1 tablet 250mg

25 cents

Ranbaxy-cefaclor

  • 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.

PO/NG:
Ranbaxy-cefaclor capsules 250mg (purple/white) and Ranbaxy Cefaclor oral suspension 125mg/5ml (white to off white)
Store at room temperature, 15-30°C
Suspension may block nasogastric tubes. Check with Pharmacist.


ADULT DOSE
PO/NG:
250-500mg 8 hourly

PAEDIATRIC DOSE
10-15mg/kg 8 hourly

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY
Dose in renal impairment [GFR (ml/min)]
<10 250mg every 8 hours
10-20 dose as in normal renal function
>20-50 dose as in normal renal function

Dose in renal replacement therapy
CAPD 250mg every 8 hours
HD 500mg every 8 hours
CVVHDF dose as in normal renal function

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 microorgansims, 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:

  • 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 Ceclor 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 recognized 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

Body as a whole:
Hypersensitivity reactions, serum-sickness-like reactions, anaphylaxis
Haemopoietic System:
Positive Coombs' tests, eosinophilia, thrombocytopenia
Skin:
Pruritus, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis
Cardiovascular System:
Syncope, or vasodilation
Gastrointestinal System:
Transient hepatitis and cholestatic jaundice, nausea and vomiting, pseudomembranous colitis, diarrhoea
Respiratory System:
Angioedema, dyspnea
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 adverse 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 pancytopenia.
Several cephalosporins have been implicated in triggering seizures, paticularly 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

[an error occurred while processing this directive]