Brands of Cefaclor in Kenya
Ceclor®, Eli Lilly
Cefclor®, Unicorn
Clofort®, Isis Pharmaceuticals
Cosclor®, Cosmos Limited
Labclor®, Laboratory & Allied
Halocef®, Aristo
Vercef®, Sun Pharmaceutical Industries Limited
Mechanism of Action
As with other cephalosporins, the bactericidal action of cefaclor results from inhibition of cell-wall synthesis.
Mechanism of Resistance
Resistance to cefaclor is primarily through hydrolysis of beta-lactamases, alteration of penicillin binding proteins (PBPs) and decreased permeability. Pseudomonas spp., Acinetobacter calcoaceticus and most strains of Enterococi (Enterococcus faecalis, group D streptococci), Enterobacter spp., indole-positive Proteus, Morganella morganii (formerly Proteus morganii), Providencia rettgeri (formerly Proteus rettgeri) and Serratia spp. are resistant to cefaclor. Cefaclor is inactive against methicillin-resistant staphylococci, β lactamase-negative, ampicillin-resistant strains of H. influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility to this agent.
INDICATIONS
Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes
Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
DOSAGE AND ADMINISTRATION
Cefaclor is administered orally.
Adults–The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.
Pediatric patients–The usual recommended daily dosage for children is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
Cefaclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
DRUG INTERACTIONS
There have been rare reports of increased prothrombin time, with or without clinical bleeding, in patients receiving cefaclor and warfarin concomitantly. It is recommended that in such patients, regular monitoring of prothrombin time should be considered, with adjustment of dosage if necessary.
The renal excretion of cefaclor is inhibited by probenecid.
ADVERSE REACTIONS
Gastro-intestinal: The most frequent side-effect has been diarrhoea. It is rarely severe enough to warrant cessation of therapy. Colitis, including rare instances of pseudomembranous colitis, has been reported. Nausea and vomiting have also occurred.
Hypersensitivity: Allergic reactions such as morbilliform eruptions, pruritus and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness-like reactions (erythema multiforme minor, rashes or other skin manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported. Lymphadenopathy and proteinuria are infrequent, there are no circulating immune complexes and no evidence of sequelae. Occasionally, solitary symptoms may occur, but do not represent a serum sickness-like reaction. Serum sickness-like reactions are apparently due to hypersensitivity and have usually occurred during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and usually subside within a few days of cessation of therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome. No serious sequelae have been reported.
There are rare reports of erythema multiforme major (Stevens-Johnson syndrome), toxic epidermal necrolysis, and anaphylaxis. Anaphylaxis may be more common in patients with a history of penicillin allergy. Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, or vasodilatation.
Rarely, hypersensitivity symptoms may persist for several months.
Haematological: Eosinophilia, positive Coombs’ tests and, rarely, thrombocytopenia. Transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance. See ‘Interactions with other Medicaments and other forms of Interaction’.
Hepatic: Transient hepatitis and cholestatic jaundice have been reported rarely, slight elevations in AST, ALT or alkaline phosphatase values.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Miscellaneous: Genital pruritus, vaginitis and vaginal moniliasis.
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:
Cefaclor in Kenya
Cefaclor in Kenya
Cefaclor in Kenya
Cefaclor in Kenya
Cefaclor in Kenya
Cefaclor in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: B (No risk in non-human studies)
Routes of Administration: Oral
Bioavailability: Well absorbed, independent of food intake
Protein Binding: Not Available
Metabolosim: 15% to 40%
Onset of Action: N/A
Elimination Half life: 0.6 to 0.9 hours
Excretion: Renal
Legal Status | Dosage forms & Strengths
Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
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Drug Images
References/ Citation:
- PPB Drugs Retention Register
- Murray, Dennis L., et al. “Cefaclor—a cluster of adverse reactions.” New England Journal of Medicine 303.17 (1980).
- Disney, F. A., et al. “The use of cefaclor in the treatment of beta-haemolytic streptococcal throat infections in children.” Postgraduate medical journal 55 (1979): 50.
- Preston, D. A. “Summary of laboratory studies on the antibacterial activity of cefaclor.” Infection 7.6 (1979): S557-S561.