Cefaclor

ADMINISTRATION ROUTES:

PO, NG

ALTERNATIVE NAMES:

Ranbaxy-cefaclor

ICU INDICATIONS:

1. Treatment of infections caused by susceptible organisms

Note 1: used on occasion as de-escalation from IV therapy in patients recovering from serious infections in the ICU

Note 2: beta-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains

PRESENTATION AND ADMINISTRATION:

PO/NG:

Ranbaxy-cefaclor capsules 250 mg (purple/white) and Ranbaxy Cefaclor oral suspension 125mg/5 mL (white to off white)

Store at room temperature 15-30°C

Suspension may block nasogastric tubes. Check with ICU Pharmacist

DOSAGE:

PO:

250-500 mg TDS

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:

Dose in renal impairment

Dose in renal replacement therapy

DOSAGE IN PAEDIATRICS:

10-15 mg/kg TDS

CLINICAL PHARMACOLOGY:

Cefaclor is a semisynthetic cephalosporin antibiotic for oral administration. Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food.

In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis. Cefaclor is shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections:

Aerobes, Gram-Positive:

• Staphylococci, including coagulase-positive, coagulase-negative, and penicillinase- producing strains.

• Streptococcus pneumoniae, streptococcus pyogenes

Aerobes, Gram-Negative:

• Escherichia coli
• Haemophilus influenza, excluding beta-lactamase-negative ampicillin-resistant strains
• Klebsiella spp
• Proteus mirabilis.

Note: Pseudomonas sp, Acinetobacter and most strains of enterococci (Enterococcus faecalis), Enterobacter spp, indole-positive Proteus, and Serratia spp are resistant to cefaclor

CONTRAINDICATIONS:

1. Hypersensivity to cephalosporins

WARNINGS:

Anaphylaxis

Cephalosporins are a common cause of anaphylactic reactions and cross reactivity with penicillins may occur

Pseudomembranous colitis

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefaclor, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents

PRECAUTIONS:

General:

Prescribing cefaclor in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. It should be recognised that a positive Coombs' test may be due to the drug.

Laboratory Tests:

No tests additional to usual ICU tests are required

Drug/Laboratory Test Interactions:

May cause a positive Coombs’ test and may cause false positive on some urinary glucose tests

IMPORTANT DRUG INTERACTIONS IN ICU:

None of note

ADVERSE REACTIONS:

Body as a whole:

Hypersensitivity reactions, serum-sickness-like reactions, anaphylaxis

Haemopoietic System:

Positive Coombs' tests, eosinophilia, thrombocytopaenia

Skin:

Pruritus, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis

Cardiovascular System:

Syncope, vasodilation

Gastrointestinal System:

Transient hepatitis and cholestatic jaundice, nausea and vomiting, pseudomembranous colitis, diarrhoea

Respiratory System:

Angioedema, dyspnoea

Genitourinary System:

Genital pruritus and vaginitis, reversible interstitial nephritis

Nervous System:

Paraesthesias

Cephalosporin-Class Adverse Reactions:

In addition to the adverse reactions listed above that have been observed in patients treated with cefaclor, the following reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, haemorrhage, false positive test for urinary glucose, elevated bilirubin, elevated LDH, and pancytopaenia.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated