Consumer medicine information

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.

5. What should I know while using Curam?

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.

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

4.9 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

5.3 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. Carcinogenicity studies have not been conducted with amoxicillin/clavulanic acid or its components.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Amoxicillin sodium. Amoxicillin sodium is designated chemically as sodium (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylate. Its empirical formula is C₁₆H₁₈N₃NaO₅S (MW: 387.4).
Chemical structure. Its chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXSO.gif CAS number. 34642-77-8.
Potassium clavulanate. Potassium clavulanate is chemically designated as potassium (2R,3Z,5R)-3-(2- hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate. Its empirical formula is C₈H₈KNO₅ (MW: 237.3).
Chemical structure. Its chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPOTCLA.gif CAS number. 61177-45-5.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CURAMIST.gif