Consumer medicine information

Amoxycillin Generichealth

Amoxicillin

BRAND INFORMATION

Brand name

Amoxycillin Generichealth

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Amoxycillin Generichealth.

What is in this leaflet

This leaflet answers some common questions about Amoxycillin generichealth.

It does not contain all the available information.

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

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available.

The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Amoxycillin generichealth against the benefits it is expected to 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 Amoxycillin generichealth is used for

Amoxicillin is an antibiotic 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.

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

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

Your doctor may have prescribed Amoxycillin generichealth for another reason.

Ask your doctor if you have any questions about why Amoxycillin generichealth has been prescribed for you.

Amoxicillin is not addictive.

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

Before you take Amoxycillin generichealth

When you must not take it

Do not take Amoxycillin generichealth if you have an allergy to:

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

Some of the symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue.

Do not take Amoxycillin generichealth if the packaging is torn or shows signs of tampering.

Do not take Amoxycillin generichealth if the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking Amoxycillin generichealth, contact your doctor.

Before you start to take it

Tell your doctor if you have had an allergic reaction (such as a rash) to any antibiotics in the past.

Tell your doctor if you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have ever had any other health problems / medical conditions, including:

  • glandular fever (mononucleosis);
  • blood disorders such as leukaemia;
  • liver or kidney problems. The dosage of Amoxycillin generichealth may need to be changed or you may need to be given an alternative medicine.

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

Tell your doctor if you are pregnant or intend to become pregnant, or are breastfeeding. Your doctor or pharmacist will discuss the possible risks and benefits involved. Amoxicillin can be used during pregnancy (Australian Use in Pregnancy Category A). Amoxicillin can pass to your baby from breast milk.

If you have not told your doctor about any of the above, tell them before you take Amoxycillin generichealth.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with amoxicillin. These include:

  • medicines used to treat gout (eg. probenecid or allopurinol);
  • other antibiotics (eg. tetracyclines);
  • anticoagulants (used to prevent blood clots) such as warfarin;
  • methotrexate, a medicine used to treat arthritis and some types of cancers

These medicines may be affected by amoxicillin, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Talk to your doctor about the need for an additional method of contraception while taking Amoxycillin generichealth. Some antibiotics may decrease the effectiveness of some birth control pills.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking Amoxycillin generichealth.

How to take Amoxycillin generichealth

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

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

How much to take

The usual adult dose is one capsule (250 mg or 500 mg) three times a day.

How to take it

Swallow Amoxycillin generichealth capsules whole with a glass of water. Amoxycillin generichealth can be taken with or without food. The effects of Amoxycillin generichealth are not changed by food.

Space the doses as evenly as possible throughout the day. For example, if you are taking Amoxycillin generichealth three times a day, take a dose about every eight hours.

How long to take it

Continue taking Amoxycillin generichealth until you finish the pack or until your doctor recommends.

Do not stop taking your capsules because you are feeling better. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your capsules as you would normally.

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

If you have trouble remembering to take your capsules, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to the Accident and Emergency department at your nearest hospital, if you think that you or anyone else may have taken too much Amoxycillin generichealth. Do this even if there are no signs of discomfort or poisoning.

Keep these telephone numbers handy.

If you take too much amoxicillin you may get diarrhoea and nausea.

While you are taking Amoxycillin generichealth

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

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

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

If you develop itching with swelling or skin rash or difficulty breathing while you are taking Amoxycillin generichealth, do not take any more and contact your doctor immediately.

If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after amoxicillin has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

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

If you get a sore white mouth or tongue while taking or soon after stopping Amoxycillin generichealth, tell your doctor.

Also tell your doctor if you get vaginal itching or discharge. This may mean you 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.

If you become pregnant while you are taking Amoxycillin generichealth, tell your doctor.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Amoxycillin generichealth.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Amoxycillin generichealth.

Things you must not do

Do not stop taking your capsules because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely, or it may return and be more difficult to treat.

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

Do not use Amoxycillin generichealth to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Amoxycillin generichealth affects you. Amoxicillin generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, amoxicillin may cause dizziness/drowsiness/tiredness in some people.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Amoxycillin generichealth. Amoxicillin helps most people with infections, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor if you notice any of the following and they worry you:

  • soreness of the mouth or tongue;
  • diarrhoea (several loose bowel movements per day), indigestion, feeling sick or being sick;
  • overgrowth of yeast infections (thrush).

These side effects are usually mild.

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

  • 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.

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

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

  • wheezing;
  • swelling of the lips/ mouth;
  • difficulty in breathing;
  • hayfever;
  • lumpy rash (hives);
  • fainting.

These could be symptoms of an allergic reaction.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These 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 you feel unwell.

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

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

After taking Amoxycillin generichealth

Storage

Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the blister pack they may not keep well.

Keep it in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. 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 tells you to stop taking the capsules or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.

Product description

What it looks like

Amoxycillin generichealth 250 mg are yellow, hard gelatine capsule imprinted with “RX 654” in black on both cap and body.

Amoxycillin generichealth 500 mg are maroon/yellow, hard gelatine capsule, imprinted with “RX 655” in black.

Available in blister packs of 20 capsules.

Ingredients

Active ingredient

Amoxycillin generichealth capsules contain 250 mg or 500 mg of amoxicillin (as trihydrate) as the active ingredient.

Other ingredients

  • sodium lauryl sulfate;
  • colloidal anhydrous silica;
  • croscarmellose sodium;
  • microcrystalline cellulose;
  • magnesium stearate;
  • iron oxide yellow
  • iron oxide red (500 mg capsule only);
  • iron oxide black;
  • titanium dioxide;
  • gelatin;
  • TekPrint SW-9008 Black Ink (PI 2328).

Amoxycillin generichealth does not contain lactose, sucrose, gluten or tartrazine.

Australian Registration Numbers

Amoxycillin generichealth 250 mg capsules:
AUST R 207004.

Amoxycillin generichealth 500 mg capsules:
AUST R 207005.

Distributor

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

E-mail: [email protected]
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au

This leaflet was prepared in February 2024.

Published by MIMS March 2024

BRAND INFORMATION

Brand name

Amoxycillin Generichealth

Active ingredient

Amoxicillin

Schedule

S4

 

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Amoxicillin trihydrate.

2 Qualitative and Quantitative Composition

Amoxycillin Generichealth capsules contain 250 mg or 500 mg amoxicillin (as trihydrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Amoxycillin Generichealth 250 mg capsules.

Yellow, hard gelatin capsules imprinted with "RX 654" in black on both cap and body.

Amoxycillin Generichealth 500 mg capsules.

Maroon/yellow, hard gelatin capsules imprinted with "RX 655" in black.

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, nonpenicillinase producing; Streptococcus; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

Respiratory (acute and chronic).

H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, nonpenicillinase 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 (nonpenicillinase 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 nonpregnant adult females.

Adults.

3 g as a 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 10 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) 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.
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 a longer or larger course of therapy.

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 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.

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 will be necessary.
 Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin is administered to a nursing woman.

4.7 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 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 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 occasionally been noted, 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 leukopenia (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. 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 www.tga.gov.au/reporting-problems.

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 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 13 11 26 (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.
Amoxicillin is active in vitro against most strains of Haemophilus influenzae*, Neisseria gonorrhoeae*, Neisseria meningitides*, 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-haemolytic and β-haemolytic Streptococci, Diplococcus pneumoniae, nonpenicillinase 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.

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 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.
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 and 500 mg result in average peak serum levels 1 to 2 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.

6 Pharmaceutical Particulars

6.1 List of Excipients

The capsules contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, gelatin, sodium lauryl sulfate, colloidal anhydrous silica and croscarmellose sodium.
The capsule shells are made of gelatin, titanium dioxide, sodium lauryl sulfate, iron oxide yellow and TekPrint SW-9008 Black Ink (PI 2328). In addition, the 500 mg capsule shells contain iron oxide red and iron oxide black.

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

Stored below 25°C and protected from moisture.

6.5 Nature and Contents of Container

Amoxycillin Generichealth 250 mg and 500 mg capsules: Available in PVC/PVdC/Al and PVC/PE/PVdC/Al blister packs of 20 capsules.
Not all strengths or blister pack types may be marketed.

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 semi-synthetic 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-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