1. Name Of The Medicinal Product
Cefalexin 250mg/5ml Powder for Oral Suspension BP
2. Qualitative And Quantitative Composition
Each 5ml contains Cefalexin 250mg (as Monohydrate) after reconstitution.
For excipients, see 6.1.
3. Pharmaceutical Form
Powder for Oral Suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
Cefalexin is indicated in the treatment of the following infections: Respiratory tract infections; otitis media; skin and soft tissue infections; bone and joint infections; genito-urinary infections, including acute prostatitis and 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 influenza; 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, clostridium difficile, and the following species: legionella, campylobacter, pseudomonas or herellea species.
4.2 Posology And Method Of Administration
Adults
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.
More severe infections, or those caused by less susceptible organisms may need larger doses.
If daily doses greater than 4g are required other parenteral cephalosporins, in appropriate doses, should be considered.
Elderly
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).
Children
The recommended daily dosage for children is 25
In the case of skin, 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 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.
Clinical studies have shown that for otitis media a dosage of 75-100 mg/kg/day is required, in four divided doses.
In the treatment of ß-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.
Route of administration
Oral
4.3 Contraindications
Cefalexin is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics or in patients with acute 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
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.
Positive direct Coombe's test have been reported during treatment with cephalosporins, during transfusions, cross-matching or haematological studies when antihaemoglobin tests are performed on the minor side, or in Coombe's testing of new-borns whose mothers received cephalosporins. It should be noted that the positive Coombe's test may be due to Cefalexin.
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
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 cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both drugs.
Probenecid causes reduced excretion of cefalexin leading to increased plasma concentrations. Cephalosporins may have an increased risk of nephrotoxicity in the presence of amphotericin, loop diuretics, aminoglycosides, capreomycin or vancomycin.
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. Low concentrations of Cefalexin are excreted in the breast milk.
Following a 500mg dose, levels of 4 micrograms/ml were detected up to 4 hours after administration. No drug being detected after 8 hours. Cefalexin should be given to the nursing mother with caution, possible effects to the infant include modification of bowel flora.
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. The most frequent side effect has been diarrhoea. It is rarely severe enough to warrant cessation of therapy. As with other broad spectrum antibiotics, there have been reports of pseudomembranous colitis, especially with higher doses. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Such colitis may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, appropriate measures should be taken.
Hypersensitivity: Allergies (in the form of rash, urticaria and angio-oedema) have been observed and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. 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: As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. Slight elevations of AST and ALT have been observed.
Miscellaneous: Other reactions have included genital and anal pruritis, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, fever, arthralgia, arthritis and joint disorder. Reversible interstitial nephritis has been reported.
4.9 Overdose
Symptoms of overdosage may include nausea, vomiting, epigastric distress 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, 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.
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 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
None
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium Benzoate (E211)
Disodium Edetate
Citric Acid (Anhydrous)
Sodium Citrate
Sorbitol Powder
Saccharin Sodium
Capsaroma Orange DC 100pH flavour
Colloidal Silicon Dioxide
Monoammunium Glycerrhyzinate
Quinoline Yellow (E104)
Xantham Gum
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
Dry Powder: 2 years
Reconstituted Suspension: 14 days
6.4 Special Precautions For Storage
Dry Powder: Do not store above 25°C. Keep the container tightly closed.
Reconstituted Suspension:
This suspension should be stored in a cool place, preferably a refrigerator. Discard any unused medicine after 14 days.
6.5 Nature And Contents Of Container
High density polyethylene bottles of 100 ml with an open end equipped to accept a polyethylene closure with tamper-evident tear strip.
6.6 Special Precautions For Disposal And Other Handling
To the Pharmacist:
To prepare, add 87 ml of potable water and shake until powder is dissolved.
The reconstituted solution may be further diluted with sorbitol solution BP, syrup BP or purified water if required.
A pale orange, free flowing granular powder, which readily disperses in water to give an orange suspension with an odour of orange.
7. Marketing Authorisation Holder
Milpharm Limited,
Ares,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
8. Marketing Authorisation Number(S)
PL 16363/0123
9. Date Of First Authorisation/Renewal Of The Authorisation
04/03/2009
10. Date Of Revision Of The Text
04/03/2009
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