FELEXIN Powder for oral suspension Ref.[28224] Active ingredients: Cefalexin

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.

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.

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 If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered.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.

Felexin 125 mg/5 ml and 250 mg/5 ml powder for oral suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Felexin 125 mg/5 ml powder for oral suspension contains carmoisine azorubine E122, which may cause allergic reactions.

Felexin 250 mg/5 ml powder for oral suspension contains sunset yellow FCF E110, which may cause allergic reactions.

Felexin 125 mg/5 ml and 250 mg/5 ml powder for oral suspension contains sodium benzoate which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Felexin 125 mg/5 ml powder for oral suspension contains 35 mg sodium (main ingredient of cooking/table salt) in each dose (maximum daily dose). This is equivalent to 1.75% of the recommended daily intake of sodium for an adult.

Felexin 250 mg/5 ml powder for oral suspension contains less than 1 mmol sodium (23 mg) per dose (maximum daily dose), that is to say essentially ‘sodium-free’.

As with other beta-lactam drugs, renal excretion of cefalexin is inhibited by probenecid.

In a single study of 12 healthy subjects given single 500 mg doses of cefalexin and metformin, plasma metformin C_max and AUC increased by an average of 34% and 24%, respectively, and metformin renal clearance decreased by an average of 14%. No side-effects were reported in the 12 healthy subjects in this study. No information is available about the interaction of cefalexin and metformin following multiple dose administration. The clinical significance of this study is unclear, particularly as no cases of “lactic acidosis” have been reported in association with concomitant metformin and cefalexin treatment.

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

Pregnancy

Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing Felexin in pregnant women.

Breast-feeding

The excretion of cefalexin in human breast milk increased up to 4 hours following a 500 mg 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.

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. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.

Hypersensitivity

Allergic reactions have been observed in the form of rash, urticaria, angioedema, and, 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. Anaphylaxis has also been reported.

Haemic and lymphatic system

Eosinophilia, neutropenia, thrombocytopenia, and haemolytic anaemia have been reported.

Skin and subcutaneous tissue disorders (frequency: not known)

Acute generalised exanthematous pustulosis (AGEP)

Other

These have included genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported rarely. Slight elevations in AST and ALT have been reported.

Reporting of suspected adverse reactions

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 via the national reporting system.

Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

None known.