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Cipro (Ciprofloxacin Hydrochloride)
for Inhalation Anthrax
Message to Physicians and Health Practitioners on Cipro
- Cipro (ciprofloxacin hydrochloride) is indicated for
inhalational anthrax (post-exposure), to reduce the incidence or
progression of disease following exposure to aerosolized Bacillus
anthracis. Drug administration should begin as soon as possible
after suspected or confirmed exposure to aerosolized Bacillus
anthracis spores.
- Cipro (ciprofloxacin hydrochloride) therapy should not
be begun in the absence of suspected or confirmed exposure to
aerosolized Bacillus anthracis. Cipro reduces the
risk of severe disease following exposure, but does not prevent
exposure to aerosolized Bacillus anthracis.
- If a person is exposed to B. anthracis, the risk of adverse
events caused by Cipro (ciprofloxacin hydrochloride)
therapy may be acceptable because of the severity of this disease.
However, in the absence of exposure, the risk of these side effects
may not be acceptable.
Possible adverse events and other
concerns include:
- CNS effects (dizziness, confusion, tremors, hallucinations,
depression, increased risk of seizures)
- Drug Interactions – (Cipro may increase levels of theophylline
and caffeine, other vitamin and drug products may reduce
availability of Cipro)
- Hypersensitivity
- Pseudomembraneous colitis
- Tendonitis/ Tendon rupture
- Photosensitivity
- Use of an antibiotic inappropriately (for example when exposure has
not been confirmed) can lead to the emergence of resistant strains of
bacteria. The usefulness of Cipro (ciprofloxacin
hydrochloride) as an antibiotic may be lost if widespread use occurs.
- The safety and effectiveness of Cipro in patients less
than 18 years of age is not established except for use post-exposure
in inhalational anthrax. Ciprofloxacin causes arthropathy in juvenile
animals.
- Fluroquinolones are not generally recommended during pregnancy
because of their known association with arthropathy in adolescent
animals and small numbers of children. However, animal studies have
not shown evidence of teratogenicity related to exposure to Cipro.
While there are no controlled studies of Cipro use in pregnant women
to show safety and efficacy, a 1999 review of published data on
experiences with Cipro use during pregnancy by TERIS - the Teratogen
Information System - concluded that therapeutic doses of Cipro during
pregnancy are unlikely to pose a substantial teratogenic risk, but the
data are insufficient to state that there is no risk1. In addition, a
1999 consensus statement by the Working Group on Civilian Biodefense
recommends that Cipro be used at usual adult doses in pregnant women
for therapy and postexposure prophylaxis following anthrax exposure2.
- For more information, please see the Cipro
label
1 Friedman JM and Polifka
JE. Teratogenic Effects of Drugs. A Resource for Clinicians
(TERIS). Baltimore, MD: The Johns Hopkins University Press;
2000:149-150.
2 Inglesby TV, et al.
Anthrax as a biological weapon: medical and public health
management. Working Group on Civilian Biodefense. JAMA 1999 May 12;281(18):1735-45.
[Erratum in: JAMA 2000 Apr 19;283(15):1963]
For more information about Cipro, please contact the Division of
Drug Information at druginfo@fda.hhs.gov or
1-888-INFOFDA (463-6332).
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FDA/Center for Drug Evaluation and Research
Last Updated: October 19, 2001
Originator: OTCOM/DLIS
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