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a third-generation cephalosporin antibiotic used in treatment of bronchitis, pharyngitis, tonsillitis, and acute otitis media; administered orally.



Pharmacologic class: Third-generation cephalosporin

Therapeutic class: Anti-infective

Pregnancy risk category B


Interferes with bacterial cell-wall synthesis and division by binding to cell wall, causing cell to die. Active against gram-negative and gram-positive bacteria, with expanded activity against gram-negative bacteria. Exhibits minimal immunosuppressant activity.


Capsules: 400 mg

Oral suspension: 90 mg/5 ml

Indications and dosages

Acute bacterial exacerbations of chronic bronchitis caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae; pharyngitis and tonsillitis caused by Streptococcus pyogenes; acute bacterial otitis media caused by H. influenzae, M. catarrhalis, and S. pyogenes
Adults and children ages 12 and older: 400 mg P.O. q 24 hours for 10 days
Children ages 12 and younger: 9 mg/kg P.O. daily for 10 days. Maximum dosage shouldn't exceed 400 mg daily.

Dosage adjustment

• Renal impairment

Off-label uses

• Urinary tract infections


• Hypersensitivity to cephalosporins and penicillins


Use cautiously in:

• renal impairment, hepatic disease, biliary obstruction, phenylketonuria

• history of GI disease

• elderly patients

• pregnant or breastfeeding patients

• children.


• Obtain specimens for culture and sensitivity testing as necessary before starting therapy.

• Give oral suspension at least 1 hour before or 2 hours after a meal.

Adverse reactions

CNS: headache, lethargy, paresthesia, syncope, seizures

CV: hypotension, palpitations, chest pain, vasodilation

EENT: hearing loss

GI: nausea, vomiting, diarrhea, abdominal cramps, oral candidiasis, pseudomembranous colitis

GU: vaginal candidiasis, nephrotoxicity

Hematologic: lymphocytosis, eosinophilia, bleeding tendency, hemolytic anemia, hypoprothrombinemia, neutropenia, thrombocytopenia, agranulocytosis, bone marrow depression

Hepatic: hepatic failure, hepatomegaly

Musculoskeletal: arthralgia

Respiratory: dyspnea

Skin: urticaria, easy bruising, maculopapular or erythematous rash

Other: chills, fever, superinfection, anaphylaxis, serum sickness


Drug-drug. Aminoglycosides, loop diuretics: increased risk of nephrotoxicity

Probenecid: decreased excretion and increased blood level of ceftibuten

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, eosinophils, gamma-glutamyltransferase, lactate dehydrogenase: increased levels
Coombs' test, urinary 17-ketosteroids, nonenzyme-based urine glucose tests (such as Clinitest): false-positive results

Hemoglobin, platelets, white blood cells: decreased values

Drug-herbs. Angelica, anise, arnica, asafetida, bogbean, boldo, celery, chamomile, clove, danshen, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, horse chestnut, horseradish, licorice, meadowsweet, onion, papain, passionflower, poplar, prickly ash, quassia, red clover, turmeric, wild carrot, wild lettuce, willow: increased risk of bleeding

Patient monitoring

• Assess CBC and kidney and liver function test results.

• Monitor for signs and symptoms of superinfection and other serious adverse reactions.

• Be aware that cross-sensitivity to penicillins may occur.

Patient teaching

• Instruct patient to take oral suspension at least 1 hour before or 2 hours after a meal.

• Inform diabetic patient that oral suspension contains 1 g sucrose per teaspoon.

• Advise patient to continue to take full amount prescribed even when he feels better.

• Tell patient to report signs and symptoms of allergic response and other adverse reactions, such as rash, easy bruising, bleeding, severe GI problems, or difficulty breathing.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.


/cef·ti·bu·ten/ (sef-ti´bu-ten) a third-generation cephalosporin used in treatment of bronchitis, pharyngitis, tonsillitis, and otitis media.


A broad-spectrum cephalosporin antibiotic, C15H14N4O6S2, used primarily to treat ear and respiratory infections.


an oral third-generation cephalosporin.
indications It is prescribed in the treatment of chronic bronchitis, acute bacterial otitis media, pharyngitis, and tonsillitis.
contraindications It should not be given to children with abdominal pain, vomiting, and diarrhea.
adverse effects The side effects most often reported include nausea, headache, diarrhea, dyspepsia, dizziness, and abdominal pain.


Cedax® A once-daily broad-spectrum cephalosporin used for acute bacterial otitis media, acute bacterial exacerbation of chronic bronchitis, pharyngitis/tonsillitis. See Cephalosporin.
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References in periodicals archive ?
Given the need for additional oral antibiotic options for infections due to ESBL-producing Enterobacteriaceae, we plan to pursue a 505(b)(2) development pathway to take advantage of the development studies performed on ceftibuten and clavulanate, the two previously approved component drugs of C-Scape.
Group 1 Group 2 Group 3 (Related side chains) (Related side chains) (Unique side chains) Amoxicillin Cefepime Cefazolin Ampicillin Cefotaxime Cefdinir Cefaclor Cefpodoxime Cefixime Cefadroxil Ceftriaxone Cefotetan Cefprozil Ceftazidime Cephalexin Ceftibuten Penicillin Cefuroxime Source: Dr.
DENVER--Acute sinusitis symptoms and quality of life improved equally well in 11 patients treated with the third-generation cephalosporin ceftibuten and in 20 patients given the less expensive antibiotics amoxicillin or trimethoprim-sulfamethoxazole, Dr.
Because National Committee for Clinical Laboratory Standards (NCCLS)-approved breakpoints are lacking for the six other cephalosporins examined in this study (cefpodoxime, cefixime, ceftibuten, cefprozil, cefaclor, and loracarbef), rates of resistance were not determined for these drugs.
Third-generation cephalosporins include cefixime and ceftibuten.
Neither cefixime nor ceftibuten has enough coverage for susceptible or resistant S.
TABLE 4 Compliance-Enhancing Ranking of Antibiotic Suspensions STRONGLY COMPLIANCE-ENHANCING * Amoxicillin * Cefdinir (Omnicef) * Loracarbef (Lorabid) * Cefaclor (Ceclor) * Cefixime (Suprax) MODERATELY COMPLIANCE-ENHANCING * Cefprozil (Cefzil) * Ceftibuten (Cedax) EQUIVOCAL COMPLIANCE-ENHANCING * Azithromycin (Zithromax) NOT COMPLIANCE-ENHANCING * Amoxicillin-clavulanate (Augmentin) * Erythromycin-sulfasoxazole (Pediazole) * TMP-SMX (Bactrim or Septra) DISCOURAGES COMPLIANCE * Cefpodoxime (Vantin) * Cefuroxime (Ceftin) * Clarithromycin (Biaxin) TMP-SMX, trimethoprim sulfamethoxazole Sources: Adapted from Steele RW, et al.
If the first-line drug resistance is high in your area, consider an oral third- generation cephalosporin, such as ceftibuten (Cedax) or cefixime (Suprax).
A total of 4,782 children were randomized to treatment with 10 days of penicillin, or 5 days of amoxicillin and potassium clavulanate (Augmentin), ceftibuten (Cedax), cefuroxime axetil (Ceftin), loracarbef (Lorabid), clarithromycin (Biaxin), or erythromycin.
There are rare errors, such as listing ceftibuten (Cedax) suspension as 90 and 180 mg per mL rather than per 5 mL.
STUDY DESIGN AND VALIDITY This was a randomized open-label design in which patients were randomized to either 10 days of penicillin V (50,000 IU/kg/day with a maximum of 2,250,000 IU/day) or 5 days of one of the following: amoxicillin clavulanate, ceftibuten, cefuroxime axetil, loracarbef, clarithromycin, or erythromycin estolate.