NEW ZEALAND DATA SHEET

1 PRODUCT NAME

Cefalexin 125 mg/5 mL Granules for oral suspension

Cefalexin 250 mg/5 mL Granules for oral suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cefalexin 125 mg/5 mL Granules for oral suspension:

When prepared as directed, each 5 mL of reconstituted suspension contains (as the active
ingredient) cefalexin monohydrate equivalent to 125 mg of cefalexin base.
Excipients with known effect: contains 3.119 g of sucrose per 5 mL after reconstitution.
Cefalexin 250 mg/5 mL Granules for oral suspension:
When prepared as directed, each 5 mL of reconstituted suspension contains as the active
ingredient, cefalexin monohydrate equivalent to 250 mg of cefalexin base.
Excipients with known effect: contains 2.972 g of sucrose per 5 mL after reconstitution.
For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Granules for oral suspension.
White granules.

4 CLINICAL PARTICULARS
4.1 Therapeutic indications

Cefalexin is indicated for the treatment of the following infections when caused by
susceptible strains of the designated microorganisms:

• bacterial sinusitis caused by streptococci, S. pneumoniae, and Staphylococcus aureus

(methicillin-sensitive only);
• respiratory tract infections caused by S. pneumoniae and S. pyogenes (penicillin is the
usual medicine of choice in the treatment and prevention of streptococcal infections,
including the prophylaxis of rheumatic fever - cefalexin is generally effective in the
eradication of streptococci from the nasopharynx; however, substantial data establishing
the efficacy of cefalexin in the subsequent prevention of either rheumatic fever or
bacterial endocarditis are not available at present);
• otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M.
catarrhalis;
• skin and skin-structure infections caused by staphylococci and/or streptococci;
• bone infections caused by staphylococci and/or P. mirabilis;
• genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis,
and Klebsiella pneumoniae;
• dental infections caused by staphylococci and/or streptococci.
Note - Culture and susceptibility tests should be initiated prior to and during therapy. Renal
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function studies should be performed when indicated.
4.2 Dose and method of administration

Dosage
Cefalexin is administered orally.
Adults
The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg
every 6 hours. For the following infections, a dosage of 500 mg may be administered every
12 hours: streptococcal pharyngitis, skin and skin-structure infections, and uncomplicated
cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days.
For more severe infections or those caused by less susceptible organisms, larger doses may
be needed. If daily doses of cefalexin greater than 4 g are required, parenteral cephalosporins,
in appropriate doses, should be considered.
Children
The usual recommended daily dosage for children is 25 to 50 mg/kg in divided doses. For
streptococcal pharyngitis in patients over 1 year of age, mild, uncomplicated urinary tract
infections, and for skin and skin-structure infections, the total daily dose may be divided and
administered every 12 hours.
Cefalexin granules for oral suspension 125 mg/5 mL
For a child weighing about 10 kg, give prepared suspension 2.5 to 5 mL four times a day or 5
to 10 mL twice a day.
For a child weighing about 20 kg, give prepared suspension 5 to 10 mL four times a day or 10
to 20 mL twice a day.
For a child weighing about 40 kg, give prepared suspension 10 to 20 mL four times a day or
20 to 40 mL twice a day.
Cefalexin granules for oral suspension 250 mg/5 mL
For a child weighing about 10 kg, give prepared suspension 1.25 to 2.5 mL four times a day
or 2.5 to 5 mL twice a day.
For a child weighing about 20 kg, give prepared suspension 2.5 to 5 mL four times a day or 5
to 10 mL twice a day.
For a child weighing about 40 kg, give prepared suspension 5 to 10 mL four times a day or 10
to 20 mL twice a day.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100
mg/kg/day in 4 divided doses is required.
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dosage of cefalexin
should be administered for at least 10 days.

Administration
Cefalexin granules for oral suspension were developed specially for paediatric use.
For instructions on reconstitution of Cefalexin granules for oral suspension, see section 6.6
Special precautions for disposal and other handling.

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4.3 Contraindications
Cefalexin is contraindicated in patients who have had previous experience of a major allergy
or anaphylaxis to a cephalosporin or penicillin.
Cefalexin is contraindicated in patients who have experienced hypersensitivity to any of the
excipients listed in section 6.1.
Limitations
Cefalexin is not indicated in the management of bacterial infections of the brain or spinal
column.

4.4 Special warnings and precautions for use

Cefalexin should not ordinarily be given to those allergic to cephalosporins or to penicillins,
especially where an allergic or urticarial reaction has occurred. Before cefalexin therapy is
instituted, careful inquiry should be made concerning previous hypersensitivity reactions to
cephalosporins, penicillins or other medicines. Cephalosporin C derivatives should be given
cautiously to penicillin-sensitive patients. Serious acute hypersensitivity reactions may
require adrenaline or epinephrine and other emergency measures. There is some clinical and
laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins.
Patients have been reported to have had severe reactions (including anaphylaxis) to both
medicines. Any patient who has demonstrated some form of allergy, particularly to medicines,
should receive antibiotics cautiously. No exception should be made with regard to cefalexin.
Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics
(including macrolides, semisynthetic penicillins, and cephalosporins); therefore, it is important
to consider its diagnosis in patients who develop diarrhoea in association with the use of
antibiotics. Mild cases of pseudomembranous colitis usually respond to medicine
discontinuance alone. In moderate to severe cases, appropriate measures should be taken.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics
including cefalexin. A toxin produced with Clostridium difficile appears to be the primary
cause. The severity of the colitis may range from mild to life threatening. It is important to
consider this diagnosis in patient who develop diarrhoea or colitis in association with antibiotic
use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases
usually respond to medicine discontinuation alone. However, in moderate to severe cases
appropriate therapy with a suitable oral antibacterial agent effective against Cl. difficile should
be considered. Fluids, electrolytes and protein replacement therapy should be provided when
indicated. Medicines that delay peristalsis e.g. opiates and diphenoxylate with atropine, may
prolong and/or worsen the condition and should not be used.

Neurotoxicity:
Reports of neurotoxicity have been identified in association with cephalosporin treatment.
Symptoms may include encephalopathy, myoclonus and seizures. Elderly patients, patients
with severe renal impairment or central nervous system disorders are particularly at risk. If
cefalexin associated neurotoxicity is suspected, discontinuation of cefalexin should be
considered.

Prothrombin time: Prolonged prothrombin time may occur in patients receiving protracted
antimicrobial therapy.
Patients should be followed carefully so that any side effects or unusual manifestations of
medicine idiosyncrasy may be detected. If an allergic reaction to cefalexin occurs, the medicine
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should be discontinued and the patient treated with the usual agents (e.g. adrenaline or
epinephrine or other pressor amines, antihistamines, or corticosteroids).
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.
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of
gastrointestinal disease, particularly colitis.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Impaired renal function: Cefalexin should be administered with caution in the presence of
markedly impaired renal function. Under such conditions, careful clinical observation and
laboratory studies should be made because safe dosage may be lower than that usually
recommended. If dialysis is required for renal failure, the daily dose of cefalexin should not
exceed 500mg.
Concurrent administration with certain other drug substances, such as aminoglycosides, other
cephalosporins, or furosemide (frusemide) and similar potent diuretics, may increase the risk
of nephrotoxicity.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this
medicine.
Also contains Allura Red AC (E129), which may cause allergic reactions.

This product contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially
‘sodium-free’.
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.

4.5 Interaction with other medicines and other forms of interaction

As with other beta-lactams, the renal excretion of cefalexin is inhibited by probenecid. As a
result, cefalexin plasma levels are increased and sustained for longer periods.
A potential interaction between cefalexin and metformin may result in accumulation of
metformin. In healthy subjects given single 500 mg doses of cefalexin and metformin, plasma
metformin Cmax and AUC increased by an average of 34% and 24%, respectively, and
metformin renal clearance decreased by an average of 14%. The interaction of cefalexin and
metformin following multiple dose administration has not been studied. Administration of a
cephalosporin to a metformin treated patient may result in increased metformin exposure. A
potential interaction between cefalexin and metformin may result in accumulation of
metformin.
As cephalosporins like cefalexin are only active against proliferating micro-organisms, they
should not be combined with bacteriostatic antibiotics.
If associated with highly potent diuretics such as furosemide or other potentially nephrotoxic
antibiotics (aminoglycosides, polymyxin, colistin), cephalosporins may show higher
nephrotoxicity.
The combined use of cephalosporins and oral anticoagulants may prolong the prothrombin
time.
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Cephalosporins may reduce the effects of oral contraceptives.

Laboratory diagnostic tests

Positive direct Coombs' tests have been reported during treatment with the cephalosporin
antibiotics. In haematologic 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 medicine.
Cefalexin may cause a false-positive glucose reaction in urine with Benedict's and Fehlings's
solutions or with copper sulfate test tablets.
The quantitative determination of urinary protein excretion using strong acids is misleading
during cefalexin therapy as precipitation of cefalexin in the urine may occur.

4.6 Fertility, pregnancy and lactation

Use in pregnancy
Category A
The daily oral administration of cefalexin to rats in doses of 250 or 500 mg/kg prior to and
during pregnancy, or to rats and mice during the period of organogenesis only, had no
adverse effect on fertility, foetal viability, foetal weight, or litter size. Note that the safety of
cefalexin during pregnancy in humans has not been established. Cefalexin showed no
enhanced toxicity in weanling and newborn rats as compared with adult animals.
Nevertheless, because the studies in humans cannot rule out the possibility of harm, cefalexin
should be used during pregnancy only if clearly needed.
Use in lactation
The excretion of cefalexin in breast milk increased up to 4 hours after a 500 mg dose; the
medicine reached a maximum level of 4 mg/l, then decreased gradually, and had disappeared
8 hours after administration. Caution should be exercised when cefalexin is administered to a
nursing woman, since the neonate is presented with the risk of candidasis and CNS toxicity
due to immaturity of the blood-brain barrier. There is a theoretical possibility of later
sensitisation.
Fertility
Refer to section 5.3 Preclinical safety data.

4.7 Effects on ability to drive and use machines

During treatment with Cefalexin, undesirable effects may occur (e.g. dizziness), which may
influence the ability to drive and use machines. Patients should be cautious when driving or
operating machinery.

4.8 Undesirable effects

Gastrointestinal
Symptoms of pseudomembranous colitis may appear either during or after antibiotic
treatment. The most frequent side effect has been diarrhoea. However, it was very rarely severe
enough to warrant cessation of therapy. Nausea and vomiting have been reported rarely.
Dyspepsia and abdominal pain have also occurred. As with some penicillins and some other
cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.
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Hypersensitivity: Allergic reactions in the form of rash, urticaria, angioedema, and, rarely,
erythema multiforme, Stevens-Johnson Syndrome, or toxic epidermal necrolysis have been
observed. These reactions usually subsided upon discontinuation of the medicine. In some of
the reactions, 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: Acute generalised exanthematous pustulosis
(AGEP) has been reported with unknown frequency.
Other: Other reactions have included genital and anal pruritis, genital moniliasis, vaginitis and
vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia,
arthritis, cutaneous vasculitis, and joint disorders. Reversible interstitial nephritis has been
reported rarely. Eosinophilia, neutropenia, thrombocytopenia, haemolytic anaemia and slight
elevations in AST and ALT have been reported. There have been reports of neurological
sequelae including tremor, myoclonia, convulsions, encephalopathy with drugs belonging to
the class of cephalosporins. Most cases occurred in patients with renal impairment who
received doses that exceeded the recommended dose and resolved following discontinuation of
treatment.

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows
continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are
asked to report any suspected adverse reactions https://pophealth.my.site.com/carmreportnz/s/

4.9 Overdose
Signs and symptoms
There is no definite experience of poisoning or severe overdosage with cefalexin. However,
clinical features of overdosage may be similar to those seen with other cephalosporins and
penicillins, i.e. convulsions, hallucinations, hyperreflexia, electrolyte imbalance, nausea,
vomiting, epigastric distress, diarrhoea, and haematuria. If other symptoms are present, it is
probably secondary to an underlying disease state, an allergic reaction, or toxicity due to
ingestion of a second medication. The oral median lethal dose of cefalexin in rats is 5,000
mg/kg.
Management
In the event of severe overdosage, general supportive care is recommended including close
clinical and laboratory monitoring of haematological, renal, hepatic functions and coagulation
status until the patient is stable. Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal
haemoperfusion have not been established as beneficial for an overdose of cefalexin; however,
it would be extremely unlikely that one of these procedures would be indicated.
For advice on the management of overdose please contact the National Poisons Centre on
0800 POISON (0800 764 766).

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group:
Antibacterials for systemic use, first-generation cephalosporins, ATC code: J01DB01.
Antibiotic class
Cefalexin is a semi-synthetic cephalosporin antibiotic intended for oral administration.
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The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound
is a zwitterion; i.e. the molecule contains both a basic and an acidic group. The isoelectric point
of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin, which is
available, is a monohydrate. It is a white or almost white crystalline solid having a bitter taste.
Solubility in water is about 1% at room temperature. It is practically insoluble in alcohol and
in ether. The cephalosporins differ from penicillins in the structure of the bicyclic ring system.
Cephalexin has a d-phenylglycyl group as substituent at the 7-amino position and an
unsubstituted methyl group at the 3-position.
Antibiotic nature and mode of action
In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition
of cell-wall synthesis. Cefalexin has been shown to be active against most strains of the
following microorganisms both in vitro and in clinical infections as described in section 4.1
Therapeutic Indications.
Aerobes, Gram-positive:
Staphylococcus aureus (including penicillinase-producing strains);
Staphylococcus epidermidis (penicillin-susceptible strains);
Streptococcus pneumoniae;
Streptococcus pyogenes.
Aerobes, Gram-negative:
Escherichia coli;
Haemophilus influenzae;
Klebsiella pneumoniae;
Moraxella catarrhalis;
Proteus mirabilis.
Susceptibility data and clinically relevant MIC ranges
Susceptibility Tests - Diffusion techniques
Quantitative methods that require measurement of zone diameters provide reproducible
estimates of susceptibility of bacteria to antimicrobial compounds. One such standardised
procedure has been recommended for use with discs to test the susceptibility of microorganisms
to cefalexin and uses the 30 mcg cephalothin disc. Interpretation involves correlation of the
diameter obtained in the disc test with the minimum inhibitory concentration (MIC) for
cefalexin.
Reports from the laboratory providing results of the standard single-disc susceptibility test
with a 30 mcg cephalothin disc should be interpreted according to the following criteria:
• a zone diameter NLT 18 mm is considered susceptible;
• a zone diameter between 15 and 17 mm is considered intermediate;
• a zone diameter NMT 14 mm is considered resistant.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited by usually
achievable concentrations of the antimicrobial compound in blood.
A report of "Intermediate" indicates that the result should be considered equivocal, and, if the
microorganism is not fully susceptible to alternative, clinically feasible medicine, the test
should be repeated. This category implies possible clinical applicability in body sites where
the drug is physiologically concentrated or in situations where high dosage of medicine can
be used. This category also provides a buffer zone that prevents small uncontrolled technical
factors from causing major discrepancies in interpretation.
A report of "Resistant" indicates that usually achievable concentrations of the antimicrobial
compound in the blood are unlikely to be inhibitory and that other therapy should be selected.
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 Measurement of MIC or MBC and achieved antimicrobial compound concentrations may be
appropriate to guide therapy in some infections (refer to section 5.2 Pharmacokinetic
Properties, for information on drug concentrations achieved in infected body sites and other
pharmacokinetic properties of this antimicrobial medicine.)
Standardised susceptibility test procedures require the use of laboratory control
microorganisms. The 30 mcg cephalothin disc should provide the following zone diameters
in these laboratory test quality control strains:
• for E. coli ATCC 25922, 15 to 21 mm;
• for S. aureus ATCC 25923, 29 to 37 mm.

Dilution techniques
Quantitative methods that are used to determine MICs provide reproducible estimates of the
susceptibility of bacteria to antimicrobial compounds. One such standardised procedure uses
a standardised dilution method (broth, agar, microdilution) or equivalent with cephalothin
powder. The MIC values obtained should be interpreted according to the following criteria:
• a MIC NMT 8 mcg/mL is considered susceptible;
• a MIC of 16 mcg/mL is considered intermediate;
• a MIC NLT 32 mcg/mL is considered resistant.
Interpretation should be as stated above for results using diffusion techniques.
As with standard diffusion techniques, dilution methods require the use of laboratory control
microorganisms. Standard cephalothin powder should provide the following MIC values:
• for E. coli ATCC 25922, 4 to 16 mcg/mL;
• for E. faecalis ATCC 29212, 8 to 32 mcg/mL;
• for S. aureus ATCC 29213, 0.12 to 0.5 mcg/mL.

Resistance
Methicillin-resistant staphylococci and most strains of enterococci (Enterococcus faecalis)
are resistant to cephalosporins including cefalexin. Penicillin-resistant Streptococcus
pneumoniae is usually cross-resistant to beta-lactam antibiotics. It is not active against most
strains of Enterobacter spp., Morganella morganii and Proteus vulgaris. It has no activity
against Pseudomonas spp. or Acinetobacter calcoaceticus.
When tested by in vitro methods, Staphylococci exhibit cross-resistance between cefalexin
and methicillin type antibiotics.

5.2 Pharmacokinetic properties

Pharmacokinetic
s Absorption
Cefalexin is acid stable and may be given without regard to meals. It is rapidly absorbed after
oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels
of approximately 9, 18 and 32 mg/L respectively were obtained at one hour. Measurable levels
were present six hours after administration.

Distribution
Cefalexin readily diffuses into tissues, including bone, joints and the pericardial as well as
pleural cavities. Only 10 to 15% of a dose is bound to plasma protein.
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Biotransformation
Cefalexin is excreted in the urine by glomerular filtration and tubular secretion. Almost the
entire dose recovered from the urine is therapeutically active.
Elimination
Elimination is mainly renal. The half-life is approximately 50 min and this increases with
reduced renal function. Studies showed that over 90% of the medicine was excreted
unchanged in the urine within 8 hours. During this period, peak urine concentrations following
the 250 mg, 500 mg and 1 g doses were approximately 1000, 2200, and 5000 mg/L
respectively.
Serum levels of cefalexin can be considerably reduced by haemodialysis or peritoneal
dialysis.

5.3 Preclinical safety data

The daily oral administration of cefalexin to rats in doses of 250 or 500 mg/kg prior to and
during pregnancy, or to rats and mice during the period of organogenesis only, had no
adverse effect on fertility, foetal viability, foetal weight, or litter size.
Cefalexin showed no enhanced toxicity in weanling and newborn rats as compared with adult
animals.
The oral LD50 of cefalexin in rats is 5,000 mg/kg.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
The granules contain the following excipients:
Sucrose
Imitation Guarana Flavour
Allura Red AC (E129)
Sodium Lauryl Sulphate
Methylcellulose 15
Dimeticone
Xanthan Gum
Pregelatinised Starch

6.2 Incompatibilities
None known.

6.3 Shelf life

Cefalexin 125 mg/5 mL Granules for oral suspension
Unopened product: 2 years
After reconstitution: to be used within 10 days.

Cefalexin 250 mg/5 mL Granules for oral suspension

Unopened product: 3 years
After reconstitution: to be used within 10 days

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6.4 Special precautions for storage

Store at or below 25°C.

Reconstituted suspension should be stored in a refrigerator (2°C-8°C).

6.5 Nature and contents of container

100 mL HDPE bottles with screw caps.

6.6 Special precautions for disposal and other handling

Reconstitution of Cefalexin granules for oral suspension 125 mg/5 mL and 250 mg/5 mL
First invert the bottle and tap to loosen the powder then add a total of 60 mL water in two
portions, shaking after each addition until suspended. The suspension is red.
Shake well before use.
No special requirements for disposal.

7 MEDICINE SCHEDULE

Prescription Medicine.

8 SPONSOR

Max Health Ltd

PO Box 44452
Pt Chevalier, Auckland 1246
Telephone: (09) 815 2664.

9 DATE OF FIRST APPROVAL

11 November 2021

10 DATE OF REVISION OF THE TEXT

19 July 2024
SUMMARY TABLE OF CHANGES
Section changed Summary of new information
4.8 Additional information regarding neurological sequelae
has been added under ‘Other’.
Updated link for reporting AEs to CARM.

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