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All about: Ceftibuten

Big Image Pronouncation: (seff-TIE-byoo-ten)
Class: Antibiotic, Cephalosporin

Trade Names:
Cedax
- Capsules 400 mg
- Powder for oral suspension 90 mg per 5 mL
- Powder for oral suspension 180 mg per 5 mL

Mechanism of Action

Pharmacology

Inhibits mucopeptide synthesis in bacterial cell wall.

Pharmacokinetics

Absorption

Capsules

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.

Distribution

Vd is about 0.21 L/kg (capsules) and 0.5 L/kg (suspension).

Elimination

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 Populations

Renal 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).

Contraindications

Hypersensitivity to cephalosporins.

Dosage and Administration

Adults 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.

General Advice

Administer oral suspension 2 h before or 1 h after meal.

Storage/Stability

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.

Drug Interactions

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.

Adverse Reactions

GI

Nausea; vomiting; diarrhea; anorexia; abdominal pain or cramps; flatulence; colitis.

Genitourinary

Pyuria; dysuria; renal function impairment; reversible interstitial nephritis; hematuria; toxic nephropathy.

Hematologic

Eosinophilia; neutropenia; lymphocytosis; leukocytosis; thrombocytopenia; decreased platelet function; anemia; aplastic anemia; hemorrhage.

Hepatic

Hepatic function impairment; abnormal LFT results.

Miscellaneous

Hypersensitivity, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis; serum sickness–like reactions (eg, skin rash, polyarthritis, arthralgia, fever); candidal overgrowth.

Precautions

Monitor

Response 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.


Pregnancy

Category B .

Lactation

Undetermined.

Children

In infants, consider benefits relative to risks. Safety and efficacy in children younger than 6 mo of age not established.

Hypersensitivity

Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-sensitivity.

Renal Function

Use drug with caution in patients with renal function impairment. Dosage adjustment based on renal function may be required.

Superinfection

May result in bacterial or fungal overgrowth on nonsusceptible microorganisms.

Pseudomembranous colitis

Consider possibility in patients in whom diarrhea develops.

Hemodialysis patients

A single 400 mg capsule or 9 mg/kg (max, 400 mg) dose may be administered at the end of each hemodialysis session.

Overdosage

Symptoms

Seizures.

Patient Information

  • 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.

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