Nucleoside reverse transcriptase inhibitors (NRTIs)
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Epivir Dosage

Drug Detail:Epivir (Lamivudine [ la-miv-ue-deen ])

Generic Name: LAMIVUDINE 150mg

Dosage Form: tablet, film coated and oral solution

Drug Class: Nucleoside reverse transcriptase inhibitors (NRTIs)

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosage for Adult Patients

The recommended dosage of EPIVIR in HIV-1‑infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. 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 (5.1)].

Recommended Dosage for Pediatric Patients

EPIVIR scored tablet is the preferred formulation for HIV-1‑infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing EPIVIR scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to safely and reliably swallow EPIVIR tablets, the oral solution formulation may be prescribed [see Warnings and Precautions (5.5)]. The recommended oral dosage of EPIVIR tablets for HIV-1‑infected pediatric patients is presented in Table 1.

Table 1. Dosing Recommendations for EPIVIR Scored (150-mg) Tablets in Pediatric Patients
a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies (14.2)].
b Patients may alternatively take one 300-mg tablet, which is not scored.

Weight

(kg)

Once-Daily Dosing Regimena

Twice-Daily Dosing Regimen Using Scored 150-mg
Tablet

AM Dose

PM Dose

Total Daily Dose

14 to <20

1 tablet
(150 mg)

½ tablet (75 mg)

½ tablet (75 mg)

150 mg

≥20 to <25

1½ tablets (225 mg)

½ tablet (75 mg)

1 tablet (150 mg)

225 mg

≥25

2 tablets (300 mg)b

1 tablet (150 mg)

1 tablet (150 mg)

300 mg

Oral Solution

The recommended dosage of EPIVIR oral solution in HIV-1‑infected pediatric patients aged 3 months and older is 5 mg per kg taken orally twice daily or 10 mg per kg taken orally once daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents [see Clinical Pharmacology (12.3)]. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment with oral solution [see Warnings and Precautions (5.5), Clinical Pharmacology (12.3)].

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)].

Table 2. Adjustment of Dosage of EPIVIR in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance

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.

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