Consumer medicine information

Keflor CD

Cefaclor

BRAND INFORMATION

Brand name

Keflor CD

Active ingredient

Cefaclor

Schedule

What is in this leaflet

This leaflet answers some common questions about Keflor CD.

It does not contain all of 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 Keflor CD 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 your medicine. You may need to read it again.

What Keflor CD is used for

Keflor CD is used to treat infections in different parts of the body caused by bacteria. Keflor CD can be used to treat infections of the:

Ears, nose, throat and tonsils (upper respiratory tract)
chest and lungs (lower respiratory tract)
bladder and kidneys (lower urinary tract)
skin.

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

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

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

Keflor CD is not recommended for use in children under 12 years of age, as there is not enough information available on its safety and effectiveness in this age group.

Keflor CD is available only with a doctor's prescription.

There is no evidence that Keflor CD is addictive.

Before you take Keflor CD

When you must not take it

Do not take Keflor CD if you are allergic to medicines containing:

cefaclor monohydrate
any other cephalosporin
any of the ingredients listed at the end of this leaflet.

Do not take Keflor CD if you have had a severe allergic reaction to penicillin. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not give Keflor CD to a child under the age of 12 years. Safety and effectiveness in children younger than 12 years old have not been established.

Do not take Keflor CD 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 Keflor CD to treat any other complaints unless your doctor has instructed you to do so.

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

Before you start to take it

Tell your doctor if you have had any type of allergic reaction to penicillin antibiotics. You may have an increased chance of being allergic to Keflor CD 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 or plan to become pregnant. The safety of Keflor CD in pregnancy has not been established. Your doctor will discuss the risks and benefits of taking Keflor CD during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. Keflor CD passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of taking Keflor CD while breastfeeding.

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

kidney problems
liver problems
severe bowel problems
bleeding problems.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Keflor CD.

Taking other medicines

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

Some medicines may be affected by Keflor CD or may affect how well Keflor CD works. These include:

anticoagulants, medicines used to prevent blood clots
salicylates or non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain or inflammation
probenecid, a medicine used to treat gout
antacids, medicines used to treat heartburn and indigestion.
To make sure there is no problem with absorption, do not take antacids within one hour of taking Keflor CD.
Antacids may interfere with the absorption of Keflor CD.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

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

How to take Keflor CD

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

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

How much to take

Your doctor will tell you how much Keflor CD you need to take.

This will depend on the type of infection you have.

The usual adult dose is one tablet (375 mg) twice a day.

How to take it

Swallow the tablets whole with a glass of water.

Do not cut, crush or chew the tablets.

When to take it

Take your tablets at about the same time each day with food. This will allow Keflor CD to have its best effect and also help you remember when to take it.

How long to take it for

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

Keep taking Keflor CD 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 the missed dose as soon as you remember, and then go back to taking Keflor CD 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) for advice, or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have taken too much Keflor CD. 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, vomiting, upset stomach or diarrhoea.

While you are taking Keflor CD

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 all the doctors, dentists and pharmacists who are treating you that you are taking Keflor CD, especially if you are being started on any new medicine.

Tell your doctor, surgeon or dentist that you are taking Keflor CD if you are about to undergo surgery or an operation. It may affect other medicines used during surgery.

Tell your doctor if you become pregnant while you are taking Keflor CD.

If you develop itching with swelling or skin rash or difficulty breathing while you are taking Keflor CD, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after stopping Keflor CD. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medicines for diarrhoea without first checking with your doctor.

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

If you have to have any blood or urine tests, tell your doctor that you are taking Keflor CD. Keflor CD may affect the results of some tests. For example, you may get a false test result with certain urine sugar tests while you are taking Keflor CD.

If you are diabetic, check with your doctor or pharmacist before using urine sugar tests. Keflor CD may cause false test results with some urine sugar 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 stop taking Keflor CD 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 take Keflor CD to treat any other complaints unless your doctor tells you to.

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

Things to be careful of

Be careful driving or operating machinery until you know how Keflor CD affects you. Keflor CD generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Keflor CD may cause dizziness or drowsiness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Keflor CD. Keflor CD treats infections in most people, but it may have unwanted side effects in some people.

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.

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

diarrhoea
itchy rash
oral thrush (white, furry sore tongue and mouth)
vaginal thrush (sore and itchy vagina, vaginal discharge).

The above list includes the more common side effects of Keflor CD. They are usually mild and short-lived.

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

nausea (feeling sick)
vomiting
drowsiness
headache
hyperactivity, nervousness, insomnia, confusion, dizziness, hallucinations (seeing, feeling, or hearing things that are not there)
severe muscle stiffness
swelling of the joints with or without fever
pain in the joints with or without fever
itching or swelling of the skin
yellowing of the skin or eyes
signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal
difficulty in swallowing or breathing
stomach (abdominal) pain or discomfort
nosebleed
unusual tiredness or weakness
watery and severe diarrhoea, which may also be bloody
fever, cough, sore throat, feeling generally unwell, skin rash (in some instances it can develop over 2 to 7 days), rashes can be painful and itchy, blistering or peeling of the skin, facial swelling, sore/red eyes or lips (in some instances reactions can be delayed by up to 3 or 4 weeks).

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, even if they occur several weeks after stopping treatment with Keflor CD:

watery and severe diarrhoea, which may also be bloody
severe stomach cramps
fever, in combination with one or both of the above.
fever, cough, sore throat, feeling generally unwell, skin rash (in some instances it can develop over 2 to 7 days), rashes can be painful and itchy, blistering or peeling of the skin, facial swelling, sore/red eyes or lips (in some instances reactions can be delayed by up to 3 or 4 weeks).

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 the nearest hospital if you notice any of the following:

sudden signs of allergy such as rash, itching, hives on the skin, with swelling of the face, lips, tongue or other parts of the body, which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

The above list includes very serious side effects which are very rare. You may need urgent medical attention or hospitalisation.

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. Some of these side effects can only be found when your doctor does tests from time to time to check your progress. These include:

swelling of the liver
inflammation of the kidney.

After using Keflor CD

Storage

Keep your medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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

Keep Keflor CD in a cool, dry place where the temperature stays below 25°C.

Do not keep Keflor CD or any other medicine in the bathroom or near a sink.

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

Disposal

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

Product description

What it looks like

Keflor CD is a blue, oval-shaped tablet.

Each pack of Keflor CD contains 10 tablets.

Ingredients

The active ingredient in Keflor CD is cefaclor (as cefaclor monohydrate). Each tablet contains 375 mg of cefaclor.

The tablets also contain the following inactive ingredients:

mannitol
hypromellose
hyprolose
methacrylic acid copolymer
stearic acid
magnesium stearate
propylene glycol
purified talc
Colour Mixture Dark Blue YS-1-4273.

The tablets are gluten free.

Supplier

Keflor CD is supplied by:

Alphapharm Pty Ltd
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian registration number:
AUST R 58655

This leaflet was prepared in
October 2020.

KeflorCD_cmi\Oct20/00

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Keflor CD

Active ingredient

Cefaclor

Schedule

1 Name of Medicine

Cefaclor monohydrate.

2 Qualitative and Quantitative Composition

Each Keflor CD modified release tablet contains 375 mg of cefaclor (as monohydrate) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Keflor CD 375 mg is a film-coated compressed tablet. Blue paracapsule shaped, dual radii, 7.62 mm, approx length 16 mm.

4 Clinical Particulars

4.1 Therapeutic Indications

Keflor CD is indicated for the treatment of the following types of infections caused by susceptible organisms, in adults and children aged 12 years or older.
Acute bronchitis and acute exacerbations of chronic bronchitis.
Upper respiratory infections, including pharyngitis, tonsillitis and acute bacterial sinusitis.
Community-acquired pneumonia of mild to moderate severity (excluding atypical pneumonia).
Symptomatic lower urinary tract infections, including cystitis.
Skin and skin structure infections.

Note.

1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflor CD is generally effective in the eradication of streptococci from the oropharynx; however, substantial data establishing the efficacy of Keflor CD in the subsequent prevention of rheumatic fever are not available.
2. Bacteriologic studies to determine the causative organism and its susceptibility to cefaclor should be performed. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

4.2 Dose and Method of Administration

Keflor CD can be taken with or without food. However, absorption is enhanced when Keflor CD is administered with food (see Section 5.2 Pharmacokinetic Properties). The tablets should not be cut, crushed or chewed.
The usual adult dosage is 375 mg twice daily.
For lower urinary tract infections, 500 mg once daily may be given. For pneumonia and acute bacterial sinusitis, the recommended dosage is 750 mg twice daily. For acute bacterial sinusitis, Keflor CD should be taken for 10 days.
In the treatment of infections caused by S. pyogenes (group A streptococci), a therapeutic dosage of Keflor CD should be administered for at least 10 days.
For patients with markedly impaired renal function, see Section 4.4 Special Warnings and Precautions for Use.

4.3 Contraindications

Keflor CD 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) or any of the excipients.

4.4 Special Warnings and Precautions for Use

As with antibiotic therapy in general, administration of Keflor CD should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained. A minimum of ten days of treatment is recommended in infections caused by group A beta-haemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis.
Prolonged use of Keflor CD 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.

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, Keflor CD should be discontinued immediately and an alternative treatment should be considered.
Except under special circumstances, this medication should not be used when the following medical problem exists.

Allergic reaction (anaphylaxis).

In penicillin-sensitive patients, cephalosporin antibiotics should be administered cautiously. There is clinical and laboratory evidence of partial cross allergenicity of the penicillins and the cephalosporins and there are instances in which patients have had reactions, including anaphylaxis, to both drug classes. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions have been reported in patients on penicillin/cephalosporin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins/cephalosporins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin/cephalosporin hypersensitivity who have experienced severe reactions when treated with a penicillin/cephalosporin.
Past history of a severe allergic reaction to penicillin/ cephalosporin is a contraindication to the use of Keflor CD. Before initiating therapy with any cephalosporin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Keflor CD should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline (epinephrine). Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Risk-benefit should be considered when the following medical problems exist.

History of colitis or gastrointestinal disease.

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.

Pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefaclor. 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 which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.

History of bleeding disorders.

All cephalosporins may cause hypoprothrombinemia and, potentially, bleeding.

Neurotoxicity.

There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus (see Section 4.8 Adverse Effects (Undesirable Effects)). Risk factors for developing neurotoxicity with cephalosporin treatment include being elderly, renal impairment, central nervous system disorders and intravenous administration. Withdrawal of the medicine should be considered if there are signs of neurotoxicity.

Use in renal impairment.

Many cephalosporins are excreted renally. Keflor CD should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuria is 2.3 to 2.8 hours, dosage adjustments for patients with moderate or severe renal impairment are usually not required. Clinical experience with cefaclor under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made.

Use in hepatic impairment.

Keflor CD should be used with caution in patients with liver disease, as documented clinical experience in this group of patients is lacking.

Dental.

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

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.

Paediatric use.

The safety and efficacy of Keflor CD has not been studied in children. Serum sickness like reactions including arthritis and arthralgia have been reported more frequently in children than in adults with the use of cefaclor.

Effects on laboratory tests.

Glucose, urine.

Administration of Keflor CD may result in a false-positive reaction for glucose in the urine. This phenomenon has been seen in patients taking cephalosporin antibiotics when the test is performed using Benedict's and Fehling's solutions and also with Clinitest tablets but not with Tes-Tape (Glucose Enzymatic Test Strip, USP).

Coombs' (antiglobulin) tests.

Positive direct Coombs' tests have been reported during treatment with cefaclor. In haematologic studies or in transfusion cross-matching procedures when anti-globulin 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.

Prothrombin time (PT).

May be prolonged.

Creatinine, serum.

Concentrations may be increased.

Carnitine or haematocrit.

Values may decrease during therapy.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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 haemorrhagic potential of nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfinpyrazone may increase the risk of haemorrhage.

Antacids.

The extent of absorption of sustained release cefaclor is diminished if magnesium or aluminium hydroxide containing antacids are taken within 1 hour of administration.

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.

Cimetidine.

Cimetidine did not alter either the rate or the extent of absorption of sustained release cefaclor.

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 cefaclor causes impaired fertility.
(Category B1)
The oral administration of high dose cefaclor (500 mg/kg) in pregnant rats and mice has resulted in a slight increase of minor skeletal malformations. Safety of this product for use during pregnancy has not been established. Cefaclor should not be used in women of child bearing potential unless, in the judgement of the treating clinician, its use is considered essential to the welfare of the patient and the expected benefits outweigh potential risks.

Labour and delivery.

Keflor CD has not been studied for use during labour and delivery. Treatment should be given only if clearly needed.
No studies have been done with Keflor CD. Small amounts of cefaclor have been detected in mother's milk following administration of single 500 mg doses of cefaclor. Average levels were 0.18, 0.20, 0.21 and 0.16 microgram/mL at 2, 3, 4 and 5 hours respectively. Trace amounts were detected at 1 hour. The effect on nursing infants is not known. Caution should be exercised when Keflor CD is administered to a nursing woman.

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)

The majority of adverse reactions observed in clinical trials of sustained release cefaclor were mild and transient. Drug related adverse reactions requiring discontinuation of therapy occurred in 1.7% of patients. The following adverse reactions have been reported following the use of sustained release cefaclor in clinical trials. Incidence rates were less than 1%, except as otherwise noted.

Gastrointestinal disorders.

Diarrhoea (3.4%), nausea (2.5%), vomiting and dyspepsia.

Immune system disorders.

Rash, urticaria or pruritus occurred in approximately 1.7% of patients. One serum sickness-like reaction (0.03%) was reported among the 3,272 patients treated with sustained release cefaclor during the controlled clinical trials.

Blood and lymphatic system disorders.

Eosinophilia.

Infections and infestations.

Vaginal moniliasis (2.5%) and vaginitis (1.7%).

Acute bacterial sinusitis.

Adverse experiences reported among patients with acute bacterial sinusitis treated with sustained release cefaclor (750 mg b.i.d.) or cefaclor capsules (500 mg t.i.d.) during a controlled clinical trial are shown in Table 1. Included are all adverse experiences occurring with an incidence of 2% or greater in either treatment group.

The following adverse effects have been reported in patients treated with sustained release cefaclor; causal relationship is uncertain. Incidence rates were less than 1%, except as otherwise noted.

Nervous system disorders.

Headache (3.2%), dizziness and somnolence.

Hepatobiliary disorders.

Transient elevations in AST, ALT and alkaline phosphatase.

Renal and urinary disorders.

Transient increase in serum urea or creatinine; and abnormal urinalysis.

Blood and lymphatic system disorders.

Transient thrombocytopenia, leucopenia, lymphocytosis and neutropenia.
In addition, the following adverse reactions and altered laboratory tests have been reported in patients treated with cefaclor.

Immune system disorders.

Fever and angioedema have been reported rarely.
Cases of serum sickness-like reactions have been reported with the use of cefaclor. These have been reported more frequently in children than in adults with an overall occurrence ranging from 0.5% (1 in 200) in one trial, to 0.024% (2 in 8,346) in overall clinical trials (with an incidence in children in clinical trials of 0.055%). The worldwide reporting rate for serum sickness-like reactions in adults is very rare (< 0.01). Serum sickness-like reactions are characterised by findings of erythema multiforme, rashes and other skin manifestations accompanied by arthritis/ arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes and no evidence to date of sequelae of the reaction. While further investigation is ongoing, serum sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy; occasionally these reactions have resulted in hospitalisation usually of short duration (median hospitalisation = 2 to 3 days, based on postmarketing surveillance studies). In those requiring hospitalisation, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in children. Antihistamines and glucocorticoids appear to enhance resolution of the signs and symptoms. No serious sequelae have been reported. More severe hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely. Anaphylaxis may be more common in patients with a history of penicillin allergy. The worldwide reporting rate for anaphylaxis in the total population is very rare (< 0.01%). Positive direct Coombs' test and genital pruritus have been reported. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment.
The following reactions have been reported rarely in patients treated with cefaclor.

Renal and urinary disorders.

Reversible interstitial nephritis.

Hepatobiliary disorders.

Hepatic dysfunction including hepatitis and cholestatic jaundice.

Blood and lymphatic system disorders.

Increased prothrombin time in patients receiving cefaclor and warfarin concomitantly, haemolytic anaemia, agranulocytosis and aplastic anaemia.

Nervous system disorders.

Reversible hyperactivity, nervousness, insomnia, confusion, hallucinations and hypertonia.

Severe cutaneous adverse reactions.

Post-marketing experience.

Nervous system disorders.

Frequency not known: seizures, encephalopathy and/or myoclonus.

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

Signs and symptoms.

The toxic symptoms following an overdose of Keflor CD may include nausea, vomiting, epigastric distress and diarrhoea. The severity of the epigastric distress and the diarrhoea are dose related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction, or the effects of other intoxication.

Treatment.

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient.
Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing charcoal.
Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion have not been established as beneficial for an overdose of cefaclor.
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.

Keflor CD (cefaclor sustained release) is a pharmaceutically-modified form of the orally active cephalosporin, cefaclor monohydrate. It is a semisynthetic cephalosporin antibiotic for oral administration. Keflor CD differs from other available products containing cefaclor in its rate of dissolution, producing a lower peak serum concentration, but retaining sustained measurable serum concentrations, which provides the advantage of twice daily dosing.
Microbiology. The in vitro bactericidal activity of Keflor CD is due to cefaclor. In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell-wall synthesis. Cefaclor is stable in the presence of bacterial β-lactamases; consequently, β-lactamase producing organisms resistant to penicillins and some cephalosporins may be susceptible to cefaclor. Cefaclor has been shown to be active against most strains of the following organisms both in vitro and in clinical infections.

Gram-positive organisms.

Staphylococcus aureus; Staphylococcus saprophyticus; Streptococcus pneumoniae; Streptococcus pyogenes (group A streptococci).

Note.

Cefaclor is inactive against methicillin-resistant staphylococci.

Gram-negative organisms.

Haemophilus influenzae; Moraxella (Branhamella) catarrhalis; Escherichia coli; Klebsiella pneumoniae; Proteus mirabilis.

Note.

Pseudomonas sp, Acinetobacter calcoaceticus, enterococci, Enterobacter sp, indole positive Proteus and Serratia sp are resistant to cefaclor.

Susceptibility testing.

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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Keflor CD is well absorbed from the gastrointestinal tract after oral administration. Although Keflor CD can be taken with or without food, total absorption is enhanced with food. When it was given within one hour after a meal, the bioavailability of sustained release cefaclor was greater than 90%, using cefaclor taken fasting as a reference. When taken in the fasting state, the bioavailability of sustained release cefaclor was 77% that of cefaclor. Compared to cefaclor (fasted state), mean peak plasma concentrations of sustained release cefaclor (both fed and fasted states) were delayed 40 to 90 minutes and were lower. Concomitant administration of cimetidine does not affect the rate or extent of absorption. Administration of magnesium- or aluminium hydroxide-containing antacids 1 hour after sustained release cefaclor had no effect on the rate of absorption but resulted in a 17% decrease in the extent of absorption. The effect of antacids taken at other times is uncertain.
Following administration of 375 mg, 500 mg and 750 mg tablets to fed subjects, average peak serum concentrations of 4, 8, and 11 microgram/mL, respectively, were obtained within 2.5 to 3 hours. No drug accumulation was noted when it was given twice daily for 2½ days.

Metabolism.

There is no evidence of metabolism of cefaclor in humans.

Excretion.

The plasma half-life in healthy subjects is independent of dosage form and averages 40-60 minutes. In elderly subjects (over age 65) with normal serum creatinine values, a higher peak plasma concentration and AUC are effects resulting from mildly diminished renal function and are not expected to have clinical significance. Therefore, dosage changes are not necessary in elderly subjects with normal renal function.

5.3 Preclinical Safety Data

Genotoxicity.

Long-term studies in animals have not been performed to evaluate the mutagenic potential of cefaclor.

Carcinogenicity.

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of cefaclor.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets also contain the inactive ingredients mannitol, hypromellose, hyprolose, methacrylic acid copolymer, stearic acid, magnesium stearate, propylene glycol, purified talc and Colour Mixture Dark Blue YS-1-4273 (ARTG PI No: 1444).

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.

6.5 Nature and Contents of Container

Container type: Keflor CD is available in blister packs (PVC/PCTFE (Aclar)/Al).
Pack sizes: 2 (sample), 10 tablets.
Some pack sizes may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 58655 - Keflor CD cefaclor 375 mg (as monohydrate) sustained release tablet blister pack.

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: 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate.
Structural formula:

Molecular formula: C₁₅H₁₄ClN₃O₄S.H₂O.
Molecular weight: 385.83.

CAS number.

53994-73-3.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

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Keflor CD

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BRAND INFORMATION

Keflor CD 375 mg