Oseltamivir

Generic name
Oseltamivir
Brand name
ATC Code
J05AH02
Compare …

Oseltamivir

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

< 1 year:
The results show that doses of 3 mg/kg twice daily in infants aged 3 to 12 months and 2.5 mg/kg twice daily in infants aged 1 to 3 months give exposures that are comparable to exposures that produce clinical effects in adults and infants/children aged 1 year or older.

> 1 year: Younger children excrete both the prodrug and the active metabolite faster than adults, resulting in a lower exposure for a given mg/kg dose. Doses of 2 mg/kg give a comparable exposure to oseltamivir carboxylate as achieved in adults who receive a single dose of 75 mg (about 1 mg/kg). The pharmacokinetics of oseltamivir in children and adolescents 12 years of age or older was the same as in children.
 

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.

General Dose Info

The liquid formulation has a very bitter taste. Parents/caregivers can mix the liquid formulation with very sweet drink mix syrup or concentrated fruit juice (e.g. thickened extracts).

Dosages

Treatment of influenza
  • Oral
    • Term neonate
      [6]
      • 6 mg/kg/day in 2 doses.
    • 1 month up to 1 year
      [2]
      • 6 mg/kg/day in 2 doses. Max: 60 mg/day.
    • ≥ 1 year and 10 up to 15 kg
      [2]
      • 60 mg/day in 2 doses.
    • ≥ 1 year and 15 up to 24 kg
      [2]
      • 90 mg/day in 2 doses.
    • ≥ 1 year and 24 up to 40 kg
      [2]
      • 120 mg/day in 2 doses.
    • ≥ 1 year and ≥ 40 kg
      [2]
      • 150 mg/day in 2 doses.
Prevention of influenza (after exposure)
  • Oral
    • Term neonate
      [6]
      • 3 mg/kg/day in 1 dose
    • 1 month up to 1 year
      [2]
      • 3 mg/kg/day in 1 dose. Max: 30 mg/day.
    • ≥ 1 year and 10 up to 15 kg
      [2]
      • 30 mg/day in 1 dose
    • ≥ 1 year and 15 up to 24 kg
      [2]
      • 45 mg/day in 1 dose
    • ≥ 1 year and 24 up to 40 kg
      [2]
      • 60 mg/day in 1 dose
    • ≥ 1 year and ≥ 40 kg
      [2]
      • 75 mg/day in 1 dose

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary
GFR 30-50 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 24 uur
GFR 10-30 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 24 uur
GFR < 10 ml/min/1.73 m2
Generalized recommendations cannot be given.

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

Children > 12 years:
Very common (> 10%): headache, nausea.

Common (1-10%): dyspepsia, vomiting, (upper) abdominal pain. Dizziness, dizziness, fatigue, fever, pain (including in the limbs). Cough, sore throat, rhinorrhoea, nasopharyngitis, sinusitis, other upper respiratory tract infections, bronchitis. Herpes simplex infections. Insomnia.

Uncommon (0.1-1%): hypersensitivity reaction. Skin rash, eczema, dermatitis, urticaria. Altered consciousness, convulsions. Cardiac arrhythmia. Rise in liver enzyme values.

Rare (0.01-0.1%): Anaphylactic and anaphylactoid reactions. Angioedema, erythema mulftiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. (Fulminant) hepatitis, liver failure. Gastrointestinal bleeding, hemorrhagic colitis. Nightmares, agitation, anxiety, confusion, hallucinations, delusions, delirium, abnormal behavior, self-injury. Visual disturbances. Thrombocytopenia.

In children up to 12 years:
Very common (> 10%): cough, nasal congestion. Vomit.

Common (1-10%): nausea, dyspepsia, abdominal pain. Headache. Earache, otitis media. Rhinorrhoea. Conjunctivitis.

Uncommon (0.1-1%): tympanic membrane disorder. Dermatitis (eg allergic, atopic).

Neuropsychiatric side effects (including delirious disorders such as confusion, hallucinations, agitation, anxiety and nightmares) have been reported, however a causal relationship has not yet been established.

In infants up to 1 year of age, vomiting, diarrhea and diaper rash are the most frequently reported adverse reactions, with an adverse event profile further consistent with that of older children.
 

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

Parents should be alert for behavioural changes and changes in consciousness and should contact the treating physician in the event of behavioural changes and/or changes in consciousness.

Overdose has been reported more frequently for children than adults and adolescents. Caution should
be exercised when preparing Oseltamivir oral suspension and when administering Tamiflu products to
children. [7,8]

Resistance of influenza viruses to oseltamivir occurs. Susceptibility to oseltamivir and prevalence of such viruses (eg, the resistance-associated mutation H275Y of the H1N1 strain) appear to vary seasonally and geographically. The development of oseltamivir-resistant virus is more common in children than in adults (in adults it is < 1%, in infants < 1 year up to 18%). Children who are carriers of oseltamivir-resistant virus transmit the virus for a longer period of time. Incidentally, the occurrence of resistance does not affect the treatment response and does not prolong influenza symptoms in the child. The incidence of oseltamivir resistance is also higher in immunocompromised patients. If resistance occurs, the virus can be spread for a longer period of time.

Neuropsychiatric side effects have been reported, particularly in children and adolescents; however, a causal relationship with the therapy has not yet been established, yet it is recommended that patients be closely monitored for behavioral changes.

Furthermore, safety and efficacy have not been sufficiently established in children with impaired liver function.

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
J05AB04
J05AB11
J05AB14
Protease inhibitors
J05AE10
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10
J05AF05
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG01
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

References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiele therapie, 2005
  2. Roche registration limited, SmPC Tamiflu. (EU/1/02/222/003) Rev 42, 24-03-2024
  3. EMEA/CHMP, FOLLOW-UP RECOMMENDATIONS FROM CHMP on Novel Influenza (H1N1) outbreak, EMEA/H/A-5.3/1172 Regulation (EC) No 726/2004 Article 5(3), 7 mei 2009, 3
  4. Gezondheisraad, Advies Antivirale middelen bij een grieppandemie, 08 dec 2015, Pulicatienr. 2015/30
  5. Schreuder, MF, et al., Oseltamivir dosing in children undergoing hemodialysis, Clin Infect Dis, 2010, 15, 50(10), 1427-8
  6. Roche, SmPC Tamiflu® 6 mg/ml Pulver (EU/1/02/222/005), Rev 42, 24-03-2023, www.ema.europa.eu
  7. Roche, SmPC Tamiflu® 30 mg/ 45 mg/75 mg Hartkapseln (EU/1/02/222/003), Rev 42, 240-04-2023, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose