Influenza

Active Ingredient: Oseltamivir

Indication for Oseltamivir

Population group: only infants (40 days - 1 year old)

Oseltamivir is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.

For this indication, competent medicine agencies globally authorize below treatments:

6 mg/kg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

6 mg per kg of body weight

Dosage regimen

3 mg per kg of body weight 2 time(s) per day every day for 5 day(s)

Detailed description

Infants 0–12 months of age

The recommended treatment dose for infants 0-12 months of age is 3 mg/kg twice daily. This is based upon pharmacokinetic and safety data indicating that this dose in infants 0-12 months provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be clinically efficacious with a safety profile comparable to that seen in older children and adults.

The following dosing regimen is recommended for treatment of infants 0-12 months of age:

Body weight* Recommended dose for 5 days
3 kg9 mg twice daily
4 kg12 mg twice daily
5 kg15 mg twice daily
6 kg18 mg twice daily
7 kg21 mg twice daily
8 kg24 mg twice daily
9 kg27 mg twice daily
10 kg30 mg twice daily

* This table is not intended to contain all possible weights for this population. For all patients under the age of 1 year, 3 mg/kg should be used to determine dose regardless of the weight of the patient.

Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.

This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.

Active ingredient

Oseltamivir

Oseltamivir (oseltamivir carboxylate) is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface. Viral neuraminidase enzyme activity is important both for viral entry into uninfected cells and for the release of recently formed virus particles from infected cells, and for the further spread of infectious virus in the body.

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