Lamivudinedosage

Adults: 100 mg, once daily. Pediatric Patients aged 2 to 17 years: 3 mg per kg once daily up to 100 mg once daily. Prescribe oral solution for pediatric patients requiring less than 100 mg daily.

Patients with Renal Impairment: Doses of lamivudine tablets (HBV) must be adjusted in accordance with renal function. Lamivudine tablets (HBV) should not be used with other medications that contain lamivudine or emtricitabine.

2.1 HIV Counseling and

Testing HIV counseling and testing should be offered to all patients before beginning treatment with Lamivudine tablets (HBV) and periodically during treatment because of the risk of emergence of resistanthuman immunodeficiency virus type 1(HIV-1) and limitation of treatment options if lamivudine tablets (HBV) is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment.

2.2 Recommended

Dosage for Adult Patients The recommended oral dosage of lamivudine tablets (HBV) is 100 mg once daily.

2.3 Recommended

Dosage for Pediatric Patients The recommended oral dosage of lamivudine tablets (HBV) for pediatric patients aged 2 to 17 years is 3 mg per kg once daily up to a maximum daily dosage of 100 mg. The oral solution formulation should be prescribed for patients requiring a dosage less than 100 mg or if unable to swallow tablets.

2.4 Patients with

Renal Impairment Dosage recommendations for adult patients with reduced renal function are provided in Table 1. Table 1. Dosage of Lamivudine Tablets (HBV) in Adult Patients with Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine Tablets (HBV) ≥50 100 mg once daily 30-49 100 mg first dose, then 50 mg once daily 15-29 100 mg first dose, then 25 mg once daily 5-14 35 mg first dose, then 15 mg once daily <5 35 mg first dose, then 10 mg once daily Following correction of the dosage for renal impairment, no additional dosage modification of lamivudine tablets (HBV) is required after routine (4-hour) hemodialysis or peritoneal dialysis. There are insufficient data to recommend a specific dosage of lamivudine tablets (HBV) in pediatric patients with renal impairment.

2.5 Important

Administration Instructions Lamivudine tablets (HBV) may be administered with or without food. The tablets and oral solution may be used interchangeably. The oral solution should be used for doses less than 100 mg. Lamivudine tablets (HBV) should not be used with other medications that contain lamivudine or medications that contain emtricitabine.

2.6 Assessing

Patients during Treatment Patients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of events such as return of persistently elevated ALT, increasing levels of HBV DNA over time after an initial decline below assay limit, progression of clinical signs or symptoms of hepatic disease, and/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic response. Such observations should be taken into consideration when determining the advisability of continuing therapy with lamivudine tablets (HBV). The optimal duration of treatment, the durability of HBeAg seroconversions occurring during treatment, and the relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis are not known.