Consumer medicine information

Cefaclor Sun

Cefaclor

BRAND INFORMATION

Brand name

Cefaclor Sun

Active ingredient

Cefaclor

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cefaclor Sun.

SUMMARY CMI

CEFACLOR SUN

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CEFACLOR SUN?

CEFACLOR SUN contains the active ingredient cefaclor monohydrate. CEFACLOR SUN is used to treat infections caused by bacteria in different parts of the body. For more information, see Section 1. Why am I using CEFACLOR SUN? in the full CMI.

2. What should I know before I use CEFACLOR SUN?

Do not use if you have ever had an allergic reaction to CEFACLOR SUN or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use CEFACLOR SUN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CEFACLOR SUN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CEFACLOR SUN?

  • Your doctor will tell you how much CEFACLOR SUN you need to take. This will depend on the type of infection you have.
  • Shake the bottle well and accurately measure the dose with a medicine measure.

More instructions can be found in Section 4. How do I use CEFACLOR SUN? in the full CMI.

5. What should I know while using CEFACLOR SUN?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using CEFACLOR SUN.
  • Tell your doctor if the symptoms of your infection do not improve within a few days, or if they become worse.
  • If you become pregnant while you are taking CEFACLOR SUN, tell your doctor immediately.
Things you should not do
  • Do not give CEFACLOR SUN to anyone else, even if they have the same condition as you.
  • Do not use CEFACLOR SUN to treat any other complaints unless your doctor tells you to.
  • Do not stop taking your medicine or change the dosage without checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how CEFACLOR SUN affects you.
Looking after your medicineCEFACLOR SUN suspension: Store in a refrigerator (2-8°C. Refrigerate. Do not freeze). Discard unused suspension after 14 days.

For more information, see Section 5. What should I know while using CEFACLOR SUN? in the full CMI.

6. Are there any side effects?

Common side effects include oral thrush-white, furry, sore tongue; vaginal thrush-sore and itchy vagina and/or abnormal discharge; itchy rash; diarrhea. Serious side effects include nausea; vomiting; drowsiness; headache; hyperactivity, nervousness, insomnia, confusion, dizziness, hallucinations; severe muscles stiffness; swelling of the joints or 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; seizures; signs of encephalopathy such as confusion, memory loss, personality changes, trouble thinking clearly or focusing; signs of myoclonus such as involuntary muscle movements such as jerks, tremors or eye movements, which may occur alone or in combination with encephalopathy.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

CEFACLOR SUN

Active ingredient(s): cefaclor monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using CEFACLOR SUN. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CEFACLOR SUN against the benefits it is expected to have for you. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CEFACLOR SUN. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.ebs.tga.gov.au. Those updates may contain important information about the medicine and its use of which you should be aware.

Where to find information in this leaflet:

1. Why am I using CEFACLOR SUN?
2. What should I know before I use CEFACLOR SUN?
3. What if I am taking other medicines?
4. How do I use CEFACLOR SUN?
5. What should I know while using CEFACLOR SUN?
6. Are there any side effects?
7. Product details

1. Why am I using CEFACLOR SUN?

CEFACLOR SUN contains the active ingredient cefaclor monohydrate. CEFACLOR SUN is in a class of medications called cephalosporin antibiotics which are closely related to penicillins.

CEFACLOR SUN is an antibiotic 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

CEFACLOR SUN works by killing the bacteria causing your infection or by stopping its growth.

CEFACLOR SUN will not work against infections caused by viruses such as colds or the flu.

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

This medicine is not addictive.

2. What should I know before I use CEFACLOR SUN?

Warnings

Do not use CEFACLOR SUN if:

  • You are allergic to cefaclor monohydrate, other cephalosporins or any of the ingredients listed at the end of this leaflet.
    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.
  • Always check the ingredients to make sure you can use this medicine.
  • You have had a serious allergic reaction to penicillin
  • The packaging is torn or shows signs of tampering
  • The expiry date on the pack has passed
    If you take this medicine after the expiry date has passed, it may not work as well (or it may make you feel sick).

Do not give CEFACLOR SUN to a child under the age of one month.

Safety and effectiveness in children younger than one month have not been established.

Check with your doctor if you:

  • If you have any type of allergic reaction to cephalosporin medicines, penicillin medicines or any other antibiotic medicines.
    You may have an increased chance of being allergic to CEFACLOR SUN if you are allergic to cephalosporins or pencillin.
  • If you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
  • If you have or have ever had any other health problems/medical conditions, including:
    - kidney disease;
    - severe bowel conditions/disease;
    - liver disease.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss the risks and benefits of using CEFACLOR SUN during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the risks and benefits of using CEFACLOR SUN when breastfeeding.

3. What if I am taking other medicines?

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

Some medicines may interfere with CEFACLOR SUN. These include:

  • Antacids containing magnesium or aluminium, used to treat stomach upset or stomach ulcers
  • Probenecid, a medicine used to treat gout and to promote the excretion of uric acid (eg. Pro-Cid).

These medicines may be affected by CEFACLOR SUN, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking CEFACLOR SUN.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CEFACLOR SUN.

4. How do I use CEFACLOR SUN?

How much to take / use

  • Your doctor will tell you how much CEFACLOR SUN you need to take.
    This depends on type of infection you have.
  • Follow the instructions provided when CEFACLOR SUN was prescribed, including the number of days it should be taken.

When to take / use CEFACLOR SUN

  • CEFACLOR SUN should be used at about the same time each day. This will have the best effect. It will also help you remember when to take this medicine.
  • It does not matter if you take this medicine with or without food.

How to take CEFACLOR SUN

Cefaclor powder for suspension must be mixed with water before use. This is usually done by your pharmacist.

This medicine is taken by mouth.

Shake the bottle well and accurately measure the dose using 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.

If you need to take an antacid tablet for indigestion, take it atleast one hour before or after taking CEFACLOR SUN.

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 complete the full course of treatment prescribed by your doctor, the infection may not clear completely or your symptoms may return.

If you forget to use CEFACLOR SUN

CEFACLOR SUN should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember and then go back to taking it as you would do normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

  • If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
  • If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much CEFACLOR SUN

If you think that you have used too much CEFACLOR SUN, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much CEFACLOR SUN, you may have:

  • sick;
  • vomiting;
  • upset stomach;
  • diarrhea.

5. What should I know while using CEFACLOR SUN?

Things you should do

  • If the symptoms of your infection do not improve within a few days, or if they become worse tell your doctor.
  • If you get a sore white mouth or tongue while taking or soon after stopping CEFACLOR SUN, tell your doctor. Also tell your doctor if your get vaginal itching or discharge.
    This may mean you have a fungal infection called thrush. Sometimes the use of CEFACLOR SUN allows fungi to grow and the above symptoms to occur. CEFACLOR SUN does not work against fungi.
  • If you become pregnant while you are taking CEFACLOR SUN, tell your doctor.
  • If you are about to start taking any new medicine, tell your doctor or pharmacist that you are taking CEFACLOR SUN
  • If you have to have any blood or urine tests, tell your doctor you are taking CEFACLOR SUN. CEFACLOR SUN may affect the results of some blood and urine 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.
    CEFACLOR SUN may cause false test results with some urine sugar tests.

Things you should not do

  • Do not stop using CEFACLOR SUN or change the dosage without checking with your doctor.
  • Do not give CEFACLOR SUN to anyone else, even if they have same condition as you.
  • Do not use CEFACLOR SUN to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CEFACLOR SUN affects you.

CEFACLOR SUN generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, CEFACLOR SUN may cause dizziness or tiredness in some people.

Children should be careful when riding bicycles or climbing trees.

Looking after your medicine

Keep CEFACLOR SUN suspension in your refrigerator at 2°C to 8°C. Do not freeze. Discard unused suspension after 14 days.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • oral thrush - white furry, sore tongue and mouth;
  • vaginal thrush - sore and itchy vagina and/or discharge;
  • itchy rash;
  • diarrhoea
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • 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.
Speak to your doctor as soon as possible if you notice any of the following and they worry you:
  • 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 if you notice any of the following, particularly if they occur several weeks after stopping treatment with CEFACLOR SUN
  • 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.
  • seizures
  • signs of encephalopathy such as confusion, memory loss, personality changes, trouble thinking clearly or focusing
  • signs of myoclonus such as involuntary muscle movements such as jerks, tremors or eye movements which may occur alone or in combination with encephalopathy
These is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.		Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What CEFACLOR SUN contains

Active ingredient
(main ingredient)		cefaclor monohydrate
Other ingredients
(inactive ingredients)
  • xanthan gum
  • sodium benzoate
  • sucrose
  • colloidal anhydrous silica
  • allura red AC
  • strawberry flavouring (PI)
  • sodium citrate
  • anhydrous citric acid
  • simethicone emulsion (PI)
Potential allergensSugars and benzoates

Do not take this medicine if you are allergic to any of these ingredients.

What CEFACLOR SUN looks like

Your pharmacist will make up the medicine in 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/5mL (AUST R 226400)
  • 250 mg/5mL (AUST R 226401)

Who distributes CEFACLOR SUN

Sun Pharma ANZ Pty Ltd
12 Waterloo Road Macquarie Park
Sydney NSW 2113 Australia
Email: [email protected]
Telephone: 1800 726 229

This leaflet was prepared in September 2024

Published by MIMS November 2024

BRAND INFORMATION

Brand name

Cefaclor Sun

Active ingredient

Cefaclor

Schedule

S4

 

1 Name of Medicine

Cefaclor (monohydrate).

2 Qualitative and Quantitative Composition

Cefaclor Sun 125 mg/5 mL.

Each 5 mL of the reconstituted suspension contains 125 mg of cefaclor (as monohydrate).

Cefaclor Sun 250 mg/5 mL.

Each 5 mL of the reconstituted suspension contains 250 mg of cefaclor (as monohydrate).
Cefaclor monohydrate is a white to off-white crystalline powder, slightly soluble in water, but is insoluble in alcohol and chloroform.
Excipients with known effect includes sugars and benzoates. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

125 mg/5 mL.

White to off-white granular powder which forms a red strawberry flavoured suspension upon reconstitution with 70 mL water.

250 mg/5 mL.

White to off-white granular powder which forms a red strawberry flavoured suspension upon reconstitution with 53 mL water.

4 Clinical Particulars

4.1 Therapeutic Indications

Cefaclor 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 tract 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. Cefaclor 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

Administer orally.

Reconstitution of oral suspension.

For 125 mg/5 mL bottles add 70 mL water, in two portions, to the granular powder. Shake well after each addition.
For 250 mg/5 mL bottles add 53 mL water, in two portions, to the granular powder. Shake well after each addition.

Adults.

The usual adult dosage is 250 mg every eight to twelve hours. For bronchitis and pneumonia, the dosage is 250 mg three times daily. For more severe infections or those caused by less susceptible organisms, doses may be doubled (500 mg every eight hours).
Doses of 2 g daily should not be exceeded.
For skin and skin structure infections, the dosage is 250 mg two to three times daily.

Children.

The usual recommended daily dosage for children with mild to moderate infections is 20 mg/kg/day in divided doses every 8 hours. The maximum dose is 1 g daily.
For streptococcal pharyngitis or tonsillitis and impetigo, administration every twelve hours 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 eight to twelve hours (maximum 2 g/day). For otitis media, administration every twelve hours appears equally effective.

Renal impairment.

Cefaclor Sun 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).

β-haemolytic streptococcal infections.

In the treatment of β-haemolytic streptococcal infections, a therapeutic dosage of Cefaclor Sun should be administered for at least ten days.

4.3 Contraindications

Known allergy to cephalosporins or previous experience of a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use) or any of the excipients listed (see Section 6.1 List of Excipients).
Infants under the age of 1 month; safety and efficacy of this product have not been established in premature infants and infants under 1 month of age.

4.4 Special Warnings and Precautions for Use

As with antibiotic therapy in general, administration of Cefaclor Sun 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 10 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 Cefaclor Sun 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.

Allergic reaction (anaphylaxis).

Penicillin sensitive patients, or those with hypersensitivity to other allergens. Cephalosporin antibiotics should be administered cautiously in this patient group. 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 drug from the penicillin or cephalosporin group of drugs is a contraindication to the use of cefaclor. 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, Cefaclor Sun 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.

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 Clostridioides 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 Clostridioides 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, may prolong and/or worsen the condition and should not be used.

History of bleeding disorders.

All cephalosporins may cause hypoprothrombinaemia and, potentially, bleeding.

Dental.

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

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.

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, Cefaclor Sun should be discontinued immediately and an alternative treatment should be considered.

Use in hepatic impairment.

Cefaclor Sun should be used with caution in patients with hepatic disease, as documented clinical experience in this group of patients is lacking.

Use in renal impairment.

Many cephalosporins are excreted renally. Cefaclor Sun 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.

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 and adjustment in dosage and/or dosing interval in patients receiving cephalosporins.
In elderly subjects (> 65 years) with normal serum creatinine values, a higher peak plasma concentration and area under the curve are effects resulting from mildly diminished renal function and are not expected to have clinical significance. Therefore dosage change is not necessary in elderly subjects with normal renal function.

Paediatric use.

Safety and effectiveness of this product for use in infants less than 1 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.

Effect on laboratory tests.

Glucose, urine.

Administration of Cefaclor Sun 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 haematological studies or in transfusion cross matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborn infants whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

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

Anti-coagulants, 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.

Hypoprothrombinaemia induced by large doses of salicylates and/or cephalosporins, and the gastrointestinal ulcerative or hemorrhagic potential of non-steroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfinpyrazone may increase the risk of haemorrhage.

Antacids.

The extent of absorption of cefaclor is diminished if magnesium or aluminium hydroxide containing antacids are taken within one 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Adequate and well-controlled studies in humans have not been done. Reproduction studies in animals 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 malformation. Safety of this product for use during pregnancy has not been established. Cefaclor Sun should not be used in women of childbearing potential unless, in the judgment of the treating physician, its use is considered essential to the welfare of the patient and the expected benefits outweigh potential risks.

Labour and delivery.

Cefaclor has not been studied for use during labour and delivery. Treatment should be given only if clearly needed.
 Small amounts of cefaclor have been detected in breast 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 breastfed infants is not known. Caution should be exercised when Cefaclor Sun is administered to a breastfeeding 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 cefaclor (see Section 4.4 Special Warnings and Precautions for Use). Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment.

Hepatobiliary disorder.

Hepatic dysfunction, including transient hepatitis and cholestatic jaundice have been reported rarely.
Slight elevations in AST, ALT, or alkaline phosphatase values have also been reported.

Immune system disorders.

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, toxic epidermal necrolysis and anaphylaxis, 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%).
Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, or vasodilatation.
Rarely, hypersensitivity symptoms may persist for several months.
The following reactions have been reported rarely in patients treated with cefaclor:

Blood and lymphatic system disorders.

Eosinophilia, transient lymphocytosis leucopoenia 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.
There have also been reports of transient fluctuations in leucocyte count, predominantly lymphocytosis in infants and young children.

Renal and urinary disorders.

Slight elevation in serum urea or serum creatinine or abnormalities of urinalysis (haematuria; pyuria), reversible interstitial nephritis.

Infection and infestations.

Genital pruritus, moniliasis or vaginitis.

Central nervous system disorders.

Reversible hyperactivity, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, headache or somnolence have been reported rarely.

Other.

Transitory abnormalities in clinical laboratory test results have been reported, but their clinical significance is uncertain.

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.
The following adverse reactions have been reported in patients treated with other beta-lactam antibiotics:

Renal dysfunction, and toxic nephropathy.

Several beta-lactam antibiotics have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

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

Symptoms.

The toxic symptoms following an overdose of cefaclor 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 the 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 131126 (Australia).

5 Pharmacological Properties

Cefaclor is a semisynthetic, broad spectrum cephalosporin antibiotic for oral administration.

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology. In vitro tests demonstrate that the bactericidal action of the 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 Staphylococcus aureus); Streptococcus pyogenes (group A β-haemolytic Streptococci), Streptococcus (Diplococcus) pneumoniae; Escherichia coli; Proteus mirabilis; Klebsiella sp; Haemophilus influenzae; Neisseria gonorrhoeae (penicillinase and non-penicillinase producing strains); Moraxella (Branhamella) catarrhalis.

Note.

Pseudomonas sp., Acinetobacter calcoaceticus, Enterococci, Enterobacter sp., indole-positive Proteus, and Serratia sp. are resistant to cefaclor. Methicillin resistant strains are also resistant to cefaclor.
Susceptibility testing.

Dilution or diffusion technique.

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.

Cefaclor 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 to 60 minutes 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.

Excretion.

The plasma half-life in healthy subjects is independent of dosage form and averages 40 to 60 minutes. Also see Section 4.4 Special Warnings and Precautions for Use, Use in the elderly.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Xanthan gum, sodium benzoate, sucrose, colloidal anhydrous silica, allura red AC, strawberry flavouring (PI), sodium citrate dihydrate, citric acid and simethicone emulsion (PI).

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Powder.

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

After mixing.

Store in a refrigerator (2-8°C. Refrigerate. Do not freeze). Discard unused suspension after 14 days.

6.5 Nature and Contents of Container

Cefaclor Sun oral suspension is intended for oral administration. Each bottle contains either 125 mg or 250 mg cefaclor per 5 mL when reconstituted.

125 mg/5 mL.

White to off-white granular powder which forms a red strawberry flavoured suspension upon reconstitution with 70 mL water. HDPE bottles of 100 mL when reconstituted.

250 mg/5 mL.

White to off-white granular powder which forms a red strawberry flavoured suspension upon reconstitution with 53 mL water. HDPE bottles of 75 mL when reconstituted.

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

Chemical structure.


Molecular formula: C15H14ClN3O4S.H2O.
Molecular weight: 385.8.

CAS number.

70356-03-5.

7 Medicine Schedule (Poisons Standard)

S4: Prescription Only Medicine.

Summary Table of Changes