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Product Name
OMNICLOR (dry powder)
Chemical Name
Therapeutic Category
Pharmacologic Category
Antibiotic, Cephalosporin (Second Generation)
Pharmaceutical Form
Dry powder
Cefaclor 125mg / 250mg
Monitoring Parameters
Dosing: Adult
Treatment of infections: Oral: Dosing range: 250-500 mg every 8 hours

Dosing: Pediatric

Treatment of infections: Oral: Children >1 month: Dosing range: 20-40 mg/kg/day divided every 8-12 hours; maximum dose: 1 g/day
Otitis media: Oral: 40 mg/kg/day divided every 12 hours
Pharyngitis: Oral: 20 mg/kg/day divided every 12 hours

Dosing: Geriatric

Refer to adult dosing.

Dosing: 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%)
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
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% (Limited to important or life-threatening): 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, PT prolonged, pruritus, pseudomembranous colitis, seizure, serum-sickness, somnolence, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, urticaria, vomiting
Reactions reported with other cephalosporins: Abdominal pain, cholestasis, fever, hemorrhage, renal dysfunction, superinfection, toxic nephropathy
Hypersensitivity to cefaclor, any component of the formulation, or other cephalosporins
Warnings / Precautions Drug
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.
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
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.
Pregnancy Implications
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.
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.
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)
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