Consumer medicine information

Maxamox Powder for Oral Suspension

Amoxicillin

BRAND INFORMATION

Brand name

Maxamox Powder for Oral Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Maxamox Powder for Oral Suspension.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Maxamox 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 Maxamox Suspension 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 MAXAMOX SUSPENSION IS USED FOR

The name of your medicine is Maxamox Suspension. It contains the active ingredient amoxicillin trihydrate.

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

Maxamox Suspension belongs to a group of antibiotics called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

This medicine can also be used to prevent certain infections.

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

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

Maxamox Suspension is available only with a doctor's prescription.

Maxamox Suspension is not addictive.

BEFORE YOU TAKE MAXAMOX SUSPENSION

When you must not take it

Do not take Maxamox Suspension if:

  • you have an allergy to amoxicillin, any other penicillins or any of the ingredients listed at the end of this leaflet
  • you have had a serious allergic reaction to any β-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenem or monobactam). These are another group of antibiotics similar to penicillins.
    Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, skin rash, itching or hives.

Do not take Maxamox Suspension after the expiry date printed on the pack has passed.

Do not take Maxamox Suspension if the packaging is torn or shows signs of tampering or if the medicine does not look quite right.

If you are not sure if you should start taking Maxamox Suspension, contact your doctor.

Before you start to take it

Tell your doctor if:

  1. you have had any type of allergic reaction to any penicillin or cephalosporin medicines.
You may have an increased chance of being allergic to Maxamox Suspension if you are allergic to any penicillins or cephalosporins.
  1. you have any allergies to:
  • any other medicines
  • any other substances such as foods, preservatives or dyes.
  1. you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of using Maxamox Suspension during pregnancy.
  1. you are breast-feeding or intend to breast-feed.
Maxamox Suspension passes into breast milk. No detrimental effects for the breast-fed infant have been reported after taking amoxicillin. Amoxicillin can be used during breast-feeding. However, breast-feeding must be stopped if gastrointestinal disorders (diarrhoea, candidosis or skin rash) occur in the new born. Your doctor will discuss the risks and benefits of taking Maxamox Suspension when breast-feeding.
  1. you have or have had any medical conditions, including:
  • asthma
  • kidney problems
  • liver problems
  • lymphatic leukaemia
  • glandular fever
  • diabetes
  • seizures history
  • stomach or bowel problems
  • a history of allergic problems, including hayfever.

Taking other medicines

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

Some medicines may interfere with Maxamox Suspension. These include:

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

These medicines may be affected by Maxamox Suspension or may affect how well it works. You may need to take 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 Maxamox Suspension. Some antibiotics may decrease the effectiveness of some birth control pills.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Maxamox Suspension.

HOW TO TAKE MAXAMOX SUSPENSION

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 pack, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you the dose of the suspension you will need to use each day. This depends on the condition being treated and whether any other medicines are being used.

In adults, the usual dosage is 250-500mg three times daily.

In children, the dosage may vary depending on the condition being treated and the weight of the child.

How to take it

The suspension will be prepared by your pharmacist who checks the seal prior to reconstitution. Shake the bottle well and accurately measure the dose with a measuring spoon. Your pharmacist will explain how many millilitres of suspension will be needed to receive the correct dose.

Do not use the reconstituted suspension if the colour is not off-white.

Shaking the bottle and using a measuring spoon will make sure that you get the correct dose.

When to take it

In order for Maxamox Suspension to be most effective, it should be taken at regular times through the day. For example, if you are taking it three times a day, take a dose every 8 hours.

Your doctor or pharmacist can advise you on a dosing schedule if you are unsure.

Maxamox Suspension can be taken with or without food.

How long to take it

Continue taking the suspension until it is finished or for as long as your doctor recommends.

Keep taking this medicine for the full course of treatment, even if you begin to feel better after a few days. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

Check with your doctor if you are not sure how long you should be taking Maxamox Suspension.

Your doctor may recommend that you continue taking Maxamox suspension for two to three days after the symptoms of your infection have disappeared.

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 medicine as you would normally.

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

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

If you have trouble remembering when to take your medicine, 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), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Maxamox Suspension. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Maxamox Suspension, you may experience symptoms such as diarrhoea, nausea, vomiting or stomach cramps.

WHILE YOU ARE TAKING MAXAMOX SUSPENSION

Things you must do:

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

If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after Maxamox Suspension 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 diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while taking or soon after stopping Maxamox Suspension, 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 Maxamox Suspension allows fungi to grow and the above symptoms to occur. Maxamox Suspension does not work against fungi.

Tell your doctor if you become pregnant while taking Maxamox Suspension.

If you have to test your urine for sugar while you are using Maxamox Suspension, make sure your doctor knows which type of test you use. Maxamox Suspension may affect the results of some of these tests.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Maxamox Suspension.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Maxamox Suspension.

Things you must not do

Do not stop taking your medicine 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.

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

Do not use this medicine 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 Maxamox Suspension affects you. Maxamox Suspension may cause tiredness or dizziness in some people. Make sure you know how you react to Maxamox Suspension before you drive a car, operate machinery or do anything else that may be dangerous if you are affected.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Maxamox Suspension.

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. The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash.

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

WHILE YOU ARE TAKING MAXAMOX SUSPENSION

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

  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina or discharge
  • diarrhoea
  • feeling sick (nausea), vomiting
  • soreness of the mouth or tongue
  • discoloration of the teeth (especially with the suspension). Usually the discoloration can be removed by teeth brushing
  • headache, tiredness.

These side effects are usually mild.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • signs of anaemia such as looking pale, short of breath when exercising, dizziness
  • signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • bruising or bleeding more easily than normal
  • dark coloured urine or blood in the urine
  • passing more or less urine than is normal for you.

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

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

  • any skin rash, itching or hives or blistering or peeling of the skin
  • wheezing, shortness of breath or difficulty breathing
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • aching or swollen joints
  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above.

These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention. However, this side effect is rare.

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

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

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

AFTER USING MAXAMOX SUSPENSION

Storage

Keep your medicine in its original container, in a safe place out of the reach of children.

Do not store your medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Do not leave your medication in a car or on a window sill.

Store the powder for suspension in a cool dry place below 25°C. Keep the container tightly closed.

After mixing - Store in a refrigerator (2°C-8°C). Discard unused suspension after 14 days.

Discard any unused suspension after 14 days or after the expiry date placed by your pharmacist on the label of the bottle during the preparation of the suspension.

Disposal

If your doctor tells you to stop taking Maxamox Suspension, or the medicine has passed its expiry date, ask your pharmacist what to do with any medicine left over.

PRODUCT DESCRIPTION

What it looks like

After mixing, the suspension is a white to slightly yellowish and is available in a 100 mL bottle.

Ingredients

Maxamox Suspension contains 500mg of amoxicillin (as amoxicillin trihydrate) per 5 mL.

It also contains:

  • anhydrous citric acid
  • sodium benzoate
  • aspartame
  • purified talc
  • guar gum
  • sodium citrate anhydrous
  • silicon dioxide
  • lemon flavouring
  • orange flavouring
  • peach-apricot flavouring.

This medicine does not contain lactose, sucrose, or gluten.

Supplier

Sandoz Pty Ltd
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

This leaflet was revised in August 2020.

Australian register number

500 mg/5 mL Powder for Oral Suspension: AUST R 93722 (bottles)

Published by MIMS October 2020

BRAND INFORMATION

Brand name

Maxamox Powder for Oral Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

Name of the medicine

Amoxicillin trihydrate.

Excipients.

Anhydrous citric acid, sodium benzoate, aspartame, purified talc, anhydrous sodium citrate, guar gum, silicon dioxide, lemon flavouring, peach-apricot flavouring and orange flavouring.

Description

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. MW: 419.4. CAS: 61336-70-7. Amoxicillin trihydrate is a white or almost white, crystalline powder. It is slightly soluble in water and in ethanol (96%); practically insoluble in chloroform, in ether and in fatty oils.

Pharmacology

Microbiology.

Amoxicillin trihydrate is a broad spectrum penicillin similar to ampicillin in its bactericidal action. It is believed to act through the inhibition of biosynthesis of cell wall mucopeptide. It is active against both Gram positive and Gram negative microorganisms. Amoxicillin is active in vitro against beta-lactamase negative strains of Proteus mirabilis, and Haemophilus influenza. In vitro studies have also demonstrated activity against most strains of alpha and beta-haemolytic Streptococci, Streptococcus pneumoniae, and beta-lactamase negative strains of Staphylococci, Neisseria gonorrhoeae, Neisseria meningitidis and Enterococcus faecalis. However, some of the organisms are sensitive to amoxicillin only at concentrations achieved in the urine. Strains of gonococci which are relatively resistant to benzyl penicillin may also be resistant to amoxicillin. Amoxicillin is not effective against penicillinase producing bacteria, particularly resistant Staphylococci which now have a high prevalence. All strains of Pseudomonas, Klebsiella, Enterobacter, indole positive Proteus, Serratia marcescens, Citrobacter, penicillinase producing N. gonorrhoeae and penicillinase producing H. influenzae are also resistant. Escherichia coli isolates are becoming increasingly resistant to amoxicillin in vitro due to the presence of penicillinase producing strains. See Table 1.

Disc susceptibility testing.

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 may 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.

Pharmacokinetics.

Amoxicillin is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food. Peak serum levels are reached within one to two hours after ingestion. Amoxicillin readily distributes in 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. Concentrations in the bile vary and are dependent upon normal biliary function. Amoxicillin is eliminated with a half-life of 61.3 minutes with normal renal function and up to 16-20 hours in the absence of renal function. Amoxicillin is excreted in the urine as unchanged drug and as penicilloic acid. Approximately 75% of a 1 g dose is excreted in the urine within six hours with normal renal function. However, there is a proportional difference in the amount excreted following different doses, due to lack of linearity in the rate of absorption with higher doses. Elimination of amoxicillin can be delayed by concurrent administration of probenecid. Amoxicillin is only 17% protein bound in serum.
Orally administered doses of amoxicillin 250 and 500 mg result in average peak serum levels one to two hours after administration of 5 microgram/mL and 10.25 microgram/mL respectively. Detectable serum levels of amoxicillin are present eight hours after ingestion of a single dose.

Clinical Trials

The clinical efficacy of amoxicillin 30 mg/kg twice daily versus 15 mg/kg three times daily dosage regimen in the treatment of acute otitis media (AOM) in children was determined in a large double blind, randomised, multicentre study. 516 patients were included in the study and treated for 8 to 10 days. Patients were assessed during therapy (days 3-5), after end of therapy (days 12-14) and at follow-up (days 38-46).
The primary efficacy variable for the study was clinical response rate at the end of therapy (days 12-14) and the secondary efficacy variable was clinical success rate and recurrence rate at follow-up (days 38-46).
A total of 515 subjects aged from 6 months to 12 years received treatment and were included in the intent to treat population. 166 (51.6%) were male, mean (SD) age was 4.080 (2.649) years, mean (SD) bodyweight 17.864 (8.489) kg and 509 (98.6%) were white. Compliance with the dose regimens was ≥ 80.0% for over 90.0% subjects.
For clinically evaluable patients, the results are shown in Table 2.
No significant differences in the efficacy results between the two dosage regimens and the 95% confidence intervals (CI) confirm the noninferiority of the twice daily dosage regimen.
Limited bacteriological results were reported in this study.

Indications

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. Amoxicillin alone or in combination with another antibiotic, may be used in an emergency where the causative organism has not been identified.
Respiratory tract infections (acute and chronic) including acute otitis media (AOM). H. influenzae; Streptococcus; S. pneumoniae; Staphylococcus, nonpenicillinase producing; E. coli (see Microbiology).
Urogenital infections (complicated and uncomplicated, acute and chronic). E. coli (see Microbiology), P. mirabilis and Strep. faecalis.
Gonorrhoea. N. gonorrhoeae (nonpenicillinase producing).
Skin and skin structure infections. Staphylococcus, nonpenicillinase producing; Streptococcus; E. coli (see Microbiology).
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.
Infections caused by pathogens with established penicillin G susceptibility should preferentially be treated with penicillin G.

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, carbapenem or monobactam). Potential cross allergy to other beta-lactams such as cephalosporins should be taken into account.
Known and suspected hypersensitivity to the active substance, to any of the penicillins or known hypersensitivity to any of the excipients.
Antibiotics have no place in trivial infections.

Precautions

Hypersensitivity reactions.

Serious, and occasionally fatal, hypersensitivity (anaphylaxis) reactions 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. Patients should be told about the potential occurrence of allergic reactions and instructed to report them.
Serious anaphylactic reactions should require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airways management, including intubation should be administered as indicated.
Special caution should be exercised in patients with allergic diatheses or bronchial asthma and hay fever.

Nonsusceptible 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.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced by 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.

Convulsions.

Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or meningeal disorders (see Adverse Effects).

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.
Patients should be told about the potential occurrence of allergic reactions and instructed to report them.
If allergic reactions occur, the drug should be discontinued and the usual treatment with adrenaline, antihistamines and corticosteroids should be instituted, as necessary.

Prolonged therapy.

As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of superinfection with mycotic or bacterial pathogens should be kept in mind. If superinfection occurs (usually involving Aerobacter, Pseudomonas or Candida) discontinue the drug and/or institute appropriate therapy.

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.

Crystalluria.

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria.
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 higher dose or prolonged course of treatment may be appropriate.
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.

Fertility.

There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in animals have shown no effects on fertility.
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.

Paediatric use.

Precaution should be taken in premature children and during neonatal period: renal, hepatic and haematological functions should be monitored.

Use in renal impairment.

Dosage should be adjusted in patients with renal impairments (see Dosage and Administration, Precautions, Convulsions).

Skin reactions.

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

Use in pregnancy.

(Category A)
Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
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 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.

Use in lactation.

Ampicillin class antibiotics are excreted in breast milk and caution should be exercised when amoxicillin is administered to nursing mothers. So far no detrimental effects for the breastfed infant have been reported after taking amoxicillin. Amoxicillin can be used during breastfeeding. However, breastfeeding must be stopped if gastrointestinal disorders (diarrhoea, candidosis or skin rash) occur in the newborn.

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 enzyme based glucose oxidase reactions (such as Clinistix, or Testape) be used.

Effects on ability to drive and use machines.

No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see Adverse Effects).

Interactions

Allopurinol.

The concurrent administration of allopurinol and ampicillin may promote the occurrence of skin rashes. The underlying mechanism is still poorly understood. 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.

Concomitant administration of amoxicillin and anticoagulants from the coumarin class, may prolong the bleeding time. A dose adjustment of anticoagulants may be necessary (see Precautions). If coadministration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
A large number of cases showing an increase of oral anticoagulant activity has been reported in patients receiving antibiotics. The infectious and inflammatory context, age and the general status of the patient appear as risk factors. In these circumstances, it is difficult to know the part of the responsibility between the infectious disease and its treatment in the occurrence of INR disorders. However, some classes of antibiotics are more involved, notably fluoroquinolones, macrolides, cyclines, cotrimoxazole and some cephalosporins.
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.

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 Precautions). Amoxicillin decreases the renal clearance of methotrexate, probably by competition at the common tubular secretion system.

Tetracyclines.

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

Probenecid.

Concomitant use of probenecid is not recommended. The concomitant administration of probenecid produces sustained and higher plasma levels by reducing renal elimination of amoxicillin.
Oral administration of amoxicillin will result in high urine concentrations of amoxicillin. Since high urine concentrations of ampicillin 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 enzyme based glucose oxidase reactions (such as Clinistix or Testape) be used.
Caution is recommended when amoxicillin is given concomitantly with the following.

Oral hormonal contraceptives.

Administration of amoxicillin can transiently decrease the plasma level of oestrogens and progesterone, and may reduce the efficacy of oral contraceptives. It is therefore recommended to take supplemental nonhormonal contraceptive measures.

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.

Adverse Effects

Amoxicillin 30 mg/kg twice daily versus 15 mg/kg three times daily dosage regimen was compared in a large double blind, randomised, multicentre study of 516 children with acute otitis media (AOM). 515 patients were evaluable for safety analysis. One or more drug related adverse events (AEs) were reported in 14.3% (37/259) of b.i.d. and in 11.7% (30/256) of t.i.d. patients (95% CI -3.2%, 8.4%). The most frequently reported drug related AEs in each group were gastrointestinal symptoms (b.i.d. 11.3% versus t.i.d. 9.8%, 95% CI -4.8%, 7.9%), which were mainly of mild or moderate severity. 12 b.i.d. (4.6%) and 15 t.i.d. patients (5.9%) discontinued therapy prematurely because of the occurrence of AEs. Six serious AEs were reported (4 b.i.d., 2 t.i.d.) although none of these events were related to the study medication.
The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash.
Tables 3 and 4 provide a listing of the adverse events reported in the evaluable study population and the subgroup of patients ≤ 2 years of age.
The results show no significant differences in the tolerability of the two dosage forms.
The following adverse reactions have been reported as associated with the use of amoxicillin.

Gastrointestinal.

Nausea, vomiting, diarrhoea. Intestinal candidiasis, antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis), superficial discoloration of the teeth (especially with the suspension) have been reported rarely (see Precautions). Usually the discoloration can be removed by teeth brushing. If severe and persistent diarrhoea occurs, the very rare possibility of pseudomembranous colitis should be considered. The administration of antiperistaltic drug is contraindicated. Black hairy tongue and haemorrhagic colitis have been reported very rarely.

Hypersensitivity.

Erythematous maculopapular rash, pruritus and urticaria have been reported occasionally. Rarely, skin reactions such as erythema multiforme exsudativum, acute generalised exanthematous pustulosis (AGEP), Lyells syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Jarisch-Herxheimer reaction and bullous and exfoliative dermatitis have been reported. As with other antibiotics, severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness, hypersensitivity vasculitis and interstitial nephritis (crystalluria) 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 Precautions).

Hepatic.

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 Overdosage) have been reported very rarely.

Central nervous system 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.

Infections and infestations.

Mucocutaneous candidiasis have been reported very rarely.

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.

Dosage and Administration

Normal renal function.

Upper respiratory tract infections; genitourinary 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 8 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 8 hours for children may be needed.

Acute otitis media (AOM).

Children (6 months to 12 years old).

30 mg/kg twice daily (to a maximum dose of 1 g twice daily).
Treatment should be continued for 48 to 72 hours after the child becomes asymptomatic.

Lower respiratory tract infections.

Adults.

500 mg every eight hours.

Children (under 20 kg).

40 mg/kg/day every 8 hours in equally divided doses.

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.

3 g as a single dose.

Use in neonates.

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

Paediatric use.

The children's dosage is intended for individuals whose weight will not cause dosage greater than that recommended for adults. Children receiving amoxicillin every 8 hours and weighing more than 20 kg should receive the adult recommended doses.
The maximum weight for children receiving 12 hourly dosing is approximately 35 kg.

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 dose.
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.

Frequent biological and clinical appraisals are recommended for patients under treatment for chronic urinary tract infections. Doses smaller than those recommended should not be used. Therapy for stubborn infections may have to be extended for several weeks.
Bacteriological and clinical appraisals may have to be continued for several months following cessation of treatment.

Duration of treatment.

Treatment should be continued for a minimum of 48 to 72 hours beyond the time when patients become asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be a minimum of 10 days treatment for any infection caused by haemolytic Streptococci to prevent occurrence of acute rheumatic fever or glomerulonephritis.

Prophylaxis of endocarditis.

Dental procedures.

Prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues, who are not having general anaesthetic, and who have not received a penicillin in the previous month.

(Note.

Patients with prosthetic heart valves should be referred to hospital.)

Adults (including elderly).

3 g orally, 1 hour before procedure. A second dose may be given 6 hours later if considered necessary.

Children.

Under 10 years.

Half adult dose.

Under 5 years.

Quarter adult dose.

(Note.

Prophylaxis with alternative antibiotics should be considered if the patient has received penicillin within the previous month, or is allergic to penicillin.)

Overdosage

Please contact the Poisons Information Centre (telephone 131 126) for advice on overdose management.
Signs of overdosage of amoxicillin would predominantly be gastrointestinal related. The symptoms may include abdominal or stomach cramps and pain, severe nausea, vomiting or diarrhoea. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Adverse Effects). Treatment of penicillin overdosage should be symptomatic and supportive. Haemodialysis may aid in the removal of penicillins from the blood.
Please also refer to Precautions and Adverse Effects.

Presentation

Maxamox Powder for Oral Suspension is a white to slightly yellowish powder containing 500 mg/5 mL amoxicillin (as trihydrate). It is available in 100 mL bottles.

Storage

Powder.

Store below 25°C. Keep the container tightly closed.

After mixing.

Store in a refrigerator (2°C-8°C). Discard unused suspension after 14 days.

Poison Schedule

S4.