Consumer medicine information

APX-Amoxicillin/Clavulanic acid 500/125; APX-Amoxicillin/Clavulanic acid 875/125

Amoxicillin; Clavulanic acid

BRAND INFORMATION

Brand name

APX-Amoxicillin/Clavulanic Acid

Active ingredient

Amoxicillin; Clavulanic acid

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APX-Amoxicillin/Clavulanic acid 500/125; APX-Amoxicillin/Clavulanic acid 875/125.

SUMMARY CMI

APX-AMOXICILLIN/CLAVULANIC ACID 500/125
APX-AMOXICILLIN/CLAVULANIC ACID 875/125

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 APX-AMOXICILLIN/CLAVULANIC ACID?

APX-AMOXICILLIN/CLAVULANIC ACID contains the active ingredients amoxicillin and clavulanic acid.

APX-AMOXICILLIN/CLAVULANIC ACID is used for the short term treatment of a wide range of infections caused by bacteria.

For more information, see Section 1. Why am I taking APX-AMOXICILLIN/CLAVULANIC ACID? in the full CMI.

2. What should I know before I take APX-AMOXICILLIN/CLAVULANIC ACID?

Do not take if you have ever had an allergic reaction to amoxicillin trihydrate, potassium clavulanate, penicillin or similar types of antibiotics (such as cephalosporins), 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 APX-AMOXICILLIN/CLAVULANIC ACID? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APX-AMOXICILLIN/CLAVULANIC ACID 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 APX-AMOXICILLIN/CLAVULANIC ACID?

  • Follow the directions given to you by your doctor and pharmacist. Their directions may differ from the information contained in this leaflet.

More instructions can be found in Section 4. How do I take APX-AMOXICILLIN/CLAVULANIC ACID? in the full CMI.

5. What should I know while taking APX-AMOXICILLIN/CLAVULANIC ACID?

Things you should do
  • Take APX-AMOXICILLIN/CLAVULANIC ACID exactly as your doctor has prescribed.
  • Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
  • Remind any doctor, dentist or pharmacist you visit that you are taking APX-AMOXICILLIN/CLAVULANIC ACID.
  • Tell your doctor if the symptoms of your infection become worse, or do not improve within a few days of starting APX-AMOXICILLIN/CLAVULANIC ACID.
Things you should not do
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use to treat any other complaints unless your doctor says to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how
    APX-AMOXICILLIN/CLAVULANIC ACID affects you.
Drinking alcohol
  • Alcohol should be avoided during and for several days after treatment with
    APX-AMOXICILLIN/CLAVULANIC ACID.
Looking after your medicine
  • Keep your tablets in the original pack until it is time to take them.
  • Store it in a cool dry place, away from moisture where the temperature stays below 25°C.

For more information, see Section 5. What should I know while taking APX-AMOXICILLIN/CLAVULANIC ACID? in the full CMI.

6. Are there any side effects?

The most common side effects of APX-AMOXICILLIN/CLAVULANIC ACID are diarrhoea, nausea and vomiting.

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

APX-AMOXICILLIN/CLAVULANIC ACID 500/125
APX-AMOXICILLIN/CLAVULANIC ACID 875/125

Active ingredients: amoxicillin trihydrate and potassium clavulanate

Consumer Medicine Information (CMI)

This leaflet provides important information about taking APX-AMOXICILLIN/CLAVULANIC ACID. 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 APX-AMOXICILLIN/CLAVULANIC ACID.

Where to find information in this leaflet:

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

1. Why am I taking APX-AMOXICILLIN/CLAVULANIC ACID?

APX-AMOXICILLIN/CLAVULANIC ACID contains two active ingredients. One of these is a penicillin called amoxicillin and the other is potassium clavulanic.

APX-AMOXICILLIN/CLAVULANIC ACID belongs to the penicillin group of antibiotics.

APX-AMOXICILLIN/CLAVULANIC ACID is used for the short term treatment of a wide range of infections caused by bacteria. These infections may affect the chest (e.g. bronchitis or pneumonia), bladder (e.g. cystitis), sinuses (e.g. sinusitis), the ears (e.g. otitis media) or the skin.

Your doctor may prescribe APX-AMOXICILLIN/CLAVULANIC ACID for another use. If you want more information, ask your doctor.

There is no evidence that APX-AMOXICILLIN/CLAVULANIC ACID is addictive.

2. What should I know before I take APX-AMOXICILLIN/CLAVULANIC ACID?

Warnings

Do not take APX-AMOXICILLIN/CLAVULANIC ACID if:

  • you are allergic to amoxicillin trihydrate, potassium clavulanate, penicillin or similar types of 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 skin rash, itching, difficulty in breathing and swelling of the face or tongue.
  • you have previously experienced liver problems after taking APX-AMOXICILLIN/CLAVULANIC ACID or any other medicines.
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Always check the ingredients to make sure you can use this medicine.

Do not give this medicine to anyone else; your doctor has prescribed it specifically for you and your condition.

Check with your doctor if you:

  • have ever had an allergic reaction (such as a rash) to antibiotics or other substances in the past.
  • are allergic to foods, dyes, preservatives or any other medicines.
  • have experienced liver problems after taking APX-AMOXICILLIN/CLAVULANIC ACID or any other medicines.
  • have glandular fever (mononucleosis) or leukaemia.
  • have any kidney or liver problems.
    The dosage of APX-AMOXICILLIN/CLAVULANIC ACID may need to be changed or you may need to be given an alternative medicine.
  • have to test your urine for sugar.
    APX-AMOXICILLIN/CLAVULANIC ACID may affect the results of these tests.

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 will discuss with you the possible risks and benefits of taking APX-AMOXICILLIN/CLAVULANIC ACID during pregnancy or while you are breast-feeding. APX-AMOXICILLIN/CLAVULANIC ACID can pass to your baby from breast milk.

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.

In particular, tell your doctor or pharmacist if you are taking any of the following:

  • warfarin or other medicines used to prevent blood clots.
  • mycophenolate.
  • medicines used to treat gout (e.g. probenecid or allopurinol).
  • other antibiotics. These may interfere with the actions of APX-AMOXICILLIN/CLAVULANIC ACID.
  • methotrexate (a medicine used to treat cancer or rheumatic diseases).
  • contraceptive pill. As with other antibiotics, you may need to use extra birth control methods (e.g. condoms) while taking APX-AMOXICILLIN/CLAVULANIC ACID.

Some medicines may interfere with APX-AMOXICILLIN/CLAVULANIC ACID and affect how it works. Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APX-AMOXICILLIN/CLAVULANIC ACID.

4. How do I take APX-AMOXICILLIN/CLAVULANIC ACID?

Follow the directions given to you by your doctor and pharmacist. Their directions may differ from the information contained in this leaflet.

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

How much to take

Swallow APX-AMOXICILLIN/CLAVULANIC ACID tablet with a full glass of water or other liquid.

When to take APX-AMOXICILLIN/CLAVULANIC ACID

APX-AMOXICILLIN/CLAVULANIC ACID should be taken immediately before or with the first mouthful of food. APX-AMOXICILLIN/CLAVULANIC ACID works best when taken this way. It may also help to prevent stomach upsets. However, APX-AMOXICILLIN/CLAVULANIC ACID will still work if taken without food.

Space the doses as evenly as possible throughout the day. If you are taking APX-AMOXICILLIN/CLAVULANIC ACID twice a day, take a dose about every twelve hours.

How long to take it for

Keep taking APX-AMOXICILLIN/CLAVULANIC ACID until the course is finished or for as long as your doctor tells you.

Do not stop taking APX-AMOXICILLIN/CLAVULANIC ACID just because you feel better as the infection can return.

Do not stop taking APX-AMOXICILLIN/CLAVULANIC ACID, or change the dose, without first checking with your doctor.

If you forget to take APX-AMOXICILLIN/CLAVULANIC ACID

If your next dose is due within six hours, skip the dose you missed and take your next dose at the normal time. Otherwise, take the missed dose as soon as you remember and then go back to taking your tablets as directed by your doctor.

Do not take a double dose to make up for the dose you missed. Taking more than the prescribed dose can increase the chance of unwanted side-effects.

If you take too much APX-AMOXICILLIN/CLAVULANIC ACID

If you think that you have taken too much APX-AMOXICILLIN/CLAVULANIC ACID, 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.

Symptoms of overdose include mild to severe nausea, vomiting, cramps and diarrhoea.

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

5. What should I know while taking APX-AMOXICILLIN/CLAVULANIC ACID?

Things you should do

Take APX-AMOXICILLIN/CLAVULANIC ACID exactly as your doctor has prescribed.

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise your doctor may think that it was not working as it should and change your treatment unnecessarily.

Tell your doctor if the symptoms of your infection become worse, or do not improve within a few days of starting APX-AMOXICILLIN/CLAVULANIC ACID.

Remind any doctor, dentist or pharmacist you visit that you are taking APX-AMOXICILLIN/CLAVULANIC ACID before starting any other medicines. Some medicines may affect the way other medicines work.

Things you should not do

  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use to treat any other complaints unless your doctor says to.

Things to be careful of

If you develop severe diarrhoea either when taking APX-AMOXICILLIN/CLAVULANIC ACID or within several weeks after treatment, tell your doctor as soon as possible. Do not take any medication to stop the diarrhoea (e.g. Lomotil® or Imodium®).

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APX-AMOXICILLIN/CLAVULANIC ACID affects you.

Generally, this medicine does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, APX-AMOXICILLIN/CLAVULANIC ACID may cause dizziness or tiredness in some people.

Drinking alcohol

Alcohol should be avoided during and for several days after treatment with APX-AMOXICILLIN/CLAVULANIC ACID. Some people who drink alcohol while taking antibiotics similar to APX-AMOXICILLIN/CLAVULANIC ACID have experienced adverse effects.

Looking after your medicine

Keep your tablets in the original pack until it is time to take them. If you take the tablets out of its original pack it may not keep well.

Store in a cool dry place, away from moisture where the temperature stays below 25°C. Do not store it:

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

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine 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
  • Diarrhoea (several loose bowel movements per day), indigestion, pain in the stomach, feeling sick or being sick.
  • Nausea, vomiting.
  • White, furry, sore tongue and mouth (oral thrush), abnormal taste.
  • Soreness or itching of the vagina or vaginal discharge (vaginal thrush).
  • Headache, dizziness, tiredness, hot flushes.
  • Tooth discolouration.
  • Unusually active (hyperactivity).
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, rash.
  • Dark urine or pale stools.
  • Yellowing of the skin or eyes (jaundice).
  • Severe stomach cramps.
  • Severe watery or bloody diarrhoea.
  • Unusual bleeding or bruising.

Rare Events:

  • Inflammation of the bowl (colitis).
  • Inflammation of the liver (hepatitis).
  • Inflammation of the kidney (nephritis).
  • Blood disorders.
  • Crystals in the urine (crystalluria).
Tell your doctor immediately if you notice any of these symptoms during or after taking APX-AMOXICILLIN/CLAVULANIC ACID.
  • Fits/seizures.
  • Aseptic meningitis.
  • A red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, neck.

Allergic Reactions:

  • Wheezing, hives, severe skin reaction, fainting, swelling of limbs, face, lips, mouth or throat, difficulty swallowing or breathing, joint discomfort or swelling, swollen lymph glands, nausea and vomiting or fever.
Stop taking APX-AMOXICILLIN/CLAVULANIC ACID and call your doctor immediately, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Remember, you should tell your doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems occur during or after treatment with APX-AMOXICILLIN/CLAVULANIC ACID.

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

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

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

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 APX-AMOXICILLIN/CLAVULANIC ACID contains

Active ingredient
(main ingredient)		APX-AMOXICILLIN/CLAVULANIC ACID 500/125
  • 500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as potassium clavulanate)
APX-AMOXICILLIN/CLAVULANIC ACID 875/125
  • 875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as potassium clavulanate)
Other ingredients
(inactive ingredients)
  • Magnesium stearate
  • Purified talc
  • Povidone
  • Croscarmellose sodium
  • Microcrystalline cellulose
  • Triethyl citrate
  • Ethylcellulose
  • Sodium lauryl sulfate
  • Cetyl alcohol
  • Hypromellose
  • Titanium dioxide
APX-AMOXICILLIN/CLAVULANIC ACID 875/125 also contains silicon dioxide.
Potential allergensAPX-AMOXICILLIN/CLAVULANIC ACID 500/125 and APX-AMOXICILLIN/CLAVULANIC ACID 875/125 contains 25 mg potassium per tablet.

APX-AMOXICILLIN/CLAVULANIC ACID 500/125 and APX-AMOXICILLIN/CLAVULANIC ACID 875/125 does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

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

What APX-AMOXICILLIN/CLAVULANIC ACID looks like

APX-AMOXICILLIN/CLAVULANIC ACID 500/125 is an off-white, oval biconvex, film-coated tablet, scored on both sides (AUST R 351832).

Available in strip pack of 10 tablets.

APX-AMOXICILLIN/CLAVULANIC ACID 875/125 is a white to pale yellow, oblong biconvex, film-coated tablet, scored on both sides (AUST R 351833).

Available in strip pack of 10 tablets.

Who distributes APX-AMOXICILLIN/CLAVULANIC ACID

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

This leaflet was prepared in June 2024.

Published by MIMS August 2024

BRAND INFORMATION

Brand name

APX-Amoxicillin/Clavulanic Acid

Active ingredient

Amoxicillin; Clavulanic acid

Schedule

S4

 

1 Name of Medicine

Amoxicillin trihydrate and potassium clavulanate.

2 Qualitative and Quantitative Composition

APX-Amoxicillin/Clavulanic Acid 500/125 and APX-Amoxicillin/Clavulanic Acid 875/125 tablet preparations are a combination products containing amoxicillin trihydrate and potassium clavulanate.
APX-Amoxicillin/Clavulanic Acid 500/125 tablets contain amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium clavulanate) 125 mg.
APX-Amoxicillin/Clavulanic Acid 875/125 tablets contain amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium clavulanate) 125 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APX-Amoxicillin/Clavulanic Acid 500/125 tablets: Off-white, oval, biconvex, film-coated and scored on both sides.
APX-Amoxicillin/Clavulanic Acid 875/125 tablets: White to pale yellow, oblong, biconvex, film-coated and scored on both sides.

4 Clinical Particulars

4.1 Therapeutic Indications

Short-term treatment of bacterial infections at the following sites when caused by amoxicillin/clavulanic acid sensitive, beta-lactamase producing organisms:
Skin and skin structure infections.
Urinary tract infections (complicated and uncomplicated).
Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis.
Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis.
Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin/clavulanic acid tablet preparations. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate.
The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

4.2 Dose and Method of Administration

Dosage.

Adults.

The usual adult dose is one APX-Amoxicillin/Clavulanic Acid 500/125 tablet every 12 hours.
For more severe infections, the dose should be one APX-Amoxicillin/Clavulanic Acid 875/125 tablet every 12 hours.

Note.

Although the proportion of amoxicillin increases with increasing strength of amoxicillin/clavulanic acid tablet preparations, the amount of clavulanic acid remains the same. Therefore, the tablets are not directly substitutable.
Treatment should usually be continued for 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. Treatment should not exceed 14 days without review.

Method of administration.

Amoxicillin/clavulanic acid tablet preparations should be taken immediately before or with the first mouthful of food, to minimise potential gastrointestinal intolerance and to optimise absorption.

Dosage adjustment.

Renal impairment. APX-Amoxicillin/Clavulanic Acid 875/125 tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance less than or equal to 30 mL/minute).
Both amoxicillin and clavulanic acid are excreted by the kidneys and the serum half-life increases in patients with renal failure. No adjustment to the initial dose is necessary, but the dosing interval should be extended according to the degree of renal impairment. The following schedule is proposed for amoxicillin/clavulanic acid tablets preparations:

Mild impairment (creatinine clearance > 30 mL/minute).

No change in dosage.

Moderate impairment (creatinine clearance 10 to 30 mL/minute).

APX-Amoxicillin/Clavulanic Acid 500/125 - one tablet, 12-hourly only.

Severe impairment (creatinine clearance < 10 mL/minute).

APX-Amoxicillin/Clavulanic Acid 500/125 - one tablet every 24 hours.
Haemodialysis decreases serum concentrations of both amoxicillin and clavulanic acid and an additional dose should be administered at the end of dialysis.
Hepatic impairment. Data are currently insufficient for a dosage recommendation. Dose with caution, and monitor hepatic function at regular intervals.
Children. Children weighing 40 kg and more should be dosed according to the adult recommendations.
Treatment should usually be continued for 48 to 72 hours beyond the time that the child becomes asymptomatic or evidence of bacterial eradication has been obtained. Treatment should not exceed ten days except for lower respiratory tract infection due to H. influenzae where treatment may be extended up to 14 days.
Children weighing less than 40 kg should not use amoxicillin/clavulanic acid tablet preparations.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.
History of allergic reactions to beta-lactams, e.g. penicillins, cephalosporins, carbapenems or monobactams.
Previous history of amoxicillin/clavulanic acid associated jaundice/hepatic dysfunction.

4.4 Special Warnings and Precautions for Use

Hypersensitivity reactions.

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to amoxicillin or clavulanic acid (see Section 4.8 Adverse Effects (Undesirable Effects)). If an allergic reaction occurs, amoxicillin/clavulanic acid should be discontinued and the appropriate therapy instituted. Serious anaphylactoid 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/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 administration of amoxicillin/clavulanate) 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.

Pseudomembranous colitis.

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 antibiotic agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement therapy 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.

General.

As with any potent drug, periodic assessment of organ system functions, including renal, hepatic and haematopoietic function, is advisable during prolonged therapy.
Since amoxicillin/clavulanic acid tablet preparations contain amoxicillin, an aminopenicillin, it 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/clavulanic acid should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxicillin induced skin rashes.
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.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin/clavulanic acid 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.
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.
Cholestatic hepatitis, which may be severe but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent until several weeks after treatment has ceased. In most cases, resolution has occurred with time. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications.
Hepatic events subsequent to amoxicillin/clavulanic acid therapy have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. Hepatitis and cholestatic jaundice have also been reported rarely. These events have been noted with other penicillins and cephalosporins.

Use in hepatic impairment.

Amoxicillin/clavulanic acid should be used with care in patients with evidence of hepatic dysfunction.
Data is currently insufficient for a dosage recommendation. Dose with caution, and monitor hepatic function at regular intervals.

Use in renal impairment.

APX-Amoxicillin/Clavulanic Acid 875/125 tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance less than or equal to 30 mL/minute). APX-Amoxicillin/Clavulanic Acid 500/125 should be used with care in patients with moderate or severe renal impairment. The dosage of APX-Amoxicillin/Clavulanic Acid 500/125 should be adjusted as recommended in Section 4.2 Dose and Method of Administration.
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
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 (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.9 Overdose).

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

Oral administration of amoxicillin/clavulanic acid will result in high urine concentrations of amoxicillin. Since high urine concentrations of ampicillin may result in false positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict's solution or Fehling's solution, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Testape) be used.
The presence of clavulanic acid in amoxicillin/clavulanic acid tablets may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.
There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving amoxicillin/clavulanic acid who were subsequently found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and confirmed by other diagnostic methods.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol glucuronide, conjugated estrone and estradiol has been noted. This effect may also occur with amoxicillin and therefore amoxicillin/clavulanic acid tablet preparations.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid decreases the renal tubular secretion of amoxicillin but does not affect clavulanic acid excretion. Concurrent use with amoxicillin/clavulanic acid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.
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. There are no data with amoxicillin/clavulanic acid and allopurinol administered concurrently.
No information is available about the concurrent use of amoxicillin/clavulanic acid and alcohol.
However, the ingestion of alcohol whilst being treated with some other beta-lactam antibiotics has precipitated a disulfiram (Antabuse) like reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with amoxicillin/clavulanic acid tablets.
In common with other antibiotics, amoxicillin/clavulanic acid may affect the gut flora, leading to lower estrogen re-absorption and reduced efficacy of combined oral contraceptives. Patients should be warned accordingly.
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.
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid (MPA) has been reported following commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not accurately represent changes in overall MPA exposure. However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Amoxicillin/clavulanic acid at oral doses of up to 1200 mg/kg/day had no effect on fertility and reproductive performance in rats dosed with a 2:1 ratio formulation of amoxicillin and clavulanate.
(Category B1)
Animal studies with orally and parenterally administered amoxicillin/clavulanic acid have shown no teratogenic effects. There is limited experience of the use of amoxicillin/clavulanic acid in human pregnancy. In women with preterm, premature rupture of the foetal membrane (pPROM), prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the doctor.

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/clavulanic acid in humans during labour or delivery has 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 infant will be necessary.
 Both amoxicillin and clavulanic acid are excreted into breast milk. Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breastfed infant. The possibility of sensitisation should be taken into account. Therefore, caution should be exercised when amoxicillin/clavulanic acid is given to a breastfeeding woman.

4.7 Effects on Ability to Drive and Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

Amoxicillin/clavulanic acid is generally well tolerated. The majority of events were of a mild and transient nature.

Clinical trials.

Amoxicillin/clavulanic acid 875 mg/125 mg tablets.

The most frequently reported adverse events related or possibly related to amoxicillin/clavulanic acid 875 mg/125 mg tablets were diarrhoea (14.9%), nausea (7.9%), headache (6.8%), abdominal pain (4.5%), vomiting (3.8%), genital moniliasis (3.6%) and vaginitis (3.4%). The following adverse events have been observed during clinical trials with the amoxicillin/clavulanic acid 875 mg/125 mg tablets twice daily regimen, however it should be noted that causality has not necessarily been established for these events. See Table 1.

Amoxicillin/clavulanic acid 500 mg/125 mg and amoxicillin/clavulanic acid 250 mg/125 mg tablets.

In clinical trials with the 250 mg/125 mg and 500 mg/125 mg strengths, the overall incidence of adverse effects, of suspected or unknown relationship to the drug, varied between 16 and 23.3%, depending on the dose. The majority of side effects observed were of a mild and transient nature, but therapy was discontinued because of drug related side effects in 4.2% of cases at the low dose (amoxicillin/clavulanic acid 250 mg/125 mg tablets three times daily) and 7% of cases at the high dose (amoxicillin/clavulanic acid 500 mg/125 mg tablets three times daily). The most frequently reported adverse effects were diarrhoea (6%), nausea (2%), vomiting (1%), abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness, and hot flushes. The incidence and severity of adverse effects, particularly nausea and diarrhoea, increased with the higher recommended dose.
In recent trials with amoxicillin/clavulanic acid 500 mg/125 mg tablets, the most frequently reported adverse events related or possibly related to treatment were diarrhoea (12.8%), nausea (5.2%), headache (4.8%), abdominal pain (4.5%).
The following adverse events have been observed during clinical trials with the amoxicillin/clavulanic acid 500 mg/125 mg tablets, however it should be noted that causality has not necessarily been established for these events. See Table 2.

Post-marketing.

The following adverse reactions have been reported for ampicillin class antibiotics and may occur with amoxicillin/clavulanic acid tablet preparations.
Very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1,000 and < 1/100; rare: ≥ 1/10,000 and < 1/1,000; very rare: < 1/10,000; not known: cannot be estimated from the available data.

Infections and infestations.

Common: mucocutaneous candidiasis.
Not known: overgrowth of non-susceptible organism.

Cardiac disorders.

Not known: Kounis syndrome (see Section 4.4 Special Warnings and Precautions for Use).

Gastrointestinal disorders.

Very common: diarrhoea.
Common: nausea, vomiting.
Uncommon: indigestion.
Rare: gastritis, stomatitis, glossitis, black 'hairy' tongue, enterocolitis, antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis) (see Section 4.4 Special Warnings and Precautions for Use).
Not known: drug-induced enterocolitis syndrome, pancreatitis acute.

Hepatobiliary.

Uncommon: moderate rise in AST and/or ALT.
Rare: hepatitis, cholestatic jaundice, which may be severe but is usually reversible.

Nervous system disorders.

Uncommon: dizziness, headache.
Very rare: reversible hyperactivity, convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Not known: aseptic meningitis.

Haemopoietic and lymphatic systems.

Uncommon: thrombocytosis.
Rare: anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, reversible leucopenia (including neutropenia or agranulocytosis); these are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena; prolongation of bleeding time and prothrombin time.
Not known: haemolytic anaemia.

Hypersensitivity and skin.

Common: skin rashes, pruritus, urticaria.
Rare: angioneurotic oedema, anaphylaxis, serum sickness like syndrome, erythema multiforme, Stevens-Johnson syndrome, hypersensitivity, vasculitis, toxic epidermal necrolysis, bullous exfoliative dermatitis and acute generalised 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 rarely. Whenever such reactions occur, amoxicillin/clavulanic acid tablets should be discontinued, unless in the opinion of the doctor, no alternative treatment is available and continued therapy is considered essential. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillins (see Section 4.4 Special Warnings and Precautions for Use).
Not known: linear IgA disease.

Renal and urinary tract disorders.

Rare: interstitial nephritis.
Not known: crystalluria (including acute renal injury) (see Section 4.9 Overdose).

Miscellaneous.

Rare: superficial tooth discolouration, which 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 www.tga.gov.au/reporting-problems.

4.9 Overdose

Serious and severe clinical symptoms are unlikely to occur after overdosage with amoxicillin/clavulanic acid. If encountered, 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.
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin may 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.

Amoxicillin/clavulanic acid preparations are a combination products containing the semisynthetic antibiotic amoxicillin (as the trihydrate) and the beta-lactamase inhibitor potassium clavulanate (as the potassium salt of clavulanic acid).
Microbiology. Like other penicillins, amoxicillin has a bactericidal effect on sensitive organisms during the stage of active multiplication. However, amoxicillin is susceptible to hydrolysis by beta-lactamases and the addition of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms normally resistant to amoxicillin due to beta-lactamase production. In vitro studies have demonstrated the susceptibility of most strains of the following organisms. (See Table 3 to Table 6.)
Susceptibility testing.

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 used 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 solutions 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 concentration 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.

Amoxicillin/clavulanic acid 875 mg/125 mg tablets twice daily versus amoxicillin/clavulanic acid 500 mg/125 mg tablets three times daily.

Three studies in 1,361 patients treated for 7 to 14 days for either lower respiratory tract infections, upper respiratory infections or complicated urinary tract infections compared a regimen of amoxicillin/clavulanic acid 875 mg/125 mg tablets every 12 hours to amoxicillin/clavulanic acid 500 mg/125 mg tablets dosed every eight hours (584, 170 and 607 patients respectively). Comparable efficacy was demonstrated between the 12 hourly and eight hourly dosing regimens.
There was no significant difference in the percentage of adverse events in each group. The most frequently reported adverse event in two of the studies was diarrhoea; incidence rates were similar for the 875 mg/125 mg tablets every 12 hours and 500 mg/125 mg tablets every eight hours dosing regimens (14.9 and 14.3%, respectively). However, there was a statistically significant difference (p < 0.05) in rates of severe diarrhoea or withdrawals with diarrhoea between the regimens: 1.0% for 875 mg/125 mg 12 hourly dosing versus 2.5% for the 500 mg/125 mg eight hourly dosing. In the third study, the most frequently reported adverse event was headache with an incidence of 5.7% (amoxicillin/clavulanic acid 500 mg/125 mg tablets every eight hours) versus 8.3% (amoxicillin/clavulanic 875 mg/125 mg tablets every 12 hours).
As noted previously, although there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhoea or diarrhoea-related withdrawals between the regimens.

Amoxicillin/clavulanic acid 500 mg/125 mg tablets twice daily versus amoxicillin/clavulanic acid 250 mg/125 mg tablets three times daily.

Two studies in 908 patients treated for between five and ten days for either uncomplicated skin and skin structure infections (SSSI) or acute exacerbation of chronic bronchitis (AECB) compared a regimen of amoxicillin/clavulanic acid 500 mg/125 mg tablets every 12 hours with amoxicillin/clavulanic acid 250 mg/125 mg tablets every eight hours. Comparable efficacy was demonstrated between the 12 hourly and eight hourly dosing regimens.
There was no significant difference in the percentage of adverse events in each group, with the most frequently reported adverse event in the two studies being diarrhoea.
The clinical efficacy of amoxicillin/clavulanic acid 250 mg/125 mg tablets given in a twice daily versus three times daily regimen have been shown to be comparable in AECB and SSSI, despite the differences in some pharmacokinetic parameters.
Given the similar TMIC and the demonstration of equivalence between AECB and SSSI, it would be reasonable to extrapolate to the remaining indications. Clinical safety and efficacy in other indications have been investigated; however, these supportive studies were not sufficiently designed to demonstrate the relative efficacy of the twice daily versus three times daily dosage regimens, or compared the proposed regimen with other treatments.

5.2 Pharmacokinetic Properties

Absorption.

Amoxicillin/clavulanic acid tablet preparations are stable in the presence of gastric acid. Their two components are rapidly absorbed if administered before or with a meal, but if given after meals, the serum levels of clavulanic acid are significantly reduced. To optimise absorption of clavulanic acid, amoxicillin/clavulanic acid tablet preparations should be administered at the start of a meal. The pharmacokinetics of amoxicillin are not affected by food.
Oral administration at the start of a light meal of amoxicillin/clavulanic acid 875 mg/125 mg tablets every 12 hours was compared with amoxicillin/clavulanic acid 500 mg/125 mg tablets every eight hours.
The following mean pharmacokinetic parameters (see Table 7 and Table 8) were observed for amoxicillin and clavulanic acid following administration of amoxicillin/clavulanic acid 875 mg/125 mg tablets every 12 hours and amoxicillin/clavulanic acid 500 mg/125 mg tablets every eight hours:
The half-life and Cmax for clavulanate for amoxicillin/clavulanic acid 875 mg/125 mg tablets were not significantly different from amoxicillin/clavulanic acid 500 mg/125 mg tablets. However, the AUC(0-24 hours) was reduced, as would be expected with the lower daily dose of clavulanate, i.e. twice daily dose (125 x 2 mg of clavulanate) versus three times daily dose (125 x 3 mg of clavulanate).
Oral administration of amoxicillin/clavulanic acid 500 mg/125 mg tablets every 12 hours was compared with amoxicillin/clavulanic acid 250 mg/125 mg tablets every eight hours at the start of a light meal. The following mean pharmacokinetic parameters were observed (see Table 9 and Table 10).

Distribution.

Following oral administration, both amoxicillin and clavulanic acid have been shown to diffuse in significant concentrations into pus, bile, pleural, synovial and peritoneal fluids. Both penetrate poorly into the cerebrospinal fluid (CSF) when the meninges are normal. Amoxicillin penetrates into the CSF better through inflamed meninges but the maximum concentrations are still much lower than the peak serum levels. There are no data at present on the CSF penetration of clavulanic acid in patients with meningeal inflammation.
Neither amoxicillin nor clavulanic acid is highly protein bound. Clavulanic acid has been variously reported to be bound to human serum in the range of 9 to 30% and amoxicillin approximately 20%. From animal studies, there is no evidence to suggest either component accumulates in any organ.

Metabolism.

2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid is the major metabolite.

Excretion.

As with other penicillins, renal excretion is the major route of amoxicillin clearance, while clavulanate elimination is via both renal and non-renal mechanisms. Approximately 70% of the dose of amoxicillin is excreted in urine as amoxicillin.
For clavulanic acid, following the administration of 125 mg of radiolabelled potassium clavulanate orally to normal volunteers, 68% of the administered radioactivity was recovered in the urine in 24 hours. Of this, 34% (i.e. 23% of the administered dose) is present as unchanged clavulanic acid. 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid (the major metabolite) and 1-amino-4-hydroxy-butan-2-one accounted for a further 23 and 12% (i.e. 16 and 8%, respectively, of the administered dose). Small amounts of other yet unidentified metabolites were also present.
Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.

5.3 Preclinical Safety Data

Genotoxicity.

The genotoxic potential of amoxicillin/clavulanic acid was investigated in assays for chromosomal damage (mouse micronucleus test and a dominant lethal test) and gene conversion. All were negative.

Carcinogenicity.

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Magnesium stearate, purified talc, povidone, croscarmellose sodium, microcrystalline cellulose, triethyl citrate, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, hypromellose and titanium dioxide.
Amoxicillin/clavulanic acid 875/125 mg tablets also contain silicon dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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.

6.5 Nature and Contents of Container

APX-Amoxicillin/Clavulanic Acid 500/125 tablets are available in aluminium/aluminium strip packs x 10 tablets (AUST R 351832).
APX-Amoxicillin/Clavulanic Acid 875/125 tablets are available in aluminium/aluminium strip packs x 10 tablets (AUST R 351833).
Not all presentations may be marketed in Australia.

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 trihydrate.

Amoxicillin trihydrate is white to almost white, crystalline powder, slightly soluble in water and in alcohol, practically insoluble in ether and in fatty oils. It dissolves in dilute acids and dilute solutions of alkali hydroxides.

Chemical structure.


Chemical name: (2S, 5R, 6R)-6-[(R)-2-amino-2-(4-hydroxyphenyl) acetamido]-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.

Potassium clavulanate.

Potassium clavulanate is white to almost white, crystalline powder, hygroscopic, freely soluble in water, slightly soluble in alcohol, and very slightly soluble in acetone.

Chemical structure.


Chemical name: Potassium (Z)-(2R, 5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate.
Molecular formula: C8H8KNO5.
Molecular weight: 237.3.

CAS number.

Amoxicillin trihydrate.

61336-70-7.

Potassium clavulanate.

61177-45-5.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes