Consumer medicine information

APO-Amoxycillin Suspension

Amoxicillin

BRAND INFORMATION

Brand name

APO-Amoxycillin Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Amoxycillin Suspension.

What is in this leaflet

Read this leaflet carefully before giving your child this medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about your child taking this medicine.

This leaflet answers some common questions about amoxicillin.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. Some more recent information on the medicine may be available. Speak to your pharmacist or doctor to obtain the most up to date information on the medicine.

All medicines have risks and benefits. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have.

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

What this medicine is used for

The name of your child's medicine is APO-Amoxycillin Suspension. It contains a penicillin called amoxicillin (as trihydrate) as the active ingredient.

It is an antibiotic which used to treat infections in different parts of the body caused by bacteria.

Amoxicillin can also be used to prevent infection.

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

How it works

Amoxicillin is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your child's infection.

Ask your doctor if you have any questions about why this medicine has been prescribed for your child. Your doctor may have prescribed amoxicillin for another reason.

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

There is no evidence that this medicine is addictive.

Use in children

Amoxicillin suspension is the most suitable form of amoxicillin to give to children.

If you are an adult and you are taking this suspension, you should also read the leaflet about Amoxicillin capsules.

Before you give this medicine

When your child must not take it

This medicine must not be taken if your child has had an allergic reaction to:

  • amoxicillin
  • other penicillins or cephalosporins
  • any of the ingredients listed near the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, throat or other parts of the body, muscle pain or tenderness, joint pain or rash, itching or hives on the skin.

This medicine must not be taken after the expiry date (EXP) printed on the pack. If this medicine is taken after the expiry date has passed, it may not work as well.

This medicine must not be taken if the packaging is torn or shows signs of tampering or if it does not look quite right. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether your child should start taking amoxicillin, talk to your doctor or pharmacist.

Before your child starts to take it

Tell your doctor if:

  1. Your child is allergic to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes
  1. Your child has ever had an allergic reaction (such as a rash) to any antibiotics in the past.
  2. Your child has or has had any medical conditions, especially the following:
  • glandular fever (mononucleosis)
  • blood disorders such as leukaemia
  • liver or kidney problems

If you have not told your doctor about any of the above, tell them before your child starts taking amoxicillin.

Taking other medicines

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

Some medicines and amoxicillin may interfere with each other. These include:

  • medicines used to treat gout (eg probenecid or allopurinol)
  • other antibiotics (e.g. tetracyclines)

These medicines may be affected by amoxicillin or may affect how well it works. Your child may need different amounts of medicine, or he/she may need to take different medicines.

Your doctor and pharmacist will advise you. They will tell you if your child is taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking amoxicillin.

How to give this medicine

Follow all directions from your doctor or pharmacist carefully. They may be different to the information in this leaflet.

If you do not understand any written instructions, ask your doctor or pharmacist for help.

How much to give

Your doctor or pharmacist will tell you how much liquid you will need to give. This depends on your child's condition and whether or not they are taking any other medicines.

The usual dose of amoxicillin suspension is one dose three times a day. The dose may vary according to your child's weight.

How to give it

Shake the suspension in the bottle well before measuring out the dose in a suitable measure. Make sure that the whole dose is swallowed each time.

When to give it

Give it at about the same time each day. Giving the medicine at the same time each day will have the best effect. It will also help you remember when to give it.

Space the doses as evenly as possible throughout the day. For example, if your child is taking amoxicillin three times a day, give a dose about every eight hours.

Amoxicillin can be taken with or without food. The effects of amoxicillin are not changed by food.

How long to give it for

Continue giving amoxicillin to your child until your doctor says so.

Do not stop giving this medicine to your child because he/she is feeling better.

If the full course prescribed by your doctor is not completed, the infection may not clear completely or it may return.

Make sure you have enough to last over weekends and holidays.

If you forget to give it

If it is almost time for your child's next dose, skip the dose they missed and give the next dose when you are meant to. Otherwise, give it as soon as you remember, and then go back to giving the doses as you would normally.

Do not give a double dose to make up for the dose that was missed. This may increase the chance of your child getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to give the doses, ask your pharmacist for some hints.

If your child takes too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) or go to the Accident and Emergency Department at the nearest hospital, if you think that your child or anyone else may have taken too much amoxicillin.

Do this even if there are no signs of discomfort or poisoning.

Your child may need urgent medical attention.

If your child takes too much amoxicillin, they may feel sick or get diarrhoea.

While your child is taking this medicine

Things you must do

Tell your doctor if:

  1. The symptoms of your child's infection do not improve within a few days, or if they become worse.
  2. Your child develops itching with swelling or skin rash or difficulty breathing. Stop giving this medicine and contact your doctor immediately.
  3. Your child gets severe diarrhoea. Tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after your child stopped taking amoxicillin.
Diarrhoea may mean that your child has a serious condition affecting the bowel. They may need urgent medical care.
Do not give any anti-diarrhoea medicine without first checking with your doctor.
  1. Your child gets a sore white mouth or tongue while taking or soon after stopping amoxicillin, or if your daughter gets vaginal itching or discharge
This may mean they have a fungal infection called thrush. Sometimes the use of amoxicillin allows fungi to grow and the above symptoms to occur. Amoxicillin does not work against fungi.
  1. Your child is about to have any blood tests.
  2. Your child is about to start taking any other new medicine.

Tell any other doctors, dentists, and pharmacists who are treating your child that they are taking amoxicillin.

Keep any appointments with your doctor. Your doctor may want to do tests to make sure the medicine is working and to prevent side effects.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to your child's.

Do not give this medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop giving your child this medicine, or change the dosage, without checking with your doctor.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for your child.

Tell your doctor or pharmacist as soon as possible if your child does not feel well while they are taking amoxicillin.

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

Following is a list of possible side effects. Do not be alarmed by this list. Your child may not experience any of them.

Tell your doctor or pharmacist if you notice your child has any of the following and they are troublesome or ongoing:

  • oral thrush - white and sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • diarrhoea
  • nausea (feeling sick), indigestion or vomiting
  • discoloured teeth. This usually goes away with extra brushing.

The above list includes the more common side effects. Mostly, these are mild.

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

  • itching or any type of skin rash
  • unusual bleeding or bruising
  • yellowing of the skin or eyes
  • dark urine or pale stools
  • difficulty or pain on passing urine
  • severe diarrhoea
  • feeling hyperactive or having trouble concentrating.

These may be serious side effects. Your child may need medical attention. Most of these side effects are rare

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

  • allergic reaction including wheezing, fainting, swelling of limbs, face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing.

These are very serious side effects. Your child may need urgent medical attention or hospitalisation.

Tell your doctor immediately if your child develops any of the following side effects, even if they occur several weeks after your child has stopped taking amoxicillin:

  • 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.

These are rare but serious side effects. Your child may have a serious condition affecting the bowel. Therefore, he/she may need urgent medical attention. This side effect is rare.

Do not give any anti-diarrhoea medicine without checking with your doctor first.

Other side effects not listed above may occur in some patients.

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

Ask your doctor or pharmacist if you don't understand anything in this list.

Storage and disposal

Storage

Keep amoxicillin suspension in its original bottle until it is time to give it. If you put the suspension in a different container it may not keep well.

Keep this medicine in a refrigerator; do not freeze it.

Do not use any suspension that is left after 14 days.

Do not store this medicine, or any other medicine, in the bathroom or near a sink.

Do not leave it on a window sill or in the car on hot days. 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 or pharmacist tells you to stop giving this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your child's condition.

Product description

What APO-Amoxycillin Suspension looks like

APO-Amoxycillin Suspension when reconstituted by the pharmacist forms a 100 mL orange suspension, and is available in the following strengths:

  • 125 mg/5 mL
  • 250 mg/5 mL

Ingredients

Active Ingredient:

The suspension contains either 125 mg or 250 mg of amoxicillin (as trihydrate) in every 5 mL.

It also contains the following inactive ingredients:

  • sorbitol
  • sunset yellow FCF
  • tutti frutti flavour (PI 183)
  • xanthan gum
  • sodium citrate dihydrate
  • colloidal anhydrous silica
  • saccharin sodium

Allergen information

APO-Amoxycillin Suspension contains saccharin.

APO-Amoxycillin Suspension contains sorbitol. The 125 mg/5 mL strength contains 18 g sorbitol in 120 mL reconstituted suspension. The 250 mg/5 mL strength contains 7.2 g sorbitol in 60 mL reconstituted suspension. Products containing sorbitol may have a laxative effect or cause diarrhoea.

APO-Amoxycillin 125 mg/5 mL Suspension contains 1.14 mg sodium in 1 ml reconstituted suspension.

APO-Amoxycillin Suspension does not contain lactose, sucrose, gluten or tartrazine.

Australian Registration Numbers

APO-Amoxycillin
125 mg/5 mL Suspension
Bottle: AUST R 137882

APO-Amoxycillin
250 mg/5 mL Suspension
Bottle: AUST R 137883

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street,
Cremorne, VIC 3121
Australia

This leaflet was updated in July 2023.

Published by MIMS September 2023

BRAND INFORMATION

Brand name

APO-Amoxycillin Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin (as amoxicillin trihydrate).

2 Qualitative and Quantitative Composition

Each 5 mL contains 125 mg or 250 mg amoxicillin (as trihydrate).

Excipients with known effect.

Saccharin, sodium, sorbitol.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Amoxycillin Powder for Suspension 125 mg/5 mL.

White to off-white powder forming an orange suspension upon reconstitution with water.

APO-Amoxycillin Powder for Suspension 250 mg/5 mL.

White to off-white powder forming an orange suspension upon reconstitution with water.

4 Clinical Particulars

4.1 Therapeutic Indications

It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms.

Note.

Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. Clinical judgment will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.

Skin and skin structure.

Staphylococcus, non-penicillinase producing; Streptococcus; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

Respiratory (acute and chronic).

H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, non-penicillinase producing; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

Genitourinary tract (complicated and uncomplicated, acute and chronic).

E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology), P. mirabilis and Strep. faecalis.

Gonorrhoea.

N. gonorrhoeae (non-penicillinase producing).

Prophylaxis of endocarditis.

Amoxicillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

4.2 Dose and Method of Administration

APO-Amoxycillin Powder for Suspension is intended for oral administration.

Dosage.

Normal renal function.

Upper respiratory tract infections, genitourinary tract infections, skin and soft tissue infections.

Adults and children (over 20 kg).

250 mg every eight hours.

Children (under 20 kg).

20 mg/kg/day in equally divided doses every eight hours.
In severe infections or those caused by less susceptible organisms, 500 mg every eight hours for adults and 40 mg/kg/day in equally divided doses every eight hours for children may be needed.
Lower respiratory tract infections.

Adults.

500 mg every eight hours.

Children (under 20 kg).

40 mg/kg/day in equally divided doses every eight hours.
Urethritis, gonococcal.

Adults.

3 g as a single dose.
Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving amoxicillin and monthly serological tests for a minimum of four months.
Acute uncomplicated lower urinary tract infections in nonpregnant adult females.

Adults.

3 g as a single dose.

Use in neonates.

Experience in neonates is too limited to make any recommendations regarding dosage or the appropriateness of the oral route.

Use in children.

The children's dosage is intended for individuals whose weight will not cause dosage to be calculated greater than that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations.

Renal impairment.

In renal impairment the excretion of the antibiotic will be delayed, and depending on the degree of impairment, it may be necessary to reduce the total daily dosage.
In patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day. Amoxicillin may be removed from the circulation by haemodialysis.

Chronic urinary tract infections.

It should be recognised that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

Duration of treatment.

Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least ten days treatment for any infection caused by haemolytic Streptococci, to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

Prophylaxis of endocarditis.

See Table 1.

4.3 Contraindications

Amoxicillin is a penicillin and should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins).

4.4 Special Warnings and Precautions for Use

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis, anaphylactoid and severe cutaneous reactions) have been reported in patients receiving β-lactam antibiotics. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. Before commencing therapy with any penicillin careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and amoxicillin therapy discontinued.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation should also be administered as indicated.
Drug induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see Section 4.8 Adverse Effects (Undesirable Effects)). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after administration of amoxicillin) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise of abdominal pain, diarrhoea, hypotension, or leucocytosis with neutrophilia. There have been severe cases including progression to shock.
Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and amoxicillin therapy discontinued.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. Clostridium difficile associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhoea to fatal colitis. 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). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibiotic agent effective against Clostridium 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.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Amoxicillin, an aminopenicillin, is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used.
Amoxicillin should be given with caution to patients with lymphatic leukaemia, since they are especially susceptible to ampicillin induced skin rashes.
Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A positive culture may be evidence of a complicated or upper urinary tract infection and call for a longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.

Use in renal impairment.

Dosage should be adjusted in patients with renal impairment (see Section 4.2 Dose and Method of Administration).
In patients with reduced urine output, crystalluria (including acute renal injury) has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.9 Overdose).

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Oral administration of amoxicillin will result in high urine concentrations of amoxicillin. Since high urine concentrations of amoxicillin may result in false positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict's solution or Fehling's solution, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Tes-Tape) be used.
Following administration of ampicillin to pregnant women a transient decrease in plasma concentration of total conjugated oestriol, oestriol glucuronide, conjugated oestrone and oestradiol has been noted. This effect may also occur with amoxicillin.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. Similar reactions can be expected with amoxicillin.
In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If coadministration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Methotrexate.

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Animal studies with amoxicillin have shown no teratogenic effects. Amoxicillin has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies.
Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Use in labour and delivery.

Oral ampicillin class antibiotics are generally poorly absorbed during labour. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions and duration of contractions. However, it is not known whether the use of amoxicillin in humans during labour or delivery has immediate or delayed adverse effects on the foetus, prolongs the duration of labour or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn infant will be necessary.
Ampicillin class antibiotics are excreted in breast milk; therefore, caution should be exercised when amoxicillin 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)

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins.
The following adverse reactions have been reported as associated with the use of amoxicillin.

Cardiac disorders.

Kounis syndrome: not known.

Infections and infestations.

Mucocutaneous candidiasis has been reported very rarely.

Gastrointestinal.

Nausea, vomiting, diarrhoea. Intestinal candidiasis and antibiotic associated colitis, including pseudomembranous colitis and haemorrhagic colitis have been reported rarely. Black hairy tongue has been reported very rarely. Drug induced enterocolitis syndrome: not known (see Section 4.4 Special Warnings and Precautions for Use).

Skin and subcutaneous tissue disorders.

Linear IgA disease: not known.

Hypersensitivity reactions.

Erythematous maculopapular rash, pruritus and urticaria have been reported occasionally. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous, exfoliative dermatitis and acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. As with other antibiotics, severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness, hypersensitivity vasculitis and interstitial nephritis have been reported rarely.
Whenever such reactions occur, amoxicillin should be discontinued.

Note.

Urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Anaphylaxis is the most serious reaction experienced (see Section 4.4 Special Warnings and Precautions for Use).

Hepatic.

A moderate rise in AST and/or ALT has been noted occasionally but the significance of this finding is unknown. As with other β-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely.

Haemic and lymphatic systems.

Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia and leucopenia (including severe neutropenia or agranulocytosis) have been reported during therapy with other penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Prolongation of bleeding time and prothrombin time have also been reported rarely.

Renal and urinary tract disorders.

Interstitial nephritis, crystalluria including renal injury: not known (see Section 4.9 Overdose).

CNS effects.

CNS effects have been seen rarely. These include aseptic meningitis, hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Miscellaneous.

Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

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 http://www.tga.gov.au/reporting-problems and contact Arrotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.9 Overdose

Symptoms.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident.

Treatment.

Symptoms of water/ electrolyte imbalance should be treated symptomatically. During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin can be removed from the circulation by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology. Amoxicillin is similar to ampicillin in its bactericidal action against Gram positive and Gram negative susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of the cell wall mucopeptide.
It is active in vitro against most strains of Haemophilus influenzae*, Neisseria gonorrhoeae*, N. meningitidis, Escherichia coli*, Proteus mirabilis* and Salmonellae. Because amoxicillin does not resist destruction by penicillinase, it is not active against penicillinase producing organisms, particularly penicillinase producing staphylococci. All strains of Pseudomonas species, Klebsiella species, Enterobacter species, indole positive Proteus species, Serratia marcescens, Citrobacter species, penicillinase producing N. gonorrhoeae and penicillinase producing H. influenzae are resistant. In vitro studies have demonstrated the susceptibility of most strains of the following Gram positive bacteria: α and β-haemolytic streptococci, Diplococcus pneumoniae, non-penicillinase producing staphylococci and Streptococcus faecalis. These organisms are susceptible to amoxicillin at serum concentrations which may be expected following the recommended doses. However, some of the organisms were susceptible to amoxicillin only at concentrations achieved in the urine (see Section 4.1 Therapeutic Indications).
* Activity refers only to β-lactamase negative strains.
Escherichia coli isolates are becoming increasingly resistant to amoxicillin in vitro due to the presence of penicillinase producing strains.
Strains of gonococci that are relatively resistant to benzylpenicillin may be sensitive to amoxicillin.
The following in vitro data are available, but their clinical significance is unknown. See Table 2.
A positive β-lactamase test predicts resistance to penicillin, ampicillin and amoxicillin. See Table 3.

Breakpoints.

Streptococcus pneumoniae: S ≤ -2 microgram/mL; I = 4 microgram/mL; R ≥ 8 microgram/mL.

Note.

Because amoxicillin has a greater in vitro activity against S. pneumoniae than does ampicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin are fully susceptible to amoxicillin.

Susceptibility tests.

Dilution or diffusion techniques, either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections. This information gives only an approximate guidance on probabilities whether organisms will be susceptible to amoxicillin.
Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing performed where necessary.

Cross resistance.

Other β-lactams, β-lactam/ β-lactamase inhibitor combinations and cephalosporins.

Resistance mechanisms.

Production of penicillinase, altered penicillin binding proteins.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Amoxicillin is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food.
Orally administered doses of 250 and 500 milligrams result in average peak serum levels one to two hours after administration of 5 microgram/mL and 6.6 to 10.8 microgram/mL respectively. Detectable serum levels of amoxicillin are present 8 hours after ingestion of a single dose.

Distribution.

Amoxicillin is not highly protein bound, being only 17% protein bound in serum as measured by ultrafiltration or equilibrium dialysis.
Amoxicillin diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid except when the meninges are inflamed. Amoxicillin has been shown to diffuse into sputum and saliva and is excreted mainly via the urine where it exists in a high concentration.
The amount to be found in the bile is variable depending on normal biliary secretory function.

Excretion.

The half-life of amoxicillin is 61.3 minutes with normal renal function, and in the absence of renal function is 16 to 20 hours.
Amoxicillin is excreted in the urine both unchanged and as penicilloic acid. About 75% of a 1 g dose is excreted in the urine in six hours in the presence of normal renal function (60% is biologically active and 15% is penicilloic acid). However about 32% of a 3 g dose is excreted via the urine as the biologically active component in 8 hours (by which time most of the urinary excretion is complete). This proportional difference in the amount excreted from the different doses reflects a lack of linearity between doses and extent of absorption with a levelling off at higher doses of oral amoxicillin.
Excretion of amoxicillin can be delayed by concurrent administration of probenecid, thus prolonging its therapeutic effect.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Saccharin sodium, colloidal silica anhydrous, sodium citrate dihydrate, sorbitol, sunset yellow FCF, xanthan gum, tutti frutti flavour (PI 183).

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.
Unused suspension must be discarded after 14 days.

6.4 Special Precautions for Storage

Store the powder below 25°C. Protect from moisture.
After reconstitution with water, stored at 2 - 8°C in a refrigerator. Do not freeze.

6.5 Nature and Contents of Container

APO-Amoxycillin Powder for Suspension 125 mg/5 mL.

100 mL when reconstituted.
Bottle: AUST R Number 137882.

APO-Amoxycillin Powder for Suspension 250 mg/5 mL.

100 mL when reconstituted.
Bottle: AUST R Number 137883.
Not all strengths may be available.

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

Amoxicillin trihydrate is a white or almost white, crystalline powder, slightly soluble in water and in alcohol.
Amoxicillin trihydrate is a semisynthetic antibiotic and is a member of the penicillinase stable group of penicillins derived from the penicillin nucleus, 6-aminopenicillanic acid, isolated at Beecham Research Laboratories.

Chemical structure.


Chemical name: (2S,5R,6R)-6[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
Molecular formula: C16H19N3O5S.3H2O. Molecular weight: 419.4.

CAS number.

61336-70-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes