Consumer medicine information

Fisamox

Amoxicillin

BRAND INFORMATION

Brand name

Fisamox

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fisamox.

SUMMARY CMI

FISAMOX®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using FISAMOX?

FISAMOX contains the active ingredient amoxicillin sodium. FISAMOX is used to treat some infections in different parts of the body caused by bacteria. For more information, see Section 1. Why am I using FISAMOX? in the full CMI.

2. What should I know before I use FISAMOX?

Do not use if you have ever had an allergic reaction to FISAMOX or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use FISAMOX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FISAMOX and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use FISAMOX?

FISAMOX must only be given by a doctor or nurse. More instructions can be found in Section 4. How do I use FISAMOX? in the full CMI.

5. What should I know while using FISAMOX?

Things you should do
  • Remind any doctor, dentist or pharmacist who is treating you that you have been given FISAMOX.
  • If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
  • If you develop itching with swelling or skin rash or difficulty breathing after you have been given FISAMOX, you may be having an allergic reaction to FISAMOX. Contact your doctor immediately.
  • If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after FISAMOX has been stopped.
Things you should not do
  • If you experience diarrhoea, do not take any diarrhoea medicine without first checking with your doctor.
  • Do not breast-feed while using this medicine.
Driving or using machines
  • Be careful driving or operating machinery until you know how FISAMOX affects you.
Looking after your medicine
  • FISAMOX will be stored in the pharmacy or on the ward.
  • FISAMOX is kept in a cool dry place, protected from light and moisture, where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using FISAMOX? in the full CMI.

6. Are there any side effects?

Tell your doctor if you notice any of the following and they worry you: oral thrush - white, furry, sore tongue and mouth, vaginal thrush - sore and itchy vagina and/or discharge, a mild rash or pain or redness at the site of injection.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following: severe rash, wheezing, irregular heartbeat or you are feeling faint.
Tell your doctor immediately if you notice any of the following side effects, even if they occur up to several weeks after finishing treatment with FISAMOX: severe abdominal cramps or stomach cramps, watery and severe diarrhoea, which may also be bloody, or fever, in combination with one or both of the aforementioned side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

FISAMOX®

Active ingredient(s): amoxicillin sodium


Consumer Medicine Information (CMI)

This leaflet provides important information about using FISAMOX. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FISAMOX.

Where to find information in this leaflet:

1. Why am I using FISAMOX?
2. What should I know before I use FISAMOX?
3. What if I am taking other medicines?
4. How do I use FISAMOX?
5. What should I know while using FISAMOX?
6. Are there any side effects?
7. Product details

1. Why am I using FISAMOX?

FISAMOX contains the active ingredient amoxicillin sodium. FISAMOX is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

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

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

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

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

There is no evidence that FISAMOX is addictive.

2. What should I know before I use FISAMOX?

Warnings

Do not use FISAMOX if:

  • you are allergic to any medicine containing amoxicillin or penicillin, any other similar antibiotics such as cephalosporins or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue or other parts of the body
    - rash, itching or hives on the skin
    Always check the ingredients to make sure you can use this medicine.
    Tell your doctor if you have suffered from any allergic conditions due to the use of penicillin.
  • you have ever had liver problems as a result of taking penicillins.

If you are not sure whether you should be given this medicine, talk to your doctor.

Check with your doctor if you:

  • have allergies to any other medicines, foods, preservatives or dyes.
  • have or have had any of the following medical conditions:
    - asthma
    - kidney or liver disease

If you have not told your doctor about any of the above, tell them before you start using FISAMOX.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Do not breast-feed if you are using this medicine.

The active ingredient in FISAMOX passes into breast milk and there is a possibility that your baby may be affected.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

Some medicines may interfere with FISAMOX. These include:

  • Probenecid, a medicine used to treat gout
  • Allopurinol (these are medicines used to treat gout or kidney stones)
  • Any other antibiotics such as tetracyclines, erythromycin and chloramphenicol
  • Anticoagulants such as warfarin, which is used to prevent blood clots.

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

Your doctor has more information on medicines to be careful with or avoid whilst receiving FISAMOX.

Some antibiotics may decrease the effectiveness of some birth control pills.

Talk to your doctor about the need for an additional method of contraception whilst receiving FISAMOX.

4. How do I use FISAMOX?

How FISAMOX is given

FISAMOX may be given in two ways:

  • as a slow injection into a vein
  • as a deep injection into a large muscle

FISAMOX must only be given by a doctor or nurse.

Your doctor will decide what dose and for how long you receive FISAMOX. This depends on your infection and other factors, such as your weight. For most infections, FISAMOX is usually given in divided doses throughout the day.

Sometimes only a single dose of FISAMOX is required for the treatment and prevention of certain infections.

If you are given too much FISAMOX

This rarely happens as FISAMOX is administered under the care of a highly trained doctor or nurse. However, if you are given too much FISAMOX, you may experience some of the effects listed under ‘6. Are there any side effects?’ below. Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using FISAMOX?

Things you should do

  • If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
  • If you get a sore white mouth or tongue after you have been given FISAMOX, tell your doctor. Also tell your doctor if you get a vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of FISAMOX allows fungi to grow and the above symptoms to occur. FISAMOX does not work against fungi.
  • If you become pregnant while you are receiving FISAMOX, tell your doctor.
  • If you have to have any urine tests tell your doctor you have been given FISAMOX. FISAMOX may affect the results of some tests.

Call your doctor straight away:

  • If you develop itching with swelling or skin rash or difficulty breathing after you have been given FISAMOX, you may be having an allergic reaction to FISAMOX.
  • If you get severe diarrhoea. Call your doctor immediately even if it occurs several weeks after FISAMOX has been stopped.
    Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.
    Do not take any diarrhoea medicine without first checking with your doctor.

Remind any doctor, dentist or pharmacist you visit that you are using FISAMOX.

Driving or using machines

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

Looking after your medicine

FISAMOX will be stored in the pharmacy or on the ward. FISAMOX is kept in a cool dry place, protected from light and moisture, where the temperature stays below 25°C.

FISAMOX is not to be given after the expiry date on the label.

6. Are there any side effects?

Tell your doctor as soon as possible if you have any problems whilst receiving FISAMOX, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

This medicine helps most people with infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Whilst being given FISAMOX

Less serious side effects

Less serious side effectsWhat to do
  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • a mild rash
  • pain or redness at the site of injection
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • a severe rash
  • wheezing
  • irregular heartbeat
  • feeling faint
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

After finishing FISAMOX

Serious side effects

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

FISAMOX can change bacteria (which are normally present in the bowel and normally harmless) to multiply and therefore cause the above symptoms.

  • an illness consisting of a rash, swollen glands, joint pains and fever may occur about a week after treatment.
Tell your doctor immediately if you notice any of the following rare but serious side effects, even if they occur up to several weeks after finishing treatment with FISAMOX.

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

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What FISAMOX contains

Active ingredient
(main ingredient)
1000 mg of amoxicillin (as amoxicillin sodium)

Do not take this medicine if you are allergic to this ingredient.

What FISAMOX looks like

FISAMOX is a fine white to off-white homogenous powder which must be dissolved in water before it is injected.

It is available in packs of 10 vials.

(AUST R 90880).

Sponsor

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in November 2023.

FISAMOX® is a Viatris company trade mark

FISAMOX_cmi\Nov23/00

Published by MIMS January 2024

BRAND INFORMATION

Brand name

Fisamox

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin sodium.

2 Qualitative and Quantitative Composition

Each Fisamox vial contains 1000 mg of amoxicillin (as amoxicillin sodium) as the active ingredient.

3 Pharmaceutical Form

The powder for injection is a fine white to off-white homogenous powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Fisamox is indicated in the treatment of infections due to susceptible strains of the organisms listed below. Fisamox is intended for use where the patient's condition precludes the administration of the oral form. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not yet 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 Section 5.1 Pharmacodynamic Properties), P. mirabilis, Streptococcus, S. pneumoniae, S. faecalis and Salmonella typhi.

Skin and skin structure.

Streptococci, non-β-lactamase-producing Staphylococci, E. coli (see Section 5.1 Pharmacodynamic Properties).

Respiratory, acute and chronic.

H. influenzae, Streptococci, S. pneumoniae, non-β-lactamase-producing Staphylococci, E. coli (see Section 5.1 Pharmacodynamic Properties).

Genito-urinary tract (complicated and uncomplicated), acute and chronic.

E. coli (see Section 5.1 Pharmacodynamic Properties), P. mirabilis and S. faecalis.

Gonorrhoea.

N. gonorrhoeae (non-β-lactamase-producing).

Prophylaxis of endocarditis.

Fisamox 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.

4.2 Dose and Method of Administration

Fisamox may be given by: intramuscular injection, intravenous infusion, slow intravenous injection.

Dosage in normal renal function.

Upper respiratory tract infections; genito-urinary tract infection; skin and skin structure infections.

Adults.

250 mg every 6 to 8 hours, depending on the patient's condition.

Children (under 20 kg).

20 mg/kg/day in equally divided doses every 6 to 8 hours.
In severe infections, or those caused by less susceptible organisms, 500 mg every 6 to 8 hours for adults and 40 mg/kg/day in equally divided doses every 6 to 8 hours for children may be needed.
Lower respiratory tract infections.

Adults.

500 mg every 6 to 8 hours.

Children (under 20 kg).

40 mg/kg/day in equally divided doses every 6 to 8 hours.
Bacterial septicaemia. In more serious infections in adults, Fisamox can be given as 1000 mg every 6 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 to 40 mg/kg every 6 hours.

Dosage adjustment in renal impairment.

In renal impairment, the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage (see Table 1).

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 adult recommendations.
Frequent bacteriological and clinical appraisals are necessary in the treatment of chronic urinary tract infections. 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 after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.
To prevent the occurrence of acute rheumatic fever or glomerulonephritis, it is recommended that there be at least ten days treatment for any infection caused by haemolytic Streptococci.

Preparation of injections.

Amoxicillin sodium is unstable in concentrated solutions and, when prepared for injection, should be administered immediately. Fisamox is for use in one patient on one occasion only and any residue should be discarded.
Fisamox should be administered immediately following reconstitution, to reduce microbiological hazard. If required, Fisamox may be held under refrigeration (2°C to 8°C) for the time periods described in Table 3 (see Section 6.4 Special Precautions for Storage).

1000 mg vial.

For intramuscular use, add 5.2 mL of water for injections and shake vigorously. Doses larger than 500 mg should be divided between multiple injection sites.
For IV use, dissolve contents in 20 mL of water for injections. Dilutions in excess of 10 mL should be carried out in the syringe. Table 2 may be used as a guide to assist in the preparation of fractional doses of Fisamox.
A transient pink colouration or slight opalescence may appear during reconstitution.
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. For direct intravenous injection, administer by slow injection (at least over a period of 3 to 4 minutes, preferably 10 to 15 minutes). More rapid administration may result in convulsive seizures.

4.3 Contraindications

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

4.4 Special Warnings and Precautions for Use

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics, e.g. penicillins. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any beta-lactam antibiotic, careful enquires should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If a hypersensitivity reaction occurs, appropriate therapy should be instituted and Fisamox therapy discontinued.
Serious anaphylactoid reactions require emergency treatment with adrenaline (epinephrine). 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 by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). 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, electrolyte 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 humans appears to be similar to that in animals, the possibility of nephrotoxic effect from amoxicillin should be borne in mind.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of super-infections with mycotic or bacterial pathogens should be kept in mind during therapy. If super-infections 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.
Caution should be exercised in the treatment of patients with an allergic diathesis. Fisamox is not the treatment of choice in patients presenting with sore throat or pharyngitis. This is because of the possibility that the underlying cause may be infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used. Patients with lymphatic leukaemia also appear to have a higher incidence of skin rashes when treated with amoxicillin.
During treatment with high doses of amoxicillin, particularly by bolus injection, an adequate fluid intake and urinary output must be maintained. In addition, indwelling catheters should be checked regularly for patency since, due to high urinary concentrations, amoxicillin may, at room temperature, precipitate out of solution. The risk of crystalluria should be avoided by maintaining a high urinary output.
The sodium content must be taken into account in patients on a sodium restricted diet if the parenteral administration of high doses is necessary (see Section 6.5 Nature and Contents of Container).

Use in renal impairment.

Dosage should be adjusted in severe and moderate renal impairment (see Section 4.2 Dose and Method of Administration).

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

As administration of Fisamox will result in high amoxicillin concentrations in the urine, false positive reactions may be elicited when testing the urine for glucose with Clinitest, Benedict's solution or Fehling's solution. Tests based on enzymatic glucose oxidase reactions such as Testape or Clinistix should be used instead.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Fisamox may result in increased and prolonged blood levels of amoxicillin.
Tetracyclines, erythromycin and chloramphenicol antagonise the action of amoxicillin. Gentamicin should not be mixed with amoxicillin when both drugs are given parenterally as inactivation occurs.
The concurrent administration of allopurinol and amoxicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricaemia present in these patients.
In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives. Patients should be warned that Fisamox may reduce the effectiveness of 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 co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Amoxicillin diffuses across the placenta into the fetal circulation. Animal studies with amoxicillin have shown no teratogenic effects. The product has been in clinical use since 1972 and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effect.
The use of Fisamox in pregnancy should be reserved for cases considered essential by the clinician.
Following administration of ampicillin to pregnant women a transient decrease in plasma concentration of total conjugated estriol, estriol glucuronide, conjugated oestrone and oestradiol has been noted. This effect may also occur with amoxicillin.

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 decreases uterine tone and the frequency, strength and duration of contractions. However, it is not known whether the use of amoxicillin in humans during labour or delivery has any immediate or delayed adverse effects on the fetus, prolongs the duration of labour or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
Amoxicillin is excreted in breast milk. An alternative feeding method is recommended to avoid potential sensitisation of the newborn.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

As with all penicillins, the possibility of hypersensitivity reactions should always be considered. Reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with allergic diathesis. Anaphylactic shock is most likely to occur with injected penicillins (see Section 4.4 Special Warnings and Precautions for Use).
The following adverse reactions have been reported as associated with the use of amoxicillin:

Gastrointestinal.

Glossitis, stomatitis, black hairy tongue, nausea, vomiting, diarrhoea. Intestinal candidiasis and antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis) have been reported rarely (see Section 4.4 Special Warnings and Precautions for Use).

Hypersensitivity reactions.

Erythematous maculopapular rash, pruritus and urticaria have been reported. Urticaria has occasionally been reported in association with glandular fever and some other viral diseases. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and 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. When such reactions occur, Fisamox should be discontinued.

Note.

Urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Anaphylaxis is the most serious reaction experienced (see Section 4.4 Special Warnings and Precautions for Use). A macular rash, which is not believed to be a hypersensitivity reaction, occurs predominantly in patients with infectious mononucleosis 4 to 5 days after beginning therapy with amoxicillin.

Hepatic.

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

Renal and urinary tract disorders.

Interstitial nephritis, crystalluria (see Section 4.9 Overdose) has been reported rarely.

Haemic and lymphatic systems.

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

Nervous system.

Adverse effects have been reported rarely. They include hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses. As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of amoxicillin in patients with meningitis.

Other.

Vaginal or oral moniliasis may occur following the use of antibiotics.
Ninety percent of all adverse events to amoxicillin recorded in the Australian Adverse Drug Reaction System relate to the skin (rash, pruritus and urticaria).

Injection site.

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

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water/electrolyte imbalance should be treated. During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
As with other penicillins, amoxicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures. As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of amoxicillin in patients with meningitis.
Amoxicillin may be removed from the circulation by haemodialysis. General supportive measures should be instituted.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Amoxicillin has the same spectrum of activity as ampicillin. It is bactericidal and is active against a wider range of Gram-negative organisms than benzylpenicillin. It is less active than benzylpenicillin against Gram-positive organisms but is active in vitro against Streptococcus pyogenes and many strains of Streptococcus pneumoniae, Streptococcus viridans, non-penicillinase producing Staphylococci and Enterococcus faecalis. There are strains of Escherichia coli that are sensitive to amoxicillin but isolates are becoming increasingly resistant to amoxicillin in vitro due to the presence of penicillinase-producing strains. Many strains of Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Proteus mirabilis and Salmonellae are sensitive to amoxicillin, although the increasing incidence of beta-lactamase activity in H. influenzae and E. coli is reducing the capacity of amoxicillin to treat diseases caused by these organisms. Some of the above organisms are sensitive to amoxicillin only at concentrations achieved in the urine.
Amoxicillin is not effective against penicillinase producing bacteria, particularly resistant Staphylococci, which are now common. All strains of Pseudomonas, indole-positive Proteus, Serratia marcescens, Enterobacter, Klebsiella and Citrobacter are resistant.
Like benzylpenicillin, amoxicillin is bactericidal to sensitive organisms during the stage of active cell division. It is believed to act through the inhibition of cell wall synthesis.

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 technique 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 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following intramuscular injection of 250 or 500 mg of Fisamox, peak serum levels of approximately 5.5 mg/L or 10 mg/L 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 intravenous injection over a 3 to 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 though 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.
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.
If renal function is normal, approximately 70% of a dose administered by intramuscular or rapid intravenous injection will be excreted unchanged within six hours, 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 glomerular filtration rate 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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The powder for injection contains no excipients.

6.2 Incompatibilities

Fisamox is compatible with commonly used intravenous solutions (see Section 6.4 Special Precautions for Storage). However, it should not be mixed with blood products or proteinaceous fluids such as protein hydrolysates, nor with intravenous lipid emulsions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Dry powder: store below 25°C.
Protect from light and moisture.
Solutions: when prepared for intramuscular or direct intravenous injection, Fisamox should be administered immediately after reconstitution.
Intravenous fluids: infusions should be administered over a period of 30 to 60 minutes although Fisamox maintains a satisfactory degree of activity at room temperature in various infusion fluids.
If the solutions listed below are stored under refrigeration (2°C to 8°C), they will remain stable for the time periods indicated (see Table 3).
Since Fisamox is relatively less stable in carbohydrate solutions, it is preferable to avoid adding it to them. However, it may 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 30 to 60 minutes.

As there is some loss of potency during storage at 2°C to 8°C, solutions that have been stored at 2°C to 8°C for periods within the limits stated above, should be used immediately once they have been brought to room temperature.

6.5 Nature and Contents of Container

Each one gram of monograph substance represents about 2.6 mmol of sodium (59.8 mg of sodium).
Container type: vial (glass type II clear).
Pack sizes: 5, 10.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG).

AUST R 90880 - Fisamox amoxicillin (as sodium) 1000 mg powder for injection vial.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Fisamox is a fine white to off-white homogenous powder, soluble in water.
Chemical name: d-(-)-α-amino-p-hydroxybenzylpenicillin sodium.
Molecular formula: C16H18N3NaO5S.
Molecular weight: 387.4.

CAS number.

34642-77-8.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes