Class: Antibiotic, Cephalosporin
- Capsules 400 mg
- Powder for oral suspension 90 mg per 5 mL
- Powder for oral suspension 180 mg per 5 mL
Inhibits mucopeptide synthesis in bacterial cell wall.
C max is 17.9 mcg/mL.Suspension
C max is about 15 mcg/mL. T max is about 2.6 h. AUC is about 73.7 mcg•h/mL.Food Capsules
T max is increased 1.75 h. C max is decreased 18%. AUC is decreased 8%.Suspension
C max is decreased 17% to 26%. AUC is decreased 12% to 17%. Take on an empty stomach.
Vd is about 0.21 L/kg (capsules) and 0.5 L/kg (suspension).
The t ½ is about 2.4 h. Cl is about 1.3 mL/min/kg. About 56% is excreted in the urine and 39% in the feces.
Special PopulationsRenal Function Impairment
The t ½ is increased and Cl decreased. Dosage adjustment is recommended.Elderly
Drug accumulation in the plasma was increased to 40%. Dosage adjustment may be needed.
Indications and Usage
Treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes , otitis media caused by Moraxella catarrhalis , Haemophilus influenzae (including betalactamase-producing strains) or S. pyogenes , and acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae (penicillin-susceptible strains), H. influenzae (including betalactamase-producing strains) or M. catarrhalis (including betalactamase-producing strains).
Hypersensitivity to cephalosporins.
Dosage and AdministrationAdults and Children 12 yr of age and older
PO 400 mg every day for 10 days.Children younger than 12 yr of age
PO 9 mg/kg every day (max 400 mg) for 10 days. Give suspension 2 h before or 1 h after a meal.
Administer oral suspension 2 h before or 1 h after meal.
After mixing, the suspension may be kept for 14 days stored in refrigerator. Keep tightly closed. Shake well before use. Capsules may be stored at room temperature.
None well documented.
Laboratory Test Interactions
May cause false-positive urine glucose test results with Benedict solution, Fehling solution or Clinitest tablets, but not with enzyme-based tests (eg, Clinistix , Test-tape ); false-positive test results for proteinuria with acid and denaturization-precipitation tests; false-positive direct Coombs test results in certain patients (eg, those with azotemia); false elevations in urinary 17-ketosteroid values.
Nausea; vomiting; diarrhea; anorexia; abdominal pain or cramps; flatulence; colitis.
Pyuria; dysuria; renal function impairment; reversible interstitial nephritis; hematuria; toxic nephropathy.
Eosinophilia; neutropenia; lymphocytosis; leukocytosis; thrombocytopenia; decreased platelet function; anemia; aplastic anemia; hemorrhage.
Hepatic function impairment; abnormal LFT results.
Hypersensitivity, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis; serum sickness–like reactions (eg, skin rash, polyarthritis, arthralgia, fever); candidal overgrowth.
MonitorResponse to therapy
Monitor patient's response to therapy. Notify health care provider if infection does not appear to improve or worsens.Adverse reactions
Monitor patient for GI, DERM, and general body adverse reactions, and signs of superinfection. Inform health care provider if noted and significant. Immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.
Category B .
In infants, consider benefits relative to risks. Safety and efficacy in children younger than 6 mo of age not established.
Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-sensitivity.
Use drug with caution in patients with renal function impairment. Dosage adjustment based on renal function may be required.
May result in bacterial or fungal overgrowth on nonsusceptible microorganisms.
Consider possibility in patients in whom diarrhea develops.
A single 400 mg capsule or 9 mg/kg (max, 400 mg) dose may be administered at the end of each hemodialysis session.
- Inform diabetic patients that oral suspension contains 1 g sucrose/teaspoon of suspension.
- Instruct patient to complete full course of therapy.
- Have patient take drug with food or milk to avoid GI upset.
- Notify health care provider if patient has penicillin allergy or cephalosporin allergy.
- Notify health care provider of nausea, vomiting, or diarrhea, especially if severe or contains blood, mucus or pus.
- Remind diabetic patient to use an enzyme-based test for urine glucose or may otherwise obtain a false-positive result.
- Remind patient to check body temperature daily. If fever persists for more than a few days or if high fever (higher than 102°F) or shaking chills are noted, notify health care provider.
- Instruct patient to report signs of superinfection: black “furry” tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
- Instruct patient to seek emergency care if he or she experiences wheezing or difficulty breathing.
Copyright © 2009 Wolters Kluwer Health.
More about ceftibuten
- Other brands: Cedax