Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
Cefalexin is a semi synthetic cephalosporin antibiotic for oral administration.
Cefalexin is indicated in the treatment of the following infections due to susceptible micro-organisms:
Respiratory tract infections.
Otitis media.
Skin and soft tissue infections.
Bone and joint infections.
Genito-urinary infections, including acute prostatitis.
Dental infections.
Cefalexin is active against the following organisms in vitro: β-haemolytic streptococci; staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains; Streptococcus pneumoniae; Escherichia coli; Proteus mirabilis; Klebsiella species, Haemophilus influenzae; Branhamella catarrhalis.
Most strains of enterococci (Streptococcus faecalis) and a few strains of staphylococci are resistant to cefalexin. Cefalexin is inactive against most strains of enterobacter, morganella morganii, pr. Vulgaris, Colstridium difficule, and the following species: legionella, campylobacter, pseudomonas or herellea species. When tested by in vitro methods, staphylococci exhibit cross-resistance between cefalexin and methicillin-type antibiotics.
The adult dosage ranges from 1-4 g daily in divided doses; most infections will respond to a dosage of 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the usual dosage is 250 mg every 6 hours, or 500 mg every 12 hours.
For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cefalexin greater than 4g are required parenteral cephalosporins, in appropriate doses, should be considered.
As for adults although dosage should be reduced to a daily maximum of 500mg if renal function is severely impaired (glomerular filtration rate <10ml/min) (see section 4.4).
The recommended daily dosage for children is 25-50mg/kg (10-20mg/lb) in divided doses. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours. For most infections the following schedule is suggested:
Children under 5 years:
In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75-100mg/kg/day in 4 divided doses is required.
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.
For oral use.
Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhoea and haematuria.
In the event of severe overdosage, general supportive care is recommended including close clinical and laboratory monitoring of haematological, renal and hepatic functions and coagulation status until the patient is stable. Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion have not been established as beneficial for an overdose of cefalexin. It would be extremely unlikely that one of these procedures would be indicated.
Unless 5-10 times the normal total daily dose has been ingested, gastro-intestinal decontamination should not be necessary.
There have been reports of haematuria without impairment of renal function in children accidentally ingesting more than 3.5g of cefalexin in a day. Treatment has been supportive (fluids) and no sequelae have been reported.
36 months.
Do not store above 25°C.
Keep the container tightly closed (for bottles).
Store in the original package (for blisters).
Each container consists of a polypropylene tubular container with an open end equipped to accept a polyethylene closure, with a tamper-evident tear strip, or PVC/aluminium blisters, or PVDC coated PVC/ Aluminium blisters (60g/m² PVDC on 250μm PVC/20μm Al) of an appropriate size to accomodate 7, 14, 20, 21, 28, 30, 50, 56, 60, 100, or 500 capsules. Not all pack sizes may be marketed.
No special instructions.
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