From the Guidelines
Tamiflu (Oseltamivir) is used in pediatrics to treat and prevent influenza A and B, with dosing recommendations varying by age and weight.
Treatment and Chemoprophylaxis
- For children aged 1-12 years, the treatment dose of oseltamivir is based on weight, with doses ranging from 30 mg twice daily for children weighing ≤15 kg to 75 mg twice daily for children weighing >40 kg 1.
- For children aged ≥1 year, the chemoprophylaxis dose of oseltamivir is also based on weight, with doses ranging from 30 mg once daily for children weighing ≤15 kg to 75 mg once daily for children weighing >40 kg 1.
Use in Children Under 1 Year
- Oseltamivir is not approved by the FDA for use in children under 1 year, but may be used in certain situations, such as during a pandemic, under an Emergency Use Authorization (EUA) 2.
- For infants under 1 year, weight-based dosing recommendations are available, with treatment doses ranging from 3 mg/kg/dose twice daily for infants <3 months to 3 mg/kg/dose twice daily for infants 3-11 months 3, 2.
Efficacy and Safety
- Oseltamivir has been shown to reduce the median duration of illness, incidence of otitis media, and need for antibiotic prescriptions in children with influenza 4, 5.
- Common side effects of oseltamivir in children include vomiting, with a higher incidence of vomiting reported in oseltamivir recipients compared to placebo recipients 4, 5.
Special Considerations
- Premature infants may require adjusted dosing due to immature renal function, and clinicians should consult the CDC website for treatment recommendations 2.
- Oseltamivir should be used with caution in children with underlying medical conditions, such as asthma, and clinicians should monitor for adverse events 4, 5.
From the FDA Drug Label
The safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established [see Dosage and Administration (2.2), Clinical Pharmacology (12.3), and Clinical Studies (14. 1)] and is based on: 13 to 17 years of age: Safety and efficacy in adolescent patients 13 to 17 years of age was supported by adequate and well-controlled trials in adults and adolescents and younger pediatric patients and safety data in adolescents treated with oseltamivir phosphate in a study of treatment and prophylaxis 1 year to 12 years of age: Safety and efficacy in pediatric patients 1 year to 12 years of age was supported by results of one double-blind, placebo-controlled trial in 452 pediatric patients with influenza in whom oseltamivir phosphate 2 mg per kg twice daily or placebo was administered within 48 hours of symptom onset [see Clinical Studies (14. 1)]. 2 weeks to less than 1 year of age: Safety and efficacy in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials of oseltamivir phosphate (2 to 3. 5 mg per kg twice daily for 5 days) in 136 pediatric subjects 2 weeks to less than 1 year of age.
The use of Tamiflu (Oseltamivir) in pediatrics is for:
- Treatment of influenza in pediatric patients 2 weeks old to 17 years of age
- Prophylaxis of influenza in pediatric patients 1 year to 17 years old Key points:
- The safety and efficacy of oseltamivir phosphate have been established in pediatric patients 2 weeks old to 17 years of age for the treatment of influenza
- The safety and efficacy of oseltamivir phosphate have been established in pediatric patients 1 year to 17 years old for the prophylaxis of influenza
- The safety and efficacy of oseltamivir phosphate for treatment of influenza in pediatric patients less than 2 weeks of age have not been established
- The safety and efficacy of oseltamivir phosphate for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age 6
From the Research
Use of Tamiflu (Oseltamivir) in Pediatrics
- Tamiflu (oseltamivir) is used to treat influenza in children, with treatment officially authorized for newborns two weeks of age or older 7.
- The therapy has been recommended for hospitalized children with suspected and confirmed influenza for almost 20 years, with the goal of reducing the duration of illness and preventing complications 7, 8, 9.
- Studies have shown that oseltamivir significantly reduces the intensity of influenza symptoms, thus reducing the number of days of hospitalization and post-infection complications in children 7, 8, 9.
- Early oseltamivir treatment has been associated with improved outcomes in hospitalized children with influenza, including shorter hospital stays and lower odds of readmission, ICU transfer, and death 9.
- Oseltamivir treatment started within 24 hours of symptom onset has been shown to provide substantial benefits to children with influenza A infection, including reducing the incidence of acute otitis media and shortening the median time to resolution of illness 10.
Dosage and Administration
- The recommended dosage of oseltamivir for children is 2 mg/kg/dose administered twice daily for 5 days 7.
- The drug is available in suspension form for oral administration, and healthcare providers should be aware of dosing, adverse reactions, and monitoring parameters to better treat and educate their patients 11.
Safety and Efficacy
- Oseltamivir has been shown to be well tolerated in children, with vomiting being the only adverse event with a significantly higher risk in the treatment group 8.
- The safety and efficacy of oseltamivir in children have been evaluated in several studies, with results indicating that the drug is effective in reducing the duration of illness and preventing complications in children with influenza 7, 8, 9, 10.
- However, questions about the safety and effectiveness of oseltamivir in children still surround it, and further research is needed to fully understand its benefits and risks in this population 7.