Thursday, January 10, 2013

FDA: Scattered Shortages Of Tamiflu Liquid Suspension

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Photo Credit – Wikipedia

 

# 6845

 

On Tuesday of this week it was announced that Canada Released Tamiflu From Their National Emergency Stockpile to deal with temporary shortages due to high demand this flu season.

 

Today, the FDA  announced that there are some places in the United States where the pediatric or liquid suspension version of that antiviral is in short supply as well.

 

First the FDA announcement, then what you can do if you need this medicine, and it is not immediately available.

 

FDA Current Drug Shortages: Oseltamivir Phosphate (Tamiflu) for Oral Suspension (6mg/mL 60 mL)

Thursday, January 10, 2013 3:15:00 PM

Company:

Genentech, Inc.

Product:

Oral Suspension 6 mg/mL 60 mL (NDC 00004-      0820-09)

Availability:

Genentech has Tamiflu for Oral Suspension on intermittent backorder, however supplies remain in distribution at  wholesalers and pharmacies.

Related Information:

Tamiflu 30 mg, 45 mg and 75 mg capsules remain available.

For those patients who have difficulty swallowing capsules, the contents can be mixed into sweetened liquids, such as chocolate syrup, as directed by a healthcare professional.

If there is difficulty locating commercial Tamiflu for Oral Suspension, FDA would like to remind healthcare professionals of the FDA-approved Instructions for the emergency compounding of an oral suspension from Tamiflu 75 mg capsules. These instructions provide for an alternative oral suspension when commercially manufactured oral suspension formulation is not readily available. Please see the following link for information for healthcare professionals regarding compounding an oral suspension from Tamiflu 75 mg capsules:
http://www.tamiflu.com/hcp/resources/hcp_resources_pharmacists.jsp disclaimer icon

Alternatives to Tamiflu treatment for influenza are described on the CDC website: http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm

Shortage Reason
(per New Legislation-FDASIA)*

Demand Increase for the Drug

 


It is a fairly simple matter for a qualified pharmacist to compound an oral solution using 75mg Tamiflu capsules and an appropriate syrup.

 

Directions for doing so are available at the link below, but given the importance of precisely calibrating the dosage for the intended patient, this should not be considered a do-it-yourself-at-home project.

 

 

Emergency Compounding

 

Directions for the Emergency Compounding of an Oral Suspension from Tamiflu 75-mg Capsules (Final Concentration 6 mg/mL)

These directions are provided for use only during emergency situations when Tamiflu for Oral Suspension is not commercially available in a pharmacy. These directions are not intended for use if the FDA-approved, commercially manufactured Tamiflu for Oral Suspension is readily available from wholesalers or the manufacturer. Compounding an oral suspension with this procedure will provide 1 patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

Commercially manufactured Tamiflu for Oral Suspension (6 mg/mL) is the preferred product:

  • For pediatric and adult patients who have difficulty swallowing capsules, or where lower doses are needed.

In the event that the commercially manufactured Tamiflu for Oral Suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from Tamiflu 75-mg capsules using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved Tamiflu for Oral Suspension is commercially available.

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