Consumer medicine information

AMOXIL® PARENTERAL PREPARATIONS

Amoxicillin

BRAND INFORMATION

Brand name

Amoxil Parenteral

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using AMOXIL® PARENTERAL PREPARATIONS.

What is in this leaflet?

Please read this leaflet carefully before you use AMOXIL.

This leaflet answers some common questions about AMOXIL. 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 AMOXIL against the risks this medicine could 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 is AMOXIL used for?

AMOXIL contains a penicillin called amoxycillin as the active ingredient.

Amoxycillin belongs to the penicillin group of antibiotics. AMOXIL is used to treat a range of infections caused by bacteria. These may be infections of the blood (septicaemia), chest (pneumonia), urinary and genital tract, skin and fleshy tissues.

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

Your doctor may have prescribed AMOXIL for another reason.

There is no evidence that AMOXIL is addictive.

Before you are given AMOXIL

AMOXIL must not be used if:

  • you are allergic to amoxycillin, other penicillins 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 AMOXIL.
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering

Tell your doctor if:

You must 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).
  • you are pregnant or think you may be pregnant or are breast feeding. AMOXIL may be used during pregnancy (Australian Use in Pregnancy Category A). AMOXIL can pass to your baby from breast milk.
  • you have liver or kidney problems. The dosage of AMOXIL may need to be changed or you may need to be given an alternative medicine.
  • you are taking any other medicines, including medicines you buy without a prescription. In particular tell the doctor if you are taking any of the following:
    - medicines used to treat gout eg. probenecid or allopurinol.
    - the contraceptive pill. As with other antibiotics, you may need to use extra birth control methods eg. condoms.
    - other antibiotics
    - anticoagulants (used to prevent blood clots) such as warfarin.
    These may interfere with the actions of AMOXIL .

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 AMOXIL.

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

How is AMOXIL given?

How much to give:

AMOXIL will be administered as directed under the supervision of a doctor or nurse. You will not be expected to give yourself this medication.

How AMOXIL is given:

Your doctor or nurse will inject the necessary dose of AMOXIL. It may be given by injection into the muscle of the upper arm or buttock or into a vein. Your doctor will decide the best method of giving the injection to you.

The usual dose of AMOXIL is one injection every six or eight hours.

How long to give AMOXIL for:

AMOXIL should be administered for as long as recommended by your doctor. The length of treatment will be decided by your doctor.

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

What do I do if I am given too much AMOXIL? (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have been given too much AMOXIL, 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 being given AMOXIL

Things you must do:

If you develop itching, swelling or a skin rash when you are receiving AMOXIL, tell the doctor or nurse immediately.

If you develop severe diarrhoea when receiving AMOXIL tell the doctor or nurse as soon as possible. Do not take any medication to stop the diarrhoea (eg Lomotil or Imodium).

Things you must not do:

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

Do not use AMOXIL 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 AMOXIL affects you.

What are the 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 AMOXIL, even if the problem is not listed below.

Like other medicines, AMOXIL 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 or nurse 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
  • overgrowth of yeast infections (thrush).

MORE SERIOUS EFFECTS
Tell your doctor or nurse immediately if you notice any of the following:

  • Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.
  • pain around the site of injection
  • unusual bleeding or bruising
  • yellowing of the skin or eyes
  • dark urine or pale stools
  • difficulty or pain on passing urine.
  • severe diarrhoea.

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

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.

How do I store AMOXIL?

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.

Ask your pharmacist what to do with any unused injections.

Product description

What AMOXIL looks like:

AMOXIL injections are supplied as vials containing amoxycillin sodium powder equivalent to 1 g of amoxycillin. The powder must be mixed with sterile water before use.

Ingredients:

AMOXIL injections contain the active ingredient amoxycillin. There are no inactive ingredients in AMOXIL injections.

AMOXIL does not contain lactose, sucrose or any azo dyes.

Supplier:

Your AMOXIL is supplied by:
Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

AMOXIL preparations are only available if prescribed by a doctor.

AMOXIL is also available in capsule and syrup preparations.

AMOXIL 1g injections come in packs of 10 vials (AUST R 11137).

The information provided applies only to AMOXIL®.

® AMOXIL is a registered trademark of Aspen Global Incorporated.

This leaflet is subject to copyright.

Amoxil Parenteral Preparations.
Prepared on 20 July 2009.

Version 2.0

Published by MIMS March 2013

BRAND INFORMATION

Brand name

Amoxil Parenteral

Active ingredient

Amoxicillin

Schedule

S4

 

Name of the medicine

Amoxicillin (as amoxicillin sodium).

Description

Amoxicillin sodium 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. It is identified chemically as sodium (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-carboxylate. The molecular weight of amoxicillin sodium is 387.4. CAS - 61336-70-7.
Amoxicillin sodium is a white or almost white powder, very hygroscopic, very soluble in water, sparingly soluble in ethanol, very slightly soluble in acetone.

Pharmacology

Microbiology.

Amoxicillin is similar to ampicillin in its bactericidal action against Gram positive and Gram negative susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of the cell wall mucopeptide.
Amoxicillin is active in vitro against most strains of Haemophilus influenzae*, Neisseria gonorrhoeae*, Neisseria meningitidis, Escherichia coli*, Proteus mirabilis* and Salmonellae. Because amoxicillin does not resist destruction by penicillinase, it is not active against penicillinase producing organisms, particularly penicillinase producing staphylococci. All strains of Pseudomonas species, Klebsiella species, Enterobacter species, indole positive Proteus species, Serratia marcescens, Citrobacter species, penicillinase producing N. gonorrhoeae and penicillinase producing H. influenzae are resistant. In vitro studies have demonstrated the susceptibility of most strains of the following gram positive bacteria: α-haemolytic and β-haemolytic streptococci, Diplococcus pneumoniae, nonpenicillinase producing staphylococci and Streptococcus faecalis. These organisms are susceptible to amoxicillin at serum concentrations, which may be expected following the recommended doses. However, some of the organisms were susceptible to amoxicillin only at concentrations achieved in the urine (see Indications).
*Activity refers only to β-lactamase negative strains.
Escherichia coli isolates are becoming increasingly resistant to amoxicillin in vitro due to the presence of penicillinase producing strains.
Strains of gonococci which are relatively resistant to benzylpenicillin may be sensitive to amoxicillin.
The following in vitro data are available, but their clinical significance is unknown.
In vitro data for amoxicillin vs. clinical pathogens (see Table 1).
A positive β-lactamase test predicts resistance to penicillin, ampicillin and amoxicillin. See Table 2.

Breakpoints.

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

Note.

Because amoxicillin 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 amoxicillin.

Susceptibility tests.

Dilution or diffusion techniques, either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of ‘susceptible’ indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of ‘intermediate’ indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of ‘resistant’ indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections. This information gives only an approximate guidance on probabilities whether organisms will be susceptible to amoxicillin.
Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing performed where necessary.

Cross resistance.

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

Resistance mechanisms.

Production of penicillinase, altered penicillin binding proteins.

Pharmacokinetics.

Absorption and blood levels.

Following intramuscular injection of 250 or 500 mg of amoxicillin, peak serum levels of approximately 5.5 microgram/mL or 10 microgram/mL are achieved within 60 minutes of injection and correspond to the peak values obtained after the same dose given orally.
Absorption from the intramuscular site is almost complete.
Following IV injection over a 3-4 minute period, serum levels at 1 hour were similar to those seen at 1 hour after the same dose given intramuscularly. Serum levels immediately after the IV injection were, however, higher. The serum half-life, measured as unchanged (active) antibiotic in the excretory phase, is approximately 1 hour in the presence of normal renal function, rising to about 7 hours with a creatinine clearance of 13 mL/minute without dialysis. The elimination half-life does not appear to change until creatinine clearance reaches approximately 30 mL/minute. In patients with a creatinine clearance of 10 mL/minute, elimination half-life has been shown to vary between 7.5 and 21 hours after a 2 g intravenous dose.

Distribution.

In keeping with other penicillins, penetration into the CSF is poor in the absence of inflammation. Some penetration occurs through inflamed meninges but maximum CSF levels are very much lower than peak serum levels.
Bile levels vary with the functional integrity of secretory mechanisms, being absent in the presence of biliary tract obstruction.

Protein binding.

Amoxicillin is not highly bound to human serum protein. The degree of binding as measured by ultrafiltration or equilibrium dialysis is 17%.

Excretion.

The major route of excretion is renal (by glomerular filtration and tubular secretory mechanisms). The secretory mechanisms may be inhibited by the concurrent administration of probenecid, leading to prolonged and some elevation of serum levels.
Approximately 70% of a dose administered by intramuscular or rapid intravenous injection will be excreted unchanged by this mechanism in the presence of normal renal function over a six hour period, and approximately 20% will be excreted as the penicilloic acid derivative in the same time. In patients with renal failure, renal excretion falls in relation to the GFR but therapeutic levels are still maintained in the urine.
Results of studies in man, employing thin layer chromatography and bioautography, show that amoxicillin is not changed in vivo into substances with antibacterial activity.
There appears to be only one metabolic breakdown product, namely, penicilloic acid.

Indications

Amoxil Parenteral is intended for use where the patient's condition precludes the administration of the oral form. 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 clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.

Septicaemia (bacterial).

H. influenzae, E. coli (see Pharmacology, Microbiology), P. mirabilis, Streptococcus, S. pneumoniae, S. faecalis and Salmonella typhi.

Skin and skin structure.

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

Respiratory, acute and chronic.

Haemophilus 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.

Amoxicillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with prosthetic heart valves or those who have previously had endocarditis.

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).

Precautions

Serious, and occasionally fatal, hypersensitivity (anaphylaxis) reactions have been reported in patients receiving β-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and amoxicillin therapy discontinued.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibiotic agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Amoxicillin has been found to cause dose related renal toxicity in laboratory animals when administered daily as a bolus injection at dose levels of 100 mg/kg/day and above. As the metabolic pattern of amoxicillin in man appears to be similar to that in animals, the possibility of a nephrotoxic effect from parenteral amoxicillin should be borne in mind.

Use in pregnancy.

(Category A)
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, height of contractions and duration of contractions. However, it is not known whether the use of amoxicillin in humans during labour or delivery has immediate or delayed adverse effects on the foetus, prolongs the duration of labour or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Use in lactation.

Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin 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.
The possibility of venous irritation when using that route, must be kept in mind.
Amoxicillin, an aminopenicillin, is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used.
Amoxicillin should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to ampicillin induced skin rashes.
During treatment with high doses of amoxicillin, particularly by bolus injection, an adequate urinary output must be maintained. Also indwelling catheters should be checked regularly for patency since, due to high urinary concentrations, amoxicillin may, at room temperature, precipitate out of solution.
Dosage should be adjusted in patients with renal impairment (see Dosage and Administration).
Lignocaine or benzyl alcohol may be used only when administering amoxicillin by the intramuscular route.
The sodium content must be taken into account in patients on a sodium restricted diet if the parenteral administration of high doses is necessary. Each 1 g vial of amoxicillin contains 3.3 millimol of sodium.

Effects on laboratory tests.

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 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 amoxicillin.

Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Similar reactions can be expected with amoxicillin.
In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If coadministration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

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 amoxicillin.

Gastrointestinal.

Nausea, vomiting, diarrhoea. Intestinal candidiasis and antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis) have been reported 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, acute generalised exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. As with other antibiotics, severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness, hypersensitivity vasculitis and interstitial nephritis have been reported rarely.
Whenever such reactions occur, amoxicillin should be discontinued.

Note.

Urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Anaphylaxis is the most serious reaction experienced (see 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 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. 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.

Injection site.

Pain may be experienced at the site of intramuscular injection and phlebitis at the site of IV injection.

Dosage and Administration

Normal renal function.

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

Adults.

250 mg every six to eight hours, depending on the patient's condition.

Children (under 20 kg).

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

Adults.

500 mg every six to eight hours.

Children (under 20 kg).

40 mg/kg/day in equally divided doses every six to eight hours.
Bacterial septicaemia. In more serious infections in adults, Amoxil Parenteral can be given as 1 g every six hours, slow IV injection (taking 3 to 4 minutes if injecting directly or into drip tube) or IV infusion over a period of 0.5 to 1 hour.

Children (under 20 kg).

20-40 mg/kg every 6 hours.
Prophylaxis of endocarditis. See Table 3.

Altered renal function.

In renal impairment the excretion of the antibiotic will be delayed, and depending on the degree of impairment, it may be necessary to reduce the total daily dosage (see Table 4).

Note.

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.
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.

Directions for use.

Amoxil should be administered immediately after reconstitution to reduce the microbiological hazard. This product is intended for one patient only. Discard any remaining contents.
For direct intravenous injection, administer by slow injection (at least over a period of 3-4 minutes, preferably 10-15 minutes). More rapid administration may result in convulsive seizures.
Amoxicillin sodium is unstable in concentrated solutions and when prepared for injection, should be administered immediately.

1 g vial.

For intramuscular use, add 5.2 mL Water for Injections BP and shake vigorously. Doses larger than 500 mg should be divided between multiple injection sites. Alternatively, if pain is experienced on intramuscular injection, dissolve contents in 3 mL of 1% sterile lignocaine hydrochloride solution and shake vigorously. For intravenous use, dissolve contents in 20 mL Water for Injections BP. Dilutions in excess of 10 mL should be carried out in the syringe.
Amoxicillin is normally reconstituted with Water for Injections BP, however, if pain is experienced on intramuscular injection, a 0.5% solution of procaine hydrochloride or a 1% solution of lignocaine hydrochloride may be used in place of Water for Injections BP.
A transient pink colouration may or may not develop during reconstitution. A slight opalescence may appear during reconstitution. Reconstituted solutions are normally colourless. All solutions should be shaken vigorously before injection.

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

Presentation

Vials containing amoxicillin sodium equivalent to 1 g of amoxicillin in boxes of 10 vials.

Storage

Stability of dry powder.

Store below 25°C. Potency is maintained for 2 years.

Stability of solution.

When prepared for intramuscular or direct intravenous injection, amoxicillin should be administered immediately after reconstitution.

Stability with intravenous fluids.

Infusions should be administered over a period of 0.5 to 1 hour although amoxicillin maintains a satisfactory degree of activity at room temperature in various infusion fluids.
Stability studies on amoxicillin sodium in various intravenous solutions indicate that the amoxicillin sodium will lose less than 10% activity at room temperature (20°C) for the time periods and concentrations stated in Table 5.
If the solutions listed below are stored under refrigeration (4°C), they will remain stable for the time periods indicated in Table 6.
Since amoxicillin is relatively less stable in carbohydrate solutions, it is preferable to avoid adding it to them. It may, however, be injected into the drip tubing of such an infusion or incorporated into a small volume of the solution and infused over a period of 0.5 to 1 hour. As there is some loss of potency during storage at 4°C, solutions that have been stored at 4°C for periods within the limits stated above, should be used immediately they have been brought to room temperature.

Compatibility.

Amoxicillin is compatible with commonly used intravenous solutions as described under Storage. It should not, however, be mixed with blood products or proteinaceous fluids such as protein hydrolysates, nor with intravenous lipid emulsions.

Poison Schedule

S4.