Consumer medicine information

1. Why am I using APO-AMOXY/CLAV?

APO-AMOXY/CLAV 500/125 or APO-AMOXY/CLAV 875/125 contain the active ingredients amoxicillin and clavulanic acid and are used for the short term treatment of a wide range of infections caused by bacteria. For more information, see Section 1. Why am I using APO-AMOXY/CLAV 500/125 or APO-AMOXY/CLAV 875/125? in the full CMI.

2. What should I know before I use APO-AMOXY/CLAV?

Do not use 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 use APO-AMOXY/CLAV 500/125 or APO-AMOXY/CLAV 875/125? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-AMOXY/CLAV 500/125 or APO-AMOXY/CLAV 875/125 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 APO-AMOXY/CLAV?

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 use APO-AMOXY/CLAV 500/125 or APO-AMOXY/CLAV 875/125? in the full CMI.

5. What should I know while using APO-AMOXY/CLAV?

6. Are there any side effects?

Common side effects include nausea, vomiting, pruritis or urticaria. Serious side effects include 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 or allergic reactions. All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them.
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.

Notes

Distributed by Arrotex Pharmaceuticals Pty Ltd

1 Name of Medicine

Amoxicillin trihydrate and potassium clavulanate.

2 Qualitative and Quantitative Composition

APO‐Amoxy/Clav 500/125 and APO‐Amoxy/Clav 875/125 tablets (amoxicillin and clavulanic acid tablets) are combination products containing the semisynthetic antibiotic, amoxicillin (as the trihydrate) and the β-lactamase inhibitor, potassium clavulanate (as the potassium salt of clavulanic acid).
Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
Each film coated tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO‐Amoxy/Clav 500/125 Tablets. A white, oval shaped, film coated tablet with marking "CA625" on one side.
APO‐Amoxy/Clav 875/125 Tablets. A white elongated capsule shaped film coated tablet.

4 Clinical Particulars

4.9 Overdose

Serious and severe clinical symptoms are unlikely to occur after overdosage with amoxicillin and clavulanic acid tablets. 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.
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.
Contact the Poisons Information Centre (telephone 13 11 26) for advice on overdose management.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of amoxicillin/clavulanic acid was investigated in assays for chromosomal damage (mouse micronuclucleus 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 or mutagenic potential.

6 Pharmaceutical Particulars

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. It has a pKa of 2.8 and 7.2, with a partition coefficient of -2.69.
Chemical structure. Chemically, amoxicillin trihydrate is (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-carboxylic acid trihydrate. It is susceptible to hydrolysis by β-lactamases. Amoxicillin trihydrate may be represented structurally as:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXTR.gif Molecular formula: C₁₆H₁₉N₃O₅S.3H₂O.
Molecular weight: 419.4.
CAS number. 61336-70-7.
Clavulanic acid. Potassium clavulanate is white to almost white, crystalline powder, hygroscopic, freely soluble in water, slightly soluble in alcohol, and very slightly soluble in acetone. The pKa is 2.7, with a partition coefficient of -1.38.
Chemical structure. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is an irreversible inhibitor of many β-lactamase enzymes except type 1 (Richmond). It is a β-lactam compound with only weak antibacterial activity. Chemically, potassium clavulanate is potassium (2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate, and may be represented structurally as:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPOTCLA.gif Molecular formula: C₈H₈KNO₅.
Molecular weight: 237.3.
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/APOAMOST.gif