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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.


A trademark for the drug ceftibuten.


a trademark for an oral cephalosporin (ceftibuten).


Ceftibuten, see there.
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References in periodicals archive ?
CEDAX is a patented, third-generation, broad-spectrum oral cephalosporin antibiotic indicated for the treatment of acute bacterial exacerbation of chronic bronchitis, acute bacterial otitis media (infection of the middle ear) and pharyngitis/tonsillitis.
Newman, president and chief executive officer of DJ Pharma, stated: "We are pleased to have acquired the rights to CEDAX and we intend to promote the brand vigorously to potential prescribers.
The company noted that CEDAX would expand DJ Pharma's growing portfolio of prescription pharmaceutical products.
Under terms of the agreement, Schering-Plough will manufacture CEDAX for DJ Pharma.
The product profile of CEDAX is particularly well-suited for children
Because CEDAX tastes good and doesn't have to be given two
approvals of CEDAX, a new cephalosporin antibiotic, and of INTRON A alpha interferon as adjuvant treatment for malignant melanoma.
The growth in net revenues was due primarily to a higher volume of sales of CEDAX, certain generic products and a decrease in Medicaid rebates.
With once-daily dosing, CEDAX will be available in 400 mg capsules for adults and in 9 mg/kg/day oral suspension for children.
Importantly, CEDAX offers physicians and patients an attractive alternative to combat these common respiratory infections in a product that combines effectiveness with ease of use," he added.
Recording higher sales were CLARITIN, EULEXIN, LOSEC, CEDAX and ELOCON.
CEDAX offers once-daily dosing, low side-effects and high activity against common resistant pathogens.