Consumer medicine information

Amoxicillin-WGR 250 mg/5 mL Powder for oral suspension

Amoxicillin

BRAND INFORMATION

Brand name

Amoxicillin-WGR Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

1. Why am I taking AMOXICILLIN-WGR?


AMOXICILLIN-WGR contains the active ingredient amoxicillin (as trihydrate). AMOXICILLIN-WGR is used to treat infections in different parts of the body caused by bacteria.
For more information, see Section 1. Why am I taking AMOXICILLIN-WGR? in the full CMI.

2. What should I know before I take AMOXICILLIN-WGR?


Do not take if you have ever had an allergic reaction to AMOXICILLIN-WGR 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 AMOXICILLIN-WGR? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with AMOXICILLIN-WGR 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 AMOXICILLIN-WGR?

  • Follow the instructions provided when AMOXICILLIN-WGR is prescribed, including the number of days it should be taken. AMOXICILLIN-WGR can be taken with or without food.
  • Shake the AMOXICILLIN-WGR Suspension in the bottle well, before measuring out the dose in a suitable measure. Make sure that the whole dose is swallowed each time.

More instructions can be found in Section 4. How do I take AMOXICILLIN-WGR? in the full CMI.

5. What should I know while taking AMOXICILLIN-WGR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking AMOXICILLIN-WGR.
  • Tell your doctor if the symptoms of your infection do not improve within a few days, or if they become worse.
  • Tell your doctor if you develop itching with swelling or skin rash, difficulty breathing, severe diarrhoea or sore white mouth or tongue.
Things you should not do
  • Do not stop taking AMOXICILLIN-WGR, or change the dosage, without checking with your doctor.
  • Do not give AMOXICILLIN-WGR to anyone else, even if their symptoms seem similar to yours.
  • Do not take AMOXICILLIN-WGR to treat any other complaints unless your doctor or pharmacist tells you to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how AMOXICILLIN-WGR affects you.
Looking after your medicine
  • Keep AMOXICILLIN-WGR in its original packaging until it is time to take it.
  • Keep AMOXICILLIN-WGR Dry powder in a cool dry place where the temperature will stay below 25°C. Protect it from moisture.
  • Keep the reconstituted AMOXICILLIN-WGR Suspension in refrigerator (2 to 8°C), do not freeze it. Use it within 14 days. Unused suspension must be discarded after 14 days.

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

6. Are there any side effects?


Less serious side effects are nausea (feeling sick), indigestion, vomiting, oral thrush - white and sore tongue and mouth, vaginal thrush - sore and itchy vagina and/or discharge, teeth discolouration.
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.

BRAND INFORMATION

Brand name

Amoxicillin-WGR Powder for Suspension

Active ingredient

Amoxicillin

Schedule

S4

1 Name of Medicine

Amoxicillin (as amoxicillin trihydrate).

2 Qualitative and Quantitative Composition

Each 5 mL contains 125 mg or 250 mg amoxicillin (as trihydrate).
Excipients with known effect. Saccharin, sodium, sorbitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Amoxicillin-WGR Powder for Suspension 125 mg/5 mL. White to off-white powder forming an orange suspension upon reconstitution with water.
Amoxicillin-WGR Powder for Suspension 250 mg/5 mL. White to off-white powder forming an orange suspension upon reconstitution with water.

4 Clinical Particulars

4.9 Overdose

Symptoms. Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident.
Treatment. Symptoms of water/electrolyte imbalance should be treated symptomatically. During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin can 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

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Amoxicillin trihydrate is a white or almost white, crystalline powder, slightly soluble in water and in alcohol.
Amoxicillin trihydrate is a semisynthetic antibiotic and is a member of the penicillinase-stable group of penicillins derived from the penicillin nucleus, 6-aminopenicillanic acid, isolated at Beecham Research Laboratories.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXTR.gif Chemical name: (2S,5R,6R)-6-[[(2R)-2- amino-2-(4-hydroxyphenyl) acetyl]amino]-3,3dimethyl- 7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate.
Molecular formula: C16H19N3O5S.3H2O.
Molecular weight: 419.4.
CAS number. 61336-70-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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