Biological Threats and Terrorism Assessing the Science and Response Capabilities: Workshop Summary (2002) / Chapter Skim
Currently Skimming:
Appendix E: Department of Health and Human Services: Food and Drug Administration
Appendix E: Department of Health and Human Services: Food and Drug Administration
Pages 244-251
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 244... ...
SUMMARY: The Food and Drug Administration (FDA) is clarifying that the currently approved indications for doxycycline and penicillin G procaine drug products include use in cases of inhalational exposure to Bacillus anthracis (the bacterium that causes anthrax)
|
From page 245... ...
II. Approved Drug Products Drug products containing doxycycline, doxycycline calcium, doxycycline hyclate,~ and penicillin G procaine are currently approved with indications for anthrax.2 The approved labeling for the doxycycline products states that the drugs are indicated in infections caused by Bacillus anthracis.
|
From page 246... ...
III. Doxycycline Drug Products We have determined that 100 mg of doxycycline, taken orally twice daily for 60 days, is an appropriate dosing regimen for administration to adults who have inhalational exposure to Bacillus anthracis.
|
From page 247... ...
data for the tetracycline class and Bacillus anthracis, pharmacokinetic data, data from the Sverdlovsk incident, and the outcome data from a study of inhalational exposure to Bacillus anthracis in rhesus monkeys.4 We have concluded that 100 mg of doxycycline, administered twice a day for 60 days, is an effective dosing regimen for adults who have inhalational exposure to Bacillus anthracis. The corresponding dosing regimen for children under 100 lb of 1 mg/lb of body weight (2.2 mg/kg)
|
From page 248... ...
, the recommended dosing regimen, safety information relevant to use in children and prolonged use, and other information described below. We recommend that labeling supplements for doxycycline hyclate injectable drug products include the following specific changes: ·Indications The indication for anthrax should be revised from "Bacillus anthracis" to "Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure)
|
From page 249... ...
B Effectiveness We have reviewed MIC data for penicillin G and Bacillus anthracis, pharmacokinetic data, data from the Sverdlovsk incident, clinical data regarding the use of penicillins in treatment of primarily cutaneous anthrax, and the outcome data from a study of inhalational exposure to Bacillus anthracis in rhesus monkeys.5 We have concluded that the recommended dosing regimens are effective for adults and children who have inhalational exposure to Bacillus anthracis.
|
From page 250... ...
Physicians must consider the risks and benefits of continuing administration of penicillin G procaine for more than 2 weeks or switching to an effective alternative treatment." V Conclusions Drug products containing the following active ingredients are currently approved for administration in cases of inhalational anthrax: Doxycycline Doxycycline calcium Doxycycline hyclate Penicillin G procaine We encourage the submission of labeling supplements for these drug products.
|
From page 251... ...
VI. Published Literature The published literature we have relied on in making our recommendations will be placed on display in the Dockets Management Branch (address above)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.