Cefalexin 500mg Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefalexin Capsules 500mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Cefalexin monohydrate equivalent to 500 mg Cefalexin For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard
Size 0 grey/orange capsule containing white powder printed CHX 500.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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: beta-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. It is not active against most strains of enterobacter species, morganella morganii and pr. Vulgaris. It has no activity against pseudomonas or herellea species. When tested by in vitro methods, staphylococci exhibit cross- resistance between cefalexin and methicillin-type antibiotics.
4.2 Posology and method of administration
Adults
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.
Elderly
As for adults. Reduce dosage if renal function is markedly impaired.
Children
The usual 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: 125mg every 8 hours.
Children 5 years and over: 250mg every 8 hours.
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.
Route of administration
Oral
Contraindications
4.3
Cefalexin is contraindicated in patients with known allergy to the cephalosporins group of antibiotics.
Cefalexin should be given cautiously to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial crossallergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both drugs.
Cefalexin is contraindicated in patients with porphyria.
4.4 Special warnings and precautions for use
If an allergic reaction to cefalexin occurs the drug should be discontinued and the patient treated with the appropriate agents. Prolonged use of cefalexin may result in the overgrowth of non-susceptible organisms.
Cefalexin should be administered with caution in the presence of markedly impaired renal function. Careful clinical and laboratory studies should be made because safe dosage may be lower than that usually recommended.
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets.
4.5 Interaction with other medicinal products and other forms of interaction
Probenecid causes reduced excretion of cefalexin, leading to increased plasma concentration.
4.6 Fertility, pregnancy and lactation
Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient.
Usage in nursing mothers: The excretion of cefalexin in human breast milk increased up to 4 hours following a 500mg dose. The drug reached a maximum level of 4 micrograms/ml then decreased gradually and had disappeared 8 hours after administration. Caution should be exercised when cefalexin is administered to a nursing woman.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Gastro-intestinal-nausea, vomiting, dyspepsia, and abdominal pain have occurred.
Diarrhoea has been reported infrequently. It is rarely severe enough to warrant cessation of therapy. Colitis, including rare instances of pseudomembranous colitis, has been reported.
Hypersensitivity - Allergies (in the form of rash, urticaria and angio-oedema), and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been observed. These reactions usually subside upon discontinuation of the drug. Anaphylaxis has also been reported.
Haematological - eosinophilia, neutropenia, thrombocytopenia and positive Coombe’s test have been reported.
Hepatic - slight elevations of AST and ALT have been observed. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.
Miscellaneous - other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis and joint disorder. Reversible interstitial nephritis has been reported rarely.
4.9 Overdose
Symptoms of overdosage may include nausea, vomiting, epigastric distress, diarrhoea and haematuria.
Treatment of overdosage - serum levels can be considerably reduced by haemodialysis or peritoneal dialysis.
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.
Unless 5 - 10 times the normal total daily dose has been ingested, gastrointestinal 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 sequence have been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Cefalexin is bactericidal and has antimicrobial activity similar to that of cephaloridine or cephalothin against both grampositive and gram-negative organisms.
5.2 Pharmacokinetic properties
Cefalexin is almost completely absorbed from the gastro-intestinal tract and produces peak plasma concentrations about 1 hour after administration. A dose of 500 mg produces a mean peak plasma concentration of about 18 micrograms per ml, about the same as the concentration produced by an equal dose of cephaloridine given intramuscularly and greater than that produced by cephalothin. If cefalexin is taken with food there is delayed and slightly reduced absorption and there may be delayed elimination from the plasma. About 10 to 15% of a dose is bound to plasma proteins.
The biological half-life has been reported to range from 0.6 to at least 1.2 hours and this increases with reduced renal function. About 80% or more of a dose is excreted unchanged in the urine in the first 6 hours by glomerular filtration and tubular secretion; urinary concentrations greater than 1 mg per ml have been achieved after a dose of 500 mg. Probenecid delays urinary excretion and has been reported to increase biliary excretion. Cefalexin is widely distributed in the body but does not enter the cerebrospinal fluid in significant quantities unless the meninges are inflamed. It diffuses across the placenta and small quantities are found in the milk of nursing mothers. Therapeutically effective concentrations may be found in the bile.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Magnesium stearate (E 572)
Capsule shell Black iron oxide (E172) Titanium dioxide (E171) Erythrosin (E127)
Quinoline yellow (E104) Gelatin (E 441)
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4
Special precautions for storage
Do not store above 25°C.
Keep the container tightly closed (for bottles). Store in the original package (for blisters).
6.5 Nature and contents of container
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 250pm PVC/20pm 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.
6.6 Special precautions for disposal
No special instructions
7. Marketing Authorisation Holder
Medreich Plc Warwick House Plane Tree Crescent Feltham TW13 7HF
8 MARKETING AUTHORISATION NUMBER(S)
PL 21880/0082
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 05/07/2012
10 DATE OF REVISION OF THE TEXT
12/06/2013