Consumer medicine information

CECLOR® CD

Cefaclor

BRAND INFORMATION

Brand name

Ceclor CD Sustained release tablets

Active ingredient

Cefaclor

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using CECLOR® CD.

What is in this leaflet

This leaflet answers some common questions about Ceclor CD. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ceclor 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 this medicine.

You may need to read it again.

What Ceclor CD is used for

Ceclor CD contains cefaclor monohydrate as the active ingredient.

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

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

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

Ask your doctor if you any questions about why Ceclor CD has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription.

There is no evidence that it is addictive.

There is not enough information to recommend the use of this medicine for children under the age of 12 years.

Before you take it

When you must not take it

Do not take Ceclor CD if you have ever had an allergic reaction to:

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

Do not take Ceclor CD if you have had a serious allergic reaction to penicillin.

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 give this medicine 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 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 this medicine to treat any other complaints unless your doctor has instructed you to do so.

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:

  • kidney disease
  • severe bowel conditions
  • liver disease.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of these things, tell them before you start taking Ceclor CD.

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 Ceclor CD may interfere with each other.

These include:

  • antacids

If you need to take an antacid, do not take it within 1 hour of taking Ceclor CD.

  • probenecid (e.g. Pro-Cid).

These medicines may be affected by Ceclor CD 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 and pharmacist has more information on medicines to be careful with or avoid while taking Ceclor CD.

How to take it

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

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

How much to take

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

This will depend on the type of infection you have.

How to take it

Swallow the tablets whole with a full glass of water. Do not cut, crush or chew the tablet.

When to take it

Take Ceclor CD at about the same time each day with food.

This will have the best effect. It will also help you remember when to take the tablets.

How long to take it

Continue taking your medicine 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 continue to grow and multiply so that 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 (telephone 13  11  26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Ceclor 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 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 Ceclor CD, especially if you are being started on any new medicine.

Tell your doctor, surgeon or dentist that you are taking Ceclor 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 this medicine.

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

It may interfere with the results of some 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.

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

Ceclor CD may cause false test results with some urine sugar tests.

Things you must not do

Do not take Ceclor CD to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else even if their symptoms seem similar to yours.

Do not stop taking your medicine or change the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Ceclor CD affects you.

It 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 Ceclor CD.

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

All medicines can 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:

  • diarrhoea
  • itchy rash
  • oral thrush - white, furry, sore tongue or mouth
  • vaginal thrush - sore and itchy vagina and/or discharge.

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

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

  • nausea
  • vomiting
  • drowsiness
  • headache
  • hyperactivity, nervousness, insomnia, confusion, dizziness, hallucinations
  • 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
  • frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal
  • difficulty in swallowing or breathing.

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 Ceclor CD:

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

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 requiring urgent medical attention or hospitalisation. This side effect is very rare.

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

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

  • swelling of the liver
  • inflammation of the kidney.

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

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blister pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25 degrees Celsius.

Do not store Ceclor CD 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.

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.

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

Ceclor CD 375 mg tablets are blue. Packs contain 10 tablets.

Ingredients

Active ingredient:

Ceclor CD contains cefaclor monohydrate equivalent to 375 mg of cefaclor.

Inactive ingredients:

  • mannitol
  • hypromellose
  • hydroxypropylcellulose
  • methacrylic acid copolymer
  • stearic acid
  • magnesium stearate
  • propylene glycol
  • talc - purified
  • colour mixture dark blue YS-1-4273.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

BRAND INFORMATION

Brand name

Ceclor CD Sustained release tablets

Active ingredient

Cefaclor

Schedule

S4

 

1 Name of Medicine

Cefaclor monohydrate.

2 Qualitative and Quantitative Composition

Each sustained release tablet contains cefaclor monohydrate equivalent to 375 mg (1.02 mmol) anhydrous cefaclor. The tablets also contain the inactive ingredients mannitol, hypromellose, hyprolose, methacrylic acid copolymer, stearic acid, magnesium stearate, propylene glycol, purified talc and color mixture dark blue YS-1-4273.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sustained release tablet.

4 Clinical Particulars

4.1 Therapeutic Indications

Ceclor 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. Ceclor CD is generally effective in the eradication of Streptococci from the oropharynx; however, substantial data establishing the efficacy of Ceclor 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

Ceclor CD can be taken with or without food. However, absorption is enhanced when Ceclor 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, Ceclor CD should be taken for 10 days.
In the treatment of infections caused by S. pyogenes (group A Streptococci), a therapeutic dosage of Ceclor 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

Ceclor 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).

4.4 Special Warnings and Precautions for Use

Identified precautions.

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 Ceclor 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, Ceclor CD should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Broad spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly 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 (e.g. Lomotil) may prolong and/or worsen the condition and should not be used.
As with antibiotic therapy in general, administration of Ceclor 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 β-haemolytic Streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis.
Prolonged use of Ceclor CD 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.

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, Ceclor CD should be discontinued immediately and an alternative treatment should be considered.

Use in hepatic impairment.

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

Use in renal impairment.

Ceclor 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 the elderly.

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.

Paediatric use.

The safety and efficacy of Ceclor 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.

Administration of Ceclor 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).
Positive direct Coombs' tests have been reported during treatment with Ceclor. In haematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The extent of absorption of Ceclor CD is diminished if magnesium or aluminium hydroxide containing antacids are taken within 1 hour of administration; cimetidine did not alter either the rate or the extent of absorption of Ceclor CD. As with other β-lactam antibiotics, the renal excretion of Ceclor (and presumably Ceclor CD) is inhibited by probenecid. No other significant drug interactions were noted during clinical trials.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Reproduction studies have revealed no evidence of 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.

Ceclor 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 Ceclor CD. Small amounts of cefaclor have been detected in mother's milk following administration of single 500 mg doses of Ceclor. 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 Ceclor 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)

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.
The majority of adverse reactions observed in clinical trials of Ceclor CD 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 Ceclor CD in clinical trials. Incidence rates were less than 1%, except as otherwise noted.

Gastrointestinal.

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

Hypersensitivity.

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 Ceclor CD during the controlled clinical trials.

Haematologic and lymphatic systems.

Eosinophilia.

Genitourinary.

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

Acute bacterial sinusitis.

Adverse experiences reported among patients with acute bacterial sinusitis treated with Ceclor CD (750 mg bid) or Ceclor capsules (500 mg tid) 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 Ceclor CD; causal relationship is uncertain. Incidence rates were less than 1%, except as otherwise noted.

Central nervous system.

Headache (3.2%), dizziness and somnolence.

Hepatic.

Transient elevations in AST, ALT and alkaline phosphatase.

Renal.

Transient increase in serum urea or creatinine.

Laboratory tests.

Transient thrombocytopenia, leucopenia, lymphocytosis, neutropenia and abnormal urinalysis.
In addition, the following adverse reactions and altered laboratory tests have been reported in patients treated with Ceclor:
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 Ceclor:
Reversible interstitial nephritis, hepatic dysfunction including hepatitis and cholestatic jaundice, increased prothrombin time in patients receiving Ceclor and warfarin concomitantly, reversible hyperactivity, nervousness, insomnia, confusion, hallucinations, hypertonia, haemolytic anaemia, agranulocytosis, aplastic anaemia, fever and angioedema.

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, Ceclor CD should be discontinued immediately and an alternative treatment should be considered.

4.9 Overdose

Signs and symptoms.

The toxic symptoms following an overdose of Ceclor 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.

Microbiology.

The in vitro bactericidal activity of Ceclor 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 is available.

5.2 Pharmacokinetic Properties

Ceclor CD is well absorbed from the gastrointestinal tract after oral administration. Although Ceclor 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 Ceclor CD was greater than 90%, using Ceclor taken fasting as a reference. When taken in the fasting state, the bioavailability of Ceclor CD was 77% that of Ceclor. Compared to Ceclor (fasted state), mean peak plasma concentrations of Ceclor CD (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 Ceclor CD 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.
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. There is no evidence of metabolism of cefaclor in humans.

5.3 Preclinical Safety Data

Genotoxicity.

No data is available.

Carcinogenicity.

Studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential for Ceclor CD.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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 degrees celsius and protect from light.

6.5 Nature and Contents of Container

375 mg tablets (sustained release): blue capsule shaped tablets with no engraving in PVC/PCTFE (Aclar)/Al blister packs.
Packs of 2 (sample packs) or 10.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.


Ceclor 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. The active ingredient is chemically designated as 3-chloro-7-D-(2-phenyl- glycinamido)-3-cephem-4-carboxylic acid monohydrate. Ceclor 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.

CAS number.

70356-03-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes