Consumer medicine information

Noumed Amoxicillin Oral Suspension

Amoxicillin

BRAND INFORMATION

Brand name

Noumed Amoxicillin Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Noumed Amoxicillin Oral Suspension.

What is in this leaflet

This leaflet answers some common questions about Noumed Amoxicillin Oral Suspension.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

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

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

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

What this medicine is used for

The name of your medicine is Noumed Amoxicillin Oral Suspension. It contains the active ingredient amoxicillin trihydrate.

Amoxicillin is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that cause infections.

Noumed Amoxicillin Oral Suspension is used to treat infections in different parts of the body caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues.

It is also used to prevent infections before, during and after surgery.

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

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for your child.

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

Noumed Amoxicillin Oral Suspension is not addictive.

Before your child takes this medicine

When your child must not take it

Noumed Amoxicillin Oral Suspension must not be taken if your child has an allergy to:

  • amoxicillin
  • any β-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenem or monobactam)
  • 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

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

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

Before your child starts to take it

Tell your doctor if:

  1. you have ever had any allergies to any antibiotics, and other medicines, foods, preservatives or dyes.
  2. you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of using this medicine during pregnancy.
  1. you are breast-feeding or intend to breast-feed.
Noumed Amoxicillin passes into breast milk. Your doctor will discuss the risks and benefits of taking this medicine when breastfeeding.
  1. Tell your doctor if you have or have had any of the following medical conditions:
  • glandular fever (mononucleosis)
  • blood disorders
  • diabetes
  • seizures history
  • stomach or bowel problems
  • liver or kidney problems
  • asthma
  • history of allergic problems, including hayfever.

If you have not told your doctor about any of the above, tell them before your child takes this medicine.

Taking other medicines

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

Some medicines may interfere with this medicine. These include:

  • medicines used to treat gout (e.g. probenecid or allopurinol)
  • digoxin, a medicine used to treat heart failure
  • other antibiotics (e.g. tetracyclines)
  • anticoagulants (used to prevent blood clots) such as warfarin
  • methotrexate, a medicine used to treat arthritis and some types of cancers
  • oral contraceptives (birth control pills)

These medicines may be affected by Noumed Amoxicillin Oral Suspension, or may affect how well it works. Your child may need different amounts of the medicine, or may need to take different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while taking Noumed Amoxicillin oral suspension.

How to give this medicine to your child

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

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

How much to give

The usual dose of Noumed Amoxicillin oral suspension is one dose taken three times a day. The dose may vary according to your child’s weight.

How to give it

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

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

This medicine can be given with or without food. The effects of this medicine are not changed by food.

How long to take it

Continue giving this medicine to your child until the course is finished or for as long as your doctor recommends.

Do not stop giving this medicine to your child just because he/she feels better. If the full course prescribed by your doctor is not completed, all of the bacteria causing the infection may not be killed. These bacteria may continue to grow and multiply so that the infection may not clear completely, or it may return.

If you forget to give it

If it is almost time for your child’s next dose, skip the missed dose 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.

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

If you take too much (overdose)

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

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If your child takes too much Noumed Amoxicillin, he/she may get diarrhoea and nausea.

While you are giving this medicine

Things you must do

Tell your doctor if, for any reason, you have not given the medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your child’s treatment unnecessarily.

If the symptoms of your child’s infection do not improve within a few days, or if they become worse, tell your doctor.

If your child develops itching with swelling or skin rash, or difficulty breathing while taking Noumed Amoxicillin, do not give any more Noumed Amoxicillin and contact your doctor immediately.

If your child gets severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Noumed Amoxicillin has been stopped. 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.

If your child gets a sore white mouth or tongue while taking or soon after stopping Noumed Amoxicillin, tell your doctor. Also tell your doctor if your daughter gets vaginal itching or discharge. This may mean your child has 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.

Tell your doctor or pharmacist if your child's urine has to be tested for sugar levels while taking this medicine. Amoxicillin will produce false positive results when some of these tests are used. Your doctor will help you identify the correct test.

If your child is about to start taking any new medicine, tell your doctor and pharmacist that he/she is taking Noumed Amoxicillin.

Tell all doctors, dentists and pharmacists who are treating your child that he/she is taking Noumed Amoxicillin.

Things you must not do

Do not give Noumed Amoxicillin to anyone else, even if they have the same condition as your child.

Do not give Noumed Amoxicillin to treat any other complaints unless your doctor tells you to.

Side effects

Check with your doctor as soon as possible if your child has any problems while taking Noumed Amoxicillin, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

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

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

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

  • soreness of the tongue or mouth
  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina or discharge
  • diarrhoea (several loose bowel movements per day), indigestion, feeling sick or being sick
  • discoloration of the teeth. Usually the discoloration can be removed by teeth brushing
  • headache, tiredness.

These side effects are usually mild.

Tell your doctor immediately if you notice your child has any of the following:

  • signs of anaemia such as looking pale, short of breath when exercising, dizziness
  • signs of frequent infections such as fever, sever chills, sore throat or mouth ulcers
  • itching, rash
  • unusual bleeding or bruising
  • yellowing of the skin or eyes
  • dark urine or pale stools
  • difficulty or pain on passing urine

These are serious side effects. Your child may need urgent medical attention. Serious side effects are rare.

If any of the following occur, stop giving Noumed Amoxicillin and tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital:

  • wheezing, swelling of the lips/mouth, difficulty in breathing
  • any skin rash, itching or hives or blistering or peeling of the skin
  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody.

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

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making your child feel unwell.

Ask your doctor or pharmacist if you do not understand anything in this list.

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

After giving this medicine

Storage

Keep the Noumed Amoxicillin suspension in the bottle until it is time to give a dose. If you take the suspension out of the bottle, it may not keep well.

Keep the bottle in the refrigerator (but do not freeze it).

Keep all medicines well out of reach of children.

Do not use any Noumed Amoxicillin suspension left in the bottle after the expiry date printed on the label or pack (the expiry date will be 14 days after the powder is reconstituted to form a suspension by the pharmacist).

Ask your pharmacist what to do with any doses that are left over.

Disposal

If your doctor tells you to stop giving Noumed Amoxicillin to your child, or it has passed the expiry date, ask your pharmacist what to do with any suspension that is left over.

Product description

What it looks like

Noumed Amoxicillin forms 100 mL of an orange suspension when it is reconstituted by the pharmacist, and is available in the following strengths:

  • Noumed Amoxicillin
    125 mg/5 mL
  • Noumed Amoxicillin
    250 mg/5 mL

Ingredients

Noumed Amoxycillin Oral Suspension contains either 125 mg or 250 mg of amoxicillin (as amoxicillin trihydrate) per 5 mL.

Inactive ingredients:

  • sorbitol
  • sunset yellow FCF CI 15985
  • tutti frutti flavour
  • xanthan gum
  • sodium citrate
  • colloidal anhydrous silica
  • saccharin sodium

Australian Registration Numbers

  • Noumed Amoxicillin
    125 mg/5 mL: AUST R 324499
  • Noumed Amoxicillin
    250 mg/5 mL: AUST R 324500

Sponsor

Avallon Pharmaceuticals Pty Ltd
Level 5, 7 Eden Park Drive
Macquarie Park NSW 2113

This leaflet was prepared in April 2020.

Published by MIMS March 2021

BRAND INFORMATION

Brand name

Noumed Amoxicillin Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin trihydrate.

2 Qualitative and Quantitative Composition

Noumed Amoxicillin 125 mg/5 mL and 250 mg/5 mL suspension contains amoxicillin 125 mg and 250 mg, as amoxicillin trihydrate, per 5 mL (1 measuring spoonful).

Excipients with known effects.

The 125 mg/5 mL suspension contains 2.25 g of sorbitol per maximum daily dose.
The 250 mg/5 mL suspension contains 1.8 g of sorbitol per maximum daily dose.
Also contains saccharin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for oral suspension.

Noumed Amoxicillin 125 mg/5 mL granules for oral suspension.

When reconstituted, the white to off-white powder forms an orange suspension with characteristic flavour; 100 mL. AUST R 324499.

Noumed Amoxicillin 250 mg/5 mL granules for oral suspension.

When reconstituted, the white to off-white powder forms an orange suspension with characteristic flavour; 100 mL. AUST R 324500.

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 S. 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

Normal renal function.

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

Adults: 250 mg every 8 hours.
Children (under 20 kg): 20 mg/kg/day in equally divided doses every 8 hours.
In severe infections or those caused by less susceptible organisms, 500 mg every 8 hours for adults and 40 mg/kg/day in equally divided doses every 8 hours for children may be needed.

Lower respiratory tract infections.

Adults: 500 mg every 8 hours.
Children (under 20 kg): 40 mg/kg/day in equally divided doses every 8 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 4 months.

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

Adults: 3 g as a single dose.

Prophylaxis of endocarditis.

See Table 1.

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.

Impaired renal function.

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 10 days treatment for any infection caused by haemolytic Streptococci, to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

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

Hypersensitivity reactions.

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis) have been reported in patients receiving β-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.

Non-susceptible microorganisms.

Amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin. This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.
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.

Overgrowth of non-susceptible microorganisms.

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. 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 antibacterial 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.

Anticoagulants.

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.

Prolonged therapy.

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.

Lymphatic leukaemia.

Amoxicillin should be given with caution to patients with lymphatic leukaemia, since they are especially susceptible to ampicillin induced skin rashes.

Skin reactions.

The occurrence of a generalized erythema with fever and pustules at the beginning of treatment should make suspect a generalized acute exanthematous pustulosis; this necessitates the interruption of therapy and contraindicated any further administration of amoxicillin.

Jarisch-Herxheimer reaction.

The Jarisch-Herxheimer reaction has been seen following amoxicillin treatment of Lyme disease. It results directly from the bactericidal activity of amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease. Special caution should be exercised in patients with allergic diatheses or bronchial asthma and hay fever.

Crystalluria.

The presence of high urinary concentrations of amoxicillin can cause precipitation of the product in urinary catheters. Therefore, catheters should be visually inspected at intervals. At high doses, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria.

Monitoring.

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.
As with other beta-lactams, the blood formula should be checked regularly during high-dose therapy. Elevated liver enzymes and changes in blood counts have been reported.

Convulsions.

High dose therapy with beta-lactams for patients with renal insufficiency or seizures history, treated epilepsy and meningeal affection, could exceptionally lead to seizures. Dosage should be adjusted in patients with renal impairments (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.

See Section 4.2 Dose and Method of Administration; Section 4.8 Adverse Effects (Undesirable Effects), Miscellaneous.
Precaution should be taken in premature children and during neonatal period: renal, hepatic and haematological functions should be monitored.

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

Allopurinol.

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.

Digoxin.

An increase in the absorption of digoxin is possible on concurrent administration with amoxicillin. A dose adjustment of digoxin may be necessary.

Anticoagulants.

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.

Probenecid.

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.

Tetracyclines.

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Methotrexate.

Interaction between amoxicillin and methotrexate leading to methotrexate toxicity has been reported. Serum methotrexate levels should be closely monitored in patients who receive amoxicillin and methotrexate simultaneously (see Section 4.4 Special Warnings and Precautions for Use). Amoxicillin decreases the renal clearance of methotrexate, probably by competition at the common tubular secretion system.
Caution is recommended when amoxicillin is given concomitantly with:

Oral hormonal contraceptives.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen re-absorption and reduced efficacy of combined oral contraceptives.

Other forms of interactions.

Forced diuresis leads to a reduction in blood concentrations by increased elimination of amoxicillin.
Amoxicillin may decrease the amount of urinary estriol in pregnant women.
At high concentrations, amoxicillin may diminish the results of serum glycemia levels.
Amoxicillin may interfere with protein testing when colorimetric methods are used.

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:

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 (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 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).

Liver.

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. Prolongations of bleeding time and prothrombin time have also been reported rarely.

Renal and urinary tract disorders.

Interstitial nephritis, crystalluria (see Section 4.9 Overdose).

Central nervous system (CNS) effects.

CNS effects have been seen rarely. These 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.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
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 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.

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 also 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 ≤ 0.06 microgram/mL (0.03 – 0.12 microgram/mL); R ≥ 2 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.

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 mg result in average peak serum levels 1 to 2 hours after administration of 5 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.

Distribution.

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.
The amount to be found in the bile is variable depending on normal biliary secretory function.
Amoxicillin is not highly protein bound, being only 17% protein bound in serum as measured by ultrafiltration or equilibrium dialysis.

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 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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sorbitol, sunset yellow FCF, tutti frutti 51880 AP0551 (PI 183), xanthan gum, sodium citrate dihydrate, colloidal anhydrous silica, saccharin sodium.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C in a dry place, protected from moisture.
After reconstitution with water, amoxicillin suspension should be stored at 2-8°C in a refrigerator. Unused suspension must be discarded after 14 days.

6.5 Nature and Contents of Container

Noumed Amoxicillin Powder for Oral Suspension is supplied in a 100 mL HDPE bottle with a child resistant cap.

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[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
Molecular Weight: 419.4.

CAS number.

61336-70-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes