Adult Dosing

Treatment of acute otitis media, pharyngitis and tonsillitis, or acute exacerbations of chronic bronchitis

• 400 mg PO qd x 10 days

• Administer drug 1 hr before or 2 hrs after meals
• Has also been used for UTI's (not FDA approved)

Pediatric Dosing

Acute otitis media, pharyngitis and tonsillitis, or acute exacerbations of chronic bronchitis

Child 12 yrs

• 400 mg PO qd x 10 days

Child (6 mo-12 yrs)

• CAPS: 9 mg/kg PO qd x 10 days. Max: 400 mg/day
• ORAL SUSP: Based on weight
• 10 kg(22 lbs): 90 mg (1 tsp) PO qd
• 20 kg(44 lbs): 180 mg (2 tsp) PO qd
• 40 kg(88 lbs): 360 mg (4 tsp) PO qd
• >45 kg: 400 mg PO qd

• Administer drug 1 hr before or 2 hrs after meals
• Has also been used for UTI's (not FDA approved). Some evidence supports a 5-6 day course of therapy in pediatric otitis media if 6 yrs of age

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acute otitis media, pharyngitis and tonsillitis, or acute exacerbations of chronic bronchitis

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment (Based on CrCl)

Adults

• >50 mL/min: 400 mg PO qd
• 30-49 mL/min: 200 mg PO qd
• 5-29 mL/min: 100 mg PO qd
• <5 mL/min: Not defined
• Hemodialysis: 400 mg PO after each dialysis

Child

• >50 mL/min: 9 mg/kg PO qd
• 30-49 mL/min: 4.5 mg/kg PO qd
• 5-29 mL/min: 2.25 mg/kg PO qd
• <5 mL/min: Not defined
• Hemodialysis: 9 mg/kg PO (Max: 400 mg) after each dialylsis

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Prior to initiating therapy determine whether the patient has had previous hypersensitivity reactions to ceftibuten, cephalosporins, penicillins, or other drugs
• Cautiously administer in penicillin sensitive patients as cross sensitivity may occur
• Suspend therapy on occurrence of an allergic reaction and treat accordingly if serious acute hypersensitivity takes place
• Clostridium difficile associated diarrhea which may vary in severity from mild to fatal colitis, has been reported with use of cefadroxil
• Careful clinical observation and appropriate laboratory studies should be made prior to and during therapy in patients with known or suspected renal impairment
• Use of therapy in strongly suspected bacterial infection or a prophylactic indication may increase the risk of the development of drug-resistant bacteria
• Careful observation is needed in prolonged use of therapy because prolonged use may result in the overgrowth of non-susceptible organism. Appropriate measures should be taken if superinfection occurs during therapy
• Administer cautiously in patients with hx of GI disease particularly colitis

Cautions: Use cautiously in

• Renal impairment
• Penicillin-sensitive patients
• Allergic reactions
• Hypersensitivity
• Diabetes
• History of GI disease, especially colitis

Pregnancy Category:B

Breastfeeding: Limited information indicates that maternal doses of ceftibuten up to 200 mg produce low levels in milk that are not expected to cause adverse effects in breastfed infants. This drug is compatible and considered safe with breastfeeding based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 January 2011). Manufacturer advises caution.

• CNS: Seizures, headache, dizziness
• GI: Nausea, vomiting, diarrhea, dyspepsia, pseudomembranous colitis, cholestasis, elevated liver transaminases, abdominal pain, elevated bilirubin
• HEMA: Pancytopenia, hemolytic anemia, hemorrhage, elevated BUN, eosinophilia, decreased Hb count
• GU: Interstitial nephritis
• DERM: Urticaria, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme
• MISC: Anaphylaxis, serum sickness like reaction, superinfection

• Third generation cephalosporin; it binds to the bacterial cell wall membrane, causing cell death
• Well absorbed after oral administration
• Metabolism: Others; CYP450: unknown
• 56% excreted in urine; 39% in feces
• Half-life:
• Normal: 2-2.5 hrs
• CrCl 30-49 mL/min: 7.1 hrs
• CrCl 5-29 mL/min: 13.4 hrs
• CrCl < 5 mL/min: 22.3 hrs

US Trade Name(s)

• Cedax

US Availability

Cedax

• CAPS: 400 mg
• ORAL SUSP: 90 mg/5 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antibiotics

Cephalosporins; Third Generation

Infectious Disease

Antibiotics

Cephalosporins; Third Generation

Pricing data from www.DrugStore.com in U.S.A.

• Cedax 400 MG CAPS [Bottle] (PERNIX THERAPEUTICS)
  20 mg = $299.99
  60 mg = $859.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Cedax 400 MG Oral Capsule

Ingredient(s): Ceftibuten

Imprint: CEDAX;400;mg

Color(s): White

Shape: Capsule

Size (mm): 0.00

Score: 1

Inactive Ingredient(s): gelatin / sodium lauryl sulfate / titanium dioxide / polysorbate 80 / benzyl alcohol / sodium propionate / edetate calcium disodium / butylparaben / propylparaben / methylparaben

Drug Label Author:
Sciele Pharma, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Cedax 400 MG Oral Capsule

Ingredient(s): Ceftibuten

Imprint: Cedax;400mg

Color(s): White

Shape: Capsule

Size (mm): 22.00

Score: 1

Inactive Ingredient(s): benzyl alcohol / butylparaben / edetate calcium disodium / gelatin / magnesium stearate / methylparaben / cellulose, microcrystalline / polysorbate 80 / propylparaben / sodium lauryl sulfate / sodium propionate / sodium starch glycolate type a potato / titanium dioxide

Drug Label Author:
Shionogi USA, Inc.

DEA Schedule:
Non-Scheduled