Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Lamivudine

Generic name
Lamivudine
Brand name
ATC Code
J05AF05

Pharmacokinetics in children

Bioavailability: Adults: 80–85% adults, children < 12 years: 55–65%. Food has no effect on the bioavailability

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

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Dosages

Treatment HIV infection
  • Oral
    • Gestational age 32 weeks up to 37 weeks
      [4]
      • 4 mg/kg/day in 2 doses.
    • Term neonate
      [3] [4] [5]
      • 4 mg/kg/day in 2 doses.
    • 1 month up to 3 months
      [4] [7]
      • 8 mg/kg/day in 2 doses. Max: 300 mg/day.

      • Prescribing antiretroviral therapy for children is an action that is reserved for the doctors in HIV teams. The available combinations in retroviral therapy are continually changing. The above-mentioned dosing is therefore only a guide.

    • 3 months up to 3 years
      [4]
      • 10 mg/kg/day in 2 doses. Max: 300 mg/day.

      • Prescribing antiretroviral therapy for children is an action that is reserved for the doctors in HIV teams. The available combinations in retroviral therapy are continually changing. The above-mentioned dosing is therefore only a guide.

    • 3 years up to 18 years
      [4]
      • 10 mg/kg/day in 1 - 2 doses. Max: 300 mg/day.

      • Prescribing antiretroviral therapy for children is an action that is reserved for the doctors in HIV teams. The available combinations in retroviral therapy are continually changing. The above-mentioned dosing is therefore only a guide.
Chronically active hepatitis B
  • Oral
    • 1 month up to 18 years
      [1] [2]
      • 3 mg/kg/day in 1 dose. Max: 100 mg/day.
Neonatal prophylaxis in an HIV-positive mother
  • Oral
    • Premature infants Gestational age ≥ 32 weeks
      [3] [4] [5] [7]

      • Postnatal age 0-4 weeks: 4 mg/kg/day in 2 doses
        Postnatal age > 4 weeks: 8 mg/kg/day in 2 doses

      • Duration of treatment:
        • 2-6 weeks, depending on HIV NAT results, maternal viral load at the time of delivery, and additional risk factors for HIV transmission. Consultation with an expert in pediatric HIV is recommended
        • In confirmed HIV diagnosis: lifelong treatment; dose according to HIV treatment dose

      • In combination with zidovudine  plus either nevirapine or raltegravir

    • Term neonate
      [3] [4] [5] [7]

      • Postnatal age 0-4 weeks: 4 mg/kg/day in 2 doses.
        Postnatal age >4 weeks: 8 mg/kg/dayin 2 doses

      • Duration of treatment:
        • 2-6 weeks, depending on HIV NAT results, maternal viral load at the time of delivery, and additional risk factors for HIV transmission. Consultation with an expert in pediatric HIV is recommended
        • In confirmed HIV diagnosis: lifelong treatment; increase dose to HIV treatment dose
           

      • Combined with zidovudine plus either nevirapine or raltegravir

         

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Renal impaiment in children > 3 months

  • GFR ≥ 50 ml/min/1.73 m2: no adjustment
  • GFR 30-50 ml/min/1.73 m2: 50% of normal daily dose in 1 dose
  • GFR 15-30 ml/min/1.73 m2: Start: 50% of normal daily dose in 1 dose, maintenance: 33% of normal daily dose in 1 dose
  • GFR 5-15 ml/min/1.73 m2: Start: 50% of normal daily dose in 1 dose, maintenance: 16% of normal daily dose in 1 dose
  • GFR <5 ml/min/1.73 m2: Start: 16% of normal daily dose in 1 dose, maintenance: 9% of normal daily dose in 1 dose

[SmPC Epivir]

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In a study performed in paediatric patients, lower rates of virologic suppression and more frequent viral resistance were reported in children receiving the oral solution compared to those receiving the tablet formulation. Whenever possible in children, an all-tablet regimen should preferably be used. [SmPC Epivir]

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB04
J05AB11
J05AB14
Protease inhibitors
J05AE10
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG01
Neuraminidase inhibitors
J05AH02
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR10
Other antivirals
J05AX12
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR10
Antivirals for treatment of HCV infections
J05AP57
J05AP08
J05AP55

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References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiele therapie, 2005
  2. Keam SJ, et al, Lamivudine: in children and adolescents with chronic hepatitis B virus infection., Paediatr Drugs, 2002, 4(10), 687-94
  3. CBO, Richtlijn Antiretrovirale therapie, www.cbo.nl, herziene versie december 2007
  4. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV, Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection - Lamivudine, https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv, Apr 11, 2023
  5. PENTA Steering Commitee, PENTA 2009 guidelines for the use of antiretroviral therapy, HIV Medicine, 2009, 10, 591-613
  6. Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life. , HIV Med, 2015, doi:10.1111/hiv.12217
  7. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV, Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection, Dec 30, 2020, https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/antiretroviral-management-newborns-perinatal-hiv-exposure-or-hiv-infection
  8. ViiV Healthcare BV, SmPC Epivir (EU/1/96/015) Rev 50; 29-08-2022, www.ema.europa.eu

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Changes

Changes