Consumer medicine information

Ibimicyn 500 mg Powder for injection

Ampicillin

BRAND INFORMATION

Brand name

Ibimicyn

Active ingredient

Ampicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ibimicyn 500 mg Powder for injection.

1. Why am I using IBIMICYN?


IBIMICYN contains the active ingredient ampicillin (as sodium). IBIMICYN is used to treat infections in different parts of the body caused by bacteria.
For more information, see Section 1. Why am I using IBIMICYN? in the full CMI.

2. What should I know before I use IBIMICYN?


Do not use if you have ever had an allergic reaction to IBIMICYN 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 IBIMICYN? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with IBIMICYN 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 IBIMICYN?

  • IBIMICYN must only be given by a doctor or nurse.

More instructions can be found in Section 4. How do I use IBIMICYN? in the full CMI.

5. What should I know while using IBIMICYN?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using IBIMICYN.
  • If you develop itching with swelling or skin rash or difficulty breathing after you have been given IBIMICYN, contact your doctor immediately.
  • If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after IBIMICYN has been stopped.
Driving or using machines
  • Be careful driving or operating machinery until you know how IBIMICYN affects you.
Looking after your medicine
  • IBIMICYN is stored in the pharmacy or on the ward.
  • IBIMICYN is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

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

6. Are there any side effects?


Tell your doctor if you notice any of the following: pain or redness at the site of injection, oral thrush - white, furry, sore tongue and mouth, vaginal thrush - sore and itchy vagina and/or discharge, a mild rash.
Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following: a severe skin reaction, including severe rash or blisters, wheezing, irregular heart beat, feeling faint.
Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after finishing treatment with IBIMICYN: severe abdominal cramps or stomach cramps, fever or watery and severe diarrhoea, which may also be bloody.
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

Ibimicyn

Active ingredient

Ampicillin

Schedule

S4

 

1 Name of Medicine

Ampicillin (as sodium).

2 Qualitative and Quantitative Composition

Ibimicyn is a white to off-white powder contained in a clear glass vial. This product contains no excipients.
It occurs as a white, crystalline powder, odourless; taste bitter, hygroscopic.
It is freely soluble in water, sparingly soluble in acetone and practically insoluble in ether, fatty oils and in liquid paraffin.
Each gram of ampicillin sodium contains approximately 2.7 mmol of sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ampicillin (as sodium), 500 mg powder for injection vial.
Ampicillin (as sodium), 1 g powder for injection vial.

4 Clinical Particulars

4.9 Overdose

Symptoms. The injection of large doses has caused toxicity in patients with impaired kidney function or an impaired blood-brain barrier. Signs and symptoms of ampicillin toxicity may include nausea, vomiting, diarrhoea, electrolyte disturbances, decreased consciousness, muscle fasciculations, seizures, and coma.
Encephalopathy can occur when the ampicillin blood level reaches 800 mg/L. As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of ampicillin in patients with meningitis. This can result in drowsiness, hyper-reflexia, myoclonic twitches, convulsions and coma.
Treatment. There is no specific treatment for Ibimicyn overdosage. Ampicillin is removed by haemodialysis. Patients usually recover as the penicillin blood level decreases.
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. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: (2S, 5R, 6R)-6- [[(2R)-2-amino- 2-phenylacetyl]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/CSAMPSOD.gif CAS number. 69-52-3.
Formula weight: 371.39.
Molecular formula: C16H18N3NaO4S.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes

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