Emtricitabine

Generic name
Emtricitabine
Brand name
ATC Code
J05AF09
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Emtricitabine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetics in infants and children are the same as the pharmacokinetics in adults.

T½: approximately 10 hours
Vd: 1.4 ± 0.3 l/kg
bioavailability: tablet: 93%; liquid formulation: 75%.
Cl: 4.03 ml/min/kg 

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Treatment HIV infection
  • Oral
    • Liquid solution
      • 1 month up to 3 months
        • 3 mg/kg/day in 1 dose
      • ≥ 3 months
        • 6 mg/kg/day in 1 dose. Max: 240 mg/day.
        • Directions for administration:

          If there is vomiting within 1 hour after taking the tablet, give a new tablet.

          If a dose is forgotten, it can still be taken as long as this is noticed within 12 hours of the usual time at which it should have been taken. If more than 12 hours have elapsed, the skipped dose should no longer be taken and the usual dosing regimen should be continued.

      • Term neonate
        • 3 mg/kg/day in 1 dose
    • Capsule, hard
      • ≥ 33 kg
        • 200 mg/day in 1 dose

Renal impaiment in children > 3 months

Liquid formulation:
GFR > 30: no adjustment
GFR 10-30: 33.3% of the normal dose each time and the interval between two doses: 24 hours
GFR < 10: no generalized recommendations are given

In dialysis:
Haemodialysis: 25% of the normal dose each time and the interval between two doses: 24 hours. Do not dialyse during the first 12 hours after taking emtricitabine.

Tablet:
GFS > 30: no adjustment
GFR 10-30: 100% of the normal dose each time and the interval between two doses: 72 hours
GFR < 10: no generalized recommendations are given

In dialysis:
Haemodialysis: 100% of the normal dose each time and the interval between two doses: 96 hours. Do not dialyse during the first 12 hours after taking emtricitabine.

Clinical consequences

The risk of toxicity increases.
If the trough level is insufficient, the antiviral effect may possibly not be sufficient; this can cause resistance.

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

Side effects in children

In children: hyperpigmentation (approx. 32%, particularly on palms and soles of feet, otherwise asymptomatic).

The following adverse reactions were observed more frequently in paediatric patients: anaemia was common (9.5%) and skin discolouration (increased pigmentation) was very common (31.8%) in paediatric patients.

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

No information available on specific warnings and precautions in children.

Interactions

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

DIRECT ACTING ANTIVIRALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB12
J05AB06
J05AB16
J05AB04
J05AB11
J05AB14
Phosphonic acid derivatives
J05AD01
Protease inhibitors
J05AE08
J05AE10
J05AE07
J05AE02
J05AE04
J05AE03
J05AE01
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF06
J05AF02
J05AF10
J05AF05
J05AF04
J05AF07
J05AF13
J05AF13
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG06
J05AG03
J05AG04
J05AG01
J05AG05
Neuraminidase inhibitors
J05AH02
J05AH01
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Other antivirals
J05AX28
J05AX12
J05AX07
J05AX09
J05AX08
J05AX24
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Integrase inhibitors
J05AJ04
Antivirals for treatment of HCV infections
J05AP54
J05AP57
J05AP51
J05AP08
J05AP55

References

  1. Gilead Sciences International Ltd., SmPC Emtriva (EU/01/03/261/003) Rev 33; 18-04-2023), www.ema.europa.eu
  2. 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
  3. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children., Guideline for the use of Antiretroviral agents in pediatric HIV infection, https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/, accessed 25 May 2022
  4. 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

Changes

Therapeutic Drug Monitoring


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