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Oseltamivir Oral Suspension Concentration Revised to Ensure Accurate Dosing
Manufacturer Launches Take-back Program for Old Product
By News Staff
FDA Approves 2011-12 Flu Vaccine; Shipments Under Way
The trivalent vaccine protects against the virus strains that -- based on global surveillance -- are expected to be the most common during the flu season. The three 2011-12 strains are the same as those used during the 2010-11 flu season:
- A/California/7/09 (H1N1)-like virus (pandemic 2009 influenza virus)
- A/Perth /16/2009 (H3N2)-like virus
- B/Brisbane/60/2008-like virus
The CDC's Advisory Committee on Immunization Practices and the AAFP recommend that everyone 6 months of age and older receive an annual influenza vaccination unless contraindicated.
Genentech has addressed that issue by packaging the 6 mg/mL version of oseltamivir with a new measuring device that uses milliliters and updating the dosing table that accompanies the product with a column for milliliters. The product's container labels and carton packaging will be updated to reflect the changes.
Based on those changes, the FDA issued the following information for physicians:
- Prescribers should include the new (6 mg/mL) concentration and dose in milliliters on prescriptions for oseltamivir for oral suspension. An updated dosing chart is included in the revised product label.
- It's possible that patients may receive either concentration at pharmacies during the 2011-12 flu season, and patients should be educated about this possibility to avoid medication errors.
- The two versions of the product label may be in circulation during the 2011-12 influenza season and contain different dosing and compounding instructions for the oral suspension.
- Prescribers should be aware that pediatric strength oseltamivir capsules -- 30 mg and 45 mg -- remain available and have not changed. These capsules can be prescribed for pediatric patients who can swallow capsules. For patients who cannot swallow capsules, these can be opened and the capsule contents can be mixed with flavored foods.
- Report adverse events or medication errors involving oseltamivir to the FDA's MedWatch program.
AFP By Topic: Influenza
CDC: Seasonal Influenza Information for Health Care Professionals