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Medication Safety Issues
Sound-alike/look-alike issues:
Cefaclor may be confused with cephalexin
Pronunciation
(SEF a klor)
U.S. Brand Names
Generic Available
Yes: Excludes chewable tablet
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of susceptible bacterial infections including otitis media, lower respiratory tract infections, acute exacerbations of chronic bronchitis, pharyngitis and tonsillitis, urinary tract infections, skin and skin structure infections
Use: Dental
Alternative antibiotic for treatment of orofacial infections in patients allergic to penicillins; susceptible bacteria including aerobic gram-positive bacteria and anaerobes
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies; therefore, cefaclor is classified as pregnancy category B. It is not known if cefaclor crosses the placenta; other cephalosporins cross the placenta and are considered safe for use during pregnancy. An increased risk of teratogenic effects has not been observed following maternal use of cefaclor.
Lactation
Enters breast milk/use caution
Breast-Feeding Considerations
Small amounts of cefaclor are excreted in breast milk. The manufacturer recommends that caution be exercised when administering cefaclor to nursing women. Nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to cefaclor, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• H. influenzae infections: Beta-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae should be considered resistant to cefaclor.
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
Special populations:
• Pediatrics: Extended release tablets are not approved for use in children <16 years of age.
Dosage form specific issues:
• Phenylalanine: Some products may contain phenylalanine.
Adverse Reactions
1% to 10%:
Dermatologic: Rash (maculopapular, erythematous, or morbilliform) (1% to 2%)
Gastrointestinal: Diarrhea (3%)
Genitourinary: Vaginitis (2%)
Hematologic: Eosinophilia (2%)
Hepatic: Transaminases increased (3%)
Miscellaneous: Moniliasis (2%)
<1%: Agitation, agranulocytosis, anaphylaxis, angioedema, aplastic anemia, arthralgia, cholestatic jaundice, CNS irritability, confusion, dizziness, hallucinations, hemolytic anemia, hepatitis, hyperactivity, insomnia, interstitial nephritis, nausea, nervousness, neutropenia, paresthesia, pruritus, pseudomembranous colitis, PT prolonged, seizure, serum-sickness, somnolence, Stevens-Johnson syndrome, urticaria, thrombocytopenia, toxic epidermal necrolysis, vomiting
Reactions reported with other cephalosporins: Fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, cholestasis
Drug Interactions
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Uricosuric Agents: May decrease the excretion of Cephalosporins. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Cefaclor serum levels may be decreased slightly if taken with food. The bioavailability of cefaclor extended release tablets is decreased 23% and the maximum concentration is decreased 67% when taken on an empty stomach.
Storage
Store at controlled room temperature. Refrigerate suspension after reconstitution. Discard after 14 days. Do not freeze.
Mechanism of Action
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.
Pharmacodynamics/Kinetics
Absorption: Well absorbed, acid stable
Distribution: Widely throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, peritoneal fluids; bile, sputum, and urine; bone, myocardium, gallbladder, skin and soft tissue
Protein binding: 25%
Metabolism: Partially hepatic
Half-life elimination: 0.5-1 hour; prolonged with renal impairment
Time to peak: Capsule: 60 minutes; Suspension: 45 minutes
Excretion: Urine (80% as unchanged drug)
Dosage
Usual dosage range:
Children >1 month: Oral: 20-40 mg/kg/day divided every 8-12 hours (maximum dose: 1 g/day)
Adults: Oral: 250-500 mg every 8 hours
Indication-specific dosing:
Children: Oral:
Otitis media: 40 mg/kg/day divided every 12 hours
Pharyngitis: 20 mg/kg/day divided every 12 hours
Dosing adjustment in renal impairment:
Clcr 10-50 mL/minute: Administer 50% to 100% of dose
Clcr <10 mL/minute: Administer 50% of dose
Hemodialysis: Moderately dialyzable (20% to 50%)
Dental Usual Dosing
Orofacial infections: Adults: Oral: Dosing range: 250-500 mg every 8 hours
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels.
Chewable tablet: Should be chewed before swallowing; should not be swallowed whole.
Oral suspension: Shake well before using.
Monitoring Parameters
Assess patient at beginning and throughout therapy for infection; monitor for signs of anaphylaxis during first dose
Test Interactions
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
Dietary Considerations
Capsule, chewable tablet, and suspension may be taken with or without food. Raniclor™ contains phenylalanine 2.8 mg/cefaclor 125 mg.
Patient Education
Do not take any new medication during therapy unless approved by prescriber. 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. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Complete full course of medication, even if you feel better. May cause false test results with Clinitest®; use of another type of testing is preferable. May cause diarrhea (yogurt, boiled milk, or buttermilk may help). Report rash; breathing or swallowing difficulty; persistent diarrhea, nausea, vomiting, or abdominal pain; changes in urinary pattern or pain on urination; opportunistic infection (eg, vaginal itching or drainage; sores in mouth; blood in stool or urine, vaginal itching or drainage, unusual fever or chills); or CNS changes (eg, irritability, agitation, nervousness, insomnia, hallucinations); or other adverse reactions. Breast-feeding precaution: Consult prescriber if breast-feeding.
Geriatric Considerations
Has not been studied in the elderly. Adjust dose for renal function in elderly. Considered to be one of the drugs of choice in the outpatient treatment of community-acquired pneumonia in elderly.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported (see Dental Comment)
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Dental Comment
Patients allergic to penicillins can use a cephalosporin; the incidence of cross-reactivity between penicillins and cephalosporins is 1% when the allergic reaction to penicillin is delayed. Cefaclor is effective against anaerobic bacteria, but the sensitivity of alpha-hemolytic Streptococcus varies; approximately 10% of strains are resistant. Nearly 70% are intermediately sensitive. If the patient has a history of immediate reaction to penicillin, the incidence of cross-reactivity is 20%; cephalosporins are contraindicated in these patients.
Mental Health: Effects on Mental Status
May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins
Mental Health: Effects on Psychiatric Treatment
May rarely cause neutropenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess other pharmacological or herbal products patient may be taking for potential interactions (eg, nephrotoxicity). Assess results of laboratory tests, therapeutic effectiveness, and adverse effects (hypersensitivity can occur days after therapy is started) regularly during therapy. Advise patients with diabetes about use of Clinitest®. Teach patient proper use, possible side effects/appropriate interventions, and adverse symptoms to report (eg, hypersensitivity, opportunistic infection).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule: 250 mg, 500 mg
Powder for oral suspension: 125 mg/5 mL (75 mL, 150 mL); 250 mg/5 mL (75 mL, 150 mL); 375 mg/5 mL (50 mL, 100 mL)
Tablet, chewable:
Raniclor™: 250 mg [contains phenylalanine 5.6 mg/tablet and tartrazine; fruity flavor]; 375 mg [contains phenylalanine 8.4 mg/tablet and tartrazine; fruity flavor]
Tablet, extended release: 500 mg
Pricing: U.S. (www.drugstore.com)
Capsules (Ceclor)
250 mg (30): $75.99
500 mg (30): $139.99
Capsules (Cefaclor)
250 mg (30): $37.99
500 mg (30): $41.99
Suspension (reconstituted) (Cefaclor)
125 mg/5 mL (75): $11.99
125 mg/5 mL (150): $18.99
187 mg/5 mL (50): $11.99
187 mg/5 mL (100): $18.99
250 mg/5 mL (75): $16.99
250 mg/5 mL (150): $29.99
375 mg/5 mL (50): $22.99
375 mg/5 mL (100): $29.99
Tablet, 12-hour (Cefaclor CR)
500 mg (20): $75.86
References
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.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
Content last modified August 2008
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