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Public Health Emergency Home Preparation Instructions for Doxycycline
The following home preparation instructions for doxycycline are not to be used except in the case of a declared public health emergency. Although the instructions have not been fully evaluated and will require additional scientific study, the FDA has concluded that the current version of home preparation instructions should be available to public health emergency planners at this time.
The FDA will continue to update these instructions as new scientific data supporting their use is developed. The instructions have been modified from previous instructions based on the results of the following additional research:
- Stability, dose uniformity and palatability of doxycycline were studied. (Sadrieh N, Brower J, Yu L et al. (2005) Stability, dose uniformity, and palatability of three counterterrorism drugs – human subject and electronic tongue studies. Pharmaceutical Research 22:1747-1756.). The following links contain information on the palatability, stability, and dose uniformity of doxycycline.
- Crushing the pills is difficult. Dissolution studies demonstrated that the pills could be softened for 5 minutes in water prior to crushing, thereby making the crushing easier (unpublished information).
- FDA received comments that the layout of the instructions, the language used, and lack of useful illustrations made the instructions difficult to understand. The instructions have been updated based on unpublished studies assessing the ability of consumers to understand the instructions.
No studies have been completed on the current versions of home preparation instructions, specifically on the consumers’ ability to follow the instructions as written or to administer the correct dose, and the variability in preparation of a dose using these instructions. Furthermore, there is no information on the availability of these recommended foodstuffs in the average home. As these studies are performed and additional information is made available to the FDA, these instructions will be updated.
These emergency home preparation instructions for doxycycline have been prepared by FDA for use only during a public health emergency, and should only be distributed and used if instructed to do so by a public health official during such an emergency.
- Pamphlet: "In an Emergency: How to Prepare Doxycycline for Children and Adults Who Cannot Swallow Pills"
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Date created: July 2, 2008 |
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