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ZITHROMAX is contraindicated in patients with
known hypersensitivity to azithromycin, erythromycin or
any macrolide antibiotic.
WARNINGS
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Serious
allergic reactions, including angioedema, anaphylaxis,
and dermatologic reactions
including Stevens Johnson Syndrome and toxic epidermal
necrolysis have been reported rarely in patients on
azithromycin therapy. Although rare, fatalities have
been reported. Despite initially successful symptomatic
treatment of the allergic symptoms, when symptomatic
therapy was discontinued, the allergic symptoms recurred
soon thereafter in some patients without further
azithromycin exposure. These patients required prolonged
periods of observation and symptomatic treatment. The
relationship of these episodes to the long tissue
half-life of azithromycin and subsequent prolonged
exposure to antigen is unknown at present.
If an allergic reaction occurs, the drug should be
discontinued and appropriate therapy should be nstituted.
Physicians should be aware that reappearance of the
allergic symptoms may occur when symptomatic therapy is
discontinued. In the treatment of pneumonia,
azithromycin has only been shown to be safe and
effective in the treatment of community-acquired
pneumonia due to Chlamydia pneumoniae, Haemophilus
influenzae, Mycoplasma pneumoniae or Streptococcus
pneumoniae in patients
appropriate for oral therapy. Azithromycin should not be
used in patients with pneumonia who are judged to be
inappropriate for oral therapy because of moderate to
severe illness or risk factors such as any of the
following: patients with cystic fibrosis, patients with
nosocomially acquired infections, patients with known or
suspected bacteremia, patients requiring hospitalization,
elderly or debilitated patients, or patients with
significant
underlying health problems that may compromise their
ability to respond to their illness (including
immunodeficiency or functional asplenia).
Pseudomembranous colitis has been reported with nearly
all antibacterial agents and may
range in severity from mild to life-threatening.
Therefore, it is important to consider this
diagnosis in patients who present with diarrhea
subsequent to the administration of
antibacterial agents.
Treatment with antibacterial agents alters the normal
flora of the colon and may permit
overgrowth of clostridia. Studies indicate that a toxin
produced by Clostridium difficile is a
primary cause of “antibiotic-associated colitis.”
After the diagnosis of pseudomembranous colitis has been
established, therapeutic measures should be initiated.
Mild cases of pseudomembranous colitis usually respond
to discontinuation of the drug alone. In moderate to
severe cases, consideration should be given to
management with fluids and electrolytes, protein
supplementation, and treatment with an antibacterial
drug clinically effective against Clostridium difficile
colitis. |