Consumer medicine information

AMOXIL PAEDIATRIC PREPARATIONS [8219]

Amoxicillin

BRAND INFORMATION

Brand name

Amoxil Paediatric Drops

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using AMOXIL PAEDIATRIC PREPARATIONS [8219].

What is in this leaflet?

Please read this leaflet carefully before you give AMOXIL to your child.

This leaflet answers some common questions about AMOXIL. It does not contain all of the available information.

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

All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your child’s doctor has weighed the expected benefits of your child taking AMOXIL against the risks this medicine could have for your child.

AMOXIL must be given to your child as instructed. If you have any concerns about this medicine, ask your child’s doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What is AMOXIL used for?

AMOXIL contains a penicillin called amoxycillin as the active ingredient.

Amoxycillin belongs to the penicillin group of antibiotics.

AMOXIL is used to treat a range of infections caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), inner ear (otitis media), urinary and genital tract or skin and fleshy tissues.

AMOXIL works by killing the bacteria that cause these infections. AMOXIL can also be used to prevent infection.

Your child’s doctor may have prescribed AMOXIL for another reason.

There is no evidence that AMOXIL is addictive.

Before you give AMOXIL

Do not give AMOXIL if:

  • your child is allergic to penicillin or similar types of antibiotics such as cephalosporins. If your child has ever had an allergic reaction (such as a rash) when taking an antibiotic, tell the doctor before any AMOXIL is given.
  • your child has ever had an allergic reaction to amoxycillin or any of the ingredients listed toward the end of this leaflet. (See "Ingredients")
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Tell your child’s doctor if:

  • your child has ever had an allergic reaction (such as a rash) to any antibiotics in the past.
  • your child has glandular fever (mononucleosis) or a blood disorder.
  • your child has liver or kidney problems. The dosage of AMOXIL may need to be changed or your child may need to be given an alternative medicine.
  • your child is allergic to foods, dyes, preservatives or any other medicines.
  • your child is taking any other medicines, including medicines you buy without a prescription. In particular tell the doctor if your child is taking any of the following:
    - probenecid or allopurinol.
    - other antibiotics.
    - anticoagulants (used to prevent blood clots) such as warfarin.
    These may interfere with the actions of AMOXIL.

Some medicines may affect the way other medicines work. The doctor or pharmacist will be able to tell you which medicines are safe to take with AMOXIL.

If you have not told the doctor about any of these things, tell them before you give your child any AMOXIL.

How to give AMOXIL to your child

Follow the doctor's instructions about how and when to give AMOXIL. The doctor will advise how many doses are needed each day, and for how long your child will need to take AMOXIL.

Please read the direction label carefully. If you have any concerns about how to give AMOXIL, talk to the doctor or pharmacist.

How much AMOXIL to give:

Give AMOXIL as directed by your child’s doctor or pharmacist.

The usual dose of AMOXIL is one dose taken three times a day. The dose may vary depending on your child's weight.

How to give AMOXIL:

Shake the bottle well before measuring out the dose in a suitable measure. The dose of AMOXIL Paediatric Drops is drawn up and given using the dosing syringe provided with the medicine. Make sure the whole dose is swallowed each time.

AMOXIL Paediatric Drops syringe user instructions:

  1. Shake bottle well before use.
  1. Remove cap.
    FIRST TIME ONLY: Insert adaptor into the bottle neck, ensuring it is firmly attached.
  2. Insert syringe into adaptor.
  1. Invert bottle and withdraw required dose.
  1. Place bottle upright and remove syringe from adaptor.
  1. Administer dose into mouth.
  2. Rinse syringe in clean water.
  1. Replace bottle cap, ensuring adaptor remains in bottle.

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

AMOXIL can be given with or without food. The effects of AMOXIL are not changed by food.

How long to give AMOXIL for:

Keep giving AMOXIL to your child until the course is finished or for as long as the doctor tells you.

Do not stop giving AMOXIL just because your child feels better as the infection can return.

Do not stop giving AMOXIL to your child, or change the dose without first checking with your child’s doctor.

If you forget to give AMOXIL:

If you forget to give a dose of AMOXIL, give it as soon as you remember. Then go back to giving it as directed by the doctor.

Do not give a double dose to make up for the dose that has been missed. Do not give two doses within an hour or so of each other. Giving more than the prescribed dose can increase the chance of unwanted side effects.

What do I do if I give too much AMOXIL? (Overdose)

Immediately telephone the doctor or Poisons Information Centre (telephone 13 11 26) for advice if you think your or anyone else may have taken too much AMOXIL, even if there are no signs of discomfort or poisoning.

If you are not sure what to do, contact your child’s doctor, pharmacist or nearest hospital.

While you are giving AMOXIL to your child

Things you must do:

Tell your child’s doctor if, for any reason, you have not given the medicine exactly as directed.

Otherwise, your child’s doctor may think that it was not working as it should and change your child's treatment unnecessarily.

Tell the doctor or pharmacist your child is taking AMOXIL before giving any other prescribed medicine. Some medicines may affect the way other medicines work.

If your child develops itching, swelling or a skin rash while taking AMOXIL, do not give any more AMOXIL and tell the doctor at once.

If your child develops severe diarrhoea while taking AMOXIL, tell the doctor as soon as possible. Do not give any medication to stop the diarrhoea (e.g. Lomotil® or Imodium®).

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 use AMOXIL to treat any other complaints unless the doctor says to.

What are the side-effects?

Check with your child’s doctor as soon as possible if you think your child is experiencing any side-effects or allergic reactions due to taking AMOXIL, even if the problem is not listed below.

Like other medicines, AMOXIL can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

MILD EFFECTS

  • Tell the doctor if any of the following are troublesome or ongoing:
    - diarrhoea (several loose bowel movements per day), indigestion, feeling sick or being sick
    - soreness of the mouth or tongue, abnormal taste, white or furry tongue (oral thrush)
    - soreness or itching of the vagina and/or discharge (vaginal thrush)

MORE SERIOUS EFFECTS

  • Tell the doctor immediately if any of the following occur:
    - itching, rash
    - unusual bleeding or bruising
    - yellowing of the skin or eyes
    - dark urine or pale stools
    - difficulty or pain on passing urine
    - severe diarrhoea
    - excessive abnormal muscle movements
    - dizziness or convulsions
    - tooth discolouration
  • Stop giving AMOXIL and contact the doctor or take your child to the emergency department of the nearest hospital if any of the following happens:
    - Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

Remember you should tell the doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems occur during or after your child's treatment with AMOXIL.

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Tell your child’s doctor or pharmacist if you notice any side effects from your child's medicine which are not mentioned here.

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

How do I store AMOXIL?

Keep this medicine where children cannot reach it, such as in a locked cupboard.

Keep the bottle in a cool dry place where the temperature stays below 25°C. Do not leave it in the car on a hot day. Do not store medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Do not use any AMOXIL left in the bottle 14 days after opening. Ask your pharmacist what to do with any doses that are left over.

Return any unused or expired medicine to your pharmacist.

Product description

What AMOXIL looks like:

AMOXIL syrups are available as:

  • a yellow or off-white sugar free syrup containing 125mg amoxycillin/5mL (Amoxil Syrup), and
  • a yellow or off-white sugar free syrup containing 250mg amoxycillin/5mL (Amoxil Syrup Forte).

AMOXIL Paediatric Drops are available as:

  • an off-white liquid suspension containing 100mg amoxycillin/mL.

Ingredients:

All AMOXIL preparations contain the active ingredient amoxycillin.

AMOXIL syrups also contain the inactive ingredients

  • disodium edetate,
  • sodium benzoate,
  • saccharin sodium,
  • xanthan gum,
  • colloidal anhydrous silica,
  • silicon dioxide,
  • sorbitol
  • and lemon/peach/strawberry fruit mix flavour PHS-141289.

AMOXIL Paediatric Drops also contain the inactive ingredients

  • sodium benzoate,
  • carmellose sodium 12,
  • crospovidone,
  • xanthan gum,
  • silica - hydrophobic colloidal anhydrous,
  • aspartame,
  • magnesium stearate
  • and lemon/peach/strawberry fruit mix flavour PHS-141289.

Supplier:

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065

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 condition.

AMOXIL preparations are only available if prescribed by a doctor.

AMOXIL is also available as capsules and injections.

AMOXIL paediatric preparations come in the following packs:

  • AMOXIL 125mg/5mL Syrup 100mL (AUST R 11133).
  • AMOXIL Forte 250mg/5mL Syrup 100mL (AUST R 11134).
  • AMOXIL Paediatric Drops 20mL (AUST R 201566).

The information provided applies only to AMOXIL®.

Prepared on: 08 January 2013

Version 4.0

BRAND INFORMATION

Brand name

Amoxil Paediatric Drops

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin trihydrate.

6.7 Physicochemical Properties

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.
Amoxicillin trihydrate is a white or almost white, crystalline powder, slightly soluble in water and in alcohol.

Chemical structure.

Amoxicillin trihydrate may be represented structurally as:
It is identified chemically as (2S,5R,6R)-6-[(R)-2-amino-2-(4-hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
The molecular weight of amoxicillin trihydrate is 419.4.
Molecular Formula: C16H19N3O5S, 3H2O.

CAS number.

61336-70-7.

2 Qualitative and Quantitative Composition

Each Amoxil 250 and 500 mg capsule contains amoxicillin trihydrate equivalent to either 250 mg or 500 mg of amoxicillin.
Each bottle of Amoxil powder for oral liquid contains amoxicillin trihydrate equivalent to 125 mg, 250 mg or 100 mg per 5 mL of amoxicillin when reconstituted.
Excipients of known effect: powder for oral liquid - benzoates and sorbitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Amoxil 250 and 500 mg capsules.

250 mg.

A size '2' hard gelatin capsule with yellow body and maroon cap printed with 'AM250' on cap and body in white ink linearly and containing white/off white powder.

500 mg.

A size 'OEL' hard gelatin capsule with yellow body and maroon cap printed with 'AM250' on cap and body in white ink linearly and containing white/off white powder.

Amoxil Sugar Free Syrup.

Amoxicillin 125 mg/5 mL (as trihydrate) powder for oral liquid bottle.

White free flowing powder. Each 5 mL of the off-white reconstituted oral suspension contains amoxicillin trihydrate equivalent to amoxicillin 125 mg.

Amoxil Forte Sugar Free Syrup.

Amoxicillin 250 mg/5 mL (as trihydrate) powder for oral liquid bottle.

White free flowing powder. Each 5 mL of the off-white reconstituted oral suspension contains amoxicillin trihydrate equivalent to amoxicillin 250 mg.

Amoxil Paediatric Drops.

Amoxicillin 100 mg/mL (as trihydrate) powder for oral liquid bottle.

White free flowing powder. Each 1 mL of off-white reconstituted oral suspension contains amoxicillin trihydrate equivalent to Amoxicillin 100 mg.

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.
Amoxicillin is active in vitro against most strains of Haemophilus influenzae*, Neisseria gonorrhoeae*, Neisseria 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: alpha- and beta-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 beta-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 which are relatively resistant to benzylpenicillin may be sensitive to amoxicillin.
The following in vitro data (see Table 3) are available, but their clinical significance is unknown.
A positive β-lactamase test predicts resistance to penicillin, ampicillin and amoxicillin. See Table 4.

Breakpoints.

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

Note.

Because amoxicillin has 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.

Distribution.

Amoxicillin diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid, except when 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 16-20 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 6 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.
Amoxicillin is not highly protein-bound, being only 17% protein-bound in serum as measured by ultrafiltration or equilibrium dialysis.
Orally administered doses of 250 mg and 500 mg amoxicillin result in average peak serum levels one to two hours after administration of 5.0 microgram/mL and 6.6-10.8 microgram/mL, respectively. Detectable serum levels of amoxicillin are present 8 hours after ingestion of a single dose.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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 judgement 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; S. 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 S. faecalis.

Gonorrhoea.

N. gonorrhoeae (non-penicillinase producing).

Prophylaxis of endocarditis.

Amoxil 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.

4.3 Contraindications

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

4.4 Special Warnings and Precautions for Use

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. 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 my 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 longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.
Dosage should be adjusted in patients with renal impairment (see Section 4.2 Dose and Method of Administration).

Use in renal impairment.

Dosage should be adjusted in patients with renal impairment (see Section 4.2 Dose and Method of Administration).

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 Testape) 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 hyperuricemia 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 co-administration 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Animal studies with amoxicillin have shown no teratogenic effects. The product 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 will be necessary.
Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin is administered to a nursing woman.

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.

Infections and infestations.

Mucocutaneous candidiasis have 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 (see Section 4.4 Special Warnings and Precautions for Use).

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, acute generalised 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).

Liver.

A moderate rise in AST and/or ALT has occasionally been noted, but the significance of this finding is unknown. As with other beta-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 (see Section 4.9 Overdose).

CNS effects.

CNS effects have been seen rarely. They include 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 www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Normal renal function.

Upper respiratory tract infections; genito-urinary tract infections; skin and soft tissue infections.

Adults.

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 single dose. Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving Amoxil and monthly serological tests for a minimum of four months.

Acute uncomplicated lower urinary tract infections in non-pregnant adult female.

Adults.

3 g as single dose.

Note.

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

Directions for reconstitution of Amoxil Paediatric Drops.

Prepare the drops at time of dispensing as follows: Tap bottle until all the powder flows freely. Add the total amount of water for reconstitution (see Table 2), invert bottle and shake well to suspend powder.
When reconstituted, a suspension is produced containing a 125 mg/1.25 mL (100 mg/mL) suspension of amoxicillin trihydrate.

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.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and 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 minimize 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 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

Schedule 4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Amoxil capsules.

Erythrosine, gelatin, indigo carmine, iron oxide yellow, magnesium stearate, purified talc, TekPrint SW-0012 White Ink (PI 13175), titanium dioxide.

Amoxil and Amoxil Forte Sugar Free Syrup.

Colloidal anhydrous silica, disodium edetate, lemon peach strawberry fruit mix flavour phs-141289 (pi 12618), saccharin sodium, silicon dioxide, sodium benzoate, sorbitol, xanthan gum.

Amoxil Paediatric Drops.

Aspartame, carmellose sodium, crospovidone, hydrophobic colloidal silica anhydrous, lemon peach strawberry fruit mix flavour phs-141289 (pi 12618), magnesium stearate, sodium benzoate, 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

Amoxil capsules.

Store below 25°C.

Amoxil and Amoxil Forte Sugar Free Syrup and Amoxil Paediatric Drops.

Store below 25°C. Once reconstituted the suspension should be used within 14 days and stored below 25°C.

6.5 Nature and Contents of Container

Amoxil capsules.

Available in blister packs of 3, 20 or 30* capsules.
(* Pack of 30 not currently marketing in Australia).

Amoxil and Amoxil Forte Sugar Free Syrup and Amoxil Paediatric Drops.

Clear glass bottle, tightly closed with a child resistant cap, containing 20 g of a free flowing white powder. On reconstitution, an off-white suspension is formed.

Amoxil Paediatric Drops.

HDPE glass bottles. Supplied with a dosing syringe comprised of a polypropylene pipette and polystyrene crystal plunger. Available in 20 mL, 12.5 mL and 10 mL powder for oral liquid.
Not all dose forms/container sizes are being distributed in Australia.

6.6 Special Precautions for Disposal

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

Summary Table of Changes