Consumer medicine information

RANMOXY Oral Suspension

Amoxicillin

BRAND INFORMATION

Brand name

Ranmoxy

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about Ranmoxy oral suspension.

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 possible risks of taking amoxycillin against the expected benefits.

If you have any concerns about your child taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.

What RANMOXY Oral Suspension is used for

RANMOXY oral suspension contains the active ingredient amoxicillin, an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that cause infections. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues.

RANMOXY is used to treat infections in different parts of the body caused by bacteria.

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

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

Your doctor may have prescribed RANMOXY for another reason.

Ask your doctor if you have any questions about why RANMOXY has been prescribed for your child. This medicine is available only with a doctor’s prescription.

RANMOXY is not addictive.

Before your child takes RANMOXY

When your child must not take it

RANMOXY must not be taken if your child has an allergy to:

  • amoxycillin
  • other penicillins
  • 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.

RANMOXY must not be taken if your child has an allergy to cephalosporins.

There may be an increased risk of your child being allergic to amoxycillin if they are allergic to cephalosporins.

RANMOXY must not be taken if the packaging is torn or shows signs of tampering.

RANMOXY must not be taken if the expiry date (EXP) printed on the pack has passed.

If this medicine is taken after the expiry date has passed, it may not work as well.

If you are not sure whether your child should start taking RANMOXY, contact your doctor.

Before your child starts to take it

Tell your doctor if your child has ever had any allergies to any antibiotics, any other medicines or any other substances, such as foods, preservatives or dyes.

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

  • glandular fever (mononucleosis)
  • blood disorders
  • liver or kidney problems

Tell your doctor or pharmacist if your child’s urine has to be tested for sugar levels while taking RANMOXY.

Amoxycillin will produce false positive results when some of these tests are used. Your doctor will help you to identify the correct test.

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

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 RANMOXY. These include:

  • medicines used to treat gout (e.g. probenecid or allopurinol)
  • other antibiotics (e.g. tetracyclines)
  • anticoagulants (used to prevent blood clots) such as warfarin

These medicines may be affected by RANMOXY, 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 RANMOXY.

How to give RANMOXY to your child

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 bottle, ask your doctor or pharmacist for help.

How much to give

The usual dose of RANMOXY 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 RANMOXY three times a day, give a dose about every eight hours.

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

How long to give it

Continue giving RANMOXY to your child until the course is finished or for as long as your doctor recommends. Do not stop giving RANMOXY 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 your child takes too much (overdose)

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

Keep these telephone numbers handy.

If your child takes too much RANMOXY, he/she may get diarrhoea and nausea. There are unlikely to be any serious problems from an overdose of RANMOXY.

While you are giving RANMOXY

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 RANMOXY, do not give any more RANMOXY 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 RANMOXY 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 RANMOXY, 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 amoxycillin allows fungi to grow and the above symptoms to occur. Amoxycillin does not work against fungi.

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

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

Things you must not do

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

Do not give RANMOXY 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 RANMOXY, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, RANMOXY 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
  • overgrowth of yeast infections (thrush)
  • diarrhoea (several loose bowel movements per day), indigestion, feeling sick or being sick

These side effects are usually mild.

Tell your doctor immediately if you notice your child has 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. Your child may need urgent medical attention. Serious side effects are rare.

If any of the following occur, stop giving RANMOXY 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, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

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 RANMOXY

Storage

Keep the RANMOXY 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 RANMOXY 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 RANMOXY 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 RANMOXY Suspension looks like

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

  • RANMOXY 125 mg amoxycillin/5 mL
  • RANMOXY 250 mg amoxycillin/5 mL

Ingredients

  • Ranmoxy 125mg/5mL contains 125 mg amoxycillin as the active ingredient.
  • Ranmoxy 250mg/5mL contains 250 mg amoxycillin as the active ingredient.

Inactive ingredients:

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

Australian Registration Numbers

  • RANMOXY125 mg/5 mL : AUST R 137884
  • RANMOXY250 mg/5 mL: AUST R 137885

Sponsor

Ranbaxy Australia Pty Ltd
Suite 4.02, Level 4, Building D
12-24 Talavera Road
North Ryde, NSW 2113
Australia

This leaflet was prepared in Feb 2013

Published by MIMS August 2013

BRAND INFORMATION

Brand name

Ranmoxy

Active ingredient

Amoxicillin

Schedule

S4

 

Name of the medicine

Amoxycillin (as trihydrate).

Excipients

Sorbitol, sunset yellow FCF CI 15985, tutti frutti flavour, xanthan gum, sodium citrate, anhydrous colloidal silica, saccharin sodium.

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. MW: 419.4. CAS: 61336-70-7. Amoxycillin trihydrate is a white or almost white, crystalline powder, slightly soluble in water and in alcohol. Amoxycillin 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.

Pharmacology

Microbiology.

Amoxycillin 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. meningitides*, Escherichia coli*, Proteus mirabilis* and Salmonellae. 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 pneumonia, nonpenicillinase producing staphylococci and Streptococcus faecalis. These organisms are susceptible to amoxycillin at serum concentrations which may be expected following the recommended doses. However, some of the organisms were susceptible to amoxycillin only at concentrations achieved in the urine (see Indications).
*Activity refers only to β-lactamase negative strains.
Escherichia coli isolates are becoming increasingly resistant to amoxycillin in vitro due to the presence of penicillinase producing strains.
Strains of gonococci that are relatively resistant to benzylpenicillin may be sensitive to amoxycillin.
The following in vitro data are available, but their clinical significance is unknown. See Table 1.
A positive β-lactamase test predicts resistance to penicillin, ampicillin and amoxycillin. See Table 2.

Breakpoints.

Streptococcus pneumoniae: S ≤ 0.06 mcg/mL (0.03-0.12 mcg/mL); R ≥ 2 mcg/mL.

Note.

Because amoxycillin 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 amoxycillin.

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 amoxycillin.

Cross resistance.

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

Resistance mechanisms.

Production of penicillinase, altered penicillin binding proteins.

Pharmacokinetics.

Absorption.

Amoxycillin is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food.

Distribution.

Amoxycillin diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid except when the meninges are inflamed. Amoxycillin 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.

Excretion.

The half-life of amoxycillin is 61.3 minutes with normal renal function, and in the absence of renal function is 16 to 20 hours.
Amoxycillin 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 amoxycillin.
Excretion of amoxycillin can be delayed by concurrent administration of probenecid, thus prolonging its therapeutic effect.
Amoxycillin 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 mcg/mL and 6.6-10.8 mcg/mL respectively. Detectable serum levels of amoxycillin are present 8 hours after ingestion of a single dose.

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 amoxycillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.

Skin and skin structure.

Staphylococcus, nonpenicillinase producing; Streptococcus; E. coli (see Microbiology).

Respiratory (acute and chronic).

H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, nonpenicillinase producing; E. coli (see Microbiology).

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

E. coli (see Microbiology), P. mirabilis and S. faecalis.

Gonorrhoea.

N. gonorrhoeae (nonpenicillinase producing).

Prophylaxis of endocarditis.

Amoxycillin 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.

Contraindications

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

Precautions

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 amoxycillin 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 amoxycillin. 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). 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.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxycillin 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.

Use in pregnancy.

(Category A)
Animal studies with amoxycillin have shown no teratogenic effects. Amoxycillin has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies.
Amoxycillin 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 amoxycillin 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.

Use in lactation.

Ampicillin class antibiotics are excreted in breast milk; therefore, caution should be exercised when amoxycillin is administered to a nursing woman.
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.
Amoxycillin, 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 amoxycillin is used.
Amoxycillin should be given with caution to patients with lymphatic leukaemia, since they are especially susceptible to ampicillin induced skin rashes.
Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A positive culture may be evidence of a complicated or upper urinary tract infection and call for a longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxycillin.
Dosage should be adjusted in patients with renal impairment (see Dosage and Administration).

Interactions

Probenecid decreases the renal tubular secretion of amoxycillin. Concurrent use with amoxycillin may result in increased and prolonged blood levels of amoxycillin.
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 amoxycillin.
In common with other antibiotics, amoxycillin 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 amoxycillin. If coadministration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxycillin.
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxycillin.

Effects on laboratory tests.

Oral administration of amoxycillin will result in high urine concentrations of amoxycillin. Since high urine concentrations of amoxycillin 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 amoxycillin.

Adverse 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 amoxycillin.

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 Precautions).

Hypersensitivity reactions.

Erythematous maculopapular rash, pruritus and urticaria have been reported occasionally. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous, exfoliative dermatitis and acute generalized exanthematous pustulosis (AGEP) 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, amoxycillin 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 Warnings).

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 Overdosage).

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.

Dosage and 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 amoxycillin 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.
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. Amoxycillin 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 3.

Overdosage

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 amoxycillin, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxycillin crystalluria. Amoxycillin crystalluria, in some cases leading to renal failure, has been observed (see Precautions).
Amoxycillin can be removed from the circulation by haemodialysis.
Contact the Poisons Information Centre on 131 126 (Australia) for advice on the management of overdosage.

Presentation

Granules for oral suspension (white to off white powder, forms orange suspension with characteristic flavour), 125 mg/5mL (reconstituted): 100 mL (AUST R 137884); 250 mg/5mL (reconstituted): 100 mL (AUST R 137885) (HDPE bottle).

Storage

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

Poison Schedule

S4.