Consumer medicine information

1 Name of Medicine

Amoxicillin sodium and potassium clavulanate.

2 Qualitative and Quantitative Composition

Amoxiclav Juno 500/100. Amoxiclav Juno 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.
Amoxiclav Juno 1000/200. Amoxiclav Juno 1000/200 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 1 g 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.
Amoxiclav Juno 2000/200. Amoxiclav Juno 2000/200 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 2 g 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.
Amoxiclav Juno contains no other excipients.

3 Pharmaceutical Form

Amoxiclav Juno 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 Poisons Information Centre on 13 11 26 (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 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. 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.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXSO.gif CAS number. 34642-77-8.
Molecular weight. 387.4.
Molecular formula. C₁₆H₁₈N₃NaO₅S.
Potassium clavulanate. Chemical name. Potassium Z-(2R,5R)-3-(2- hydroxyethylidene) 7-oxo-4- oxa-1-azabicyclo[3.2.0] heptane-2-carboxylate.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPOTCLA.gif CAS number. 61177-45-5.
Molecular weight. 237.25.
Molecular formula. C₈H₈KNO₅.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes

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