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Lamivudine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

150 mg orally twice a day or 300 mg orally once a day

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Chronic Hepatitis B

100 mg orally once a day
Duration of therapy: The optimum duration of therapy is not known.

Approved indication: For the treatment of chronic HBV infection associated with evidence of hepatitis B viral replication and active liver inflammation

Usual Adult Dose for Nonoccupational Exposure

(Not approved by FDA)

CDC recommendations: 150 mg orally twice a day or 300 mg orally once a day
Duration of therapy: 28 days

Comments:
-Lamivudine should be used in combination with efavirenz plus (zidovudine or tenofovir) or with lopinavir-ritonavir plus zidovudine.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

Usual Adult Dose for Occupational Exposure

(Not approved by FDA)

US Public Health Service working group recommendations:
Preferred dose: 300 mg orally once a day
-Alternative dose: 150 mg orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-Lamivudine is recommended as a component in various alternative regimens for HIV postexposure prophylaxis.
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on the institution's protocol.
-The most current therapeutic guidelines should be consulted for more information.

Usual Pediatric Dose for HIV Infection

Oral solution:
Less than 4 weeks: 2 mg/kg orally twice a day (for prevention of transmission or treatment)
4 weeks to less than 16 years: 4 mg/kg orally twice a day
Maximum dose: 150 mg/dose

Tablets:
14 to 21 kg: 75 mg orally twice a day (AM and PM)
Greater than 21 to less than 30 kg: 75 mg orally in the AM and 150 mg in the PM
30 kg or more: 150 mg orally twice a day (AM and PM)

16 years or older:
Less than 50 kg: 4 mg/kg orally twice a day
Maximum dose: 150 mg/dose
50 kg or more: 150 mg orally twice a day or 300 mg orally once a day

Comments:
-FDA approved for patients 3 months or older; dosing for all age ranges recommended by the Department of Health and Human Services Panel on Antiretroviral Therapy and Medical Management of HIV-infected Children.

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for Chronic Hepatitis B

2 years or older: 3 mg/kg orally once a day
Maximum dose: 100 mg/day
Duration of therapy: The optimum duration of therapy is not known.

Approved indication: For the treatment of chronic HBV infection associated with evidence of hepatitis B viral replication and active liver inflammation

Renal Dose Adjustments

HIV:
Adults and Adolescents at least 30 kg:
CrCl 30 to 49 mL/min: 150 mg orally once a day
CrCl 15 to 29 mL/min: 150 mg orally as first dose, then 100 mg orally once a day
CrCl 5 to 14 mL/min: 150 mg orally as first dose, then 50 mg orally once a day
CrCl less than 5 mL/min: 50 mg orally as first dose, then 25 mg orally once a day

Pediatric patients: Insufficient data to recommend a specific dose; reduction in dose and/or increase in dosing interval should be considered.

HBV:
Adults:
CrCl 30 to 49 mL/min: 100 mg orally as first dose, then 50 mg orally once a day
CrCl 15 to 29 mL/min: 100 mg orally as first dose, then 25 mg orally once a day
CrCl 5 to 14 mL/min: 35 mg orally as first dose, then 15 mg orally once a day
CrCl less than 5 mL/min: 35 mg orally as first dose, then 10 mg orally once a day

Pediatric patients: Insufficient data to recommend a specific dose

Liver Dose Adjustments

No adjustment recommended.

Comments:
-Safety and efficacy have not been established in patients with decompensated liver disease.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Conventional 4-hour hemodialysis and peritoneal dialysis (CAPD and APD): No additional dose adjustments recommended after adjustment for CrCl.
Prolonged or continuous hemodialysis: Data not available

Other Comments

Administration advice:
-May be taken without regard to food
-Epivir(R) tablets and oral solution (for use in HIV-1 infection) contain a higher dose of lamivudine than Epivir-HBV(R) tablets and oral solution (for use in chronic HBV infection); only use products appropriate for treatment of HIV-1 in patients with HIV-1 infection.
-Oral solution is preferred for patients unable to reliably swallow tablets.

General:
-Lamivudine for the treatment of HIV-1 should be used in combination with other antiretroviral agents.
-Lamivudine oral solution contains sucrose (Epivir-HBV[R]: 4 g sucrose per 20 mL; Epivir[R]: 3 g sucrose per 15 mL).

Monitoring:
-Gastrointestinal: For signs/symptoms of pancreatitis in pediatric patients
-General: HIV testing (before starting and periodically during HBV therapy)
-Hepatic: ALT and HBV DNA levels (during HBV therapy); hepatic function of HBV-infected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
-Renal: Renal function in elderly patients

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