Consumer medicine information

Aclor

Cefaclor

BRAND INFORMATION

Brand name

Aclor

Active ingredient

Cefaclor

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Aclor.

What is in this leaflet

This leaflet answers some common questions about ACLOR. 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 ACLOR against the benefits they expect it will have for you.

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

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

What ACLOR is used for

ACLOR 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 (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 have any questions about why ACLOR has been prescribed for you. Your doctor may have prescribed it for another reason.

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

This medicine is not addictive.

Before you take it

When you must not take it

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

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not give this medicine to a child under the age of one month. Safety and effectiveness in children younger than one month have not been established.

Do not take this medicine after the expiry date printed on the carton and bottle label 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.

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

Before you start to take it

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

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

  • kidney disease
  • severe bowel conditions
  • liver disease

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

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

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 may interfere with ACLOR. These include:

  • probenecid (e.g. Pro-Cid), a medicine used to treat gout and to promote the excretion of uric acid

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

How to take CECLOR

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 carton or bottle label, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much ACLOR you need to take. This will depend on the type of infection you have.

How to take it

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

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

How long to take it

Continue taking ACLOR 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 the 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 ACLOR. 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 ACLOR

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 treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately. 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. ACLOR may cause false test results with some urine sugar tests.

Things you must not do

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

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

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

Things to be careful of

Be careful driving or operating machinery until you know how ACLOR affects you. This medicine may cause dizziness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Children should be careful when riding bicycles or climbing trees.

Side effects

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

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.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

Tell your doctor or pharmacist 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 ACLOR. 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 and 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.

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

  • 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.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

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.

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

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

After using ACLOR

Storage

Keep ACLOR suspension in your refrigerator at 2°C to 8°C where young children cannot reach it. Do not freeze.

Keep the bottle tightly closed.

The suspension should be shaken well before use and discarded after 14 days.

Disposal

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

Product Description

What it looks like

Your pharmacist will make up the medicine in the bottle before dispensing it to you. The resulting suspension is pink and has a strawberry taste.

It is available in two different strengths:

  • 125 mg/5 mL
  • 250 mg/5 mL

Ingredients

ACLOR 125 mg/5 mL contains 25 mg/mL of cefaclor as the active ingredient.

ACLOR 250 mg/5 mL contains 50 mg/mL of cefaclor as the active ingredient.

The oral liquid also contains the following inactive ingredients:

  • dimeticone 350
  • erythrosine
  • methylcellulose
  • sodium lauryl sulfate
  • strawberry flavour 52312 AP0551
  • sucrose
  • tapioca starch
  • xanthan gum

ACLOR contains sugars. This medicine does not contain lactose, gluten, tartrazine or any other azo dyes.

Distributor

ACLOR is distributed in Australia by:

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

This leaflet was prepared in September 2020.

ACLOR 125 mg/5 mL: AUST R 100155

ACLOR 250 mg/5 mL: AUST R 100158

Aclor_cmi\Sep20/00

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Aclor

Active ingredient

Cefaclor

Schedule

S4

 

1 Name of Medicine

Cefaclor (as monohydrate).

2 Qualitative and Quantitative Composition

Each 5 mL of Aclor powder for oral liquid upon reconstitution contains 125 mg or 250 mg of cefaclor (as monohydrate) as the active ingredient.

Excipients of known effect.

Sugars.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Aclor 125 mg/5 mL and 250 mg/5 mL powder for oral liquids are pink free-flowing dry powders. After constitution, a red coloured suspension with a characteristic strawberry odour is formed.

4 Clinical Particulars

4.1 Therapeutic Indications

Aclor is indicated for the treatment of the following types of infections caused by or likely to be caused by susceptible organisms.
Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis.
Upper respiratory infections, including pharyngitis, tonsillitis and otitis media.
Skin and skin structure infections.
Urinary tract infections, including pyelonephritis and cystitis.

Note.

1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Aclor appears to be as effective as phenoxymethylpenicillin in the eradication of Streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
2. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

4.2 Dose and Method of Administration

Aclor is administered orally.

Directions for reconstitution of Aclor.

125 mg/5 mL.

Add 60 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.

250 mg/5 mL.

Add 45 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.

Adults.

The usual adult dosage is 250 mg every 8 to 12 hours. For bronchitis and pneumonia, the dosage is 250 mg administered 3 times daily. For more severe infections or those caused by less susceptible organisms, doses may be doubled (500 mg 8 hourly).
Doses of 2 g/day should not be exceeded.
For skin and skin structure infections, the dosage is 250 mg 2-3 times a day.

Children.

The usual recommended daily dosage for children with mild to moderate infections is 20 mg/kg/day in divided doses every 8 hours (maximum 1 g/day).
For streptococcal pharyngitis/ tonsillitis and impetigo, 12 hourly administration appears equally effective.
In more serious infections, otitis media, and infections caused by less susceptible organisms, the recommended dosage is 40 mg/kg/day in divided doses every 8 to 12 hours (maximum 2 g/day). For otitis media, 12 hourly administration appears equally effective.
Aclor may be administered in the presence of impaired renal function. Under such a condition, the dosage is usually unchanged (see Section 4.4 Special Warnings and Precautions for Use).
In the treatment of β-haemolytic streptococcal infections, a therapeutic dosage of Aclor should be administered for at least 10 days.

4.3 Contraindications

Aclor 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).
Aclor is also contraindicated in infants under the age of one month as safety and efficacy of this product has not been established in prematures and infants under one month of age.

4.4 Special Warnings and Precautions for Use

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 Aclor. 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, Aclor 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.
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 (Lomotil) may prolong and/or worsen the condition and should not be used.
As with antibiotic therapy in general, administration of Aclor 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 Aclor 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, Aclor should be discontinued immediately and an alternative treatment should be considered.

Use in hepatic impairment.

Aclor 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.

Aclor 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.

Safety and effectiveness of this product for use in infants less than one month of age have not been established. Serum sickness-like reactions including arthritis and arthralgia have been reported more frequently in children than in adults.

Effects on laboratory tests.

Administration of Aclor 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 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.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As with other β-lactam antibiotics, the renal excretion of Aclor is inhibited by probenecid.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(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 childbearing 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.
 Small amounts of cefaclor have been detected in the 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 Aclor 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)

Gastrointestinal.

The most frequent side effect has been diarrhoea.
Nausea and vomiting have been reported rarely. Colitis, including rare instances of pseudomembranous colitis, has been reported in conjunction with therapy with Aclor (see Section 4.4 Special Warnings and Precautions for Use).

Hepatic.

Transient hepatitis and cholestatic jaundice have been reported rarely.

Hypersensitivity.

Allergic reactions, such as urticaria and morbilliform eruptions, have been observed, as have pruritus and positive Coombs' tests. These reactions usually subsided upon discontinuation of the drug. Angioedema and fever 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%).

Blood.

Eosinophilia, transient lymphocytosis, leukopenia and, rarely, thrombocytopenia, thrombocytosis, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance. There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving cefaclor and warfarin concomitantly.

Kidney.

Reversible interstitial nephritis.

Superinfection.

Genital pruritus, moniliasis or vaginitis.

Central nervous system.

Rare: reversible hyperactivity, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, headache or somnolence have been reported.

Other.

Transitory abnormalities in clinical laboratory test results have been reported, but their clinical significance is uncertain. These include slight elevations in AST, ALT, or alkaline phosphatase values; transient fluctuations in leukocyte count, predominantly lymphocytosis in infants and young children; and slight elevations in serum urea or serum creatinine or abnormalities of urinalysis (haematuria, pyuria).

Severe and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Signs and symptoms.

The toxic symptoms following an overdose of Aclor 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, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or 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.

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: Staphylococci, including coagulase positive and penicillinase-producing strains (but not methicillin-resistant strains of Staph. aureus); Streptococcus pyogenes (group A β-haemolytic Streptococci); Strep. (Diplococcus) pneumoniae; Escherichia coli; Proteus mirabilis; Klebsiella sp.; Haemophilus influenzae; Neisseria gonorrhoeae (penicillinase-producing and non-penicillinase producing strains); Moraxella (Branhamella) catarrhalis.

Note.

Pseudomonas species, Acinetobacter calcoaceticus, enterococci, Enterobacter, indole-positive Proteus, and Serratia species are resistant to cefaclor. Methicillin resistant strains are also 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.

Aclor is well absorbed after oral administration, whether taken with food or while fasting, however, when it is taken with food, the peak concentration achieved is 50% to 75% of that observed when the drug is administered to fasting subjects and generally appears from 45 minutes to 1 hour later. The presence of food in the gastrointestinal tract does not alter the total amount of cefaclor absorbed. Following administration of 250 mg, 500 mg, and 1 g doses to fasting subjects, average peak plasma levels of antibacterial activity (expressed as microgram/mL of cefaclor) of 7, 13 and 23 microgram/mL, respectively, were obtained at 30 to 60 minutes. The reduced peak serum levels resulting from the administration of cefaclor with food should be considered with reference to the sensitivity of the infecting organism, severity of illness, the dose being administered and the variability in the peak plasma levels which occur with cefaclor.

Metabolism.

There is no evidence of metabolism of cefaclor in humans. The plasma half-life in healthy subjects is independent of dosage form and averages 40-60 minutes.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The powder for oral liquid also contains the following inactive ingredients: dimeticone 350, erythrosine, methylcellulose, sodium lauryl sulfate, Strawberry Flavour 52312 AP0551 (Proprietary Ingredient 274), sucrose, tapioca starch and xanthan gum.

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

Dry powder: store below 25°C.
Reconstituted suspension: store at 2°C to 8°C (Refrigerate. Do not freeze). Use within 14 days and discard remaining portion thereafter. Discard unused portion 14 days after mixing.

6.5 Nature and Contents of Container

Container type: bottle (HDPE).
Pack sizes: 75 mL (250 mg/5 mL), 100 mL (125 mg/5 mL).
Some strengths, pack sizes and/or pack types may not be marketed.

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.
Molecular formula: C15H16ClN3O5S.
Molecular weight: 385.8.
Aclor (cefaclor monohydrate) is a semisynthetic cephalosporin antibiotic for oral administration.
Cefaclor monohydrate is a white to off white crystalline powder, slightly soluble in water, but is insoluble in alcohol and chloroform.

CAS number.

70365-03-5.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes