Consumer medicine information

Xycilan Capsules

Amoxicillin

BRAND INFORMATION

Brand name

Xycilan Capsules

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Xycilan Capsules.

What is in this leaflet

Please read this leaflet carefully before you take XYCILAN.

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

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

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

Take XYCILAN as instructed. 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 XYCILAN is used for

XYCILAN contains a penicillin called amoxycillin as the active ingredient.

XYCILAN belongs to a group of medicines called penicillins.

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

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

Your doctor may have prescribed XYCILAN for another reason.

There is no evidence that XYCILAN is addictive.

Before you take XYCILAN

When you must not take it:

  • you are allergic to penicillin or similar types of antibiotics such as cephalosporins. If you have ever had an allergic reaction (such as a rash) when taking an antibiotic you should tell your doctor before you take XYCILAN;
  • you have ever had an allergic reaction to amoxycillin or any of the ingredients listed towards the end of this leaflet. (See "Ingredients");
  • the expiry date printed on the pack has passed; or
  • the packaging is torn or shows signs of tampering.

Tell your doctor if:

  • you are allergic to foods, dyes, preservatives or any other medicines;
  • you have ever had an allergic reaction (such as a rash) to any antibiotics in the past;
  • you have glandular fever (mononucleosis) or a blood disorder;
  • you are pregnant or think you may be pregnant or are breast feeding. XYCILAN may be used during pregnancy (Australian Use in Pregnancy Category A). XYCILAN can pass to your baby from breast milk;
  • you have liver or kidney problems. The dosage of XYCILAN may need to be changed or you may need to be given an alternative medicine; and/or
  • you are taking any other medicines, including medicines you buy without a prescription. In particular tell your doctor if you are taking any of the following:
    - medicines used to treat gout e.g. probenecid or allopurinol;
    - the contraceptive pill. As with other antibiotics, you may need to use extra birth control methods e.g. condoms;
    - other antibiotics. These may interfere with the actions of XYCILAN; or
    - Anticoagulants (used to prevent blood clots) such as warfarin.

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

If you have not told your doctor about any of these things, tell them before you take any XYCILAN.

How to take it

Follow your doctor's instructions about how and when to take XYCILAN. Your doctor will advise how many doses are needed each day, and for how long you will need to take XYCILAN.

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

How much XYCILAN to take

Take XYCILAN as directed by your doctor or pharmacist.

The usual dose of XYCILAN is one dose taken three times a day.

How to take XYCILAN

Swallow XYCILAN 250 mg and 500 mg capsules whole with a glass of water.

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

XYCILAN can be taken with or without food. The effects of XYCILAN are not changed by food.

How long to take XYCILAN

Keep taking XYCILAN until the course is finished or for as long as your doctor tells you.

Do not stop taking XYCILAN just because you feel better as the infection can return.

Do not stop taking XYCILAN, or change the dose without first checking with your doctor.

If you forget to take it

If you forget to take a dose of XYCILAN, take it as soon as you remember. Then go back to taking it as directed by your doctor.

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

If you take too much (overdose)

If you (or someone else) has taken a large amount of XYCILAN all at once, give plenty of water to drink and immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think you or anyone else may have taken too much XYCILAN, even if there are no signs of discomfort or poisoning.

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

While you are taking it

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.

Tell your doctor or pharmacist you are taking XYCILAN before starting any other prescribed medicine. Some medicines may affect the way other medicines work.

If you develop itching, swelling or a skin rash when you are taking XYCILAN, do not take any more XYCILAN and tell your doctor at once.

If you develop severe diarrhoea when taking XYCILAN tell your doctor as soon as possible. Do not take any medication to stop the diarrhoea.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use XYCILAN to treat any other complaints unless your doctor says to.

Things to be careful of

Be careful driving or operating machinery until you know how XYCILAN affects you.

Side effects

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

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

MILD EFFECTS

  • Tell your doctor if you notice any of the following that are troublesome or ongoing:
    - diarrhoea (several loose bowel movements per day), indigestion, feeling sick or being sick;
    - soreness of the mouth or tongue; or
    - overgrowth of yeast infections (thrush).

MORE SERIOUS EFFECTS

  • 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; or
    - severe diarrhoea.
  • Stop taking XYCILAN and contact your doctor or go to the emergency department of your nearest hospital if any of the following happens:
    - Wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

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

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

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

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

After taking it

Storage

Keep your medication in the pack until it is time to take them.

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

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

Return any unused or expired medicine to your pharmacist.

Product description

What XYCILAN looks like

XYCILAN 250 & 500 (250 & 500 mg amoxycillin as trihydrate) are presented in blister packs of 20 capsules.

XYCILAN 250 (AUST R 185795)
Maroon/yellow size ‘1’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘A’ on maroon cap and ‘85’ on yellow body with black ink.

XYCILAN 500 (AUST R 185797)
Maroon/yellow size ‘0EL’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘A’ on maroon cap and ‘86’ on yellow body with black ink.

Ingredients

Active Ingredient:

Amoxycillin (as trihydrate).

Each capsule contains 250 mg or 500 mg of amoxycillin (as trihydrate).

Other Ingredients:

  • Microcrystalline cellulose
  • Magnesium stearate

The capsule shells also contain gelatin, carmoisine (E122), iron oxide yellow (E172), patent blue V (E131), titanium dioxide (E171) and sodium lauryl sulfate.

BRAND INFORMATION

Brand name

Xycilan Capsules

Active ingredient

Amoxicillin

Schedule

S4

 

Name of the medicine

Amoxycillin trihydrate.

Excipients.

Microcrystalline cellulose, magnesium stearate.
The capsule shells contain gelatin, carmoisine (E122), iron oxide yellow (E172), patent blue V (E131), titanium dioxide (E171), sodium lauryl sulfate.

Description

Chemical name: (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl] amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid. Molecular formula: C16H19N3O5S.3H2O. MW: 419.4. CAS: 61336-70-7.
Amoxycillin is white or almost white, crystalline powder. Slightly soluble in water, very slightly soluble in alcohol, practically insoluble in fatty oils. It dissolves in dilute acids and dilute solutions of alkali hydroxides.

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*, Neisseria meningitidis, Escherichia coli*, Proteus mirabilis* and Salmonellae. Because amoxycillin does not resist destruction by penicillinase, it is not active against penicillinase producing organisms, particularly penicillinase producing Staphylococci. All strains of Pseudomonas species, Klebsiella species, Enterobacter species, indole positive Proteus species, Serratia marcescens, Citrobacter species, penicillinase producing N. gonorrhoeae and penicillinase producing H. influenzae are resistant. In vitro studies have demonstrated the susceptibility of most strains of the following Gram positive bacteria: alpha and beta-haemolytic Streptococci, Diplococcus pneumoniae, 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 betalactamase negative strains.
Escherichia coli isolates are becoming increasingly resistant to amoxycillin in vitro due to the presence of penicillinase producing strains.
Strains of gonococci which are relatively resistant to benzylpenicillin may be sensitive to amoxycillin.
The following in vitro data are available, but their clinical significance is unknown.
A positive β-lactamase test predicts resistance to penicillin, ampicillin and amoxycillin.

Breakpoints.

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

Note.

Because amoxycillin has greater in vitro activity against S. pneumoniae than does ampicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin are fully susceptible to 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 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.

Excretion.

The half-life of amoxycillin is 61.3 minutes with normal renal function and in the absence of renal function 16-20 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 mg and 500 mg amoxycillin result in average peak serum levels one to two hours after administration of 5.0 microgram/mL and 6.6-10.8 microgram/mL respectively. Detectable serum levels of 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 Pharmacology, Microbiology).

Respiratory (acute and chronic).

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

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

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

Gonorrhoea.

N. gonorrhoeae (nonpenicillinase producing).

Prophylaxis of endocarditis.

Xycilan 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 beta-lactam antibiotics (e.g. penicillins, cephalosporins).

Precautions

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any penicillin careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and 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 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.
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. The product 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 will be necessary.

Use in lactation.

Ampicillin class antibiotics are excreted in the 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 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).

Effect 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 Testape) be used.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated oestriol, oestriol-glucuronide, conjugated oestrone and oestradiol has been noted. This effect may also occur with amoxycillin.

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 hyperuricemia 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.

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 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 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 generalised 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 Precautions).

Liver.

A moderate rise in AST and/or ALT has occasionally been noted, but the significance of this finding is unknown. As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely.

Haemic and lymphatic systems.

Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia and leucopenia (including severe neutropenia or agranulocytosis) have been reported during therapy with other penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Prolongation of bleeding time and prothrombin time have also been reported rarely.

Renal and urinary tract disorders.

Interstitial nephritis, crystalluria (see Overdosage).

CNS effects.

CNS effects have been seen rarely. They include hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Miscellaneous.

Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

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 eight hours.
In severe infections or those caused by less susceptible organisms, 500 mg every eight hours for adults and 40 mg/kg/day in equally divided doses every eight hours for children may be needed.

Lower respiratory tract infections.

Adults.

500 mg every eight hours.

Children (under 20 kg).

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

Urethritis, gonococcal.

Adults.

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

Acute, uncomplicated lower urinary tract infections in nonpregnant adult female.

Adults.

3 g as single dose.

Note.

Experience in neonates is too limited to make any recommendations regarding dosage or the appropriateness of the oral route.
The children's dosage is intended for individuals whose weight will not cause dosage to be calculated greater than that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations.
As Aurobindo Pharma do not market dose strengths and forms for paediatric dosing requirements, an alternative brand name should be sought.
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 ten days treatment for any infection caused by haemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

Prophylaxis of endocarditis.

(See Table 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 minimize 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 (telephone 131 126) for advice on overdose management.

Presentation

Capsules (maroon cap marked A in black ink, yellow body, hard gelatin, filled with white-off white granular powder), amoxycillin (as trihydrate) 250 mg (size 1, marked 85 in black ink, AUST R 185795), 500 mg (size 0EL, marked 86 in black ink, AUST R 185797): 20's (PVC/Aclar aluminium foil blister packs, each blister strip containing 10 capsules).

Storage

Store below 25°C.

Poison Schedule

S4.