Ibiamox Consumer Medicine Information

amoxicillin as 250 mg, 500 mg and 1000 mg injections

What is in this leaflet

This leaflet answers some common questions about IBIAMOX. IBIAMOX is administered by injection into either a vein or muscle.

This leaflet does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of taking IBIAMOX against the benefits this medicine is expected to have for you.

If someone else is injecting IBIAMOX for you, it is important they read this leaflet carefully and learn to recognise adverse effects this medicine may produce.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine
You may need to read it again.

What IBIAMOX is used for

IBIAMOX is an antibiotic belonging to a group of medicines called penicillins. This medicine works by killing or stopping the growth of bacteria, which cause infection.

It is used to:

  • treat infections caused by a variety of bacteria.
  • prevent blood infection due to procedures such as dental extractions in patients who are at risk of developing endocarditis.
    Endocarditis is inflammation (pain, heat, swelling or redness) of the endocardium, a membrane that covers the inside surface of the heart).

IBIAMOX will not work against infections caused by viruses such as colds or the flu.

IBIAMOX is used to treat only infections that will respond to it. Some infections are resistant to the effects of IBIAMOX.

Your doctor may have prescribed IBIAMOX for another reason.

Ask your doctor if you have any questions about why IBIAMOX has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you inject IBIAMOX

When you must not use it

Do not use IBIAMOX if you have a history of allergic reaction to penicillins, cephalosporins, cephamycins or penicillamine.

Symptoms of an allergic reaction may include:

  • skin rash
  • difficulty breathing
  • hayfever
  • swelling

Do not use IBIAMOX if the packaging is torn or shows signs of tampering.

Do not use IBIAMOX after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.

Before you start using it

Tell your doctor, surgeon, dentist or pharmacist if you are allergic to any other medicines, foods, dyes or preservatives.

Severe allergic reactions require emergency medical treatment.

Caution should be exercised in patients with a history of allergy such as eczema, asthma, hay fever and hives.

Tell your doctor if you are pregnant or intend to become pregnant.
There is insufficient safety information regarding the use of amoxicillin during pregnancy.
Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.

Do not breast feed while using IBIAMOX.
There is a possibility of sensitisation, diarrhoea, thrush, and/or skin rash developing in the infant.

Tell your doctor, surgeon and dentist if you have:

  • received penicillin in the last month.
  • a prosthetic heart valve
  • suffered from endocarditis (inflammation of the endocardium) previously.

Tell your doctor if you suffer from kidney problems.

During prolonged therapy, your doctor should carry out periodic tests to assess kidney and liver function and blood cell formation.

Be aware that superinfections may occur.
This is a new infection resulting from the invasion of bacteria resistant to amoxicillin.
IBIAMOX should be discontinued and another therapy commenced.

Caution should be exercised in patients with glandular fever or lymphatic leukaemia (a type of cancer), as they are more likely to experience skin rashes.

Be aware that IBIAMOX remains in the body longer in newly born babies and the elderly due to incomplete or decreased kidney function.
They are more likely to experience side effects.

IBIAMOX is unlikely to produce an effect on the ability to drive or use machinery, however, care should be taken until you know how this medicine affects you.

There is no evidence this medicine is addictive.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with IBIAMOX.

IBIAMOX injection should not be mixed with blood products or other fluids containing protein nor with intravenous lipid emulsions. Follow the instructions exactly as to how to make up the injection solution.

Amoxicillin may interfere with:

  • probenecid - a medicine used to treat gout (excess uric acid in the blood). Probenecid may increase the concentration of amoxicillin in the body. This interaction is sometimes used to increase the antibacterial effect of amoxicillin.
  • allopurinol - a medicine used to treat gout. Using allopurinol at the same time as amoxicillin may increase the incidence of skin rash.
  • antibiotics such as chloramphenicol, erythromycin, sulfonamides or tetracyclines. These antibiotics may interfere with the effect of penicillins in the treatment of meningitis or other diseases where rapid action is necessary. Simultaneous therapy is best avoided.
  • estrogen containing oral contraceptives - Using IBIAMOX while on contraceptives may decrease the effectiveness of the contraceptive. Use an alternative or additional method of contraception while on a course of IBIAMOX.
  • blood tests - amoxicillin may interfere with some laboratory tests and give incorrect results.

Your doctor and pharmacist may have more information on medicines to be careful with or to avoid while taking this medicine

How to use IBIAMOX injection

You and your caregiver must carefully follow all directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much and when to use IBIAMOX injection

Your doctor will decide the dose by factoring in your medical condition, age and weight.

The usual dose is as follows:

Adult infections: 250 mg every 8 hours or 500 mg every 8 hours for severe infections.

Prevention of endocarditis in adults: 1 g prior to anaesthesia or 15 minutes prior to dental a procedure.

Infections in children under 20 kg: 25 mg per kg every day in equally divided doses every 8 hours or for severe infections 50 mg per kg every day, divided as above, every 8 hours.

Prevention of endocarditis in children under 10 kg: 500 mg prior to anaesthesia or 15 minutes prior to dental a procedure.

You can take this medicine before or after meals.

How to use IBIAMOX injection

Your doctor, nurse, caregiver or yourself will make the IBIAMOX injection with sterile water or another diluent depending on the method of administration. The solutions should be thoroughly mixed by vigorous shaking and checked for the presence of particulate matter before use. A pink colouration may appear during the mixing but will change to a pale straw colour.

Needles for injection are purchased separately.

Follow your doctor's instructions carefully on how to make the injection solution and use the needle safely.

Method of administration

Your doctor, nurse, caregiver or yourself will either inject directly into muscle tissue or they (not yourself) may inject slowly into a vein if an intravenous line (I.V.) exists.

The solution for injection must be used within an hour of being made up.

If pain is experienced during injection into muscle tissue, a sterile solution of 1% lignocaine HCl or 0.5% solution of procaine HCl may be used in place of water to alleviate the pain. Ask your doctor or pharmacist about these options.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and inject your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not inject a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

While you are using IBIAMOX

Things you must do

If you develop a rash, hay fever, breathing difficulties or swelling, stop taking IBIAMOX immediately and seek medical treatment.

If the symptoms of your infection do not improve within days, or they become worse, tell your doctor.

If you become pregnant while you are taking IBIAMOX tell your doctor.

If you are having any blood tests tell your doctor you are using IBIAMOX.

If you are about to start taking a new medicine tell your doctor and pharmacist that you are taking IBIAMOX.

Things you must not do

Do not stop taking IBIAMOX or lower the dosage without checking with your doctor. You should take the full course of IBIAMOX even if you feel well or the infection may reappear.

Do not give IBIAMOX to anyone else, even if they have the same condition as you.

Do not take IBIAMOX to treat any other complaints unless your doctor tells you to.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

If you develop a rash, hay fever, breathing difficulties or swelling, stop taking IBIAMOX immediately and seek medical treatment.

See your doctor immediately if you or your care-giver notice the following:

  • nausea
  • vomiting
  • diarrhoea
  • tiredness
  • weakness
  • increased thirst
  • fever
  • weight loss
  • itchy rash
  • discolouration of the skin
  • wheezing
  • sore throat, mouth ulcers or fever - these may be a sign your blood is not healthy.

Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice anything else that is making you unwell

Overdose

Immediately telephone a doctor, or the Poisons Information Centre (telephone 0800 POISON or 0800 764 766) or go to the accident and Emergency Department at your nearest hospital, if you think you or anyone else may have injected or swallowed too much IBIAMOX. Do this even if there are no signs of discomfort or poisoning.

Storage

Store IBIAMOX in a cool place protected from light and moisture.

Do not store IBIAMOX in the bathroom or near a sink. Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.

Keep IBIAMOX in the original pack it is provided in until it is time to use it. The solution for injection must be used within an hour of being made up.

Keep IBIAMOX and injection needles out of reach of children. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or it has passed it's expiry date, ask your pharmacist what to do with any vials that are left over.

Product description

What it looks like

Amoxicillin 250 mg, 500 mg and 1000 mg: a white to cream powder packed in clear glass vials. Upon mixing with water or other approved diluents, the solution may initially be red but rapidly become clear to pale yellow in colour.

All strengths of IBIAMOX come in packs of 5 vials.

Needles for injection are purchased separately.

Diluents

Intramuscular injection - Sterile water. If pain is an issue use 1% lignocaine HCl or 0.5% solution of procaine HCl.

IV - sodium chloride (normal saline), compound sodium chloride (Ringer's solution), sodium lactate, compound sodium lactate (Hartmann's solution), dextrose (5%), sodium chloride and (4%) dextrose.

Date of Preparation: 29th January 2004