Clobac® Powder for Suspension: After reconstitution, Each 5 ml reconstituted suspension contains Cefaclor Monohydrate USP 131.25 mg equivalent to Cefaclor 125 mg.
Clobac® Paediatric Drops: After reconstitution, Each ml reconstituted suspension contains Cefaclor Monohydrate USP 105 mg equivalent to Cefaclor 100 mg.
Cefaclor (Clobac®) is a semisynthetic second-generation oral cephalosporin. It is active against the following organisms *In Vitro*: Aerobes, Gram-positive: *Streptococcus pneumoniae*, *Streptococcus pyogenes* (Group A beta-haemolytic Streptococci) and *Staphylococci*. Aerobes, Gram-negative: *Moraxella catarrhalis*, *Haemophilus influenzae*, *Escherichia coli*, *Proteus mirabilis*, *Klebsiella sp.*, *Citobacter diversus* and *Neisseria gonorrhoeae*. Anaerobes: *Propionibacteria acnes*, *Bacteroides sp.* (excluding *Bacteroides fragilis*), *Peptococci* and *Peptostreptococcus sp.*.
Mode of action:
In vitro tests demonstrate that the bactericidal action of Cefaclor results from inhibition of cell-wall synthesis.
Pharmacokinetics:
Cefaclor is well absorbed after oral administration, whether taken with food or while fasting. The peak concentration achieved is 50-75% and generally appears from 45 to 60 minutes later. About 25% of cefaclor is bound to plasma proteins. Cefaclor is widely distributed in the body with bactericidal concentrations achieved in middle ear fluid, sinus drainage and bronchial secretions. The serum half-life in normal subjects is 0.6 to 0.9 hour. Approximately 60-85% of the medicine is excreted unchanged in the urine.
(a) Otitis media and sinusitis.
(b) Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis.
(c) Skin and soft tissue infections.
(d) Urinary tract infections, including pyelonephritis and cystitis.
Clobac® is administered orally.
Adults: The usual adult dosage is 250 mg every 8 to 12 hours. For bronchitis and pneumonia, the dosage is 250 mg administered 3 times daily. A dosage of 250 mg administered 3 times daily for 10 days is recommended for sinusitis. For more severe infections, such as pneumonia, or those caused by less susceptible organisms doses may be doubled. For mild to moderate infections of the urinary tract, skin and soft tissues, and upper respiratory tract, a dosage of 250 mg administered 2 times daily may be sufficient.
Children: The usual recommended dosage for children is 20 mg/kg/day in divided doses every 8 hours. The recommended dosages of Suspension & Paediatric drops are:
Age.
Recommended dose:
Dosage frequency.
Mild to moderate infections.
Dosage Severe infections.
Over 1 month.
20 mg/kg.
40 mg/kg.
8 hourly.
1 month - 1 year.
62.5 mg.
125 mg.
8 hourly.
1 year - 5 years.
125 mg.
250 mg.
8 hourly.
Over 5 years.
250 mg.
500 mg.
8 hourly.
The maximum dosage for children over one month should not exceed 1gm/day. Safety and efficacy have not been established for use in infants aged less than 1 month.
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.
Overdosage:
The symptoms following an overdose of Cefaclor may include nausea, vomiting, epigastric distress, and diarrhea. The severity of the epigastric distress and diarrhea is dose related. Unless 5 times the normal dose of Cefaclor has been ingested, gastrointestinal lavage will not be necessary.
Caution should be exercised when prescribing for the pregnant or lactating mother.
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.
Store in a cool and dry place, protected from light.