No

Antibiotic, Cephalosporin (Second Generation)

Dental: An alternate antibiotic to treat orofacial infections in patients allergic to penicillins; susceptible bacteria including aerobic gram-positive bacteria and anaerobes

Medical: Infections caused by susceptible organisms including Staphylococcus aureus and H. influenzae; treatment of otitis media, sinusitis, and infections involving the respiratory tract, skin and skin structure, bone and joint, and urinary tract

B

Hypersensitivity to cefaclor, any component, or cephalosporins

Modify dosage in patients with severe renal impairment; prolonged use may result in superinfection; a low incidence of cross-hypersensitivity to penicillins exists

1% to 10%:

Gastrointestinal: Diarrhea (1.5%)

Hematologic: Eosinophilia (2%)

Hepatic: Elevated transaminases (2.5%)

Dermatologic: Rash (maculopapular, erythematous, or morbilliform) (1% to 1.5%)

<1%: Anaphylaxis, urticaria, pruritus, angioedema, serum-sickness, arthralgia, hepatitis, cholestatic jaundice, Stevens-Johnson syndrome, nausea, vomiting, pseudomembranous colitis, vaginitis, hemolytic anemia, neutropenia, interstitial nephritis, CNS irritability, hyperactivity, agitation, nervousness, insomnia, confusion, dizziness, hallucinations, somnolence, seizures, prolonged PT

Reactions reported with other cephalosporins include fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, cholestasis

After acute overdose, most agents cause only nausea, vomiting, and diarrhea, although neuromuscular hypersensitivity and seizures are possible, especially in patients with renal insufficiency; many beta-lactam antibiotics have the potential to cause neuromuscular hyperirritability or seizures

Hemodialysis may be helpful to aid in the removal of the drug from the blood but not usually indicated, otherwise most treatment is supportive or symptom directed following GI decontamination

Increased effect: Probenecid may decrease cephalosporin elimination

Increased toxicity: Furosemide, aminoglycosides may be a possible additive to nephrotoxicity

Refrigerate suspension after reconstitution; discard after 14 days; do not freeze

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Absorption: Oral: Well absorbed, acid stable

Distribution: Widely distributed throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, and peritoneal fluids; also bile, sputum, and urine; also bone, myocardium, gallbladder, skin and soft tissue; crosses the placenta and appears in breast milk

Protein binding: 25%

Metabolism: Partially

Half-life: 0.5-1 hour, prolonged with renal impairment

Time to peak: Capsule: 60 minutes; Suspension: 45 minutes

Elimination: 80% excreted unchanged in urine

Oral:

Adults: 250-500 mg every 8 hours

Extended release tablets: 500 mg every 12 hours for 7 days for acute bacterial exacerbations of or secondary infections with chronic bronchitis or 375 mg every 12 hour for 10 days for pharyngitis or tonsillitis or for uncomplicated skin and skin structure infections

Dosing adjustment in renal impairment: Cl_cr <50 mL/minute: Administer 50% of dose

Hemodialysis: Moderately dialyzable (20% to 50%)

May be taken with food, however, there is delayed absorption

Assess patient at beginning and throughout therapy for infection; monitor for signs of anaphylaxis during first dose

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction

May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins

May rarely cause neutropenia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Do not chew or crush extended release tablets. Complete full course of medication, even if you feel better. Drink 2-3 L fluid/day. Small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may reduce nausea or vomiting. If diarrhea occurs, yogurt or buttermilk may help. May cause false-positive test with Clinitest®; use another form of testing. May interfere with oral contraceptives; additional contraceptive measures are necessary. Report severe, unresolved diarrhea; vaginal itching or drainage; sores in mouth; blood, pus, or mucus in stool or urine; easy bleeding or bruising; unusual fever or chills; rash; or respiratory difficulty. Breast-feeding precautions: Consult prescriber if breast-feeding.

With prolonged therapy, monitor CBC and stool frequency periodically

Capsule: 250 mg, 500 mg

Powder for oral suspension (strawberry flavor): 125 mg/5 mL (75 mL, 150 mL); 187 mg/5 mL (50 mL, 100 mL); 250 mg/5 mL (75 mL, 150 mL); 375 mg/5 mL (50 mL, 100 mL)

Tablet, extended release: 375 mg, 500 mg

American Thoracic Society, "Guidelines for the Initial Management of Adults With Community-Acquired Pneumonia: Diagnosis, Assessment of Severity, and Initial Antimicrobial Therapy," Am Rev Respir Dis, 1993, 148(5):1418-26.

Boguniewicz M and Leung DYM, "Hypersensitivity Reactions to Antibiotics Commonly Used in Children," Pediatr Infect Dis J, 1995, 14(3):221-31.

Donowitz GR and Mandell GL, "Beta-Lactam Antibiotics," N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500.

Hyslop DL, "Cefaclor Safety Profile: A Ten Year Review," Clin Ther, 1988, 11(Suppl A):83-94.

Levine LR, "Quantitative Comparison of Adverse Reactions to Cefaclor vs Amoxicillin in a Surveillance Study," Pediatr Infect Dis, 1985, 4(4):358-61.

Marshall WF and Blair JE, "The Cephalosporins," Mayo Clin Proc, 1999, 74(2):187-95.

Saxon A, Beall GN, Rohr AS, et al, "Immediate Hypersensitivity Reactions to Beta-Lactam Antibiotics," Ann Intern Med, 1987, 107(2):204-15.

Smith GH, "Oral Cephalosporins in Perspective," DICP, 1990, 24(1):45-51.

Wright AJ, "The Penicillins," Mayo Clin Proc, 1999, 74(3):290-307.