Consumer medicine information

Ialex Powder for oral suspension

Cephalexin

BRAND INFORMATION

Brand name

Ialex Powder for oral suspension

Active ingredient

Cephalexin

Schedule

What is in this leaflet

This leaflet answers some common questions about Ialex. 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 Ialex 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 Ialex is used for

Ialex contains cephalexin 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 (genitourinary tract).

This medicine 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.

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take Ialex if you have an allergic reaction to:

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

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.

Do not take Ialex suspension if it has been in your refrigerator for longer than two weeks.

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 are allergic to any other medicines or any 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 Ialex.

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 Ialex may interfere with each other.

These include:

probenecid (e.g. Pro-Cid), a medicine commonly used to treat gout
metformin, a medicine used in the treatment of diabetes.

These medicines may be affected by Ialex or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Ialex.

How to take it

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 or bottle, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much and how often you should take Ialex.

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

How to take it

Ialex capsules:
Swallow the capsules whole with a full glass of water.

Ialex suspension:
Shake the bottle well and accurately measure the dose with a medicine measure.

Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can buy a medicine measure from your pharmacist.

When to take it

It does not matter if you take this medicine with or without food.

How long to take it

Continue taking Ialex for as long as your doctor tells you.

It is important to complete the full course prescribed by your doctor, even if you begin to feel better after a few days. If you do not, the bacteria causing 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 (13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Ialex. 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, blood in the urine, unusually increased reflexes, convulsions or hallucinations.

While you are taking it

Things you must do

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

Tell any other doctors, dentists and pharmacists who are treating you that you are taking Ialex, especially if you are about to be started on any new medicines.

Tell your doctor if you become pregnant while taking this medicine.

If you are about to have any blood tests, tell your doctor that you are taking Ialex.

It may interfere with the results of some tests.

If you are diabetic, check with your doctor or pharmacist before using urine sugar tests.

Ialex 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 Ialex 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 change the dosage without first 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 Ialex affects you.

It may cause dizziness or drowsiness in some people.

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 Ialex.

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

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.

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

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 more common side effects of your medicine.

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

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. Serious side effects are rare.

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

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

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

You may have a serious condition affecting your bowel requiring urgent medical attention.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

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.

This is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.

Tell your doctor or pharmacist if you notice anything else 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.

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

After taking it

Storage

Ialex capsules:

Keep the capsules in the blister pack until it is time to take them.
If you take the capsules out of the blister pack, they may not keep as well.
Keep it in a cool dry place where the temperature stays below 30°C (for the 250 mg capsules) and below 25°C (for the 500 mg capsules).
Keep it 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.
Do not store it 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.

Ialex suspension:

Keep the suspension in the refrigerator between 2° and 8°C where young children cannot reach it. Do not freeze.
Keep the bottle tightly closed.
The suspension should be shaken well before use and discarded after 14 days.

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

Ialex capsules:

Ialex 250 mg capsules are opaque dark green and white, marked with "GP1"on the cap and body. They are available in packs of 20.
Ialex 500 mg capsules are opaque dark green and light green, marked with "GP2" on the cap and body. They are available in packs of 20.

Ialex suspension:
Your pharmacist will make up the medicine in the bottle before dispensing it to you. The resulting suspension is pink.

It is available in two different strengths:

125 mg/5 mL
250 mg/5 mL.

Ingredients

Ialex capsules:
Ialex capsules contain cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin as the active ingredient.

They also contain the inactive ingredients:

dimethicone 350
magnesium stearate
avicel RC 591.

The capsule shell contains gelatin, patent blue V, quinoline yellow, titanium dioxide and colorcon S-1-8144 HV black ink.

Ialex capsules do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Ialex suspension:
Ialex suspensions contain 125 mg/5 mL or 250 mg/5 mL of cephalexin monohydrate as the active ingredient.

They also contain:

sodium lauryl sulphate
methylcellulose
dimethicone 350
xanthan gum
starch - pregelatinised maize
allura red AC CI 16035
sucrose
tuttifrutti 51880 TP0551.

Ialex suspensions do not contain lactose, gluten or tartrazine.

BRAND INFORMATION

Brand name

Ialex Powder for oral suspension

Active ingredient

Cephalexin

Schedule

Name of the medicine

Cephalexin monohydrate.

Excipients

Capsules.

Avicel RC 591, dimethicone 350 and magnesium stearate. The capsule shell consists of patent blue V, quinoline yellow, titanium dioxide, gelatin and colorcon S-1-8144 black ink.

Powder for oral liquid in bottles.

Sodium lauryl sulphate, allura red AC, methylcellulose, dimethicone 350, xanthan gum, pregelatinised maize starch, tuttifrutti 51880 TP0551 and sucrose.

Powder for oral liquid in sachets.

Erythrosine (125 mg/5 mL), sunset yellow FCF (250 mg/5 mL), tuttifrutti 51880 TP0551 and sucrose.

Description

Chemical name: 7-(d-α-amino-α- phenyl-acetamido)- 3-methyl-3-cephem-4- carboxylic acid, monohydrate. Ialex (cephalexin monohydrate) is a semisynthetic cephalosporin antibiotic for oral administration.
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.

Pharmacology

Human pharmacology.

Ialex 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. Cephalexin 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 eight hours. During this period, peak urine concentrations following the 250 mg, 500 mg and 1 g doses were approximately 1,000, 2,200 and 5,000 microgram/mL, respectively.

Microbiology.

In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell wall synthesis. Ialex 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 Ialex. 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 Ialex and methicillin type antibiotics.

Disc susceptibility.

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 shown in Table 1.

Indications

Ialex 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 β-haemolytic Streptococci. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Ialex is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Ialex 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 Ialex in the treatment of bacterial infections of the brain and spinal column has not been established and Ialex 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 Ialex. Renal function studies should be performed when indicated.

Contraindications

Ialex is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or who have previously experienced a major allergy to penicillin (see Precautions).

Precautions

Before instituting therapy with cephalexin, 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 Ialex occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline 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 the 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 Cl. 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 Ialex 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.
Ialex 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 pregnancy.

(Category A)

Use in lactation.

Ialex is excreted in the milk. Caution should be exercised when Ialex is administered to a breastfeeding woman. Alternative feeding arrangements for the infant should be considered.

Interactions

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

Effects on laboratory tests

The quantitative determination of urinary protein excretion using strong acids is misleading during Ialex therapy as precipitation of cephalexin 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 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.

Adverse Effects

Adverse drug reactions reported with cephalexin 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 ALT, elevated AST.

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.

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, Stevens-Johnson syndrome, toxic epidermal necrolysis.
These reactions usually subsided upon discontinuation of the drug.

Dosage and Administration

Ialex 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 six 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 Ialex 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 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 2.)

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 four divided doses is recommended.
In the treatment of β-haemolytic streptococcal infections, a therapeutic dosage of Ialex should be administered for at least ten days.

Impaired renal function.

See Precautions.

Overdosage

There is no definite experience of poisoning or severe overdosage with cephalexin. 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 cephalexin.
Contact the Poisons Information Centre on 131 126 for management of overdose.

Presentation

Capsules (opaque, hard gelatin, marked on cap and body), cephalexin 250 mg (dark green/white, size 1, marked GP1), 500 mg (dark green/light green, size 0, marked GP2): 2's* (sample), 20's (pack).
Powder for oral liquid (white, free flowing powder forming red suspension after reconstitution), cephalexin 125 mg/5 mL, 250 mg/5 mL: sample sachets* (3's), bottle (100 mL).
*Not currently marketed in Australia.