FDA Suggests Doxycycline, Penicillin G Procaine Doses for Inhalation Anthrax
In addition, the FDA provided specific dosage recommendations for these antibiotics for treatment of inhalational anthrax (post-exposure) in adults and children. A talk paper on the topic can be found on the agency's Web site at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01112.html.
Current labeling for doxycycline and penicillin G procaine carries a general anthrax indication and does not specify a dosing regimen for inhalational anthrax exposure. However, the FDA said it has "determined that the language in the labeling of drug products containing doxycycline, doxycycline calcium, doxycycline hyclate and penicillin G procaine is intended to, and does, cover all forms of anthrax, including inhalational anthrax (post-exposure)."
Bayer's ciprofloxacin (Cipro) already carries specific labeling for inhaled anthrax. The FDA noted that in a rhesus monkey study that was conducted to support the approval of Cipro for that indication, there were doxycycline and penicillin G procaine arms, and both drugs provided a survival advantage over placebo.
The full text of the notice in the Federal Register can be found on the FDA Web site in PDF format at http://www.fda.gov/OHRMS/DOCKETS/98fr/cd01156.pdf.
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