Emergency Use of Tamiflu in Infants Less than 1 Year of Age

Featured In: Regulatory News

By Federal Drug Administration Friday, November 6, 2023

Loading...

Emergency Use of Tamiflu in Infants Less than 1 Year of Age

On October 30th, 2009, FDA issued an amendment to the Emergency Use Authorization for Tamiflu that included dosing recommendations based on weight for infants less than 1 year of age. This document was originally issued by FDA on 09-25-2009 and included age-based doses for treatment and prophylaxis for infants less than 1 year of age.

Tamiflu for Oral Suspension is approved for use in treatment and prophylaxis of influenza in pediatric patients 1 year of age and older. In certain cases, FDA has authorized emergency use of Tamiflu in infants less than 1 year of age.

Health care providers should be aware that there are limited data on safety and dosing when considering Tamiflu use in seriously ill, young infants with confirmed 2009 H1N1 influenza, or in one that has been exposed to a confirmed 2009 H1N1 influenza case. Infants should be carefully monitored for adverse events when Tamiflu is used.

Tamiflu should not be routinely used for prophylaxis in infants less than 3 months of age due to extremely limited pharmacokinetic data to guide dosing in this age group. Prophylaxis with Tamiflu in infants less than 3 months of age should be reserved for cases in which the exposure is significant and the risk of severe illness is considered high.

The following tables provide treatment (Table 1) and prophylaxis (Table 2) dosing recommendations for the emergency use of Tamiflu in Infants less than 1 year of age:

Table 1. Recommended Treatment Dose for Infants Less than 1 year of age Using Tamiflu Oral Suspension


Age
Recommended Treatment Dose for 5 Days (weight-based dosing)â€
Less than 12 months 3 mg/kg/dose twice a day

†Weight-based dosing is preferred, however, if weight is not known, dosing by age for treatment of influenza in full-term infants younger than 1 year of age may be necessary (birth-2 months = 12 mg (1 mL) twice daily; 3-5 months = 20 mg (1.6 mL) twice daily, 6-11 months = 25 mg (2 mL) twice daily)

Table 2. Recommended Prophylaxis Dose for Infants Less than 1 year of age Using Tamiflu Oral Suspension


Age
Recommended Prophylaxis Dose for 10 Days (weight-based dosing)†â€
3 months to less than 12 months 3 mg/kg/dose once daily

Younger than 3 months
Not recommended unless situation judged critical due to limited data on use in this age group

††Weight-based dosing is preferred, however, if weight is not known, dosing by age for prophylaxis of influenza in full-term infants younger than 1 year of age may be necessary (3-5 months = 20 mg once daily (1.6 mL), 6-11 months = 25 mg (2 mL) once daily).

Current weight-based dosing recommendations are not intended for premature infants.  Premature infants may have slower clearance of Tamiflu due to immature renal function, and doses recommended for full term infants may lead to very high drug concentrations in this age group.  Very limited data from a cohort of premature infants receiving an average dose of 1.7 mg/kg twice daily demonstrated drug concentrations higher than those observed with the recommended treatment dose in term infants (3 mg/kg twice daily).  Observed drug concentrations were highly variable among premature infants.  These data are insufficient to recommend a specific dose of Tamiflu for premature infants.

When dispensing Tamiflu oral suspension for infants younger than 1 year of age, the oral dosing dispenser included in the product package should always be removed and replaced with an appropriate measuring device.  The pharmacist or other health care provider should provide a 3 ml or 5 ml oral syringe to correctly measure the dose and counsel the caregiver on how to administer the prescribed dose.

    

SOURCE

Join the Discussion
Rate Article: Average 0 out of 5
register or log in to comment on this article!

0 Comments

Add Comment

Text Only 2000 character limit

Page 1 of 1

Research Exchange

Calibration Free Analysis to Measure the Concentration of Active Proteins

Nov 23

An SPR-based method, Calibration Free Concentration Analysis can be used to accurately determine the concentration of active protein in a sample, relating to the specific binding activity of the protein, and without the need for a standard.

Advances in EMCCD Technology: Making Imaging Less Arbitrary

Nov 16

Recent advances in EMCCD technology have solved the problem of non-standardized measurement units by using the photoelectron to standardize imaging experiments.

10 Tips for Successful Sample Concentration and Buffer Exchange

Nov 6

Centrifugal devices with ultrafiltration (UF) membrane can solve common problems researchers face when working with proteins.

Meeting the Challenges of Long-term Time-lapse Imaging

Oct 26

Recent technological developments in the sequence capture of cellular events through a light microscope can be combined to image multiple independent experiments automatically, with many advantages.

The Future of the FDA: Operating in an Electronic World

Oct 12

Acording to an Axendia reseach study, the FDA is currently shifting its organizational and technology infrastructures to facilitate electronic interactions with the companies it regulates.

Tissue Microarrays - Opening up new opportunities in the Therapeutics sector

Oct 12

Tissue Microarray has become a pivotal cog in the wheel for high throughput studies and is an integral part in the validation process for screening results from discovery platforms for expression studies using various approaches.

De Novo Formula Generation with Sub-ppm Confidence

Oct 12

Novel technology embodied in the micrOTOF allows precise measurement of both accurate mass and True Isotopic Pattern (TIP) over a wide dynamic range, allowing for the implementation of an open access system.

PLA 2.0 Software for Analyzing - Parallel-Line and Parallel-Logistic Assays

Oct 12

Biological or potency assays are frequently analyzed with the help of the parallel-line or parallel-logistic (4 or 5 parameter fit) methods. These methods have major advantages over traditional single-point assays.

Attention Deficit & Hyperactivity in a Drosophila Memory Mutant

Attention Deficit & Hyperactivity in a Drosophila Memory Mutant

Nov 9

Action selection is modulated by external stimuli either directly or via memory retrieval. In a constantly changing environment, animals have evolved attention-like processes to effectively filter the incoming sensory stream. These attention-like processes, in turn, are modulated by memory. The neurobiological nature of how attention, action selection and memory are inter-connected is unknown. We describe here new phenotypes of the memory mutant radish in the fruit fly Drosophila.

Mechanisms of plasticity in simple taxis behaviors in Drosophila

Nov 8

Like the proverbial moth drawn to the candle flame, the fruit fly Drosophila also stereotypically approaches light sources. This positive phototaxis is the archetypal example of hard-wired input-output behaviors.

Live cell imaging of mutant and wild-type GABA-A receptor trafficking using a novel reporter protein

Nov 8

Efficient signaling in the brain requires precise regulation and targeting of cell surface ion-channels. Mutations in these channels associated with inherited diseases can cause improper targeting and reduced surface expression.

ADP-Glo™: An Ideal Approach to Monitor the Activity of Protein Kinases and Beyond

Oct 16

Because of its versatility (alltypesofsubstrates), robustness (Z’>0.8), rapidperformance, and its ease of use, the luminescence based Kinase Glo® assay platform has gained wide acceptance in many drug screening programs for protein kinase inhibitors.

Outcome Based on Management for Duodenal Adenomas: Sporadic Versus Familial Disease.

28 minutes ago

INTRODUCTION: Management and outcomes for duodenal adenomas may vary based on etiology, familial versus sporadic. We reviewed the records of patients managed at our institution for duodenal adenomatous polyps for the 20-year period ending July 2006. DISCUSSION:...

Correlation of hypointensities in susceptibility-weighted images to tissue histology in dementia patients with cerebral amyloid angiopathy: a postmortem MRI study.

33 minutes ago

Neuroimaging with iron-sensitive MR sequences [gradient echo T2* and susceptibility-weighted imaging (SWI)] identifies small signal voids that are suspected brain microbleeds. Though the clinical significance of these lesions remains uncertain, their...

Addendum: Literature-curated protein interaction datasets

1 hour ago

Introduction Nat. Methods 6, 39–46 (2009); published online 30 December 2008; addendum published after print 25 November 2009. We assessed literature-curated protein-protein interaction (PPI) datasets for the parameters of completeness, coverage and quality by several means,...

New tools for detecting latent tuberculosis infection: Evaluation of RD1-specific long-term response.

1 hour ago

ABSTRACT: BACKGROUND: Interferon-gamma (IFN-g) release assays (IGRAs) were designed to detect latent tuberculosis infection (LTBI). However, discrepancies were found between the tuberculin skin test (TST) and IGRA results that cannot be attributed to prior...

Prokariotic Cell Collection in Denmark

Nov 6

I would like to know about a prokariotic cell collection in Denmark. Is there a cell bank in this country? I need a Lactobacillus strain for a fermentation assay and this information about the bank is very helpful for me.

Request for Entries

Oct 16

Ask the Experts is your chance to get the answers to questions on applications, materials, methods, processes, and technologies. Email you question to bst_web@advantagemedia.com, and the editors of Bioscience Technology will find an appropriate expert to answer it. Watch this space in the future to see the questions your colleagues are posting.

STAY INFORMED: SUBSCRIBE TO

Magazine and E-mail Newsletters

Loading...
E-mail:   

MULTIMEDIA

Video:

Neuroscience Diseases of The Brain and How The Mind Emerges

Neuroscience Diseases of The Brain and How The Mind Emerges

Nov 8

Dennis Choi, director of Emory Universitys Neuroscience Center, is renowned for his groundbreaking research on brain and spinal cord injury.

Podcasts:

Allen Institute for Brain Research

Allen Institute for Brain Research

Oct 14

Discussed in this interview are both the mouse brain project and the human cortex project with an emphasis on the importance of these projects to neuroscience research.