Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Hypersensitivity to the active substance, known allergy to the cephalosporin group of antibiotics or to any of the excipients listed in section 6.1.
Before instituting therapy with cefalexin, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins, or other drugs. Cefalexin should be given cautiously to penicillin-sensitive patients. There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and cephalosporins. Patients have had severe reactions (including anaphylaxis) to both drugs.
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.
If an allergic reaction to cefalexin occurs, the drug should be discontinued and the patient treated with the appropriate agents.
Acute generalised exanthematous pustulosis (AGEP) has been reported in association with cefalexin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered. Most of these reactions occurred most likely in the first week during treatment.
Prolonged use of cefalexin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
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 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 sulphate test tablets.
Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient.
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.
None known.
The following undesirable effects may occur with the use of cefalexin. Adverse reactions are ranked according to MedDRA system / organ classification. The frequency of each updating is displayed, using the following category classification: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known ( can not be estimated from the available data/ post-marketing experience)
Not known: Eosinophilia, neutropenia, thrombocytopenia, and haemolytic anaemia have been reported.
Not known: Anaphylaxis.
Not known: Hallucinations.
Not known: Dizziness, fatigue, headache, agitation, confusion.
Not known: genital and anal pruritus, genital candidiasis,vaginitis and vaginal discharge.
Common: The most frequent side-effect has been diarrhoea. It was very rarely severe enough to warrant cessation of therapy.
Rare: As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely; nausea and vomiting
Not known: Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment; dyspepsia and abdominal pain have also occurred.
Rarely: erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. These reactions usually subsided upon discontinuation of the drug, although in some cases supportive therapy may be necessary.
Not known: Allergic reactions have been observed in the form of rash, urticaria, angioedema. Acute generalised exanthematous pustulosis (AGEP)
Not known: Arthralgia, arthritis and joint disorder.
Rare: Reversible interstitial nephritis.
Not known: Slight elevations in AST and ALT.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
None known.
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