Spectracef ^® (cefditoren pivoxil) tablets

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Mild to moderate infections of the skin, throat and respiratory tract are common conditions that require a trusted solution. Spectracef ^® is indicated to treat patients 12 years of age or older with infections caused by susceptible strains of microorganisms in the conditions listed below:

• Acute bacterial exacerbation of chronic bronchitis (ABECB) caused by Haemophilus influenzae (including ß-lactamase–producing strains), Haemophilus parainfluenzae (including ß-lactamase–producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-lactamase–producing strains).

• Community-acquired pneumonia (CAP) caused by Haemophilus influenzae (including ß-lactamase–producing strains), Haemophilus parainfluenzae (including ß-lactamase–producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-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 ß-lactamase–producing strains) or Streptococcus pyogenes .

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Spectracef and other antibacterial drugs, Spectracef should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Spectracef is available in a convenient patient-friendly dose pack.

In clinical studies, Spectracef was well-tolerated with low discontinuation rates.

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Important Safety Information

SPECTRACEF is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components. SPECTRACEF is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of SPECTRACEF causes renal excretion of carnitine. SPECTRACEF tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered SPECTRACEF.

BEFORE THERAPY WITH SPECTRACEF (CEFDITOREN PIVOXIL) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDITOREN PIVOXIL, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDITOREN PIVOXIL IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG ß-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFDITOREN PIVOXIL OCCURS, THE DRUG SHOULD BE DISCONTINUED. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefditoren pivoxil, 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 normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile (C. difficile) is a primary cause of antibiotic-associated colitis.

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation 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 C. difficile colitis.

SPECTRACEF is not recommended when prolonged antibiotic treatment is necessary, since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months. As with other antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Cephalosporins may be associated with a fall in prothrombin activity.

It is not recommended that cefditoren pivoxil be taken concomitantly with antacids or with H₂-receptor antagonists because these medications alter the absorption of SPECTRACEF.

In clinical trials with SPECTRACEF, treatment-related adverse events occurring in ≥ 1% of patients with cefditoren pivoxil 200 mg or 400 mg BID were diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.