Spectracef® (cefditoren pivoxil) 200mg Tablets  
Community-Acquired Pneumonia Acute Bacterial Exacerbation of Chronic Bronchitis Pharyngitis/Tonsilitis Uncomplicated Skin and Skin-Structure Infections
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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

Community-Acquired Pneumonia Acute Bacterial Exacerbation of
Chronic Bronchitis
Pharyngitis/Tonsillitis Uncomplicated Skin
and Skin-Structure
Infections

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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