This information is intended for use by health professionals

1. Name of the medicinal product

Cefalexin oral suspension BP 250mg/5ml

2. Qualitative and quantitative composition

Each 5ml of reconstituted suspension contains Cefalexin BP equivalent to 250 mg anhydrous cefalexin.

Excipients with known effect:

Each 5ml of reconstituted suspension contains 2.75 g sucrose, 7.10 mg sodium benzoate and traces of benzyl alcohol.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Granules for oral suspension.

4. Clinical particulars
4.1 Therapeutic indications

Ospexin syrup 250mg/5ml; Tenkorex Oral Suspension 250mg/5ml; Cefalexin oral suspension BP 250mg/5ml; Kiflone syrup 250mg/5ml is indicated for the treatment of respiratory tract infections (RTI's), urinary tract infections (UTI's), skin and soft tissue infections, otitis media and other infections due to sensitive organisms.

4.2 Posology and method of administration

Posology

Adults

The dosage is 1-4 g daily in divided doses. Most infections will respond to 500mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild uncomplicated UTI's, the usual dosage is 250 mg every 6 hours or 500mg every 12 hours. For more severe infections or those caused by less susceptible organisms, larger dosages may be needed.

Older people

The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.

Paediatric population and adolescents

The usual recommended daily dosage for children is 25-50 mg/kg 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 75-100mg/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.

Method of administration

Ospexin syrup 250mg/5ml; Tenkorex Oral Suspension 250mg/5ml; Cefalexin oral suspension 250mg/5ml; Kiflone syrup 250mg/5ml is for oral use.

It must be reconstituted by the addition of 62ml of potable water and shaking until all the granules are dispersed.

4.3 Contraindications

Cefalexin is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics and patients with porphyria.

Severe systemic infections, which require parenteral cephalosporin treatment, should not be treated orally during the acute stage.

4.4 Special warnings and precautions for use

Any patient who has a relative with porphyria should be screened and advised about the potential for cephalosporins to induce acute porphyric crises.

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 cephalosporins. Patients have had severe reactions (including anaphylaxis) to both drugs.

Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semisynthetic 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 the patient experiences an allergic reaction cefalexin should be discontinued and treatment with the appropriate agents initiated.

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 as it is excreted mainly by the kidneys. Careful clinical and laboratory studies should be made because the safe dosage may be lower than that usually recommended.

Positive direct Coombs' tests have been reported during treatment with cephalosporin antibiotics. For 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. Tests based on glucose oxidation reactions may be safely used.

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.

Excipients:

This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains 7.1 mg sodium benzoate in each dose and small amounts of ethanol (alcohol), less than 100 mg per dose. It also contains lactose so patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The medicinal product contains traces of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity may occur is not known.

Do not use for more than a week in young children (less than 3 years old), as there is an increased risk due to accumulation in young children. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

4.5 Interaction with other medicinal products and other forms of interaction

As cephalosporins like cefalexin are only active against proliferating microorganisms, they should not be combined with bacteriostatic antibiotics.

Concomitant use of uricosuric drugs (e.g. probenicid) suppresses renal drug elimination. As a result, cefalexin plasma levels are increased and sustained for longer periods.

If associated with highly potent diuretics (ethacrynic acid, furosemide) or other potentially nephrotoxic antibiotics (aminoglycosides, polymyxin, colistin), cephalosprins may show higher nephrotoxicity.

Combined use of cephalosporins and oral anticoagulants may prolong prothrombin time.

A potential interaction between cefalexin and metformin may result in an accumulation of metformin and could result in fatal lactic acidosis.

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

4.6 Fertility, pregnancy and lactation

Pregnancy

Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient.

Breast-feeding

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.

4.7 Effects on ability to drive and use machines

There are no effects on ability to drive or to operate machinery.

4.8 Undesirable effects

Side effects of cefalexin include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea and abdominal discomfort. The most common of these effects is diarrhoea, but this is rarely severe enough to warrant cessation of therapy. Dyspepsia has also occurred. Transient hepatitis and cholestatic jaundice have rarely been reported.

Allergic reactions have been reported such as rash, urticaria, angioedema and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (exanthematic necrolysis). These reactions usually subsided upon discontinuation of the drug, although in some cases supportive therapy may be necessary. Anaphylaxis and Acute generalised exanthematous pustulosis (AGEP) have also been reported.

Other side effects such as genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis and joint disorders have been reported.

As with other cephalosporins interstitial nephritis has rarely been reported.

Eosinophilia, neutropenia, thrombocytopenia, haemolytic anaemia and slight elevations in AST and ALT have been reported.

As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis.

There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhoea while taking cefalexin. It may range in severity from mild to life threatening with mild case usually responding to cessation of therapy. Appropriate measures should be taken with moderate to severe cases.

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 Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.

4.9 Overdose

Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhoea and haematuria. General management consists of close clinical and laboratory monitoring of haematological, renal and hepatic functions and coagulation status until the patient is stable.

Serum levels of Cefalexin can be considerably reduced by haemodialysis or peritoneal dialysis.

Unless 5 to 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

Pharmacotherapeutic group: ANTIBACTERIALS FOR SYSTEMIC USE, OTHER BETA-LACTAM ANTIBACTERIALS, First-generation cephalosporins, ATC code: J01DB01

Cefalexin is an oral broad-spectrum antibiotic belonging to the group known as cephalosporins. In adequate concentrations it is bactericidal for sensitive proliferating microorganisms by inhibiting the biosynthesis of the cell wall. It is active against the following pathogens:

Gram Positive

Staphylococci (coagulase positive as well as penicillinase-producing strains), Streptococci, pneumococci, Corynebacterium diphtheriae, Baccillus anthracis, Clostridia, Listeria monocytogenes, Bacillus subtilis and Bacteroides melaninogenicus.

Gram Negative

Escherichia coli, Salmonellae, Shigellae, Neisseria, Proteus mirabilis, Haemophilus influenzae (some strains), Brucellae, Klebsiella species, Treponema pallidum and actinomycetes.

5.2 Pharmacokinetic properties

Cefalexin is almost completely absorbed from the gastrointestinal tract and produces peak plasma concentrations about 1 hour after administration.

A dose of 500 mg produces a peak plasma concentration of about 18 µg per ml; doubling the dose doubles the peak concentration. Cefalexin readily diffuses into tissues, including bone, joints and the pericardial as well as pleural cavities. Only 10-15% of the dose is bound to plasma proteins.

Elimination is mainly renal with 80% of the dose, recovered from the urine, therapeutically active, in the first 6 hours.

Cefalexin does not enter cerebrospinal fluid in significant quantities. Cefalexin crosses the placenta and small quantities are found in the milk of nursing mothers. Therapeutically effective concentrations may be found in the bile and some may be excreted by this route.

The half-life has been reported to range from 0.5 to 2 hours and this increases with reduced renal function.

5.3 Preclinical safety data

None stated

6. Pharmaceutical particulars
6.1 List of excipients

Saccharin sodium (E954)

Sodium benzoate (E211)

Citric acid anhydrous (E330)

Sucrose

Iron oxide yellow (E172)

Simethicone

Strawberry powdered flavour (contents include; benzyl alcohol)

Apple powdered flavour (contents include; magnesium hydroxide carbonate (E504), acetic acid (E260), ethanol, glycerol (E422) and lactose)

Raspberry powdered flavour (contents include; propylene glycol)

Tutti-frutti powdered flavour (contents include; benzyl alcohol and propylene glycol

Guar gum (E412)

6.2 Incompatibilities

There are no known incompatibilities.

6.3 Shelf life

The shelf life for Ospexin syrup 250mg/5ml; Tenkorex Oral Suspension 250mg/5ml; Cefalexin oral suspension BP 250mg/5ml; Kiflone syrup 250mg/5ml is 36 months unopened and 14 days after reconstitution.

6.4 Special precautions for storage

The following applies to the storage of Ospexin syrup 250mg/5ml; Tenkorex Oral Suspension 250mg/5ml; Cefalexin oral suspension BP 250mg/5ml; Kiflone syrup 250mg/5ml;

- Do not store the granules for oral suspension above 25°C.

- Store the reconstituted oral suspension at 2-8°C (in a refrigerator).

- Keep the container closed.

6.5 Nature and contents of container

Containers of Ospexin syrup 250mg/5ml; Tenkorex Oral Suspension 250mg/5ml and Cefalexin oral suspension BP 250mg/5ml; Kiflone syrup 250mg/5ml are glass bottles with polyethylene tamper evident caps. One container contains such a quantity of granules that if reconstituted by the addition of 62ml of water gives 100 ml of syrup/mixture.

6.6 Special precautions for disposal and other handling

Reconstitution

Ospexin syrup 250mg/5ml; Tenkorex Oral Suspension 250mg/5ml; Cefalexin oral suspension BP 250mg/5ml; Kiflone syrup 250mg/5ml has to be reconstituted by the addition of 62 ml of water and shaking until all the granules have dispersed. The reconstituted syrup/mixture can be kept for 14 days at 2-8°C (in a refrigerator). Any unused syrup/mixture should be discarded.

Administration

Ospexin syrup 250mg/5ml; Tenkorex Oral Suspension 250mg/5ml; Cefalexin oral suspension BP 250mg/5ml; Kiflone syrup 250mg/5ml is to be administered as given under the method of administration (section 4.2).

7. Marketing authorisation holder

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria.

8. Marketing authorisation number(s)

PL 04520/0002

9. Date of first authorisation/renewal of the authorisation

30 May 1996

10. Date of revision of the text

28/10/2019