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Public Health Advisory: Availability of Tamiflu for Oral Suspension
[12/11/2009] The U.S. Food and Drug Administration (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 overall product shortage, although it will not immediately resolve shortages in all areas and availability may be variable for some time.
Pharmacists may still be required to prepare a compounded version of Tamiflu oral suspension from the 75 mg capsules, as directed in the drug label, until adequate supplies are available.
- Healthcare professionals should note that 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 mg/mL whereas the Tamiflu oral suspension that is compounded from the 75 mg capsules has a concentration of 15 mg/mL.
- It is important to make sure that 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, it only has markings that measure milligram (mg) amounts, 30 mg, 45 mg and 60 mg. This has lead to confusion because healthcare professionals generally prescribe liquid medications in volume amounts, milliliters (mL) or teaspoons, which are appropriately measured with an oral syringe calibrated in milliliters (mL). If the instructions for use are written in any other unit of measure (mL, tsp, or cc), the milligram (mg) 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.
FDA is also reminding healthcare professionals and consumers of additional important safety information regarding the safe and effective use of Tamiflu suspension.
Considerations for Healthcare Professionals
- The milligram (mg) dosing device packaged with Tamiflu Oral Suspension should only be used for children older than 1 year of age.
- For 75 mg doses, patients should be instructed to give a 30 mg dose followed by a 45 mg dose.
- An oral syringe calibrated in milliliters (mL) should be dispensed for prescriptions with the dosing instructions written in milliliters (mL). The mg dosing device packaged with Tamiflu for Oral Suspension should be removed from the carton and discarded.
- The units of measure on the prescription instructions must match the dosing device provided with the medication.
- Patients should be told to store Tamiflu for Oral Suspension and the compounded Tamiflu suspension in the refrigerator.
Considerations for Patients, Parents and Caregivers
- Make sure a dosing device that can deliver the prescribed dose (mg or mL) is given to you when the medication is dispensed.
- 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.
- Store the medication in the refrigerator.
- Read the Tamiflu: Consumer Questions and Answers for additional information about the proper use of Tamiflu.
Tamiflu: Consumer Questions and Answers FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension
Emergency Use of Tamiflu in Infants Less than 1 Year of Age
Emergency Compounding of an Oral Suspension from Tamiflu 75 mg Capsules (Final Concentration 15 mg/mL) Availability of Tamiflu for Oral Suspension Overview
Availability of Tamiflu for Oral Suspension Full Version
Tamiflu (oseltamivir phosphate) Information