Cephalexin ABM

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Cefalexin monohydrate 525.8 mg equivalent to 500 mg Cefalexin anhydrous.
Available from:
Boucher & Muir (New Zealand) Limited t/a BNM Group
INN (International Name):
Cefalexin monohydrate 525.8 mg (equivalent to 500 mg Cefalexin anhydrous.)
Dosage:
500 mg
Pharmaceutical form:
Capsule
Composition:
Active: Cefalexin monohydrate 525.8 mg equivalent to 500 mg Cefalexin anhydrous. Excipient: Hard gelatin capsules size "0" Tekprint SW-9008 black ink Magnesium stearate Microcrystalline cellulose
Units in package:
Blister pack, PVC/Al or PVC/PVDC/Al, 20 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Lupin Limited
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/Al or PVC/PVDC/Al - 20 capsules - 24 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-7656
Authorization date:
2006-05-12

CONSUMER MEDICINE INFORMATION

CEPHALEXIN ABM CAPSULES

(Cephalexin monohydrate)

What is in this leaflet

This leaflet answers some common questions about Cephalexin ABM Capsules. It does not

contain all the available information. It does not take the place of talking with your doctor or

pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of you taking Cephalexin ABM Capsules against the

benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Cephalexin ABM Capsules are used for

The name of your medicine is Cephalexin ABM Capsules. It contains the active ingredient

cephalexin monohydrate.

Cephalexin is used to treat infections in different parts of the body caused by bacteria.

Cephalexin can be used to treat infections of the:

respiratory tract (throat, tonsils, chest and lungs)

nose (sinusitis)

ears (otitis media)

skin and soft tissue

kidneys and bladder (genitourinary tract)

Cephalexin belongs to a group of medicines called cephalosporins. These antibiotics work by

killing the bacteria that are causing your infection.

Ask your doctor or pharmacist if you have any questions about why this medicine has

been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor's prescription.

Before taking Cephalexin ABM Capsules

When you must not take it

Do not take Cephalexin ABM Capsules if you have an allergy to:

any medicine containing cephalexin monohydrate

other cephalosporins

any of the ingredients listed at the end of this leaflet (see 'Product Description')

Do not take this medicine if you have had a serious allergic reaction to penicillin.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or

difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching

or hives on the skin.

Do not take this medicine after the expiry date printed on the pack or if the packaging is

torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or

dyes.

Tell your doctor if you have or have had any of the following medical conditions:

liver disease

kidney disease

bowel disease

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start

taking Cephalexin ABM Capsules.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that

you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and cephalexin may interfere with each other e.g.

probenecid, a medicine commonly used to treat gout

metformin, a medicine used in the treatment of diabetes

anti-inflammatory medications

antacids or anti-ulcer medications

blood-thinning medications

any other antibiotics

How to take Cephalexin ABM capsules

Carefully follow all directions given to you by your doctor or pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the carton, ask your doctor or pharmacist

for help.

How much to take

Your doctor will tell you how much and how often you should take Cephalexin ABM

Capsules. This will depend on the type of infection. The dose varies from patient to patient.

Adults:

The usual adult dose is 250 mg every 6 hours.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

It does not matter if you take this medicine before or after food.

How long do I take it?

Continue taking your medicine until you finish the blister pack or for as long as your

doctor tells you.

Keep taking Cephalexin ABM Capsules for the full time of treatment, even if you begin

to feel better after a few days.

If you do not complete the full course prescribed by your doctor, your infection may not clear

completely or your symptoms may return.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose

when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine

as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some

hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (0800 POISON or

0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if

you think you or anyone else may have taken too much Cephalexin ABM Capsules.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical

attention.

Symptoms of an overdose may include feeling sick in the stomach, diarrhoea, convulsions or

hallucinations.

While you are taking Cephalexin ABM Capsules

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist

that you are taking Cephalexin ABM Capsules.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this

medicine.

If you become pregnant while taking this medicine, tell your doctor.

If you are about to have any blood or urine tests, tell your doctor that you are taking

Cephalexin ABM Capsules.

It may interfere with the results of some tests.

If you have to test your urine for sugar while you are taking cephalexin, make sure that

your doctor knows about the type of test you use.

Cephalexin may affect the results of some of these tests.

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and

to prevent unwanted side effects.

Things you must not do

Do not take Cephalexin ABM Capsules to treat any other complaints unless your doctor

tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your

doctor.

If you stop taking it, your condition may worsen.

Things to be careful of

Be careful driving or operating machinery until you know how Cephalexin ABM

Capsules affects you.

This medicine may cause dizziness or drowsiness in some people. If you have any of these

symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Children should be careful when riding bicycles or climbing trees.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are

taking Cephalexin ABM Capsules.

This medicine helps most people with infection but in a few people it may have unwanted

side effects. These are likely to vary from patient to patient.

All medicines have side effects. Sometimes they are serious, most of the time they are not.

You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of

them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

sore or white mouth or tongue (oral thrush)

sore and itchy vagina and/or discharge (another form of thrush)

diarrhoea

nausea

vomiting

dizziness

unusual tiredness/weakness

abdominal pain

headache

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

severe body rash

swelling of face, lips, mouth, tongue or throat which may cause difficulty in swallowing or

breathing

fever

swelling of the joints

yellowing of the skin or eyes

joint pain

confusion and hallucinations

bleeding or bruising more easily than normal

The above list includes serious side effects which may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and

Emergency at your nearest hospital:

severe stomach cramps or pain

severe, watery or bloody diarrhoea

fever, in combination with one of the above

You may have a serious condition affecting your bowel. Therefore, you may require urgent

medical attention. Do not take any diarrhoea medicine without first checking with your

doctor.

If the following happens, tell your doctor immediately or go to Accident and Emergency

at your nearest hospital:

sudden signs of allergy such as rash, itching or hives on the skin with swelling of the face,

lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

The above is a very serious side effect. You may need urgent medical attention or

hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people. Some of these side effects

can only be found when your doctor does tests from time to time to check your progress.

After taking Cephalexin ABM Capsules

Storage

Keep your capsules in the blister pack until it is time to take them.

If you take your capsules out of the blister pack, they may not keep as well.

Store below 30°C.

Do not store Cephalexin ABM Capsules or any other medicine in the bathroom or near

a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep your medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask

your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

Cephalexin ABM capsules 250 mg are Size ‘2’ capsules with a dark green cap imprinted with

“250” in black ink and a white body, containing white to yellowish-white granular powder,

and are available in packs of 20.

Cephalexin ABM Capsules 500 mg are Size ‘0’ capsules with a dark green cap imprinted

with “500” in black ink and a light green body, containing white to yellowish-white granular

powder, and are available in packs of 20.

Ingredients

Cephalexin ABM capsules contain 250 mg and 500 mg of cephalexin monohydrate as the

active ingredient.

They also contain:

Microcrystalline cellulose

Magnesium stearate

The capsule shell contains gelatin, water, sodium lauryl sulphate, sunset yellow, quinoline

yellow, titanium dioxide, and patent blue.

Cephalexin ABM Capsules do not contain lactose, sucrose, gluten or tartrazine.

Sponsor

BNM Group

39 Anzac Road

Browns Bay

AUCKLAND

Phone: 0800 565 633

This leaflet was prepared on 04 March 2019

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

New Zealand Data Sheet

1

CEPHALEXIN ABM

CEPHALEXIN ABM 250 mg and 500 mg capsules

This product may not be interchangeable with other products containing this

ingredient in the New Zealand market.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains cephalexin monohydrate equivalent to 250 mg cephalexin or

500 mg cephalexin.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Cephalexin ABM 250 mg Capsules are Size ‘2’ capsules with a dark green cap imprinted

with “250” in black ink and a white body.

Cephalexin ABM 500 mg Capsules are Size ‘0’ capsules with a dark green cap imprinted

with “500” in black ink and a light green body.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Cephalexin capsules are 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. Cephalexin is generally effective in the

eradication of streptococci from the nasopharynx; however, substantial data establishing

the efficacy of cephalexin in the subsequent prevention of either rheumatic fever or

bacterial endocarditis are not available at present.)

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

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

function studies should be performed when indicated.

4.2

Dose and method of administration

Dose

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 cephalexin 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.

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 β-haemolytic streptococcal infections, a therapeutic dosage of

cephalexin should be administered for at least 10 days.

Method of administration

Cephalexin capsules are administered orally.

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

4.3

Contraindications

Cephalexin ABM Capsules are contraindicated in patients who have had previous

experience of a major allergy to a cephalosporin or penicillin, or those who have

experienced hypersensitivity to any of the excipients.

4.4

Special warnings and precautions for use

Warnings

Before cephalexin therapy is instituted, careful inquiry should be made concerning

previous hypersensitivity reactions to cephalosporins and penicillin. Cephalexin should

be given with caution to patients who have experienced symptoms of allergy associated

with a cephalosporin or penicillin. Serious acute hypersensitivity reactions may require

adrenaline 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 cephalexin capsules.

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 including cephalosporin. Such colitis may range in severity from

mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to

medicine discontinuance alone. In moderate to severe cases, appropriate measures should

be taken. Drugs which delay peristalsis may prolong and/or worsen the condition and

should not be used.

Precautions

General

Patients should be followed carefully so that any side effects or unusual manifestations of

medicine idiosyncrasy may be detected. If an allergic reaction to cephalexin occurs, the

medicine should be discontinued, and the patient treated with the usual agents (e.g.

adrenaline or other pressor amines, antihistamines, or corticosteroids).

Prolonged use of cephalexin 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.

Cephalexin capsules should be administered with caution in the presence of markedly

impaired

renal

function.

Under

such

conditions,

careful

clinical

observation

laboratory studies should be made because safe dosage may be lower than that usually

recommended.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

As with other β-lactams the renal excretion of cephalexin is inhibited by probenecid.

Broad-spectrum antibiotics should be prescribed with caution in individuals with a history

of gastrointestinal disease, particularly colitis.

Prolonged prothrombin time may occur in patients receiving protracted antimicrobial

therapy.

As a result of administration of cephalexin, a false-positive reaction for glucose in the

urine may occur. This has been observed with Benedict's and Fehling's solutions and also

with Clinitest

tablets. 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.

Use in pregnancy

Safe use of this product during pregnancy has not been established (see Section 4.6

Fertility, pregnancy and lactation).

4.5

Interaction with other medicines and other forms of interaction

Cephalexin capsules may cause a false-positive glucose reaction in urine with Benedict's

and Fehling’s solutions and Clinitest

tablets.

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.

As with other β-lactams, the renal excretion of cephalexin is inhibited by probenecid.

In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma

metformin C

and AUC increased by an average of 34% and 24%, respectively, and

metformin renal clearance decreased by an average of 14%. No information is available

about the interaction of cephalexin and metformin following multiple dose administration.

4.6

Fertility, pregnancy and lactation

Pregnancy

The daily oral administration of cephalexin 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 cephalexin during pregnancy in humans has not been established.

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

Cephalexin showed no enhanced toxicity in weaning and newborn rats as compared with

adult animals. Nevertheless, because the studies in humans cannot rule out the possibility

of harm, cephalexin capsules should be used during pregnancy only if clearly needed.

Breastfeeding

The excretion of cephalexin in the 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 cephalexin is

administered to a nursing woman.

Fertility

No information held by the sponsor.

4.7

Effects on ability to drive and use machines

During treatment with cephalexin, 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. 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 in the form of rash, urticaria, angioedema, and, rarely, erythema

multiforme,

Stevens-Johnson

Syndrome,

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.

Other

Other reactions have included genital and anal pruritis, genital moniliasis, vaginitis and

vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations,

arthralgia,

cutaneous

vasculitis,

arthritis,

joint

disorder.

Reversible

interstitial

nephritis

been

reported

rarely.

Eosinophilia,

neutropenia,

thrombocytopenia,

haemolytic anaemia and slight elevations in AST and ALT have been reported.

Reporting of suspected adverse reactions

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

asked

report

suspected

adverse

reactions

https://nzphvc.otago.ac.nz/reporting/

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

4.9

Overdose

Signs and Symptoms

Symptoms of oral overdose may include 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.

Treatment

managing

overdosage,

consider

possibility

multiple

medicine

overdoses,

interaction among medicines, and unusual medicine kinetics in your patient.

Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal

decontamination should not be necessary. Protect the patient's airway and support

ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits,

the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of medicines from

the gastrointestinal tract may be decreased by giving activated charcoal, which, in many

cases, is more effective than emesis or lavage; consider charcoal instead of or in addition

to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some

medicines that have been absorbed. Safeguard the patient's airway when employing

gastric emptying or charcoal. Forced diuresis, peritoneal dialysis, haemodialysis, or

charcoal haemoperfusion have not been established as beneficial for an overdose of

cephalexin; however, it would be extremely unlikely that one of these procedures would

be indicated. The oral median lethal dose of cephalexin in rats is 5,000 mg/kg.

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials, first generation cephalosporins

ATC code: J01DB01

Cephalexin is a 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid

monohydrate.

Cephalexin

molecular

formula

H

molecular weight is 365.4.

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 crystalline solid having a

bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved

readily, but higher concentrations are obtained with increasing difficulty.

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.

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

Mechanism of action

Cephalexin is a semi-synthetic cephalosporin antibiotic intended for oral administration.

Microbiology - In vitro tests

In vitro tests demonstrate that the cephalosporins are bactericidal because of their

inhibition of cell-wall synthesis. Cephalexin has been shown to be active against most

strains of the following microorganisms both in vitro and in clinical infections as

described in the 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 influenza

Klebsiella pneumoniae

Moraxella catarrhalis

Proteus mirabilis

Note: Methicillin-resistant staphylococci and most strains of enterococci (Enterococcus

faecalis)

resistant

cephalosporins

including

cephalexin.

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.

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

that has been recommended for use with discs to test the susceptibility of

microorganisms to cephalexin uses the 30 mcg cephalothin disc. Interpretation involves

correlation of the diameter obtained in the disc test with the minimum inhibitory

concentration (MIC) for cephalexin.

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:

Zone Diameter (mm)

Interpretation

Greater than or equal to 18

(S) Susceptible

15-17

(I) Intermediate

Less than or equal to 14

(R) Resistant

A report of "Susceptible" indicates that the pathogen is likely to be inhibited by usually

achievable

concentrations

antimicrobial

compound

blood.

report

"Intermediate" indicates that the result should be considered equivocal, and, if the

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

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.

Measurement of MIC or MBC and achieved antimicrobial compound concentrations may

be appropriate to guide therapy in some infections (See 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

laboratory

control

microorganisms. The 30 mcg cephalothin disc should provide the following zone

diameters in these laboratory test quality control strains:

Microorganism

Zone Diameter (mm)

E. coli ATCC 25922

15-21

S. aureus ATCC 25923

29-37

1

National

Committee

for

Clinical

Laboratory

Standards.

Performance

Standards

for

Antimicrobial Disc Susceptibility Tests--5th ed. Approved Standard NCCLS Document M2-A5,

Vol 13, No 24, NCCLS, Villanova, PA, 1993.

Dilution techniques

Quantitative methods that are used to determine MICs provide reproducible estimates of

susceptibility

bacteria

antimicrobial

compounds.

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:

MIC (mcg/mL)

Interpretation

Greater than or equal to 8

(S) Susceptible

(I) Intermediate

Less than or equal to 32

(R) 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:

Microorganism

MIC (mcg/mL)

E. coli ATCC 25922

4-16

E. faecalis ATCC 29212

8-32

S. aureus ATCC 29213

0.12-0.5

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

2

National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial

Susceptibility Tests for Bacteria That Grow Aerobically--3rd ed. Approved Standard NCCLS

Document M7-A3, Vol 13, No 25, NCCLS, Villanova, PA, 1993.

5.2

Pharmacokinetic properties

Absorption

Cephalexin 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.

Elimination

Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. 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.

5.3

Preclinical safety data

No further data of relevance.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Microcrystalline cellulose

Magnesium stearate

6.2

Incompatibilities

Not applicable

6.3

Shelf life

24 months

6.4

Special precautions for storage

Store below 30

6.5

Nature and contents of container

Blister packs of 20 capsules

CEPHALEXIN ABM

Cephalexin monohydrate capsules 250 mg and 500 mg

6.6

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicine or waste material should be disposed of in accordance with local

requirements.

7

MEDICINE SCHEDULE

Prescription medicine

8

SPONSOR

BNM Group

39 Anzac Road

Browns Bay

Auckland 0753

Phone 0800 565 633

9

DATE OF FIRST APPROVAL

Date of publication in the New Zealand Gazette of consent to distribute the medicine:

24 April 2008

10

DATE OF REVISION OF TEXT

04 March 2019

Section changed

Summary of new information

Datasheet re-formatted in line with SPC style template

Change in sponsor from ABM Pharma Ltd to BNM Group

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