Consumer medicine information

Ibilex

Cefalexin

BRAND INFORMATION

Brand name

Ibilex

Active ingredient

Cefalexin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ibilex.

What is in this leaflet

This leaflet answers some common questions about IBILEX.

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

All medicines have benefits and risks. Your doctor has weighed the risks of you taking IBILEX against the benefits expected for you.

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

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

What IBILEX is used for

IBILEX contains cefalexin monohydrate as the active ingredient.

It is used to treat infections caused by bacteria in different parts of the body, including infections of the:

  • respiratory tract (throat, tonsils, chest and lungs)
  • nose (sinusitis)
  • ears (otitis media)
  • skin and soft tissue
  • kidneys and bladder (urinary tract).

IBILEX is an antibiotic that belongs to a group of medicines called cephalosporins. These medicines work by killing the bacteria that are causing your infection.

Ask your doctor if you have any questions about why IBILEX has been prescribed for you. Your doctor may have prescribed IBILEX for another reason.

IBILEX will not work against infections caused by viruses, such as colds or flu.

IBILEX is available only with a doctor's prescription.

There is no evidence that IBILEX is addictive.

Before you take IBILEX

When you must not take it

Do not take IBILEX if you are allergic to:

  • any medicine containing cefalexin monohydrate
  • other cephalosporins
  • any of the ingredients listed at the end of this leaflet.

Do not take IBILEX if you have had a serious allergic reaction to penicillin. You may have an increased chance of being allergic to IBILEX if you are allergic to penicillins.

Some of the symptoms of an allergic reaction may include skin rash, itching; shortness of breath; swelling of the face, lips, tongue or other parts of the body.

Do not take IBILEX if the expiry date printed on the pack or bottle has passed. If you take this medicine after the expiry date, it may not work as well.

Do not take IBILEX if the packaging shows signs of tampering or the capsules or mixture do not look quite right.

Before you start to take it

Tell your doctor if you have had any type of allergic reaction to penicillin antibiotics. You may have an increased chance of being allergic to IBILEX if you are allergic to penicillins.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding. Your doctor will discuss the risks and benefits of taking IBILEX.

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

  • liver problems
  • kidney problems
  • bowel problems.

Your doctor may want to take special care if you have any of these conditions.

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

Taking other medicines

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

Some medicines may be affected by IBILEX, or may affect how well it works. These include:

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

Your doctor can tell you what to do if you are taking this medicine.

Talk to your doctor about the need for additional contraception while taking IBILEX. Some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with IBILEX.

How to take IBILEX

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

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

How much to take

Adults

Your doctor will tell you how much IBILEX you need to take each day and when to take it.

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

Children

The dose for children will depend on the child's age, weight and the type of infection. Your doctor and pharmacist will tell you how much IBILEX your child should take.

How to take IBILEX

Capsules:

Swallow whole with a glass of water.

Suspension:

Shake the bottle well then accurately measure the correct dose. Always use a metric measure.

When to take IBILEX

IBILEX can be taken with or without food.

Take IBILEX at about the same time each day, spaced evenly apart. This will allow IBILEX to have its best effect and also help you remember when to take it.

How long to take IBILEX for

Keep taking IBILEX until you finish the pack or bottle, or for as long as your doctor recommends.

Do not stop taking IBILEX, even if you feel better, unless advised by your doctor. Your infection may not clear completely if you stop taking your medicine too soon.

If you forget to take IBILEX

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 the missed dose 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 you missed.

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

If you take too much IBILEX (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much IBILEX. Do this even if there are no signs of discomfort or poisoning. If you have taken too much IBILEX, you may feel sick in the stomach, experience diarrhoea, or have convulsions or hallucinations.

While you are taking IBILEX

Things you must do

If your symptoms 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 you have stopped taking IBILEX. 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 checking with your doctor.

If you become pregnant while taking IBILEX, tell your doctor.

Before starting any new medicine, tell your doctor or pharmacist that you are taking IBILEX.

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

If you have to have any blood or urine tests, tell your doctor that you are taking IBILEX. IBILEX may affect the results of some tests.

Things you must not do

Do not stop taking IBILEX or lower the dose because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, your infection may not clear completely or your symptoms may return.

Do not use IBILEX to treat any other conditions unless your doctor tells you to.

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

Things to be careful of

If you get a sore, white mouth or tongue while taking or soon after stopping IBILEX, 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 IBILEX allows fungi to grow and the above symptoms to occur. IBILEX does not work against fungi.

Be careful driving or operating machinery until you know how IBILEX affects you. IBILEX generally does not cause any problems with your ability to drive a car or operate machinery. However, IBILEX may rarely cause dizziness, tiredness or fatigue in some people. If this occurs, do not drive, operate machinery or do anything else that may 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 IBILEX. IBILEX treats infections in most people and is usually well tolerated, but it may have unwanted side effects in some people. These side effects are very rare.

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.

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

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

While you are taking IBILEX

Tell your doctor 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 milder side effects of IBILEX. They are usually short-lived.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital 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
  • seizure potential
  • bleeding or bruising more easily than normal.

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

After you have finished taking IBILEX

Tell your doctor immediately if you notice any of the following, even if they occur several weeks after stopping treatment with IBILEX:

  • severe stomach cramps or pain
  • severe, watery or bloody diarrhoea
  • fever, in combination with one of the above.

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

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

After taking IBILEX

Storage

Keep IBILEX 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.

Keep your capsules in the pack until it is time to take them. If you take your capsules out of the pack, they may not keep as well.

Keep your capsules in a cool dry place where the temperature stays below 30°C.

Keep IBILEX suspension in the refrigerator but not in the freezer, and keep the bottle tightly closed. Do not use any mixture that is left in the bottle after 14 days.

Do not store IBILEX or any other medicine in the bathroom or near a sink.

Do not leave IBILEX in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking IBILEX, or your medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

IBILEX is available as capsules or suspensions.

CAPSULES

The capsules come in two strengths:

  • IBILEX 250 - green and white capsule
  • IBILEX 500 - dark green and light green capsule

Each pack contains 20 capsules.

SUSPENSIONS

The suspensions come in two strengths:

  • IBILEX 125 - A white free-flowing powder before reconstitution and a red, fruity bubble gum flavoured suspension after reconstitution.
  • IBILEX 250 - A white free-flowing powder before reconstitution and a red, fruity bubble gum flavoured suspension after reconstitution.

Each bottle contains 100 mL when reconstituted with water.

Ingredients

The active ingredient in IBILEX capsules and suspensions is cefalexin monohydrate.

  • each IBILEX 250 capsule contains 250 mg of cefalexin (as monohydrate)
  • each IBILEX 500 capsule contains 500 mg of cefalexin (as monohydrate)
  • each 5 mL of IBILEX 125 suspension contains 125 mg of cefalexin (as monohydrate)
  • each 5 mL of IBILEX 250 suspension contains 250 mg of cefalexin (as monohydrate).

CAPSULES

The capsules also contain the following inactive ingredients:

  • Avicel RC 591
  • dimeticone 350
  • magnesium stearate
  • gelatin
  • patent blue V
  • quinoline yellow
  • titanium dioxide

SUSPENSIONS

The suspensions contain the following inactive ingredients:

  • sodium lauryl sulfate
  • allura red AC
  • methylcellulose
  • dimeticone 350
  • xanthan gum
  • pregelatinised maize starch
  • sucrose
  • tuttifrutti 51880 TP0551.

IBILEX suspensions contain sugars.

IBILEX capsules and suspensions do not contain gluten, lactose or tartrazine.

Supplier

IBILEX is supplied by:

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in July 2023.

Australian registration numbers:

Capsules
IBILEX 250 - AUST R 73524
IBILEX 500 - AUST R 73525

Suspensions
IBILEX 125 - AUST R 92972
IBILEX 250 - AUST R 92973

IBILEX® is a Viatris company trade mark

IBILEX_cmi\Jul23/00

Published by MIMS August 2023

BRAND INFORMATION

Brand name

Ibilex

Active ingredient

Cefalexin

Schedule

S4

 

1 Name of Medicine

Cefalexin monohydrate.

2 Qualitative and Quantitative Composition

Each capsule (pulvule) contains cefalexin monohydrate equivalent to 250 mg or 500 mg of cefalexin.
Powder for oral liquid in bottle contains cefalexin monohydrate equivalent to 125 mg or 250 mg of cefalexin per 5 mL upon reconstitution.

Excipient with known effect.

Powder for oral liquid contains sugars.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ibilex 250 capsules.

An opaque green and white capsule, size 1 containing 250 mg cefalexin.

Ibilex 500 capsules.

An opaque dark green and light green capsule, size 0 containing 500 mg cefalexin.

Ibilex 125 powder for oral liquid.

A white free-flowing powder before reconstitution and a red suspension after reconstitution containing 125 mg cefalexin per 5 mL.

Ibilex 250 powder for oral liquid.

A white free-flowing powder before reconstitution and a red suspension after reconstitution containing 250 mg cefalexin per 5 mL.

4 Clinical Particulars

4.1 Therapeutic Indications

Ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms.
Respiratory tract infections caused by S. pneumoniae and group A beta-haemolytic Streptococci. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefalexin monohydrate is generally effective in the eradication of Streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefalexin monohydrate 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 soft tissue 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 Ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and Ibilex 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 Ibilex. Renal function studies should be performed when indicated.

4.2 Dose and Method of Administration

Ibilex 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 streptococcal pharyngitis or tonsillitis, mild, uncomplicated urinary tract infections, and skin and soft tissue infections, a dosage of 500 mg may be administered every 12 hours.
For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Ibilex 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 1 year of age, tonsillitis, mild, uncomplicated urinary tract infection, and skin and soft tissue infections, the total daily dose may be divided and administered every 12 hours. See Table 1.
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 recommended.
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dosage of Ibilex should be administered for at least 10 days.

4.3 Contraindications

Ibilex is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or who have previously experienced a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Before instituting therapy with cefalexin monohydrate, 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 Ibilex occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline (epinephrine) or other pressor amines, antihistamines or corticosteroids).
Antibiotic associated pseudomembranous colitis has been reported with virtually all broad spectrum antibiotics (including macrolides, semisynthetic penicillins and cephalosporins). 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 patients 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 Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Broad spectrum antibiotics should therefore be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected.
Prolonged use of Ibilex 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.

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 Ibilex. Anticonvulsant therapy can be given if clinically indicated.

Use in renal impairment.

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

Use in the elderly.

No data available.

Paediatric use.

No data available.

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 in patients taking beta-lactam antibiotics. When SCAR is suspected, Ibilex should be discontinued immediately and an alternative treatment should be considered.

Effects on laboratory tests.

The quantitative determination of urinary protein excretion using strong acids is misleading during Ibilex therapy as precipitation of cefalexin monohydrate in the urine may occur.
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with Clinitest.
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 drug.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As with other β-lactams, the renal excretion of Ibilex is inhibited by probenecid.
In healthy subjects given single 500 mg doses of cefalexin monohydrate 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 monohydrate 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
 Cefalexin monohydrate is excreted in the milk. Caution should be exercised when Ibilex is administered to a nursing 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 monohydrate are very rare (< 0.01%) and are listed below.

Blood and lymphatic system disorders.

Eosinophilia, neutropenia, thrombocytopenia, haemolytic anaemia.

Gastrointestinal disorders.

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain.

General disorders and administration site conditions.

Fatigue.

Hepatobiliary disorders.

Cholestatic jaundice, transient hepatitis, elevated SGOT, elevated SGPT.

Immune system disorders.

Allergic reactions, urticaria, angioedema.
These reactions usually subsided upon discontinuation of the drug.
Anaphylaxis has also been reported.

Infections and infestations.

Pseudomembranous colitis.

Musculoskeletal and connective tissue disorders.

Joint disorder, arthralgia, arthritis.

Nervous system disorders.

Dizziness, headache, seizure potential.

Psychiatric disorders.

Hallucinations, agitation, confusion.

Renal and urinary disorders.

Reversible interstitial nephritis.

Reproductive and breast disorders.

Genital and anal pruritus, genital moniliasis, vaginitis, 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 monohydrate. However, clinical features of overdosage may be similar to those seen with other cephalosporins and penicillins, i.e. convulsions, hallucinations, hyper-reflexia, 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 monohydrate.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell wall synthesis. Ibilex is active against the following organisms in vitro: Beta-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 Ibilex. It is not active against most strains of Enterobacter sp., Morganella morganii (formerly Proteus morganii) and Proteus 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 monohydrate 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 severe infections.
Minimal inhibitory concentration (MIC) breakpoints. Zone diameters, reported off cephalothin discs, are provided with corresponding breakpoints. See Table 2.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Ibilex 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 1 hour. Measurable levels were present 6 hours after administration.

Excretion.

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

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each capsule (pulvule) contains Avicel RC 591 (ARTG PI No: 2530), dimeticone 350, magnesium stearate, patent blue V, quinoline yellow, titanium dioxide and gelatin.
Powder for oral liquid in bottle contains sodium lauryl sulfate, allura red AC, methylcellulose, dimeticone 350, xanthan gum, pregelatinised starch, Tuttifrutti 51880 TP0551 (ARTG PI No: 1775) and sucrose.

6.2 Incompatibilities

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

Ibilex capsules.

Ibilex 250 mg and 500 mg: Store below 30 degrees Celsius.

Ibilex powder for oral liquid.

Store below 25 degrees Celsius and protect from light. Upon reconstitution, the suspension must be stored in a refrigerator between 2 and 8 degrees Celsius. Do not freeze. Discard unused portion 14 days after mixing.

6.5 Nature and Contents of Container

Ibilex 250 and 500 capsules: PVC/Al blister pack of 20.
Ibilex 125 and 250 Powder for oral liquid: HDPE bottle of 100 mL.

Australian register of therapeutic goods (ARTG).

AUST R 73524 - Ibilex 250 cefalexin 250 mg capsule blister pack.
AUST R 73525 - Ibilex 500 cefalexin 500 mg capsule blister pack.
AUST R 92972 - Ibilex 125 cefalexin 125 mg/5 mL powder for oral liquid bottle.
AUST R 92973 - Ibilex 250 cefalexin 250 mg/5 mL powder for oral liquid bottle.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: 7-(D-α-amino-α-phenyl-acetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate.
Structural:
Molecular formula: C16H17N3O4S.H2O.
Molecular weight: 365.41.

CAS number.

23325-78-2.
The nucleus of cefalexin monohydrate 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 cefalexin monohydrate in water is approximately 4.5 to 5.
The crystalline form of cefalexin 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. Cefalexin monohydrate has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes