Consumer medicine information

Noumed Cefalexin

Cefalexin

BRAND INFORMATION

Brand name

Noumed Cefalexin

Active ingredient

Cefalexin

Schedule

What is in this leaflet

This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking NOUMED CEFALEXIN against the benefits it is expected to have for you.

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

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

What this medicine is used for

NOUMED CEFALEXIN capsules contain cefalexin. Cefalexin is an antibiotic used to treat infections in different parts of the body caused by bacteria. NOUMED CEFALEXIN can be used to treat infections of the:

Respiratory tract (throat, tonsils, chest and lungs)
Nose (sinusitis)
Ears (otitis media)
Skin
Kidneys and bladder (genitourinary tract)

NOUMED CEFALEXIN capsules belong to a group of antibiotic medicines called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.

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

NOUMED CEFALEXIN Capsules are available only with a doctor's prescription.

Before taking this medicine

When you must not take it

Do not take NOUMED CEFALEXIN if:

You have had an allergic reaction to NOUMED CEFALEXIN, any other medicine containing cefalexin, or other cephalosporins or any of the ingredients listed at the end of this leaflet. Signs of an allergic reaction may include itching of the skin, shortness of breath and swelling of the tongue or face.
You have had a serious allergic reaction to penicillin.
The packaging is torn or shows signs of tampering.
The expiry date on the pack has passed. If you take this medicine after the expiry date has passed, it may have no effect at all, or worse, an unexpected effect.

There is no evidence that NOUMED CEFALEXIN is addictive.

Before you start to take it

Your doctor must know about all the following before you start to take NOUMED CEFALEXIN capsules.

You must tell your doctor if:

You have had any type of allergic reaction to any medicine containing a penicillin antibiotic, or any other antibiotic. You may have an increased chance of being allergic to NOUMED CEFALEXIN, any other medicines containing cefalexin or other cephalosporins, or if you are allergic to penicillins.
You are taking any metformin medicines (oral blood glucose lowering drugs) such as Diabex, Glucophage.
You have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
You are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop.
You have ever had liver, kidney or bowel disease.
You are pregnant or intend to become pregnant.
You are breastfeeding or plan to breastfeed.

If you have not told your doctor about any of these things, tell him/her before you start taking NOUMED CEFALEXIN.

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 NOUMED CEFALEXIN may interfere with each other e.g.

probenecid, a medicine commonly used to treat gout
sulfinpyrazone, another medicine used to treat gout
metformin, a medicine used in the treatment of diabetes
aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin etc.
heparin, warfarin, coumarin or other blood thinning medicines
non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (e.g. aspirin, diclofenac, ibuprofen etc.)
antacids, medicines used to treat heartburn and indigestion

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

Your doctor or health care professional may have more information on medicines to be careful with or to avoid while being given NOUMED CEFALEXIN.

How to take this medicine

How much to take

Your doctor will tell you how much and how often you should take NOUMED CEFALEXIN. This will depend on the type of infection. The dose varies from patient to patient.

How to take it

NOUMED CEFALEXIN capsules should be swallowed whole with a glass of water.

When to take it

NOUMED CEFALEXIN can be taken with or without food.

How long to take it

Continue taking NOUMED CEFALEXIN until you finish the blister pack or for as long as your doctor tells you.

Keep taking NOUMED CEFALEXIN for the full time of treatment, even if you begin to feel better after a few days. If you do not complete the full course prescribed by your doctor, your infection may not clear completely or your symptoms may return.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take a dose as soon as you remember, and then go back to taking your capsules as you would normally. Do not take a double dose to make up for the dose that you missed.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (13 11 26) for advice, or go to your nearest hospital casualty department if you think you or anyone else has taken too many NOUMED CEFALEXIN capsules. Do this even if there are no signs of discomfort or poisoning.

If you take too many NOUMED CEFALEXIN capsules, you may feel sick in the stomach or experience diarrhoea.

While you are taking this medicine

Things you must do

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

If you become pregnant while you are taking NOUMED CEFALEXIN, tell your doctor.

If you are about to start taking any new medicine, tell your doctor or pharmacist that you are taking NOUMED CEFALEXIN.

If you have to test your urine for sugar while you are taking NOUMED CEFALEXIN, make sure that your doctor knows about the type of test you use. NOUMED CEFALEXIN may affect the results of some of these tests.

If you have to have any blood tests, tell your doctor you are taking NOUMED CEFALEXIN because it may affect the results of some of these tests.

Tell all doctors, dentists and pharmacists who are treating you that you are taking NOUMED CEFALEXIN.

Tell your doctor or pharmacist before you start any new medicine while you are taking NOUMED CEFALEXIN.

Things you must not do

Do not stop taking NOUMED CEFALEXIN capsules 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 give NOUMED CEFALEXIN to anyone else, even if their symptoms are similar to yours.

Do not take NOUMED CEFALEXIN to treat other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how NOUMED CEFALEXIN affects you. NOUMED CEFALEXIN generally do not cause any problems with your ability to drive a car or operate machinery. NOUMED CEFALEXIN may cause dizziness or drowsiness in some people.

Side effects

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

Like other medicines, NOUMED CEFALEXIN can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention. Many of the side effects are dose related, so it is important you never exceed the stated dose.

While you are taking NOUMED CEFALEXIN

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
Indigestion/ flatulence
Dizziness
Unusual tiredness/weakness
Abdominal pain
Headache

These are the most common side effects of NOUMED CEFALEXIN capsules.

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
Joint pain
Yellowing of the skin or eyes
Confusion and hallucinations
Bleeding or bruising more easily than normal
Change in the color and/ or amount of urine

These are serious side effects. You may need medical attention. These sides effect is very rare.

Tell your doctor immediately or go to casualty at your hospital if you notice any of the following:

Sudden signs of allergy such as severe body rash, itching or hives on the skin with swelling of the tongue, lips or face and other parts of the body

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

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with NOUMED CEFALEXIN capsules:

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

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

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

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

Do not be alarmed by this list of possible side effects. You may not experience any of them. Tell your doctor if you notice any symptoms that worry you, even if you think the problems are not connected with the medicine or are not listed in this leaflet.

After using this medicine

Storage

Keep your capsules in the blister pack until it is time to take them. If you take your capsules out of the blister pack, they may not keep as well. Keep your capsules in a cool dry place where the temperature stays below 25°C.

All medicines should be kept where young children cannot reach them. There will be an expiry date (month, year) on the outer box and imprinted on the end of each blister strip. The medicine should not be taken after this date.

Disposal

If your doctor tells you to stop taking NOUMED CEFALEXIN capsules or you find that they have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.

Product description

What it looks like

NOUMED CEFALEXIN 500 mg capsules are dark green and light green, imprinted with RX657.

Available in blister packs of 20.

Ingredients

Active Ingredient:

Cefalexin

Inactive Ingredients:

Lactose, magnesium stearate, gelatin, iron oxide yellow, titanium dioxide, Brilliant Blue FCF and Sunset Yellow FCF. The printing ink contains shellac, absolute ethanol, isopropyl alcohol, butan-1-ol, propylene glycol, ammonia, iron oxide black, potassium hydroxide and purified water.

Australian Registration Numbers

NOUMED CEFALEXIN 500 mg: AUST R 326442

Sponsor

Avallon Pharmaceuticals Pty Ltd
Level 5, 7 Eden Park Drive
Macquarie Park NSW 2113
Australia

This leaflet was prepared in May 2020.

Published by MIMS February 2021

BRAND INFORMATION

Brand name

Noumed Cefalexin

Active ingredient

Cefalexin

Schedule

1 Name of Medicine

Cefalexin monohydrate.

2 Qualitative and Quantitative Composition

Noumed Cefalexin capsules contain cefalexin which is a semisynthetic cephalosporin antibiotic intended for oral administration. Cefalexin is a white or almost white, crystalline powder. It is sparingly soluble in water and practically insoluble in alcohol.
Noumed Cefalexin capsules do not contain gluten.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dark green and light green, self-locked hard gelatin capsules of size 0, imprinted with RX657 in black ink, containing white to off-white granular powder/pellets.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of the following bacterial infections when caused by susceptible strains of the designated microorganisms.

Respiratory tract infections.

Streptococcus pneumoniae and group A β-haemolytic streptococci. Although 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. Substantial data establishing the efficacy of cefalexin in the subsequent prevention of rheumatic fever are not available at present.

Bacterial sinusitis.

Streptococci, Streptococcus pneumoniae and Staphylococcus aureus (methicillin sensitive only).

Otitis media.

Streptococcus pneumoniae, Staphylococci (methicillin sensitive only).

Skin and skin structure infections.

Staphylococci (methicillin sensitive only) and/or Streptococci.

Genitourinary tract infections, including acute prostatitis.

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 Noumed Cefalexin capsules are not indicated in these conditions (see Section 4.3 Contraindications).

Note.

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

4.2 Dose and Method of Administration

Dose.

Cefalexin is acid stable and may be given without regard to the administration of food, at a usual dose frequency of three or four times daily.

Adults.

The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every six hours. Twice daily administration of Noumed Cefalexin capsules are not recommended when doses larger than 1 g daily are administered.

Method of administration.

Noumed Cefalexin capsules are intended only for oral administration.

Dosage adjustment in.

Renal impairment.

Noumed Cefalexin capsules 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.

Severe infections.

For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Streptococcal pharyngitis/tonsillitis/urinary tract infections/skin infections.

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.

Antibiotics.

As with all antibiotics, treatment with Noumed Cefalexin capsules should continue for at least two days after the temperature has returned to normal and the symptoms have subsided.

4.3 Contraindications

Previous history of hypersensitivity to cephalosporins or any of the excipients. 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).
Noumed Cefalexin capsules are not indicated in the management of bacterial infections of the brain or spinal column.

4.4 Special Warnings and Precautions for Use

Except under special circumstances, this medication should not be used when the following medical problem exists.

Allergic reaction (anaphylaxis).

Before instituting therapy with cefalexin, every attempt should be made to determine if the patient has had previous allergic reaction (anaphylaxis) to penicillins, penicillin derivatives, penicillamine, or cephalosporins or other medicines.
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. Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to Noumed Cefalexin capsules occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline or other pressor amines, antihistamines or corticosteroids).
Prescribing cefalexin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Prolonged use of Noumed Cefalexin capsules may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Risk-benefit should be considered when the following medical problems exist.

Gastrointestinal disease.

History of colitis.

Broad spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis. As with other broad spectrum antibiotics, colitis, including rare instances of pseudomembranous colitis (see below), has been reported in conjunction with therapy with cefalexin.

Pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics (such as macrolides, semisynthetic penicillins and cephalosporins) 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 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 C. difficile should be considered. Fluids, electrolytes and protein replacement 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.

Use in renal impairment.

Many cephalosporins are excreted renally. Noumed Cefalexin capsules should thus 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 hepatic impairment.

It is recommended that patients with severe liver disease receive a reduced dosage of cefalexin.

Use in the elderly.

Cephalosporins have been used in the geriatric population, and no geriatrics-specific problems have been documented to date. However, elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment in dosage and/or dosing interval in patients receiving cephalosporins.

History of bleeding disorders.

All cephalosporins may cause hypoprothrombinemia and, potentially, bleeding.

Dental.

Long-term therapy with cephalosporins may allow for the overgrowth of Candida albicans resulting in oral candidiasis.

Carnitine deficiency.

Some cephalosporins increase renal excretion of carnitine.

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, Noumed Cefalexin should be discontinued immediately and an alternative treatment should be considered.

Effects on laboratory tests.

Positive direct Coombs' tests have been reported during treatment with 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.
A false positive reaction for glucose in urine may occur with Benedict's and Fehling's solutions and Clinitest tablets, but not with Tes-Tape. Quantitative determination of urinary excretion using strong acids is misleading as precipitation of cefalexin in the urine may occur.
Cefalexin can interfere with the Jaffle method of measuring creatinine, giving a falsely high reading; this should be borne in mind when measuring renal function.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Aminoglycoside antibiotics.

Renal function should be monitored carefully in patients receiving cephalosporins and aminoglycosides concurrently.

Anticoagulants, coumarin- or indandione-derivative, or heparin or thrombolytic agents.

Because all cephalosporins can inhibit vitamin K synthesis by suppressing gut flora, prophylactic vitamin K therapy is recommended when any of these medications is used for prolonged periods in malnourished or seriously ill patients.

Platelet aggregation inhibitors.

Hypoprothrombinemia induced by large doses of salicylates and/or cephalosporins, and the gastrointestinal ulcerative or hemorrhagic potential of nonsteroidal anti-inflammatory drugs [NSAIDs], salicylates, or sulfinpyrazone may increase the risk of haemorrhage.

Antacids or ranitidine or histamine H₂-receptor antagonists.

Concurrent use of high doses of antacids or H₂-receptor antagonists or ranitidine may have effects on peak plasma levels of cephalosporins.

Probenecid.

Probenecid decreases renal tubular secretion of those cephalosporins excreted by this mechanism, resulting in increased and prolonged cephalosporin serum concentrations, prolonged elimination half-life, and increased risk of toxicity.

Metformin.

Concurrent administration resulted in increase of cefalexin serum concentration (34%) and reduced renal clearance by 14%. The renal clearance of metformin was reduced in a time-dependent manner in the presence of cefalexin. In healthy subjects given single 500 mg doses of cefalexin and metformin, plasma metformin C_max and AUC increased by an average of 34% and 24%, respectively, and metformin renal clearance decreased by an average of 14%. The interaction of cefalexin and metformin following multiple dose administration has not been studied. Administration of a cephalosporin to a metformin-treated patient may result in increased metformin exposure.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Adequate and well-controlled studies in humans have not been done.
However, studies in animals have not shown that cefalexin cause impaired fertility. In male and female rats, fertility and reproductive performance were not affected by cefalexin oral doses up to 1.5 times the highest recommended human dose based upon mg/m².
(Category A)
Laboratory experiments with animals and clinical experience show no evidence of teratogenicity with cefalexin, but as with all drugs, Noumed Cefalexin capsules should be administered with caution during all stages of pregnancy.
Cefalexin is excreted in the milk. Caution should be exercised when Noumed Cefalexin capsules are 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)

Blood and the lymphatic system disorders.

Eosinophilia, neutropenia, haemolytic anaemia, thrombocytopenia.

Gastrointestinal disorders.

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

Hepato-biliary disorders.

As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. Elevated SGOT and SGPT have also been reported.
Slight elevations in AST and ALT have also been reported.

Immune system disorders.

Allergic reactions in the form of rash, urticaria, angioedema and, rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported.

Infections and infestations.

Pseudomembranous colitis.

Musculoskeletal, connective tissue and bone disorders.

Arthralgia, arthritis and joint disorders.

Nervous system disorders.

Dizziness, headache, agitation, confusion, hallucinations.

Psychiatric disorders.

Hallucinations, agitation, confusion.

Renal and urinary disorders.

Reversible interstitial nephritis has been reported rarely.

Reproductive system and breast disorders.

Genital candidiasis, genital moniliasis, vaginitis, genital and anal pruritus, 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.

Postmarketing data.

No data available.

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

Symptoms.

There is no definite experience of poisoning or severe overdosage with cefalexin. However, clinical features of overdosage may be similar to those seen with other cephalosporins and penicillins, i.e. convulsions, hallucinations, hyperreflexia, electrolyte imbalance, gastrointestinal disturbances, and haematuria.

Treatment.

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 Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Cephalosporins have been classified by "generation" based on their spectrum of antibacterial activity. cefalexin is reported as a first-generation cephalosporin.
In vitro tests demonstrate that the cephalosporins inhibit bacterial septum and cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity.
Cefalexin is active against following Aerobes, Gram-positive bacteria:
Staphylococcus aureus including beta-lactamase-producing Staphylococci; and Streptococci (most species); exceptions include methicillin-resistant staphylococci and penicillin-resistant Streptococcus pneumoniae.

Note.

Cefalexin is inactive against Enterococci or Listeria monocytogenes infections.
Aerobes, Gram-negative spectrum of cefalexin includes most Escherichia coli, Klebsiella species, Moraxella catarrhalis and Proteus mirabilis.

Note.

Cefalexin is inactive against following Gram-negative aerobes:
Serratia and Enterobacter or Pseudomonas species may induce beta-lactamases that inactivate the drug after a period of exposure to the cephalosporin, producing a resistance that may be expressed late; this resistance may not be detectable by disc sensitivity techniques. And none of the cephalosporin have useful activity against Bacteroides fragilis and related Gram-negative anaerobes.

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 in Table 1.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following oral administration, cefalexin is rapidly and almost completely absorbed.
Absorption of cefalexin is delayed in young children and may be decreased up to 50% in neonates.

Distribution.

Average peak serum levels of approximately 9, 18 and 32 microgram/mL were obtained one hour following the oral administration of 250 mg, 500 mg and 1 g doses respectively. Measurable levels of cefalexin may be present six hours after administration.

Metabolism.

Cefalexin is acid stable therefore Noumed Cefalexin capsules may be given without regard to meals. Peak serum concentrations are highly lower and are attained later when cefalexin is administered with food, although the total amount of drug is unchanged. The serum half-life of cefalexin is usually about one hour.

Excretion.

Cefalexin is excreted in the urine by glomerular filtration and tubular secretion. Over 90% of the drug is excreted unchanged in the urine within eight hours. During this period, reported peak urine concentrations following 250 mg, 500 mg and 1 g doses were approximately 1,000, 2,200 and 5,000 microgram/mL respectively.
Cefalexin crosses the placenta and small amounts are found in the milk of nursing mothers. The peak concentration in the breast milk after a dose of 500 mg oral dose is 4 microgram/mL.

5.3 Preclinical Safety Data

Genotoxicity/ carcinogenicity.

Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cefalexin. Tests to determine the mutagenic potential of cefalexin have not been performed.

6 Pharmaceutical Particulars

6.1 List of Excipients

Noumed Cefalexin capsules contain the following the inactive ingredients: lactose, magnesium stearate, gelatin, iron oxide yellow, Brilliant blue FCF, Sunset yellow FCF, titanium dioxide, purified water, TekPrint SW9008 black ink (Proprietary Ingredient No. 2328).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Store below 25°C. Protect from light and moisture.

6.5 Nature and Contents of Container

PVC/PE/PVDC/Al blister packs of 20 capsules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

23325-78-2.

Molecular formula.

C₁₆H₁₇N₃O₄S.H₂O.

Chemical name.

(6R,7R)-7-[(R)-2-amino- 2-phenyl acetamido]-3-methyl- 8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.

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BRAND INFORMATION

Noumed Cefalexin 500 mg Capsules