Lamivudine
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Uses
Lamivudine Tablet is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-l) infection. Limitation of use: The dosage of this product is for HIV-1and not for HBV.
History
There is currently no drug history available for this drug.
Other Information
Lamivudine USP (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine USP is 2(1H) - Pyrimidinone, 4-amino-1- [2- (hydroxymethyl)-1,3-oxathio-lan-5-yl], (2R-cis)-. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26. It has the following structural formula:
Lamivudine USP is a white to an off white solid and soluble in water.
Lamivudine tablets are for oral administration. Each film-coated tablet contains 150 mg or 300 mg of lamivudine USP and the following inactive ingredients: crospovidone, isomalt, isopropyl alcohol, magnesium stearate and methylene chloride. The tablets are coated with opadry white containing hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.
Sources
Lamivudine Manufacturers
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Avpak
![Lamivudine Tablet, Film Coated [Avpak]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lamivudine | Avpak
2.1 Adults and Adolescents >16 years of ageThe recommended oral dose of lamivudine 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-l therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].
2.2 Pediatric PatientsLamivudine is also available as a scored tablet for HIV-l-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine Tablets in Pediatric Patients
Weight (kg) Dosage Regimen Using Scored 150 mg Tablet
Total
Daily Dose
AM 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 ImpairmentDosing of lamivudine 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 Lamivudine in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine
≥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 lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered. -
Remedyrepack Inc.
Lamivudine | 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 lamivudine must be adjusted in accordance with renal function. (2.3)The recommended oral dose of lamivudine 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-l therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].
Lamivudine is also available as a scored tablet for HIV-l-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine Tablets in Pediatric Patients
Weight (kg) Dosage Regimen Using Scored 150 mg Tablet
Total
Daily Dose
AM 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 lamivudine is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
Creatinine Clearance (mL/min)
Table 2. Adjustment of Dosage of Lamivudine in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Recommended Dosage of Lamivudine
≥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 lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered. -
Remedyrepack Inc.
Lamivudine | 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 lamivudine must be adjusted in accordance with renal function. (2.3)The recommended oral dose of lamivudine 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-l therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].
Lamivudine is also available as a scored tablet for HIV-l-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine Tablets in Pediatric Patients
Weight (kg) Dosage Regimen Using Scored 150 mg Tablet
Total
Daily Dose
AM 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 lamivudine is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
Creatinine Clearance (mL/min)
Table 2. Adjustment of Dosage of Lamivudine in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Recommended Dosage of Lamivudine
≥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 lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered. -
Remedyrepack Inc.
Lamivudine | 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 lamivudine must be adjusted in accordance with renal function. (2.3)The recommended oral dose of lamivudine 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-l therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].
Lamivudine is also available as a scored tablet for HIV-l-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine Tablets in Pediatric Patients
Weight (kg) Dosage Regimen Using Scored 150 mg Tablet
Total
Daily Dose
AM 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 lamivudine is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
Creatinine Clearance (mL/min)
Table 2. Adjustment of Dosage of Lamivudine in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Recommended Dosage of Lamivudine
≥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 lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered. -
Kaiser Foundation Hospitals
Lamivudine | Kaiser Foundation Hospitals
2.1 HIV Counseling and TestingHIV 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 resistant-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 [see Warnings and Precautions (5.3)].
2.2 Dosage in Adult PatientsThe recommended oral dosage of lamivudine tablets (HBV) is 100 mg once daily.
2.3 Dosage in Pediatric PatientsThe 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 Dosage Adjustment in Adult Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
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 [see Clinical Pharmacology (12.3)].
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 may be used interchangeably [see Clinical Pharmacology(12.3)]. 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 [see Warnings and Precautions (5.4)]. 2.6 Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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. -
Mylan Pharmaceuticals Inc.
Lamivudine | Mylan Pharmaceuticals Inc.
2.1HIV Counseling and TestingHIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets and periodically during treatment because of the risk of emergence of resistant-HIV-1 and limitation of treatment options if lamivudine tablets are prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment [see Warnings and Precautions (5.3)].
2.2Dosage in Adult PatientsThe recommended oral dosage of lamivudine tablets is 100 mg once daily.
2.3Dosage in Pediatric PatientsThe recommended oral dosage of lamivudine tablets 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.
2.4Dosage Adjustment in Adult Patients with Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
Table 1. Dosage of Lamivudine in Adult Patients with Renal ImpairmentCreatinine Clearance
(mL/min)Recommended Dosage of Lamivudine
≥ 50
100 mg once daily
30 to 49
100 mg first dose, then 50 mg once daily
15 to 29
100 mg first dose, then 25 mg once daily
5 to 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 is required after routine (4-hour) hemodialysis or peritoneal dialysis [see Clinical Pharmacology (12.3)].
There are insufficient data to recommend a specific dosage of lamivudine tablets in pediatric patients with renal impairment.
2.5Important Administration Instructions • Lamivudine tablets may be administered with or without food. • The tablets and oral solution may be used interchangeably [see Clinical Pharmacology (12.3)]. • The oral solution should be used for doses less than 100 mg. • Lamivudine tablets should not be used with other medications that contain lamivudine or medications that contain emtricitabine [see Warnings and Precautions (5.4)]. 2.6Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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.
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.
-
American Health Packaging
Lamivudine | American Health Packaging
2.1 Adults and Adolescents >16 years of ageThe recommended oral dose of lamivudine tablets 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 PatientsLamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 ImpairmentDosing of lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine Tablets
≥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 lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Aurobindo Pharma Limited
Lamivudine | Aurobindo Pharma Limited
2.1 Adults and Adolescents >16 years of age
The recommended oral dose of lamivudine tablets 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
Lamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine Tablets
≥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 lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered. -
Golden State Medical Supply, Inc.
Lamivudine | Golden State Medical Supply, Inc.
2.1 Adults and Adolescents >16 years of ageThe recommended oral dose of Lamivudine Tablets 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 PatientsLamivudine 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 Lamivudine Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow Lamivudine Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of Lamivudine Tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 ImpairmentDosing of lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine ≥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 dailyNo additional dosing of lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Remedyrepack Inc.
Lamivudine | 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 lamivudine tablets must be adjusted in accordance with renal function. (2.3)The recommended oral dose of lamivudine tablets 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)].
Lamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine Tablets
≥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 lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Remedyrepack Inc.
Lamivudine | 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 lamivudine tablets must be adjusted in accordance with renal function. (2.3)The recommended oral dose of lamivudine tablets 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)].
Lamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine Tablets
≥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 lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Remedyrepack Inc.
Lamivudine | 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 lamivudine tablets must be adjusted in accordance with renal function. (2.3)The recommended oral dose of lamivudine tablets 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)].
Lamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine Tablets
≥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 lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Remedyrepack Inc.
Lamivudine | 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 lamivudine tablets must be adjusted in accordance with renal function. (2.3)The recommended oral dose of lamivudine tablets 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)].
Lamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine Tablets
≥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 lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Apotex Corp.
Lamivudine | Apotex Corp.
2.1 Adult Patients The recommended oral dose of lamivudine tablets in HIV-1-infected adults 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)]. Lamivudine tablets may be taken with or without food. 2.2 Pediatric PatientsThe recommended oral dose of lamivudine oral solution in HIV-1-infected pediatric patients aged 3 months and older is 4 mg per kg twice daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents.
Lamivudine 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 lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine Tablets in Pediatric Patients
Weight (kg) Twice-daily Dosing Regimen Using Scored 150-mg Tablet AM Dose PM Dose Total Daily Dose 14 to <20 ½ tablet (75 mg) ½ tablet (75 mg) 150 mg ≥20 to <25 ½ tablet (75 mg) 1 tablet (150 mg) 225 mg ≥25 1 tablet (150 mg) 1 tablet (150 mg) 300 mgAdditional pediatric use information for patients aged 3 months and above is approved for ViiV Healthcare Company’s EPIVIR® (lamivudine) tablets and oral solution. However, due to ViiV Healthcare Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Patients with Renal ImpairmentDosing of lamivudine tablets are adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
Table 2. Adjustment of Dosage of Lamivudine Tablets in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance
Creatinine Clearance
(mL/min) Recommended Dosage of Lamivudine ≥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 dailyNo additional dosing of lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Bryant Ranch Prepack
Lamivudine | Bryant Ranch Prepack
2.1 Adults and Adolescents >16 years of ageThe recommended oral dose of lamivudine tablets 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 PatientsLamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 ImpairmentDosing of lamivudine tablets 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 Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine Tablets
≥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 lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Apotex Corp.
Lamivudine | Apotex Corp.
2.1 HIV Counseling and TestingHIV 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 resistant-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 [see Warnings and Precautions (5.3)].
2.2 Dosage in Adult PatientsThe recommended oral dosage of Lamivudine Tablets (HBV) is 100 mg once daily.
2.3 Dosage in Pediatric PatientsThe 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 Dosage Adjustment in Adult Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
Table 1. Dosage of Lamivudine Tablets (HBV) in Adult Patients With Renal ImpairmentCreatinine Clearance
(mL/min) Recommended Dosage of Lamivudine (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 dailyFollowing 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 [see Clinical Pharmacology (12.3)].
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 [see Clinical Pharmacology (12.3)]. 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 [see Warnings and Precautions (5.4)]. 2.6 Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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.
-
Camber Pharmaceuticals, Inc.
Lamivudine | Camber Pharmaceuticals, Inc.
2.1 HIV Counseling and TestingHIV 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 resistant-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 [see Warnings and Precautions (5.3)].
2.2 Dosage in Adult PatientsThe recommended oral dosage of lamivudine tablets (HBV) is 100 mg once daily.
2.3 Dosage in Pediatric PatientsThe 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 Dosage Adjustment in Adult Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
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 [see Clinical Pharmacology (12.3)].
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 may be used interchangeably [see Clinical Pharmacology(12.3)]. 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 [see Warnings and Precautions (5.4)]. 2.6 Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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. -
Camber Pharmaceuticals, Inc.
Lamivudine | Woonsocket Prescription Center,incorporated
drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: do not use unless directed by a doctor
-
State Of Florida Doh Central Pharmacy
Lamivudine | State Of Florida Doh Central Pharmacy
2.1 Adults and Adolescents >16 years of ageThe recommended oral dose of lamivudine tablets 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 PatientsLamivudine 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 lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine 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 ImpairmentDosing of lamivudine tablets are adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
Table 2. Adjustment of Dosage of Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine ≥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 dailyNo additional dosing of lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
-
Kaiser Foundation Hospitals
Lamivudine | Kaiser Foundation Hospitals
2.1 HIV Counseling and TestingHIV 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 resistant-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 [see Warnings and Precautions (5.3)].
2.2 Dosage in Adult PatientsThe recommended oral dosage of Lamivudine Tablets (HBV) is 100 mg once daily.
2.3 Dosage in Pediatric PatientsThe 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 Dosage Adjustment in Adult Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
Table 1. Dosage of Lamivudine Tablets (HBV) in Adult Patients With Renal ImpairmentCreatinine Clearance
(mL/min) Recommended Dosage of Lamivudine (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 dailyFollowing 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 [see Clinical Pharmacology (12.3)].
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 [see Clinical Pharmacology (12.3)]. 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 [see Warnings and Precautions (5.4)]. 2.6 Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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.
-
Prasco Laboratories
Lamivudine | Prasco Laboratories
2.1 HIV Counseling and TestingHIV 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 resistant HIV-1 and limitation of treatment options if Lamivudine tablets (HBV) are prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment [see Warnings and Precautions (5.3)].
2.2 Dosage in Adult PatientsThe recommended oral dosage of Lamivudine tablets (HBV) is 100 mg once daily.
2.3 Dosage in Pediatric PatientsThe 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 of lamivudine (EPIVIR-HBV®) should be prescribed for patients requiring a dosage less than 100 mg or if unable to swallow tablets.
2.4 Dosage Adjustment in Adult Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
Table 1. Dosage of Lamivudine Tablets (HBV) in Adult Patients With Renal ImpairmentCreatinine 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 [see Clinical Pharmacology (12.3)].
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 the oral solution formulation of lamivudine may be used interchangeably [see Clinical Pharmacology (12.3)]. • The oral solution formulation of lamivudine (EPIVIR-HBV) 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 [see Warnings and Precautions (5.4)]. 2.6 Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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.
![Lamivudine Tablet, Film Coated [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7eaa1b82-d25a-4b8f-bf31-d837faf5aff9&name=MM5.jpg)
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