SUMMARY CMI

CURAM^® Powder for injection

Consumer Medicine Information (CMI) summary

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

1. Why am I using Curam?

Curam contains two active ingredients. One of these is a penicillin called amoxicillin and the other is clavulanic acid. Curam is used to treat a wide range of infections caused by bacteria.

For more information, see Section 1. Why am I using Curam? in the full CMI.

2. What should I know before I use Curam?

Do not use if you have ever had an allergic reaction to penicillins and cephalosporins or 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 use Curam? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Curam and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Curam?

• Curam 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 do I use Curam? in the full CMI.

5. What should I know while using Curam?

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

6. Are there any side effects?

Side effects include headache, nausea, vomiting, diarrhoea, indigestion, dizziness, soreness of the mouth or tongue, and overgrowth of yeast infections(thrush). Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Curam: 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.

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

CURAM^® Powder for injection

Active ingredient(s): amoxicillin and clavulanic acid

Consumer Medicine Information (CMI)

This leaflet provides important information about using Curam. 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 Curam.

Where to find information in this leaflet:

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

1. Why am I using Curam?

Curam contains two active ingredients. One of these is a penicillin called amoxicillin and the other is clavulanic acid. Curam injection belongs to the penicillin group of antibiotics.

Curam is used to treat a wide range of infections caused by bacteria. These infections may affect the respiratory tract (bronchitis, pneumonia, tonsillitis, sinusitis), genito-urinary tract (cystitis, urethritis, pyelonephritis, gonorrhoea), gastrointestinal tract (peritonitis, intra-abdominal sepsis) the ears (otitis media) and the skin. This product can also be used to prevent infections in major surgical procedures.

Amoxicillin/ clavulanic acid injection works by killing the bacteria that cause these infections. This medicine will not work against infections caused by viruses such as colds or the flu.

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 use Curam?

Warnings

Do not use Curam if:

• you are allergic to penicillins and cephalosporins or clavulanic acid.
• you have a previous history of amoxicillin/ clavulanic acid associated jaundice / hepatic dysfunction.
• you have had an allergic reaction to cephalosporin antibiotics. You may have an increased chance of being allergic to Curam if you are allergic to cephalosporins.
• the packaging is torn or shows signs of tampering.
• 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.

Talk to your doctor if you are unsure whether you have any of the conditions listed above.

Do not use Curam if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaint unless your doctor says it is safe. Do not give this medicine to anyone else.

Check with your doctor if you:

• have any type of allergic reaction to penicillin, amoxicillin or cephalosporin antibiotics. You may have an increased chance of being allergic to Curam if you are allergic to cephalosporins.
• you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
• you have any other medical conditions, including:
  - asthma, hayfever or hives
  - kidney problems
  - glandular fever (infectious mononucleosis)
• you 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 Curam during pregnancy.

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

Your doctor will discuss the possible risks and benefits of taking / using Curam while breastfeeding.

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 Curam. 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 eg. condoms
• other antibiotics such as tetracyclines, erythromycin, chloramphenicol and gentamicin
• anticoagulants (used to prevent blood clots) such as warfarin
• 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 Curam
• methotrexate, a medicine used to treat cancer and severe psoriasis

These medicines may be affected by Curam, 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 Curam.

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

4. How do I use Curam?

How Curam is given

• Amoxicillin/ clavulanic acid may be administered either by slow intravenous injection over a period of 3 to 4 min 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 amoxicillin/ clavulanic acid by infusion only.
• Curam injection should be reconstituted with water for injection before use.
• Treatment with amoxicillin/ clavulanic acid may be initiated by the use of an intravenous preparation and completed with an appropriate oral presentation as will be considered appropriate for you.

When to take Curam

• Curam 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.

If you use too much Curam

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

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

You should immediately:

• phone the Australian Poisons Information Centre
  (by calling 13 11 26), or the New Zealand National Poisons Information Centre (by calling 0800 POISONS or 0800 764 766), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

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

5. What should I know while using Curam?

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 become pregnant while you are receiving Curam, tell your doctor.

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

If you have to have any blood or urine tests, tell your doctor you are being given Curam. 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 Curam. Do not have any more and tell your doctor immediately.
• get severe diarrhoea. Do this even if it occurs several weeks after Curam has been stopped.

Remind any doctor, dentist or pharmacist you visit that you are being treated with Curam.

Drinking alcohol

Tell your doctor if you drink alcohol.

Avoid alcohol during and for several days after treatment.

Looking after your medicine

• Curam should be stored below 25°C.
• It should be used immediately after reconstitution.
• If storage is required, it may be stored at 5°C.
  - 3 hours at 20-25°C: Ringers Solution, Hartmann's Solution; Ringer-Lactate Solution, Potassium Chloride and Sodium Intravenous Infusion B.P
  - 4 hours at 20-25°C: Sodium Lactate Intravenous Infusion, Sodium Chloride Intravenous Infusion B.P. 0.9% (w/v), Water sterile for injection
  - 8 hours at 2-8°C: Water sterile for injection, Sodium Chloride Intravenous Infusion B.P. 0.9% (w/v)

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

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 Curam:

• 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 or to Medsafe at pophealth.my.site.com/carmreportnz/s/. 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 Curam contains

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

What Curam looks like

Curam 500/100 Powder for Injection: sterile white to off-white powder providing amoxicillin sodium equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg clavulanic acid (Aust R 289317).

Curam 1000/200 Powder for Injection: sterile white to offwhite powder providing amoxicillin sodium equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg clavulanic acid (Aust R 289316).

Curam 2000/200 Powder for Injection: sterile white to offwhite powder providing amoxicillin sodium equivalent to 2000 mg amoxicillin and potassium clavulanate equivalent to 200 mg clavulanic acid (Aust R 289315).

Who distributes Curam

Australia

Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia

Tel 1800 726 369

New Zealand

Sandoz New Zealand Limited
12 Madden Street
Auckland 1010
New Zealand

Tel: 0800 726 369

This leaflet was prepared in June 2024.

^® Registered trademark. The trademarks mentioned in this material are the property of their respective owners.

Published by MIMS August 2024

1 Name of Medicine

Amoxicillin sodium/potassium clavulanate.

2 Qualitative and Quantitative Composition

Curam 500/100 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg clavulanic acid. Each vial contains 0.5 mmol (19.6 mg) of potassium and 1.4 mmol (31.4 mg) of sodium.
Curam 1000/200 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg clavulanic acid. Each vial contains 1.0 mmol (39.3 mg) of potassium and 2.7 mmol (62.9 mg) of sodium.
Curam 2000/200 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 2000 mg amoxicillin and potassium clavulanate equivalent to 200 mg clavulanic acid. Each vial contains 1.0 mmol (39.3 mg) of potassium and 5.5 mmol (125.9 mg) of sodium.
Curam 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 is a white or almost white, crystalline powder, very hygroscopic, very soluble in water. A 1% solution in water has a pH of 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.
Curam contains no other excipients.

3 Pharmaceutical Form

Curam 500 mg/100 mg, 1000 mg/200 mg and 2000 mg/200 mg powder for injection consists of vials of sterile white to off-white powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Curam 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 Curam treatment due to its amoxicillin content. Infections caused by β-lactamase producing amoxicillin resistant organisms are also amenable to Curam due to its clavulanic acid content.
Susceptibility to Curam 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.
Curam 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.
Curam 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.

Method of administration.

Dosage adjustment.

Adults.

Adults and children 40 kg and over.

Children under 40 kg.

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

No data available.

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: drug dependency, addiction and recreational abuse have not been reported as a problem with this compound.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

Mechanisms of resistance.

Susceptibility testing, dilution or diffusion techniques.

Clinical trial.

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

Amoxicillin/clavulanic acid is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solution should therefore not be added to such infusions but may be injected into the drip tubing over a period of 3-4 minutes.
Amoxicillin/clavulanic acid intravenous should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates or with intravenous lipid emulsions.
For information on interactions with other medicines and other forms of interactions, see Section 4.5.

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.

6.5 Nature and Contents of Container

Curam 500 mg/100 mg, 1000 mg/200 mg and 2000 mg/200 mg powder for injection is presented in single dose, type II colourless glass vials with a nominal capacity of 20 mL closed with rubber stopper and a flip-off cap.

500 mg/100 mg powder for injection.

1000 mg/200 mg powder for injection.

2000 mg/200 mg powder for injection.

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.

Chemical structure.

CAS number.

Potassium clavulanate.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes