Healthcare Providers

Safety and Tolerability

Rely on the tolerability and safety of SPECTRACEF¹

In clinical studies, 2675 patients received SPECTRACEF 200 mg BID and 2159 received SPECTRACEF 400 mg BID

Most common adverse events are diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, and vomiting

Most adverse events with SPECTRACEF were mild and self-limiting

≤ 3% of patients discontinued SPECTRACEF due to adverse events

SPECTRACEF has not been commonly associated with tendon rupture, peripheral neuropathy, QT interval prolongation, arrhythmia, or photosensitivity/phototoxicity

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.

Please click here for full prescribing information.

The product information provided in this site is intended only for residents of the United States. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care provider, considering the unique characteristics of the patient.

References

1. SPECTRACEF^® (cefditoren pivoxil) prescribing information, Cornerstone Therapeutics Inc., September 2009.
2. Fritsche TR, Biedenbach DJ, Jones RN. Update of the activity of cefditoren and comparator oral ß-lactam agents tested against community-acquired Streptococcus pneumoniae isolates (USA, 2004-2006). J Chemother. 2008;20:170-174.
3. Biedenbach DJ, Jones RN, Fritsche TR. Antimicrobial activity of cefditoren tested against contemporary (2004–2006) isolates of Haemophilus influenzae and Moraxella catarrhalis responsible for community-acquired respiratory tract infections in the United States. Diagn Microbiol Infect Dis. 2008;61:240-244.
4. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27-S72.
5. Data on file, Cornerstone Therapeutics Inc.
6. van Zyl L, le Roux JG, LaFata JA, et al. Cefditoren pivoxil versus cefpodoxime proxetil for community-acquired pneumonia: results of a multicenter, prospective, randomized, double-blind study. Clin Ther. 2002;24:1840-1853.
7. Gooch W, Marsh D, Stickler T, Hunt B. Cefditoren is safe and effective treatment for streptococcal pharyngitis. Poster presented at: 40th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 17-20, 2000; Toronto, Ontario. Poster 837.