Medicine Overview

Indication

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Adult Dose

Clinical InformationAdministration Information
Indication: Chronic Hepatitis B
Age: Adults and adolescents greater than or equal to 16 years
Condition: Nucleoside inhibitor treatment-naive with compensated liver disease
Dose: Tablet – 0.5 mg
Frequency: once daily
Note: Administered by mouth. Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Indication: Chronic Hepatitis B
Age: Adults and adolescents greater than or equal to 16 years
Condition: Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions
Dose: Tablet – 1 mg
Frequency: once daily
Note: Administered by mouth. Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Child Dose

Clinical InformationAdministration Information
Indication: Chronic Hepatitis B
Age: greater than or equal to 2 years
Condition: evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Dose: Not specified
Note: Safety and efficacy not established in children less than 2 years
Indication: Chronic Hepatitis B
Age: greater than 16 years
Condition: evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Dose: Not specified
Note: Dosed as adult

Renal Dose

Clinical InformationAdministration Information
Indication: Usual daily dose (0.5 mg)
CrCl greater than or equal to 50 mL/min
Condition: Renal Impairment
Dose: Tablet – 0.5 mg
Note: No dosage adjustment required
Indication: Usual daily dose (0.5 mg)
CrCl 30-49 mL/min
Condition: Renal Impairment
Dose: Tablet – 0.25 mg
Frequency: once daily
Note: Or 0.5 mg every 48 hours
Administration
  • Take on empty stomach
  • Take 2 hours before or after meals
Side Effect

Drug Interaction

Drug NameRisk Factors
Drugs that reduce renal function or compete for active tubular secretion
May increase serum concentration of either entecavir or co-administered drug

Disease Interaction

Disease NameRisk Factors
No specific contraindications listed
Monitor for general drug reactions

Pregnancy

Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Store at temperatures not above 30°C.

Data Sources

Clinical & regulatory information on this page is compiled from the following government sources:

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.