in patients with cirrhosis or high viral load.

Q5: Is Baraclude safe in pregnancy?
It is a Pregnancy Category C drug. Use only if clearly needed and after risk-benefit assessment.

Q6: How should Baraclude be stored?
Store at room temperature (15–30°C), away from moisture and sunlight. Keep out of children’s reach.

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