Cephalexin 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 tract infections, including acute prostatitis; dental infections. Cephalexin 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 Cephalexin. 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 Cephalexin and methicillin-type antibiotics

Posology:

The adult dosage ranges from 1-4g daily in divided doses; most infections will respond to a dosage of 500mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the usual dosage is 250mg 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 Cephalexin 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 (see section 4.4).

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

Cephalexin is contraindicated in patients with known allergy to the cephalosporins group of antibiotics or any of the excipients listed in Section 6.1. Cephalexin is contraindicated in patients with porphyria. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Cephalexin 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.

If an allergic reaction to Cephalexin occurs the drug should be discontinued and the patient treated with the appropriate agents. Prolonged use of Cephalexin may result in the overgrowth of non-susceptible organisms.

Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semi-synthetic penicillins, and cephalosporins. 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.

Cephalexin 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 Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In haematological studies, or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphatetest tablets.

Probenecid causes reduced excretion of Cephalexin, leading to increased plasma concentration. Cephalosporins have an increased risk of nephrotoxicity in the presence of amphotericin, loop diuretics, aminoglycosides, capreomycin or vancomycin.

Hypokalaemia has been described in patients taking cytotoxic drugs for leukaemia when they were given gentamicin and Cephalexin.

Usage in pregnancy: 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 Cephalexin 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 Cephalexin is administered to a nursing woman.

None known

Gastrointestinal-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 angioedema), 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

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, nervousness, restlessness, confusion, hallucinations, sleep disorders, arthralgia,arthritis and joint disorder. Reversible interstitial nephritis has been reported rarely..

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, 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 Cephalexin in a day. Treatment has been supportive (fluids) and no sequelae have been reported.

ATC code: J01DB01 First generation cephalosporins

Cephalexin is bactericidal and has antimicrobial activity similar to that of cephaloridine or cephalothin against both gram-positive and gram-negative organisms.

Cephalexin is almost completely absorbed from the gastro-intestinal tract and produces peak plasma concentrations about 1 hour after administration. A dose of 500mg 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 Cephalexin 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 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 1mg per ml have been achieved after a dose of 500mg. Probenecid delays urinary excretion and has been reported to increase biliary excretion. Cephalexin 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.

There are no preclinical data of relevance to the prescriber, which are additional to those already in other sections of the SmPC.

Crosspovidone (Polyplasdone XL) Sodium lauryl sulphate Colloidal silicone dioxide (Aerosil 200) Microcrystalline cellulose 102 Magnesium stearate Talc
Empty hard gelatin capsule size O’ EL capsules with light green body having ‘Omaceph 500 mg’ printed in black colour and dark green cap with ‘NPI’ logo printed in white colour contains off-white to light yellow powder.

Not applicable

3 years

Store below 25°C, protect from light and moisture.

Clear PVDC coated PVC film with printed aluminium poly film.

No special requirements for storage.