3TC Dosage/Direction for Use

The therapy should be initiated by a physician experienced in the management of HIV infection.
3TC may be administered with or without food.
3TC is available as a tablet formulation for patients who weigh at least 14 kg (see Precautions).
3TC is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets (see Precautions).
Patients changing between lamivudine tablets and lamivudine oral solution should follow the dosing recommendations that are specific for the formulation (see Pharmacology: Pharmacokinetics under Actions).
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 (see Pharmacology: Pharmacokinetics under Actions).
Adults, adolescents and children (weighing at least 25 kg): The recommended dose of 3TC is 300 mg daily. This may be administered as either 150 mg (15 ml) twice daily or 300 mg (30 ml) once daily (see Precautions).
Children (weighing less than 25 kg): Children less than three months of age: The limited data available are insufficient to propose specific dosage recommendations (see Pharmacology: Pharmacokinetics under Actions).
Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose approximately every 24 hours. When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.
Tablet: Dosing according to weight bands is recommended for 3TC tablets.
Children weighing ≥20 kg to <25 kg: The recommended dose is 225 mg daily. This may be administered as either 75 mg (one-half of a 150 mg tablet) taken in the morning and 150 mg (one whole 150 mg tablet) taken in the evening, or 225 mg (one and a half 150 mg tablets) taken once daily.
Children weighing 14 to <20 kg: The recommended dose is 150 mg daily. This may be administered as 75 mg (one-half of a 150 mg tablet) taken twice daily, or 150 mg (one whole 150 mg tablet) taken once daily.
Children from three months of age: As an accurate dosage cannot be achieved with the 300 mg non-scored tablet formulation in this patient population, it is recommended that the 3TC 150 mg scored tablet formulation is used and the corresponding recommended dosage instructions are followed.
Oral solution: Children (weighing less than 25 kg): Children from one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily, or 1 mL/kg (10 mg/kg) once daily (see Precautions and Interactions).
Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily. If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered. It should be taken into account that data for the once daily regimen are very limited in this population (see Precautions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Special populations: Older people: 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 concentrations are increased in patients with moderate - severe renal impairment due to decreased clearance. The dose should therefore be adjusted, using oral solution presentation of 3TC for patients whose creatinine clearance falls below 30 ml/min (see tables).
Dosing recommendations - Adults, adolescents and children (weighing at least 25 kg): See Table 4.

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There are no data available on the use of lamivudine in children with renal impairment. Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults. The 3TC 10 mg/mL oral solution may be the most appropriate formulation to achieve the recommended dose in children with renal impairment aged at least 3 months and weighing less than 25kg.
Dosing recommendations - Children aged at least 3 months and weighing less than 25 kg: See Table 5.

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Hepatic impairment: Data obtained in patients with moderate to severe hepatic impairment shows that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction. Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.