Cefaclor Monohydrate
Indications
Cefaclor is indicated in the treatment of
the following infections: Otitis media, Lower respiratory tract
infections, including pneumonia, bronchitis and acute exacerbation of
chronic bronchitis, Upper respiratory tract infections, including
pharyngitis and tonsillitis, Urinary tract infections, including
pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis
Pharmacology
Cefaclor is a second generation
cephalosporin antibiotic which has stability against b-lactamase
inactivation and possesses a broad spectrum of activity. Cefaclor is
active against the following organisms in vitro: Alpha and beta
haemolytic Streptococci, Staphylococci; including coagulase-positive,
coagulase negative and penicillinase-producing strains, Streptococcus
pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci),
Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella
species Haemophilus influenzae, including ampicillin-resistant strains.
Cefaclor is generally effective in the eradication of Streptococci from
the nasopharynx.
Dosage
Adult-
- Usual dose: 250 mg 8 hrly.
- Bronchitis & pneumonia: 250 mg tid.
- Sinusitis: 500 mg tid for 10 days.
- Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
- Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.
- Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
- Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
- Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.
Administration
May be taken with or without food.
Interaction
The nephrotoxicity of aminoglycoside
antibiotics such as gentamicin and tobramicin may be enhanced by any
cephalosporin. Therefore, one should be cautious in concomitant use of
these categories of drugs.
Contraindications
Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.
Side Effects
Gastro-intestinal:
Diarrhoea, nausea and vomiting have been reported. Hypersensitivity:
Allergic reactions such as eruptions, pruritis and urticaria have been
observed. These reactions usually subside upon discontinuation of
therapy. Serum sickness like reactions have been reported.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Pregnancy & Lactation
There are no adequate and well-controlled
studies in pregnant women. This drug should be used during pregnancy
only if clearly needed. Small amounts of Cefaclor have been detected in
mother's milk. The effect on nursing infants is not known. Caution
should be exercised when Cefaclor is administered to a nursing woman.
Precautions & Warnings
Cefaclor should be administered with
caution in the presence of markedly impaired renal function. Dosage
adjustments for patients with moderate or severe renal impairment are
not usually required.
Overdose Effects
Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
Therapeutic Class
Second generation Cephalosporins
Storage Conditions
Store in a cool and dry place. Protect from light.