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Monodox (doxycycline monohydrate) capsules.


WARNINGS

Clostridium difficile Clostridium difficile A common cause of bacterial colitis; it is the causative agent in 99% of pseudomembranous colitis, and 20-30% of antibiotic-associated diarrhea  associated diarrhea (CDAD CDAD Clostridium Difficile-Associated Diarrhea
CDAD Component Data Administrator
) has been reported with use of nearly all antibacterial agents, including Monodox, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora Normal flora
The mixture of bacteria normally found at specific body sites.

Mentioned in: Sputum Culture, Wound Culture
 of the colon leading to overgrowth overgrowth

Rapid growth in the sales of a mutual fund's shares to the extent that the fund has difficulty finding promising new investments or it must take such large positions in individual investments that its trading flexibility is reduced.
 of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
, as these infections can be refractory to antimicrobial therapy and may require colectomy colectomy /co·lec·to·my/ (ko-lek´tah-me) excision of the colon or of a portion of it.

co·lec·to·my
n.
Surgical removal of part or all of the colon.
. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

Information for Patients

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
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Title Annotation:Contraindications and warnings
Publication:Adverse Event Reporting News
Article Type:Brief article
Geographic Code:1USA
Date:May 6, 2008
Words:228
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