Consumer medicine information

Cefalexin Sandoz

Cefalexin

BRAND INFORMATION

Brand name

Cefalexin Sandoz 500 mg Capsules and Powder for Suspension

Active ingredient

Cefalexin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cefalexin Sandoz.

What is in this leaflet

This leaflet answers some common questions about Cefalexin Sandoz.

It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Cefalexin Sandoz against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine. You may need to read it again.

What Cefalexin Sandoz is used for

The name of your medicine is Cefalexin Sandoz. It contains the active ingredient cefalexin monohydrate.

Cefalexin Sandoz is an antibiotic used to treat infections in different parts of the body caused by bacteria.

Cefalexin Sandoz belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.

Cefalexin Sandoz 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).

Your doctor may have prescribed Cefalexin Sandoz for another reason.

Ask your doctor if you have any questions about why Cefalexin Sandoz has been prescribed for you.

Cefalexin Sandoz is available only with a doctor's prescription. It is not addictive.

Before you take Cefalexin Sandoz

When you must not take it

Do not take Cefalexin Sandoz if:

  1. you have an allergy to cefalexin monohydrate, other cephalosporins or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; skin rash, itching or hives.
  1. you have had a serious allergic reaction to any penicillins.
You may be more likely to have an allergic reaction to Cefalexin Sandoz if you are allergic to any penicillins.

Do not use Cefalexin Sandoz if the packaging is torn or shows signs of tampering.

Do not use Cefalexin Sandoz after the expiry date printed on the bottle or carton has passed.

If you are not sure whether you should start taking Cefalexin Sandoz, contact your doctor or pharmacist.

Before you start to take it

Tell your doctor if:

  1. you have had any type of allergic reaction to any cephalosporin or penicillin medicines.
You may have an increased chance of being allergic to Cefalexin Sandoz if you are allergic to any cephalosporins or penicillins.
  1. you have any allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. you are pregnant, or intend to become pregnant.
Your doctor will discuss the risks and benefits of using Cefalexin Sandoz during pregnancy.
  1. you are breastfeeding or intend to breastfeed.
Cefalexin Sandoz passes into breast milk. Your doctor will discuss the risks and benefits of using Cefalexin Sandoz when breastfeeding.
  1. you have or have had any medical conditions, including:
  • kidney disease
  • stomach or bowel problems
  • liver disease.

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

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Cefalexin Sandoz. These include:

  • probenecid, a medicine used to treat gout
  • metformin, a medicine used to treat diabetes.

These medicines may be affected by Cefalexin Sandoz, or may affect how well it works. You may need to use different amounts of your medicine or you may need to use different medicines. Your doctor will advise you.

Talk to your doctor about the need for an additional method of contraception while taking Cefalexin Sandoz. Some antibiotics may decrease the effectiveness of some birth control pills.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Cefalexin Sandoz.

How to take Cefalexin Sandoz

Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

Your Pharmacist will make up the suspension in the bottle, before giving it to you.

FOR PHARMACIST ONLY- Instructions for reconstitution:

Cefalexin Sandoz 125 mg/5mL oral solution: Invert bottle and tap to loosen granules. Add 64 ml of water to granules in the bottle. Close and shake well at once.

Cefalexin Sandoz 250 mg/5mL oral solution: Invert bottle and tap to loosen granules. Add 63 ml of water to granules in the bottle. Close and shake well at once.

How much to take

Cefalexin Sandoz is available as 500 mg capsules as well as 125 mg/5 mL and 250 mg/5 mL suspensions.

Adults
The usual adult dose is 500 mg every 6 hours. Your doctor may recommend a different dose depending on your condition.

Children
Your child's doctor will tell you how much Cefalexin Sandoz your child should take. This will depend on your child's age, weight and the type of infection.

How to take it

Capsule
Swallow Cefalexin Sandoz capsules with a glass of water.

Suspension
Always shake the bottle before measuring the correct volume to give to your child.

When to take it

Take each dose of Cefalexin Sandoz at about the same time each day. Taking each dose of Cefalexin Sandoz at the same time each day will have the best effect. It will also help you to remember when to take the medicine.

It does not matter if you take Cefalexin Sandoz before or after food.

How long to take it

Continue taking Cefalexin Sandoz until you finish the pack or until your doctor recommends.

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 Cefalexin Sandoz 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 (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Cefalexin Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep these telephone numbers handy.

If you take too much Cefalexin Sandoz you may feel sick in the stomach, experience diarrhoea, convulsions or hallucinations.

While you are using Cefalexin Sandoz

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after Cefalexin Sandoz has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while taking or soon after stopping Cefalexin Sandoz, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of Cefalexin Sandoz allows fungi to grow and the above symptoms to occur. Cefalexin Sandoz does not work against fungi.

If you become pregnant while you are taking Cefalexin Sandoz tell your doctor immediately.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Cefalexin Sandoz.

If you have to test your urine for sugar while you are using Cefalexin Sandoz, make sure your doctor knows which type of test you use. Cefalexin Sandoz may affect the results of some of these tests.

If you have to have any blood tests tell your doctor you are taking Cefalexin Sandoz. Cefalexin Sandoz may affect the results of some blood tests.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Cefalexin Sandoz.

Things you must not do

Do not stop taking Cefalexin Sandoz because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.

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

Do not use Cefalexin Sandoz to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Cefalexin Sandoz affects you. Cefalexin Sandoz may cause tiredness or dizziness in some people. Make sure you know how you react to Cefalexin Sandoz before you drive a car or do anything else that may be dangerous if you are affected.

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 Cefalexin Sandoz.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

While taking Cefalexin Sandoz

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

  • vaginal thrush - sore and itchy vagina and/or discharge
  • oral thrush - white, furry, sore tongue and mouth
  • itching of the genital area and the skin around the back passage
  • indigestion, stomach pain or discomfort
  • diarrhoea, nausea, vomiting
  • dizziness, unusual tiredness or weakness
  • headache
  • agitation, confusion
  • painful, swollen joints
  • seizure potential.

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • confusion and hallucinations (seeing, feeling or hearing things that are not there)
  • yellowing of the skin and eyes
  • dark coloured urine
  • fever
  • bleeding or bruising more easily than normal.

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, stop taking Cefalexin Sandoz and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • watery and severe diarrhoea, which may also be bloody
  • severe abdominal cramps or stomach cramps
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • any skin rash, itching, hives, blistering or peeling of the skin
  • severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
  • blood in the urine.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

After finishing Cefalexin Sandoz

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after you stop taking Cefalexin Sandoz:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above.

These are serious side effects. You may have a serious condition affecting your bowel. You may need urgent medical attention. However, these side effects are rare.

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

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Cefalexin Sandoz

Storage

Capsule

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

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

Keep your capsules in a cool dry place where the temperature stays below 25°C.

Suspension

Keep your suspension refrigerated (do not freeze). If you take the suspension out of the refrigerator, it will not keep well.

Do not use any suspension that is left in the bottle after 14 days.

Do not store Cefalexin Sandoz or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill.

Heat and dampness can destroy some medicines.

Keep Cefalexin Sandoz 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 Cefalexin Sandoz, or the capsules have passed their expiry date or more than 14 days have passed since the suspension was mixed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Cefalexin Sandoz comes as capsules and suspensions.

Cefalexin Sandoz 500 mg capsules are opaque white in colour. Each pack contains 20 capsules.

Cefalexin Sandoz 125 mg/5 mL and 250 mg/5 mL suspensions are orange-yellow in colour with a fruity flavour. Each bottle contains 100 mL.

Ingredients

Capsule

Cefalexin Sandoz capsules contain cefalexin (as monohydrate) equivalent to 500 mg of cefalexin anhydrous as the active ingredient.

The 500 mg capsule also contains magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin and titanium dioxide. The 500 mg capsule does not contain lactose, sucrose, gluten, tartrazine or azo dyes.

Suspension

Cefalexin Sandoz suspension contains cefalexin (as monohydrate) equivalent to 125 mg/5 mL or 250 mg/5 mL of cephalexin anhydrous as the active ingredient.

It also contains lactose, saccharin sodium, simethicone, citric acid anhydrous, guar galactomannan, sodium benzoate, sucrose, iron oxide yellow, strawberry, apple, raspberry and tutti frutti flavourings.

Sponsor

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

This leaflet was revised in June 2023.

Australian Register Numbers

Capsules

500 mg - AUST R 78980

Suspension

125 mg/5 mL - AUST R 78981

250 mg/5 mL - AUST R 78982

Published by MIMS August 2023

BRAND INFORMATION

Brand name

Cefalexin Sandoz 500 mg Capsules and Powder for Suspension

Active ingredient

Cefalexin

Schedule

S4

 

1 Name of Medicine

Cefalexin monohydrate.

2 Qualitative and Quantitative Composition

Cefalexin Sandoz capsules contains cefalexin (as monohydrate) equivalent to 500 mg of cefalexin anhydrous.
Cefalexin Sandoz Powder for Oral Suspension contains cefalexin (as monohydrate) equivalent to 125 mg/5 mL or 250 mg/5 mL of cefalexin anhydrous.

Excipients with known effect.

Cefalexin Sandoz Powder for Oral Suspension.

Benzoates, saccharin, sugars, lactose, milk and milk products.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Capsules.

500 mg - The capsules are white opaque in colour, containing a white to yellowish powder.

Powder for oral suspension.

The suspension is orange-yellow in colour with a fruity flavour.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of the following infections when caused by susceptible strains of the designated micro-organisms.

Respiratory tract infections.

Caused by S. pneumoniae and group A β-haemolytic Streptococci (penicillin is the usual drug 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 rheumatic fever are not available at present).

Bacterial sinusitis.

Caused by Streptococci, S. pneumoniae and S. aureus (methicillin sensitive only).

Otitis media.

Due to S. pneumoniae, Staphylococci.

Skin and skin structure infections.

Caused by Staphylococci and/or Streptococci.

Genitourinary tract infections, including acute prostatitis.

Caused by E. coli, P. mirabilis, and Klebsiella sp.
The effectiveness of cefalexin in the treatment of bacterial infections of the brain and spinal column has not been established and cefalexin is not indicated in these conditions.

Note.

Appropriate culture and susceptibility tests should be initiated prior to and during therapy to determine susceptibility of the causative organism to cefalexin. Renal function studies should be performed when indicated.

4.2 Dose and Method of Administration

Dosage.

Adults.

The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every six hours. For streptococcal pharyngitis or tonsillitis, mild, uncomplicated urinary tract infections, and skin and skin structure infections, a dosage of 500 mg may be administered every twelve hours. 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. Twice daily dosing is not recommended when doses larger than 1 g daily are administered.

Children.

The usual recommended daily dosage for children is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over one year of age, tonsillitis, mild, uncomplicated urinary tract infection, and skin and skin structure infections, the total daily dose may be divided and administered every twelve hours. See Table 1.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in four divided doses is recommended.
In the treatment of β-haemolytic streptococcal infections, a therapeutic dosage of cefalexin should be administered for at least 10 days.

Method of administration.

Administered orally.

Dosage adjustment.

Renal impairment.

See Section 4.4 Special Warnings and Precautions for Use.

4.3 Contraindications

Known allergy to the cephalosporin group of antibiotics or previous experience of a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use).
Cefalexin Sandoz is not indicated in the management of bacterial infections of the brain or spinal column.

4.4 Special Warnings and Precautions for Use

Before instituting therapy with cefalexin, every attempt should be made to determine if the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins, or other drugs. This product should be given cautiously to penicillin sensitive patients.
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 drugs.
If an allergic reaction to cefalexin occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline or other pressor amines, antihistamines or corticosteroids).
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 drug 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 drug 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.
Drugs that delay peristalsis e.g. opiates and diphenoxylate with atropine (e.g. Lomotil), may prolong and/or worsen the condition and should not be used.
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. As with other broad-spectrum antibiotics, colitis, including rare instances of pseudomembranous colitis, has been reported in conjunction with therapy with cefalexin.
Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected.
Prolonged use of cefalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported win patients taking beta-lactam antibiotics. When SCAR is suspected, cefalexin should be discontinued immediately and an alternative treatment should be considered.

Seizure potential.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue cefalexin. Anticonvulsant therapy can be given if clinically indicated.

Use in renal impairment.

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.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

The quantitative determination of urinary protein excretion using strong acids is misleading during cefalexin therapy as precipitation of cefalexin in the urine may occur.
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with Clinitest tablets, but not with Tes-Tape.
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 newborn infants whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As with other β-lactams, the renal excretion of cefalexin is inhibited by probenecid.
In healthy subjects given single 500 mg doses of cefalexin and metformin, plasma metformin Cmax and AUC increased by an average 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Laboratory experiments with animals and clinical experience shown no evidence of teratogenicity with cefalexin, but as with all drugs, Cefalexin Sandoz should be administered with caution during all stages of pregnancy.
Cefalexin is excreted in the milk. Caution should be exercised when cefalexin is administered to a breastfeeding woman. Alternative feeding arrangements for the infant should be considered.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse drug reactions reported with cefalexin are very rare (< 0.01%) and are listed below:

Blood and lymphatic system disorders.

Eosinophilia, neutropenia, thrombocytopenia, haemolytic anaemia.

Gastrointestinal disorders.

The most frequent side effect has been diarrhoea, which may rarely be severe enough to warrant cessation of therapy with cefalexin. Nausea and vomiting have been reported rarely. Dyspepsia and abdominal pain have also occurred.

General disorders and administration site conditions.

Fatigue.

Hepatobiliary disorders.

Cholestatic jaundice, transient hepatitis, slight elevations in AST and ALT have been reported.

Immune system disorders.

Allergic reactions in the form of urticaria, and angioedema have been observed. These reactions usually subsided upon discontinuation of the medicine. Anaphylaxis has also been reported.

Infections and infestations.

Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment.

Musculoskeletal and connective tissue disorders.

Arthralgia, arthritis and joint disorders.

Nervous system disorders.

Dizziness, headache, seizure potential.

Psychiatric disorders.

Hallucinations, agitation, confusion.

Renal and urinary disorders.

Reversible interstitial nephritis has been reported rarely.

Reproductive and breast disorders.

Genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge.

Skin and subcutaneous tissue disorders.

Rash, erythema multiforme.
These reactions usually subsided upon discontinuation of the drug.
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

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, gastrointestinal disturbances and haematuria.
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.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

A semisynthetic cephalosporin antibiotic for oral administration. The nucleus of cefalexin is related to that of other cephalosporin antibiotics.

Mechanism of action.

Microbiology. In vitro tests demonstrate that the cephalosporins are bactericidal because they inhibit cell wall synthesis. Cefalexin is active against the following organisms in vitro: β-haemolytic Streptococci, Staphylococci, including coagulase-positive, coagulase-negative, and penicillinase producing strains, Streptococcus (Diplococcus) pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella sp.

Note.

Most strains of Enterococci (Enterococcus faecalis) and a few strains of Staphylococci are resistant to cefalexin. It is not active against most strains of Enterobacter sp., Morganella morganii (formerly Pr. morganii), and Pr. vulgaris. It has no activity against Pseudomonas or Acinetobacter calcoaceticus (formerly Mima and Herellea sp.). When tested by in vitro methods, Staphylococci exhibit cross-resistance between cefalexin and methicillin type antibiotics.
Disc susceptibility tests. Dilution or diffusion techniques - either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, 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 drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable, other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating with severe infections.

Clinical trials.

Not applicable.

5.2 Pharmacokinetic Properties

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 microgram/mL, respectively were obtained at one hour. Measurable levels were present six hours after administration.

Distribution.

No data available.

Metabolism.

No data available.

Excretion.

Cefalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug is 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 microgram/mL, respectively.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Capsule 500 mg.

Magnesium stearate and microcrystalline cellulose. The capsule shell also contains gelatin and titanium dioxide.

Suspension.

Saccharin sodium, iron oxide yellow, simethicone, citric acid, strawberry, apple, raspberry and tutti frutti artificial flavouring, guar gum, sodium benzoate, and sucrose.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Capsule 500 mg.

Store below 25°C.

Powder for oral suspension.

Before mixing: Store below 25°C. Protect from light and moisture.
After mixing: Store at 2 to 8°C. (Refrigerate. Do not freeze.)

6.5 Nature and Contents of Container

Capsules.

Cefalexin Sandoz capsules 500 mg: Each blister pack contains 20 capsules.

Powder for oral suspension.

It is available in bottle pack sizes of 60 mL, 75 mL or 100 mL containing PE/PP child resistant screw closure with liner.
Not all presentations may be marketed in Australia.

6.6 Special Precautions for Disposal

Other handling.

Directions for mixing.

Reconstitution of Cefalexin Sandoz granules for oral suspension 125 mg/5 mL.

Invert bottle and tap to loosen granules. Add 64 mL of water to make up 100 mL. Close and shake well at once. Store the prepared suspension under refrigeration (2 to 8°C), and use within 14 days of preparation. Shake well before use.

Reconstitution of Cefalexin Sandoz granules for oral suspension 250 mg/5 mL.

Invert bottle and tap to loosen granules. Add 63 mL of water to make up 100 mL. Close and shake well at once. Store the prepared suspension under refrigeration (2 to 8°C), and use within 14 days of preparation. Shake well before use.
Discard unused portion 14 days after reconstitution.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

The compound is a zwitterion; i.e. the molecule contains both a basic and an acidic group. The isoelectric point of cefalexin in water is approximately 4.5 to 5. The crystalline form of cefalexin, 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. Cefalexin has a d-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.

Chemical structure.


Chemical name: (6R,7R)-7-[(R)-2-amino-2-phenylacetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
Molecular formula: C16H17N3O4S.H2O.
Molecular weight: 365.41.

CAS number.

23325-78-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes