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Lamivudine Dosage

Applies to the following strength(s): 150 mg ; 10 mg/mL ; 100 mg ; 5 mg/mL ; 300 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

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

Use: 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 optimal duration of therapy is not known.

Use: 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

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

Comments:
-Recommended as part of preferred regimens for nonoccupational postexposure prophylaxis of HIV infection; this drug should be used with efavirenz plus (zidovudine or tenofovir) or with lopinavir-ritonavir plus zidovudine.
-Also recommended as a component in various alternative regimens (NNRTI-based, protease inhibitor-based, or triple NRTI)
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure

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:
-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 institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

3 months or older:
Oral solution: 4 mg/kg orally twice a day or 8 mg/kg orally once a day
-Maximum dose: 300 mg/day

Tablets:
14 to less than 20 kg: 75 mg orally twice a day or 150 mg orally once a day
20 to less than 25 kg: 75 mg orally in the morning and 150 mg in the evening, or 225 mg orally once a day
25 kg or more: 150 mg orally twice a day or 300 mg orally once a day

Comments: For patients starting therapy with the oral solution, HIV-1 viral load and CD4+ cell count/percentage should be considered when selecting dosing interval.

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

Panel on Antiretroviral Therapy and Medical Management of HIV-infected Children Recommendations:
Oral solution:
Less than 4 weeks (for prevention of transmission or treatment): 2 mg/kg orally twice a day
4 weeks to less than 3 years: 4 mg/kg orally twice a day
-Maximum dose: 150 mg/dose
3 years to less than 16 years: 4 mg/kg orally twice a day or 8 to 10 mg/kg orally once a day
-Maximum dose: 300 mg/day

Tablets:
14 to 21 kg: 75 mg orally twice a day
Greater than 21 to less than 30 kg: 75 mg orally in the morning and 150 mg in the evening
30 kg or more: 150 mg orally twice a day

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: May consider switching from twice-daily dosing to once-daily dosing of this drug in clinically stable patients 3 years or older with a reasonable once-daily regimen, an undetectable viral load, and stable CD4 count; a dose of 8 to 10 mg/kg/dose (up to 300 mg/day) is recommended for such patients.

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 optimal duration of therapy is not known.

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

Renal Dose Adjustments

HBV Infection:
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

HIV Infection:
Adults and Adolescents (at least 25 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.

Liver Dose Adjustments

No adjustment recommended.

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

Precautions

US BOXED WARNINGS:
-LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs alone or in combination with other antiretrovirals. Therapy should be suspended in any patient with clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
-EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients with HBV (including those coinfected with HIV-1) after stopping this drug. Hepatic function of HBV-infected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.
-IMPORTANT DIFFERENCES AMONG LAMIVUDINE-CONTAINING PRODUCTS: 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 products appropriate for treatment of HIV-1 should be used in HIV-1-infected patients.
-HIV-1 RESISTANCE RISK WITH EPIVIR-HBV(R) USE IN UNRECOGNIZED/UNTREATED HIV-1 INFECTION: Epivir-HBV(R) is not approved for treatment of HIV-1 infection; lamivudine dose is subtherapeutic and monotherapy is inappropriate. HIV-1 resistance may develop in chronic HBV-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before starting Epivir-HBV(R) and periodically during therapy.

Safety and efficacy of Epivir(R) and Epivir-HBV(R) have not been established in patients younger than 3 months and 2 years, respectively.

Consult WARNINGS section for additional precautions.

Dialysis

Conventional 4-hour hemodialysis and peritoneal dialysis: No additional dose adjustments needed after adjustment for renal dysfunction (based on CrCl); no supplemental dose needed after dialysis.
Prolonged or continuous hemodialysis: Data not available

Other Comments

Administration advice:
-May administer without regard to food
-If patient is unable to reliably swallow a tablet, use the oral solution.
-Only use products appropriate for treatment of HIV-1 in patients with HIV-1 infection; use in combination with other antiretroviral agents.
-Use the formulation and dose recommended for HIV-1 therapy (as part of an appropriate combination regimen) in patients coinfected with HIV-1 and HBV.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Oral solutions: Store in tightly closed bottles at 20C to 25C (68F to 77F)
-Tablets: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

General:
-Due to development of high resistance rates in treated patients, starting this drug for treatment of chronic HBV should only be considered when an alternative antiviral with a higher genetic barrier to resistance is not available or appropriate.
-During HBV therapy, combinations of events (e.g., persistently elevated ALT recurring, HBV DNA levels increasing over time after initial decline below assay limit, clinical signs/symptoms of hepatic disease progression, and/or hepatic necroinflammatory findings worsen) may indicate loss of therapeutic response; such events should be considered when deciding whether to continue this drug.
-The durability of hepatitis B e antigen (HBeAg) seroconversions occurring during HBV therapy and the relationship between treatment response and long-term outcomes (e.g., hepatocellular carcinoma, decompensated cirrhosis) have not been established.
-The oral solutions contain sucrose; Epivir(R) contains 3 g sucrose per 15 mL dose and Epivir-HBV(R) contains 4 g sucrose per 20 mL dose.

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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