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Availability of Tamiflu for Oral Suspension Full Version

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On December 11, 2009 the Food and Drug Administration issued a public health advisory titled: Availability of Tamiflu for Oral Suspension.

I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.

FDA is informing healthcare professionals and consumers that additional quantities of the commercially prepared Tamiflu for Oral Suspension are being shipped to wholesalers and pharmacies. This new supply should address the current product shortage, although it will not immediately resolve shortages in all areas and availability of Tamiflu for Oral Suspension may be variable for some time.  Therefore, some pharmacists may still be required to prepare a compounded version of Tamiflu oral suspension from the 75 milligram capsules, as directed in the drug label, until adequate supplies are available.

FDA is also reminding healthcare professionals and consumers of important safety information regarding the safe and effective use of Tamiflu suspension.

  • The concentrations of the commercially available Tamiflu for Oral Suspension and the compounded Tamiflu oral suspension are different. The commercial Tamiflu for Oral Suspension has a concentration of 12 milligrams per milliliter whereas the Tamiflu oral suspension that is compounded from the 75 milligram capsules has a concentration of 15 milligrams per milliliter. 
  • Ensure the dosing device dispensed with the product has markings that match the units of measure prescribed.  The dosing device that is packaged with Tamiflu for Oral Suspension is preferred because it provides the most accurate measurement of the commercially available suspension. However, this dosing device only has markings that measure 30, 45 and 60 milligram amounts. This has led to confusion because healthcare professionals generally prescribe liquid medications in volume amounts, in either milliliters or teaspoons, which are appropriately measured with an oral syringe calibrated in milliliters.

The following recommendations for healthcare professionals will help to ensure the safe use of Tamiflu Suspension:

  • Physicians should prescribe the dose in milligrams.
  • The milligram dosing device should only be used for children older than one year of age.
  • For doses prescribed as 30, 45, 60 or 75 milligrams, the dosing device packaged with Tamiflu for Oral Suspension should be dispensed to the patient provided the prescription instructions for use are written in milligram doses.  If the instructions for use are described with any other unit of measure, such as milliliter, teaspoon or cc (also known as cubic centimeters) the dosing device packaged with Tamiflu for Oral Suspension should be removed from the carton and replaced with a device that can measure the units of measure on the prescription instructions.
  • For 75 milligram doses, patients should be instructed to give a 30 milligram dose followed by a 45 milligram dose.
  • Pharmacists should ensure that for children under the age of 1 year the milligram dose should always be converted to milliliters and the directions should be written in milliliters.
  • An oral syringe calibrated in milliliters should be dispensed for prescriptions with the dosing instructions written in milliliters. The milligram dosing device packaged with Tamiflu for Oral Suspension should be removed from the carton and discarded.  
  • Any dose written as a volume amount such as milliliters or teaspoons should be checked for correctness based on the patient’s weight and the concentration of the oral suspension to be dispensed.
  • Any dose written in teaspoons should be converted to milliliters to ensure the dose can be accurately measured with an oral syringe.
  • Ensure that the units of measure on the prescription instructions match the dosing device provided with the medication.
  • Pharmacists should ensure that the commercial Tamiflu for Oral Suspension is properly reconstituted prior to being dispensed.
  • Instruct patients to store Tamiflu for Oral Suspension and the compounded Tamiflu suspension in the refrigerator.

The following recommendations for consumers will help to ensure the safe use of Tamiflu Suspension:

  • Discuss with the pharmacists how much of and how often to give the medication.
  • Make sure a dosing device that can deliver the prescribed dose, either milligram or milliliter, is given to you when the medication is dispensed.
  • Ensure you understand how to use the dosing device that is given to you.
  • If the dosing device given to you with the medication is lost or misplaced, contact your pharmacist. Do not substitute a teaspoon or other measuring device.
  • Shake the bottle of Tamiflu for Oral Suspension or the compounded Tamiflu suspension before use.
  • Store the medication in the refrigerator.
  • Read the Tamiflu: Consumer Questions and Answers at F-D-A dot GOV slash D-R-U-G slash D-R-U-G S-A-F-E-T-Y slash P-O-S-T-M-A-R-K-E-T D-R-U-G-S-A-F-E-T-Y I-N-F-O-R-M-A-T-I-O-N for PatientsandProviders slash u-c-m-1-8-8-8-5-9 dot htm for additional information about the proper use of Tamiflu. 

We urge healthcare providers and patients to report serious side effects that may be associated with the use of Tamiflu for Oral Suspension to us at the FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

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