Consumer medicine information

APO-Amoxycillin Suspension

Amoxicillin

BRAND INFORMATION

Brand name

APO-Amoxycillin Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Amoxycillin Suspension.

SUMMARY CMI

APO-AMOXYCILLIN

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 taking APO-AMOXYCILLIN?

APO-AMOXYCILLIN contains the active ingredient amoxicillin (as trihydrate). APO-AMOXYCILLIN is used to treat infections in different parts of the body caused by bacteria.

For more information, see Section 1. Why am I taking APO-AMOXYCILLIN? in the full CMI.

2. What should I know before I take APO-AMOXYCILLIN?

Do not take if you have ever had an allergic reaction to APO-AMOXYCILLIN 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 take APO-AMOXYCILLIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-AMOXYCILLIN 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 take APO-AMOXYCILLIN?

  • Follow the instructions provided when APO-AMOXYCILLIN is prescribed, including the number of days it should be taken.
    APO-AMOXYCILLIN can be taken with or without food.
  • Shake the APO-AMOXYCILLIN Suspension in the bottle well, before measuring out the dose in a suitable measure. Make sure that the whole dose is swallowed each time.

More instructions can be found in Section 4. How do I take APO-AMOXYCILLIN? in the full CMI.

5. What should I know while taking APO-AMOXYCILLIN?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking APO-AMOXYCILLIN.
  • Tell your doctor 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, difficulty breathing, severe diarrhoea or sore white mouth or tongue.
Things you should not do
  • Do not stop taking APO-AMOXYCILLIN, or change the dosage, without checking with your doctor.
  • Do not give APO-AMOXYCILLIN to anyone else, even if their symptoms seem similar to yours.
  • Do not take APO-AMOXYCILLIN to treat any other complaints unless your doctor or pharmacist tells you to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how APO-AMOXYCILLIN affects you.
Looking after your medicine
  • Keep APO-AMOXYCILLIN in its original packaging until it is time to take it.
  • Keep APO-AMOXYCILLIN Dry powder in a cool dry place where the temperature will stay below 25°C. Protect it from moisture.
  • Keep the reconstituted APO-AMOXYCILLIN Suspension in refrigerator (2 to 8°C), do not freeze it. Use it within 14 days. Unused suspension must be discarded after 14 days.

For more information, see Section 5. What should I know while taking APO-AMOXYCILLIN? in the full CMI.

6. Are there any side effects?

Less serious side effects are nausea (feeling sick), indigestion, vomiting, oral thrush - white and sore tongue and mouth, vaginal thrush - sore and itchy vagina and/or discharge, teeth discolouration.

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

APO-AMOXYCILLIN

Active ingredient: amoxicillin (as trihydrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about taking APO-AMOXYCILLIN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking APO-AMOXYCILLIN or giving it to your child.

Where to find information in this leaflet:

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

1. Why am I taking APO-AMOXYCILLIN?

APO-AMOXYCILLIN contains the active ingredient amoxicillin (as trihydrate). Amoxicillin (as trihydrate) is an antibiotic that belongs to a group of medicines called penicillins. It is used to treat infections in different parts of the body caused by bacteria. It works by killing the bacteria that are causing the infection. Amoxicillin (as trihydrate) can also be used to prevent infection.

Amoxicillin (as trihydrate) will not work against infections caused by viruses such as colds or the flu.

Use in children

APO-AMOXYCILLIN Suspension is a more suitable form of amoxicillin (as trihydrate) for giving to children than capsules.

2. What should I know before I take APO-AMOXYCILLIN?

Warnings

Do not take APO-AMOXYCILLIN if:

  • you are allergic to amoxicillin (as trihydrate), other penicillins or cephalosporins, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can take APO-AMOXYCILLIN.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, throat or other parts of the body, muscle pain or tenderness, joint pain or rash, itching or hives on the skin.

Check with your doctor if you:

  • are allergic to any other medicines.
  • are allergic to any other substances, such as foods, preservatives or dyes.
  • have ever had an allergic reaction (such as a rash) to any antibiotics in the past.
  • have any other medical conditions, especially the following:
    - glandular fever (mononucleosis)
    - blood disorders such as leukaemia
    - liver or kidney problems
  • take any medicines for any other condition
  • are pregnant or plan to become pregnant or are breastfeeding.

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.

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

Your doctor can discuss with you the risks and benefits involved. APO-AMOXYCILLIN may be used during pregnancy (Category A). It can pass to your baby through breast milk.

If you have not told your doctor about any of the above, tell them before you start taking APO-AMOXYCILLIN.

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 APO-AMOXYCILLIN and affect how it works. These include:

  • Medicines used to treat gout (e.g. probenecid or allopurinol)
  • Other antibiotics (e.g. tetracyclines)
  • The contraceptive pill. As with other antibiotics you may need to use extra birth control methods (e.g. condoms)
  • Anticoagulants, used to prevent blood clots (e.g. warfarin)

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APO-AMOXYCILLIN.

4. How do I take APO-AMOXYCILLIN?

How much to take

  • Your doctor or pharmacist will tell you the dose you will need to take. This depends on your condition and whether or not you are taking any other medicines.
  • Follow the instructions provided when APO-AMOXYCILLIN is prescribed, including the number of days it should be taken.
  • The usual adult dose is 250 mg - 500 mg three times a day.
  • In children, the usual dosage is 125 mg - 250 mg three times daily and may vary depending on the weight of your child.

When to take APO-AMOXYCILLIN

  • Take it at about the same time each day.
  • Space the doses as evenly as possible throughout the day. For example, if you are taking APO-AMOXYCILLIN three times a day, take a dose about every eight hours.

How to take APO-AMOXYCILLIN

  • APO-AMOXYCILLIN can be taken with or without food.
    The effects of APO-AMOXYCILLIN are not changed by food.
  • APO-AMOXYCILLIN suspension will be prepared by your pharmacist who checks the seal prior to reconstitution. Shake the bottle well and accurately measure the dose with a suitable measure. Your pharmacist will explain how many millilitres of suspension will be needed to receive the correct dose. Make sure that the whole dose is swallowed each time.

How long to take it for

  • Do not stop taking APO-AMOXYCILLIN because you are feeling better.
  • If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.
  • Make sure you have enough to last over weekends and holidays.
  • Unused APO-AMOXYCILLIN must be discarded after 14 days.

If you forget to take APO-AMOXYCILLIN

APO-AMOXYCILLIN should be taken regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

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

This may increase the chance of you getting an unwanted side effect.

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

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much APO-AMOXYCILLIN

If you think that you have taken too much APO-AMOXYCILLIN, you may need urgent medical attention.

You should immediately:

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

If you take too much APO-AMOXYCILLIN, you may feel sick or get diarrhoea.

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

5. What should I know while taking APO-AMOXYCILLIN?

Things you should do

Tell your doctor if:

  • The symptoms of your infection do not improve within a few days, or if they become worse.
  • You develop itching with swelling or skin rash or difficulty breathing. Stop taking APO-AMOXYCILLIN and contact your doctor immediately.
  • You get severe diarrhoea. Tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after you stop taking APO-AMOXYCILLIN. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any anti-diarrhoea medicine without first checking with your doctor.
  • You get a sore white mouth or tongue while taking or soon after stopping APO-AMOXYCILLIN, or if you get vaginal itching or discharge.
    This may mean you have a fungal infection called thrush. Sometimes the use of APO-AMOXYCILLIN allows fungi to grow and the above symptoms to occur. APO-AMOXYCILLIN does not work against fungi.
  • You are about to have any blood tests.
  • You become pregnant.
  • You are about to start taking any other new medicine.

Remind any doctor, dentist or pharmacist you visit that you are taking APO-AMOXYCILLIN.

Keep any appointments with your doctor.

Your doctor may want to do tests to make sure APO-AMOXYCILLIN is working and to prevent side effects.

Things you should not do

  • Do not stop taking APO-AMOXYCILLIN, or change the dosage, without checking with your doctor.
  • Do not give APO-AMOXYCILLIN to anyone else, even if their symptoms seem similar to yours.
  • Do not take APO-AMOXYCILLIN to treat any other complaints unless your doctor or pharmacist tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APO-AMOXYCILLIN affects you.

APO-AMOXYCILLIN generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, APO-AMOXYCILLIN may cause dizziness, drowsiness or tiredness in some people.

Looking after your medicine

Keep APO-AMOXYCILLIN in the original packaging until it is time to take it. If you take it out of the original packaging it may not keep well.

Keep APO-AMOXYCILLIN Dry powder in a cool dry place where the temperature will stay below 25°C. Protect it from moisture.

Keep the reconstituted APO-AMOXYCILLIN Suspension in refrigerator (2 to 8°C), do not freeze it. Use it within 14 days. Unused suspension must be discarded after 14 days.

Do not store APO-AMOXYCILLIN:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Do not take APO-AMOXYCILLIN after the expiry date (EXP) printed on the pack. If you take APO-AMOXYCILLIN after the expiry date has passed, it may not work as well.

Do not take APO-AMOXYCILLIN if the packaging is torn or shows signs of tampering or if it does not look quite right.

If it has expired or is damaged, return it to your pharmacist for disposal.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take APO-AMOXYCILLIN or it is out of date, take it to any pharmacy for safe disposal.

Do not take APO-AMOXYCILLIN after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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

Less serious side effects

Less serious side effectsWhat to do
  • Oral thrush - white and sore tongue and mouth.
  • Vaginal thrush - sore and itchy vagina and/or discharge.
  • Diarrhoea.
  • Nausea (feeling sick).
  • Indigestion.
  • Vomiting.
  • Teeth discolouration (especially with the suspension).
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
  • Itching or any type of skin rash
  • Unusual bleeding or bruising
  • Yellowing of the skin or eyes
  • Dark urine or pale stools
  • Difficulty or pain on passing urine
  • Severe diarrhoea
  • Feeling hyperactive or having trouble concentrating.
  • A red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck.
  • Tell your doctor immediately if you notice any of the following side effects, even if they occur several weeks after you have stopped taking APO-AMOXYCILLIN:
    - severe abdominal cramps or stomach cramps
    - watery and severe diarrhoea, which may also be bloody
    - fever, in combination with one or both of the above.
    These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention.
    Do not take any anti-diarrhoea medicine without checking with your doctor first.
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.

Very serious side effects

Very serious side effectsWhat to do
Allergic reaction including:
  • Wheezing, shortness of breath or difficulty breathing.
  • Fainting.
  • Swelling of limbs, face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing.
  • Dizziness or convulsions
  • Severe abdominal cramps or stomach cramps
You may need urgent medical attention or hospitalisation. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects.

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

APO-AMOXYCILLIN is only available with a doctor's prescription.

What APO-AMOXYCILLIN Suspension contains

Active ingredient
(main ingredient)		Amoxicillin (as trihydrate)
Other ingredients
(inactive ingredients)
  • Saccharin sodium
  • Colloidal silica anhydrous
  • Sodium citrate dihydrate
  • Sorbitol
  • Sunset yellow FCF
  • Xanthan gum
  • Tutti Frutti flavor (PI 183)
Potential allergens
  • Saccharin
  • Sodium
  • Sulfites

Do not take APO-AMOXYCILLIN if you are allergic to any of these ingredients.

APO-AMOXYCILLIN Suspension contains sorbitol:

The 125 mg/5 mL strength contains 18 g sorbitol in 120 mL reconstituted suspension.

The 250 mg/5 mL strength contains 7.2 g sorbitol in 60 mL reconstituted suspension. Products containing sorbitol may have a laxative effect or cause diarrhoea.

APO-AMOXYCILLIN 125 mg/5 mL Suspension contains 1.14 mg sodium in 1 ml reconstituted suspension.

APO-AMOXYCILLIN Suspension does not contain lactose, sucrose or tartrazine.

What APO-AMOXYCILLIN Suspension looks like

APO-AMOXYCILLIN Suspension when reconstituted by the pharmacist forms a 100 mL orange suspension, and is available in the following strengths:

APO-AMOXYCILLIN 125 mg/5 mL Suspension
Bottle: AUST R 137882

APO-AMOXYCILLIN 250 mg/5 mL Suspension
Bottle: AUST R 137883

Who distributes APO-AMOXYCILLIN Suspension

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street,
Cremorne, VIC 3121
www.arrotex.com.au

This leaflet was prepared in September 2024.

Published by MIMS October 2024

BRAND INFORMATION

Brand name

APO-Amoxycillin Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin (as amoxicillin trihydrate).

2 Qualitative and Quantitative Composition

Each 5 mL contains 125 mg or 250 mg amoxicillin (as trihydrate).

Excipients with known effect.

Saccharin, sodium, sorbitol.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Amoxycillin Powder for Suspension 125 mg/5 mL.

White to off-white powder forming an orange suspension upon reconstitution with water.

APO-Amoxycillin Powder for Suspension 250 mg/5 mL.

White to off-white powder forming an orange suspension upon reconstitution with water.

4 Clinical Particulars

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

Skin and skin structure.

Staphylococcus, non-penicillinase producing; Streptococcus; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

Respiratory (acute and chronic).

H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, non-penicillinase producing; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

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

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

Gonorrhoea.

N. gonorrhoeae (non-penicillinase producing).

Prophylaxis of endocarditis.

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

4.2 Dose and Method of Administration

APO-Amoxycillin Powder for Suspension is intended for oral administration.

Dosage.

Normal renal function.

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

Adults and children (over 20 kg).

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 a single dose.
Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving amoxicillin and monthly serological tests for a minimum of four months.
Acute uncomplicated lower urinary tract infections in nonpregnant adult females.

Adults.

3 g as a single dose.

Use in neonates.

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

Use in children.

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.

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.
In patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day. Amoxicillin may be removed from the circulation by haemodialysis.

Chronic urinary tract infections.

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.

Duration of treatment.

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 1.

4.3 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).

4.4 Special Warnings and Precautions for Use

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis, anaphylactoid and severe cutaneous reactions) have been reported in patients receiving β-lactam antibiotics. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. 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.
Drug induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see Section 4.8 Adverse Effects (Undesirable Effects)). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after administration of amoxicillin) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise of abdominal pain, diarrhoea, hypotension, or leucocytosis with neutrophilia. There have been severe cases including progression to shock.
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. Clostridium difficile associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhoea to fatal colitis. 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.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.
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 should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
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.
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.
Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A positive culture may be evidence of a complicated or upper urinary tract infection and call for a longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.

Use in renal impairment.

Dosage should be adjusted in patients with renal impairment (see Section 4.2 Dose and Method of Administration).
In patients with reduced urine output, crystalluria (including acute renal injury) has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.9 Overdose).

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Oral administration of amoxicillin will result in high urine concentrations of amoxicillin. Since high urine concentrations of amoxicillin may result in false positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict's solution or Fehling's solution, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Tes-Tape) be used.
Following administration of ampicillin to pregnant women a transient decrease in plasma concentration of total conjugated oestriol, oestriol glucuronide, conjugated oestrone and oestradiol has been noted. This effect may also occur with amoxicillin.

4.5 Interactions with Other Medicines and Other Forms of 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 hyperuricaemia 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.

Methotrexate.

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Animal studies with amoxicillin have shown no teratogenic effects. Amoxicillin 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 infant will be necessary.
 Ampicillin class antibiotics are excreted in breast milk; therefore, caution should be exercised when amoxicillin is administered to a nursing woman.

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 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.

Cardiac disorders.

Kounis syndrome: not known.

Infections and infestations.

Mucocutaneous candidiasis has been reported very rarely.

Gastrointestinal.

Nausea, vomiting, diarrhoea. Intestinal candidiasis and antibiotic associated colitis, including pseudomembranous colitis and haemorrhagic colitis have been reported rarely. Black hairy tongue has been reported very rarely. Drug induced enterocolitis syndrome: not known (see Section 4.4 Special Warnings and Precautions for Use).

Skin and subcutaneous tissue disorders.

Linear IgA disease: not known.

Hypersensitivity reactions.

Erythematous maculopapular rash, pruritus and urticaria have been reported occasionally. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous, exfoliative dermatitis and acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS), and symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) (baboon syndrome) 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 Section 4.4 Special Warnings and Precautions for Use).

Hepatic.

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

Haemic and lymphatic systems.

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

Renal and urinary tract disorders.

Interstitial nephritis, crystalluria including renal injury: not known (see Section 4.9 Overdose).

CNS effects.

CNS effects have been seen rarely. These include aseptic meningitis, 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.

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 http://www.tga.gov.au/reporting-problems and contact Arrotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.9 Overdose

Symptoms.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident.

Treatment.

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 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).
Amoxicillin can be removed from the circulation by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.
It is active in vitro against most strains of Haemophilus influenzae*, Neisseria gonorrhoeae*, N. 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 and β-haemolytic streptococci, Diplococcus pneumoniae, non-penicillinase 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 Section 4.1 Therapeutic 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 that are relatively resistant to benzylpenicillin may be sensitive to amoxicillin.
The following in vitro data are available, but their clinical significance is unknown. See Table 2.
A positive β-lactamase test predicts resistance to penicillin, ampicillin and amoxicillin. See Table 3.

Breakpoints.

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

Note.

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

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Amoxicillin is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food.
Orally administered doses of 250 and 500 milligrams result in average peak serum levels one to two hours after administration of 5 microgram/mL and 6.6 to 10.8 microgram/mL respectively. Detectable serum levels of amoxicillin are present 8 hours after ingestion of a single dose.

Distribution.

Amoxicillin is not highly protein bound, being only 17% protein bound in serum as measured by ultrafiltration or equilibrium dialysis.
Amoxicillin diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid except when the meninges are inflamed. Amoxicillin has been shown to diffuse into sputum and saliva and is excreted mainly via the urine where it exists in a high concentration.
The amount to be found in the bile is variable depending on normal biliary secretory function.

Excretion.

The half-life of amoxicillin is 61.3 minutes with normal renal function, and in the absence of renal function is 16 to 20 hours.
Amoxicillin is excreted in the urine both unchanged and as penicilloic acid. About 75% of a 1 g dose is excreted in the urine in six 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 amoxicillin.
Excretion of amoxicillin can be delayed by concurrent administration of probenecid, thus prolonging its therapeutic effect.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Saccharin sodium, colloidal silica anhydrous, sodium citrate dihydrate, sorbitol, sunset yellow FCF, xanthan gum, tutti frutti flavour (PI 183).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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.
Unused suspension must be discarded after 14 days.

6.4 Special Precautions for Storage

Store the powder below 25°C. Protect from moisture.
After reconstitution with water, stored at 2 - 8°C in a refrigerator. Do not freeze.

6.5 Nature and Contents of Container

APO-Amoxycillin powder for suspension 125 mg/5 mL.

100 mL when reconstituted.
Bottle: AUST R Number 137882.

APO-Amoxycillin powder for suspension 250 mg/5 mL.

100 mL when reconstituted.
Bottle: AUST R Number 137883.
Not all strengths may be available.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Amoxicillin trihydrate is a white or almost white, crystalline powder, slightly soluble in water and in alcohol.
Amoxicillin trihydrate is a semisynthetic antibiotic and is a member of the penicillinase stable group of penicillins derived from the penicillin nucleus, 6-aminopenicillanic acid, isolated at Beecham Research Laboratories.

Chemical structure.


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 trihydrate.
Molecular formula: C16H19N3O5S.3H2O.
Molecular weight: 419.4.

CAS number.

61336-70-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes