Epivir

Add Info

Epivir Recall

Get an alert when a recall is issued.

Ask a Question

Questions & Answers

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

Legal Issues

There is currently no legal information available for this drug.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

Uses

EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.

Add Info

History

There is currently no drug history available for this drug.

Add Info

Other Information

EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula:

Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.

EPIVIR Tablets are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

EPIVIR Oral Solution is for oral administration. One milliliter (1 mL) of EPIVIR Oral Solution contains 10 mg of lamivudine (10 mg/mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).

Sources

Epivir Manufacturers

State Of Florida Doh Central Pharmacy

Epivir | State Of Florida Doh Central Pharmacy

2.1 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)].
2.2 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.
Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
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 2.3 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 (≥30 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.

No Recall
Physicians Total Care, Inc.

Epivir | Physicians Total Care, Inc.

2.1 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)].
2.2 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.
Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
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 2.3 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 (≥30 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.

No Recall
Rebel Distributors Corp

Epivir | Rebel Distributors Corp

2.1 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)].
2.2 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.
Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
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 2.3 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 (≥30 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.

No Recall
Glaxosmithkline Llc

Epivir | Glaxosmithkline Llc

2.1 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)].
2.2 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.
Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
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 2.3 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 (≥30 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.

No Recall
Kaiser Foundation Hospitals

Epivir | Kaiser Foundation Hospitals

2.1 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)].
2.2 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.
Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
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 2.3 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 (≥30 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.

No Recall
Remedyrepack Inc.

Epivir | Remedyrepack Inc.

Adults:
The recommended oral dose of EPIVIR-HBV for treatment of chronic hepatitis B in adults is 100 mg once daily (see paragraph below and WARNINGS). Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known (see PRECAUTIONS).
The formulation and dosage of lamivudine in EPIVIR-HBV are not appropriate for patients dually infected with HBV and HIV. If lamivudine is administered to such patients, the higher dosage indicated for HIV therapy should be used as part of an appropriate combination regimen, and the prescribing information for EPIVIR as well as EPIVIR-HBV should be consulted.

Pediatric Patients:
The recommended oral dose of EPIVIR-HBV for pediatric patients 2 to 17 years of age with chronic hepatitis B is 3 mg/kg once daily up to a maximum daily dose of 100 mg. Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known (see PRECAUTIONS).
EPIVIR-HBV is available in a 5-mg/mL oral solution when a liquid formulation is needed. (Please see information above regarding distinctions between different lamivudine-containing products.)

Dose Adjustment:
It is recommended that doses of EPIVIR-HBV be adjusted in accordance with renal function (Table 8) (see CLINICAL PHARMACOLOGY: Special Populations).

Table 8. Adjustment of Adult Dosage of EPIVIR-HBV in Accordance With Creatinine Clearance
Creatinine ClearanceRecommended Dosage of EPIVIR-HBV(mL/min)100 mg once daily30-49100 mg first dose, then 50 mg once daily15-29100 mg first dose, then 25 mg once daily5-1435 mg first dose, then 15 mg once daily<535 mg first dose, then 10 mg once dailyNo additional dosing of EPIVIR-HBV is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of EPIVIR-HBV in pediatric patients with renal impairment, a dose reduction should be considered.

No Recall
Remedyrepack Inc.

Epivir | Remedyrepack Inc.

Adults:
The recommended oral dose of EPIVIR-HBV for treatment of chronic hepatitis B in adults is 100 mg once daily (see paragraph below and WARNINGS). Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known (see PRECAUTIONS).
The formulation and dosage of lamivudine in EPIVIR-HBV are not appropriate for patients dually infected with HBV and HIV. If lamivudine is administered to such patients, the higher dosage indicated for HIV therapy should be used as part of an appropriate combination regimen, and the prescribing information for EPIVIR as well as EPIVIR-HBV should be consulted.

Pediatric Patients:
The recommended oral dose of EPIVIR-HBV for pediatric patients 2 to 17 years of age with chronic hepatitis B is 3 mg/kg once daily up to a maximum daily dose of 100 mg. Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known (see PRECAUTIONS).
EPIVIR-HBV is available in a 5-mg/mL oral solution when a liquid formulation is needed. (Please see information above regarding distinctions between different lamivudine-containing products.)

Dose Adjustment:
It is recommended that doses of EPIVIR-HBV be adjusted in accordance with renal function (Table 8) (see CLINICAL PHARMACOLOGY: Special Populations).

Table 8. Adjustment of Adult Dosage of EPIVIR-HBV in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)Recommended Dosage of EPIVIR-HBV100 mg once daily30-49100 mg first dose, then 50 mg once daily15-29100 mg first dose, then 25 mg once daily5-1435 mg first dose, then 15 mg once daily<535 mg first dose, then 10 mg once dailyNo additional dosing of EPIVIR-HBV is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of EPIVIR-HBV in pediatric patients with renal impairment, a dose reduction should be considered.

No Recall
Remedyrepack Inc.

Epivir | Remedyrepack Inc.

Adults:
The recommended oral dose of EPIVIR-HBV for treatment of chronic hepatitis B in adults is 100 mg once daily (see paragraph below and WARNINGS). Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known (see PRECAUTIONS).
The formulation and dosage of lamivudine in EPIVIR-HBV are not appropriate for patients dually infected with HBV and HIV. If lamivudine is administered to such patients, the higher dosage indicated for HIV therapy should be used as part of an appropriate combination regimen, and the prescribing information for EPIVIR as well as EPIVIR-HBV should be consulted.

Pediatric Patients:
The recommended oral dose of EPIVIR-HBV for pediatric patients 2 to 17 years of age with chronic hepatitis B is 3 mg/kg once daily up to a maximum daily dose of 100 mg. Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known (see PRECAUTIONS).
EPIVIR-HBV is available in a 5-mg/mL oral solution when a liquid formulation is needed. (Please see information above regarding distinctions between different lamivudine-containing products.)

Dose Adjustment:
It is recommended that doses of EPIVIR-HBV be adjusted in accordance with renal function (Table 8) (see CLINICAL PHARMACOLOGY: Special Populations).

Table 8. Adjustment of Adult Dosage of EPIVIR-HBV in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)Recommended Dosage of EPIVIR-HBV150 mg once daily or 300 mg once daily30-49150 mg once daily15-29150 mg first dose, then 100 mg once daily5-14150 mg first dose, then 50 mg once daily<550 mg first dose, then 25 mg once dailyNo additional dosing of EPIVIR-HBV is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of EPIVIR-HBV in pediatric patients with renal impairment, a dose reduction should be considered.

No Recall
Bryant Ranch Prepack

Epivir | Bryant Ranch Prepack

2.1 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)].
2.2 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.
Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
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 2.3 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 (≥30 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.

No Recall
Remedyrepack Inc.

Epivir | Remedyrepack Inc.

Adults and adolescents >16 years of age: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. (2.1) Pediatric patients 3 months up to 16 years of age: Dosage should be based on body weight. (2.2) Patients With Renal Impairment: Doses of EPIVIR must be adjusted in accordance with renal function. (2.3)

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)].

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.
Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
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

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 (≥30 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.

No Recall
Viiv Healthcare Company

Epivir | Viiv Healthcare Company

2.1 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 (5.2)].
2.2 Recommended Dosage for Pediatric Patients
The recommended dosage of EPIVIR oral solution in HIV‑1-infected pediatric patients aged 3 months and older is 4 mg per kg taken orally twice daily or 8 mg per kg taken orally once daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment with oral solution [see Clinical Pharmacology (12.3)].

EPIVIR is also available as a scored tablet for HIV‑1-infected pediatric patients who weigh at least 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.
Table 1. Dosing Recommendations for EPIVIR Scored (150-mg) Tablets in Pediatric Patients
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

aData 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)].

bPatients may alternatively take one 300-mg tablet, which is not scored.
2.3 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.

No Recall