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Printable Version
When certain pathogens run wild... the bugs
stop here!
NOTE: The information contained in
this section is intended for U.S. healthcare professionals only. If
you are a patient in the U.S., please visit the
Spectracef® patient site for
information about Spectracef designed especially for you.
Cornerstone BioPharma is proud to reintroduce
Spectracef (cefditoren pivoxil) Tablets to doctors and healthcare
providers in the United States. Cefditoren, already a leading oral
cephalosporin in Japan, is a semi-synthetic antibacterial agent that
is proven safe and effective against infections caused by
susceptible gram-positive and gram-negative organisms in clinical
trials.
Click on one of the tabs above to see how Spectracef works to
treat community-acquired
pneumonia (CAP), acute
bacterial exacerbation of chronic bronchitis (ABECB), pharyngitis/tonsillitis,
and uncomplicated
skin and skin-structure infections (USSSI).
Spectracef is indicated in adults and adolescents 12 years of age
or older for the treatment of mild to moderate infections that are
caused by susceptible strains of microorganisms in the following
conditions:
Community-Acquired Pneumonia
(CAP) caused by Haemophilus influenzae (including
β-lactamase-producing strains), Haemophilus parainfluenzae
(including β-lactamase-producing strains), Streptococcus
pneumoniae (penicillin-susceptible strains only), or
Moraxella catarrhalis (including β-lactamase-producing
strains)
Acute Bacterial Exacerbation of
Chronic Bronchitis (ABECB) caused by Haemophilus
influenzae (including β-lactamase-producing strains),
Haemophilus parainfluenzae (including β-lactamase-producing
strains), Streptococcus pneumoniae (penicillin-susceptible
strains only), or Moraxella catarrhalis (including
β-lactamase-producing strains)
Pharyngitis/Tonsillitis caused
by Streptococcus pyogenes NOTE: Spectracef is effective in
the eradication of Streptococcus pyogenes from the
oropharynx. Spectracef has not been studied for the prevention of
rheumatic fever following Streptococcus pyogenes
pharyngitis/tonsillitis. Only intramuscular penicillin has been
demonstrated to be effective for the prevention of rheumatic
fever.
Uncomplicated Skin and Skin-Structure
Infections (USSSI) caused by Staphylococcus aureus
(including β-lactamase-producing strains) or Streptococcus
pyogenes
Safety
Information: Spectracef is contraindicated in
patients with a known allergy to the cephalosporin class of
antibiotics or any of its components, and in patients with carnitine
deficiency or inborn errors of metabolism that may result in
clinically significant carnitine deficiency. Spectracef should not
be administered to patients with milk protein (sodium caseinate)
hypersensitivity (not lactose intolerance).
If Spectracef is to be given to
penicillin-sensitive patients, caution should be exercised because
cross-hypersensitivity among β-lactam antibiotics has been clearly
documented and may occur in up to 10 percent of patients with a
history of penicillin allergy.
Side effects experienced by patients
treated with Spectracef are generally mild and self-limiting. The
most commonly reported adverse events in clinical trials were
diarrhea, nausea, vaginal moniliasis (yeast infection), headache,
abdominal pain, dyspepsia, and vomiting.
Pseudomembranous colitis has been
reported with nearly all antibacterial agents, including Spectracef,
and may range in severity from mild to life-threatening. Therefore,
it is important to tell your physician should diarrhea occur during
or after treatment with antibacterial agents such as Spectracef.
For additional information please read
the Spectracef
full prescribing information.
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