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Patient compliance should be monitored while taking lamivudine. Discontinuation may be considered in immunocompetent patients when HBeAg and/or HBsAg seroconversion occur. Discontinuation may also be considered when loss of efficacy occurs, as indicated by recurrent signs of hepatitis.
After treatment discontinuation, patients should be periodically monitored for evidence of recurrent hepatitis.
Discontinuation of treatment is not recommended in patients with decompensated liver disease. There are limited data regarding the maintenance of long-term seroconversion after stopping treatment with lamivudine.
Renal impairment: Lamivudine serum concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased renal clearance. The dosage should therefore be reduced in patients with creatinine clearance <50ml/min.
Data available in patients undergoing intermittent haemodialysis (≤4 hrs dialysis 2-3 times weekly), indicate that following the initial dosage reduction of lamivudine to correct for the patient's creatinine clearance, no further dosage adjustments are required while undergoing dialysis.
Hepatic impairment: Data obtained in patients with hepatic impairment, including those with end-stage liver disease awaiting transplant, show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction. Based on these data, no dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment.
150 mg: Adults and adolescents (weighing at least 30 kg): 150mg twice daily or 300 mg once daily, to be taken with or without food.
Children aged more than 3 months: Children weighing between 21kg to 30kg: 75mg taken in the morning and 150mg taken in the evening.
Children weigihing between 14kg to 21kg: 75mg twice daily.
Children less than three months of age: The limited data available are insufficient to propose specific dosage recommendations.
Special populations: Elderly: No specific data are available; however, special care is advised in this age group due to age-associated changes such as the decrease in renal function and alteration of haematological parameters.
Renal impairment: Lamivudine plasma concentrations (AUC) are increased in patients with moderate - severe renal impairment due to decreased clearance. The dosage should therefore be reduced for patients with a creatinine clearance of less than 50ml/min as shown in Table 1 and Table 2. The same percentage reduction in dose applied for paediatric patients with renal impairment. (See Table 1 and Table 2).
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageHepatic impairment: No dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
Mode of Administration: To be taken orally with or without food.
150 mg: To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately.
