Cefalexin 500mg Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefalexin 500mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg of cefalexin.
3. PHARMACEUTICAL FORM
Capsule, hard.
Size 0, grey/orange capsule containing white powder printed CHX 500 and a twin triangle logo.
For excipients, see section 6.1.
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 meticillin-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 4 g 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 25-50 mg/kg (10-20 mg/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: 125 mg every 8 hours.
Children 5 years and over: 250 mg 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 75-100 mg/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.
4.3. Contraindications
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.
Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics. It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken.
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets.
Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. It should be recognised that a positive Coombs’ test may be due to the drug in haematological studies, or in transfusion crossmatching procedures when antiglobulin tests are performed on the minor side, or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorbtion should not take this medicine.
4.5. Interactions with other medicinal products and other forms of interaction
Probenecid causes reduced excretion of cefalexin, leading to increased plasma concentration.
4.6. 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.
Effects on ability to drive and use machines
4.7.
Not applicable.
4.8 Undesirable effects
Gastro-intestinal - symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. The most frequent side-effect has been diarrhoea. It was very rarely severe enough to warrant cessation of therapy. Dyspepsia and abdominal pain have also occurred - see section 4.4.
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, haemolytic anaemia and positive Coombs’ test have been reported, see section 4.4.
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 sequelae 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 gram-positive 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 pg 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.
6.1. List of excipients
Lactose monohydrate Magnesium stearate
Capsule shell:
Black iron oxide E172 Titanium dioxide E171 Erythrosine E127 Quinoline yellow E104 Gelatin
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store in a cool dry place not exceeding 25°C.
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 accommodate 7, 14, 20, 21, 28, 30, 50, 56, 60, 100 or 500 capsules.
6.6. Instruction for use and handling
No special instructions.
MARKETING AUTHORISATION HOLDER
7
PLIVA Pharma Limited Vision House Bedford Road Petersfield
Hampshire GU32 3QB United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 10622/0207
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15 April 2004
10 DATE OF REVISION OF THE TEXT
09/12/2008