Epivir Dosage
Generic name: lamivudine
Dosage form: tablet, film coated and oral solution
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This dosage information does not include all the information needed to use Epivir safely and effectively. See full prescribing information for Epivir.
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Adults and Adolescents >16 years of age
The recommended oral dose of EPIVIR in HIV-1-infected adults and adolescents >16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].
Pediatric Patients
The recommended oral dose of EPIVIR Oral Solution in HIV-1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), administered in combination with other antiretroviral agents.
EPIVIR is also available as a scored tablet for HIV-1-infected pediatric patients who weigh ≥14 kg and for whom a solid dosage form is appropriate. Before prescribing EPIVIR Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow EPIVIR Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of EPIVIR Tablets for HIV-1-infected pediatric patients is presented in Table 1.
|
Weight (kg) |
Dosage Regimen Using Scored 150-mg Tablet |
Total Daily Dose |
|
| AM Dose | PM Dose | ||
| 14 to 21 | ½ tablet (75 mg) | ½ tablet (75 mg) | 150 mg |
| >21 to <30 | ½ tablet (75 mg) | 1 tablet (150 mg) | 225 mg |
| ≥30 | 1 tablet (150 mg) | 1 tablet (150 mg) | 300 mg |
Patients With Renal Impairment
Dosing of EPIVIR is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
| Creatinine Clearance (mL/min) | Recommended Dosage of EPIVIR |
| ≥50 | 150 mg twice daily or 300 mg once daily |
| 30-49 | 150 mg once daily |
| 15-29 | 150 mg first dose, then 100 mg once daily |
| 5-14 | 150 mg first dose, then 50 mg once daily |
| <5 | 50 mg first dose, then 25 mg once daily |
No additional dosing of EPIVIR is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of EPIVIR in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
