SUMMARY CMI

Amoxiclav Juno

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 being given Amoxiclav Juno?

Amoxiclav Juno contains the active ingredients amoxicillin sodium and potassium clavulanate. Amoxiclav Juno is an antibiotic used to treat or prevent serious bacterial infections.

For more information, see Section 1. Why am I being given Amoxiclav Juno? in the full CMI.

2. What should I know before I am given Amoxiclav Juno?

Do not use if you have ever had an allergic reaction to amoxicillin or other penicillins, cephalosporins, clavulanic acid 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 am given Amoxiclav Juno? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Amoxiclav Juno 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 will I be given Amoxiclav Juno?

Amoxiclav Juno must only be given by a doctor or nurse. Your doctor will decide what dose and how long you will receive it.
This depends on your infection and other factors, such as your weight.
More instructions can be found in Section 4. How will I be given Amoxiclav Juno? in the full CMI.

5. What should I know while using Amoxiclav Juno?

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

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.

Some side effects may include:

• Headache
• Nausea
• Vomiting
• Diarrhoea
• Indigestion
• Dizziness
• Soreness of the mouth or tongue
• Overgrowth of yeast infections (thrush).

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

Amoxiclav Juno

Active ingredients: amoxicillin sodium & potassium clavulanate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Amoxiclav Juno. 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 Amoxiclav Juno.

Where to find information in this leaflet:

1. Why am I being given Amoxiclav Juno?
2. What should I know before I am given Amoxiclav Juno?
3. What if I am taking other medicines?
4. How will I be given Amoxiclav Juno?
5. What should I know while using Amoxiclav Juno?
6. Are there any side effects?
7. Product details

1. Why am I being given Amoxiclav Juno?

Amoxiclav Juno contains the active ingredients amoxicillin sodium & potassium clavulanate.

Amoxiclav Juno is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin sodium and potassium clavulanate. Amoxicillin Juno belongs to a group of medicines called “penicillins” which are antibiotics that can sometimes be stopped from working (made inactive) by resistant bacteria. The other active component (clavulanic acid) stops this from happening.

Amoxiclav Juno is used to treat:

• Respiratory infections e.g. bronchitis, pneumonia, tonsilitis, sinusitis
• Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis, gonorrhoea
• Gastrointestinal infections e.g. peritonitis, intra-abdominal sepsis
• Ear and skin infections

Amoxiclav Juno is also used to prevent infections in major surgical procedures

Your doctor may have prescribed this medicine for another reason.

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

2. What should I know before I am given Amoxiclav Juno?

Warnings

Do not use Amoxiclav Juno if:

• You are allergic to amoxicillin sodium or potassium clavulanate.
• You have had any allergic reactions to other penicillins or cephalosporins, as you may be sensitive to amoxicillin sodium as well.
• you have a previous history of amoxicillin/ clavulanic acid associated jaundice / liver dysfunction.
• The expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well.

Check with your doctor if you:

• have any other allergies to any other medicines or any other substances, such as foods, preservatives or dyes
• have any other medical condition including:
  - asthma, hay fever or hives
  - kidney problems
  - glandular fever
• have or have had any medical conditions, especially either of the following:
  - reduced kidney function
  - on controlled potassium intake

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. Your doctor will discuss the possible risks and benefits of using Amoxiclav Juno during pregnancy.

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

Your doctor will discuss the possible risks and benefits of using Amoxiclav Juno while breast feeding.

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 Amoxiclav Juno and affect how it works. These include:

• Allopurinol and probenecid, drugs used to treat high levels of uric acid in the blood such as gout and stone formations.
• The contraceptive pill. As with other antibiotics, you may need to use extra birth control methods e.g. condoms.
• Other antibiotics such as tetracyclines, erythromycin, chloramphenicol and gentamycin.
• Anticoagulants (used to prevent blood clots) such as warfarin.
• Alcohol. Due to risk of disulfiram (Antabuse) like reaction in some patients treated with beta-lactam antibiotics, the ingestion of alcohol should be avoided during and for several days after treatment with Amoxiclav Juno.

These medicines may be affected by Amoxiclav Juno, or they may affect how well it works. You may need different medicines. Your doctor will advise you.

Your doctor may have more information on medicines to be careful with or to avoid while taking Amoxiclav Juno.

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

4. How will I be given Amoxiclav Juno?

How is Amoxiclav Juno given

Amoxiclav Juno must only be given by a doctor or nurse. Your doctor will decide what dose and how long you will receive it. This depends on your infection and other factors, such as your weight.

Amoxiclav Juno may be administered either by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or via a drip tube, or by infusion over 30 to 40 min.

This medicine is not suitable for intramuscular administration.

Children aged less than 3 months should be administered Amoxiclav Juno by infusion only.

Amoxiclav Juno should be reconstituted with water for injection before use.

Treatment with amoxicillin sodium / clavulanic acid may be initiated with an intravenous preparation and completed with an appropriate oral presentation as considered appropriate for you.

If you are given too much Amoxiclav Juno

As Amoxiclav Juno will most likely be given to you in hospital or under the supervision of your doctor or nurse, it is very unlikely that you will receive an overdose.

If you think that you have been given too much Amoxiclav Juno, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor or nurse, 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 Amoxiclav Juno?

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 are about to start taking any new medicine, tell your doctor and pharmacist that you are receiving Amoxiclav Juno.

If you have to have any blood or urine tests, tell your doctor you are being given Amoxiclav Juno. It may affect the results of some blood and urine tests.

Call your doctor straight away if you:

• develop itching with swelling or skin rash or difficulty breathing while you are receiving Amoxiclav Juno. Do not have any more and tell your doctor immediately.
• get severe diarrhoea. Do this even if it occurs several weeks after Amoxiclav Juno has been stopped.
• become pregnant while you are receiving treatment with Amoxiclav Juno.

Things you should not do

• Do not stop using this medicine suddenly unless instructed by your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Amoxiclav Juno affects you.

Drinking alcohol

Do not drink alcohol during or for several days after being treated with Amoxiclav Juno.

Looking after your medicine

The hospital will store Amoxiclav Juno under the correct recommended conditions.

It should be kept in a cool, dry place away from moisture, heat or sunlight below 25°C

Do not use this medicine after the expiry date.

Getting rid of your medicine

Any unwanted medicine will be disposed of in a safe manner by your doctor, nurse or pharmacist.

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

Serious side effects

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Amoxiclav Juno:

• severe stomach cramps or abdominal 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 rare but serious condition affecting your bowel which may need urgent medical attention. 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 Amoxiclav Juno contains

Do not take this medicine if you are allergic to any of these ingredients.

What Amoxiclav Juno looks like

Amoxiclav Juno is a white to off-white powder supplied in a 20 mL clear glass vial.

Amoxiclav Juno is supplied in 3 presentations

Amoxiclav Juno 500/100 powder for injection

(AUST R 269162)

Amoxiclav Juno 1000/200 powder for injection

(AUST R 269159)

Amoxiclav Juno 2000/200 powder for injection

(AUST R 269158)

Who distributes Amoxiclav Juno

Juno Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne,
VIC 3121
Australia

This leaflet was prepared in September 2024

Published by MIMS November 2024

1 Name of Medicine

Amoxicillin sodium and potassium clavulanate.

2 Qualitative and Quantitative Composition

Amoxiclav Juno 500/100.

Amoxiclav Juno 1000/200.

Amoxiclav Juno 2000/200.

3 Pharmaceutical Form

Amoxiclav Juno powder for injection consists of vials of sterile white to off-white powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Amoxiclav Juno is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed Gram negative and Gram positive infections, and situations where microbial confirmation has not yet been obtained.
Infections caused by amoxicillin susceptible organisms are amenable to Amoxiclav Juno treatment due to its amoxicillin content. Infections caused by β-lactamase producing amoxicillin resistant organisms are also amenable to Amoxiclav Juno due to its clavulanic acid content.
Susceptibility to Amoxiclav Juno will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. Amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.
Amoxiclav Juno is indicated for the short term treatment of serious bacterial infections such as:
Upper respiratory tract infections (including ENT): e.g. mastoiditis, tonsillitis, otitis media, epiglottitis and sinusitis when accompanied by severe signs and symptoms.
Lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia.
Genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections.
Gastrointestinal infections: e.g. intra-abdominal sepsis, peritonitis.
Skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess.
Other infections: e.g. septic abortion, puerperal sepsis, post-surgical infections.
Amoxiclav Juno is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications e.g. gastrointestinal surgery.

4.2 Dose and Method of Administration

Dosage.

Adults and children 40 kg and over.

Children 3 months-12 years.

Children 0-3 months.

Elderly.

Dosage for surgical prophylaxis.

Adults.

Dosage in renal impairment.

Adults and children 40 kg and over.

Children under 40 kg.

Dosage in hepatic impairment.

Dosage in elderly.

Method of administration.

If reconstituted and maintained at room temperature, infusions should be completed within the time stated (see Table 3).

4.3 Contraindications

In patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
In patients with a previous history of amoxicillin/clavulanic acid associated jaundice/hepatic dysfunction.

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. 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)). 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 amoxicillin/clavulanic acid therapy discontinued.
Serious anaphylactic reactions require 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/clavulanate (see Section 4.8 Adverse Effects (Undesirable Effects)). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after drug administration) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.
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-clavulanate 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 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.
Amoxicillin/clavulanic acid 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.
In general amoxicillin/clavulanic acid is well tolerated and possesses the characteristic low toxicity of the penicillin group of antibiotics. However, 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 Enterobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.

Sodium and potassium content.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid.

Allopurinol.

Oral contraceptives.

Oral anticoagulants.

Tetracyclines and other bacteriostatic drugs.

Alcohol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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 this registration.

4.8 Adverse Effects (Undesirable Effects)

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin/clavulanic acid, sorted by MedDRA System Organ Class are listed below.
The following convention has been used for the classification of frequency: very common > 1/10; common > 1/100 and < 1/10; uncommon > 1/1000 and < 1/100; rare > 1/10,000 and < 1/1000; very rare < 1/10,000.

Infections and infestations.

Blood and lymphatic system disorders.

Cardiac disorders.

Immune system disorders.

Nervous system disorders.

Vascular disorders.

Gastrointestinal disorders following intravenous administration.

Hepatobiliary disorders.

Skin and subcutaneous tissue disorders.

Renal and urinary disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically, with attention to the water/electrolyte balance.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed.
Amoxicillin has been reported to precipitate in bladder catheters after intravenous administration of large doses. A regular check of patency should be maintained.
Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.
A prospective study of 51 paediatric patients at a poison control centre suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.
Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Drug abuse and dependence.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mechanisms of resistance.

Comments.

Dilution or diffusion techniques.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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.

6.4 Special Precautions for Storage

Store below 25°C. Protect from moisture. Protect from light.

6.5 Nature and Contents of Container

Amoxiclav Juno 600 mg, 1.2 g and 2.2 g Powder for Injection is presented in type III transparent, clear glass vials with a nominal capacity of 20 mL closed with chlorobutylic rubber stopper and aluminium seal. See Table 7.
(Not all pack sizes may be marketed).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Amoxicillin sodium is a white or almost white, crystalline powder, very hygroscopic, very soluble in water. pH of the aqueous solution is 8.0 to 10.0.
Potassium clavulanate is a white or almost white, hygroscopic, crystalline powder and is freely soluble in water. A 1% solution in water has a pH of 5.5 to 8.0.
Amoxiclav Juno Powder for Injection is a combination product containing the semisynthetic antibiotic, amoxicillin sodium and the β-lactamase inhibitor, potassium clavulanate (as the potassium salt of clavulanic acid).

Amoxicillin sodium.

Chemical name.

Chemical structure.

CAS number.

Molecular weight.

Molecular formula.

Potassium clavulanate.

Chemical name.

Chemical structure.

CAS number.

Molecular weight.

Molecular formula.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes