FLUCLOXIN™
flucloxacillin 250 mg, 500 mg and 1 g injections
What is in this leaflet
This leaflet answers some common questions about FLUCLOXIN. FLUCLOXIN is
administered by injection.
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 FLUCLOXIN against the benefits this medicine is expected to have for you.
If someone else is injecting FLUCLOXIN 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 FLUCLOXIN is used for
FLUCLOXIN is an antibiotic belonging to a group of medicines called
penicillin. This medicine works by killing or stopping the growth of bacteria,
which cause infection.
It is used to:
- treat skin and soft tissue infections caused by bacteria which are
resistant to penicillin.
Eg. infections of the joints, respiratory tract, urinary tract, inflammation
(pain, heat, swelling or redness) of the middle ear, inflammation of the
endocardium (a membrane that covers the inside surface of the heart), infected
blood and meningitis. - prevent infections resulting from surgery, in particular chest, bone and
joint procedures.
FLUCLOXIN will not work against infections caused by viruses such as colds or
the flu.
FLUCLOXIN is used to treat only infections that will respond to it. Some
infections are resistant to the effects of FLUCLOXIN.
Your doctor may have prescribed FLUCLOXIN for another reason.
Ask your doctor if you have any questions about why FLUCLOXIN has been
prescribed for you.
This medicine is available only with a doctor's prescription.
Before you inject FLUCLOXIN
When you must not use it
Do not use FLUCLOXIN if you have a history of allergic reaction to
penicillins, cephalosporins or other allergens.
Symptoms of an allergic reaction may include:
- skin rash
- difficulty breathing
- hayfever
- swelling
Do not use FLUCLOXIN if you have a previous history of
flucloxacillin-associated jaundice (yellowing of the skin) or liver dysfunction.
Do not use FLUCLOXIN if the packaging is torn or shows signs of tampering.
Do not use FLUCLOXIN 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.
An allergic reaction is more frequent following administration by
injection.
Severe allergic reactions require emergency medical treatment.
Tell your doctor if you are pregnant or intend to become pregnant.
There is insufficient safety information regarding the use of FLUCLOXIN during
the first trimester of pregnancy.
Use in the second and third trimester of pregnancy, and when breast feeding, has
shown no significant risk to the newly born baby.
However, there is a possibility of sensitisation, diarrhoea, thrush, and/or
skin rash developing in the infant if you take this medicine while pregnant or
breast feeding.
Your doctor will discuss the risks and benefits of taking this medicine during
pregnancy.
Caution should be exercised when administering FLUCLOXIN to newly born or
premature babies.
Flucloxacillin may cause hyperbilirubinaemia (high levels of bilirubin in the
blood). Bilirubin is produced when red blood cells are broken down. Usually the
liver processes bilirubin but in new born and premature babies, the liver is not
fully developed. High levels of bilirubin will cause jaundice and may lead to
brain damage. Babies using FLUCLOXIN must be monitored closely.
FLUCLOXIN 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.
During prolonged therapy, your doctor should carry out periodic tests to
assess kidney and liver function and blood cell formation.
Hepatitis (swelling of the liver) is associated with flucloxacillin
therapy.
Hepatitis is more frequent with increasing age and prolonged therapy. Jaundice
(yellowing of the skin) may appear several weeks after therapy and is a sign of
liver problems. Although liver function does eventually return, hepatitis in
some cases is fatal.
Pseudomembranous colitis (inflammation of the small intestine and colon)
is associated with taking antibiotics.
Diarrhoea is a common symptom of Pseudomembranous colitis and may be mild to
severe. Tell your doctor immediately if you get diarrhoea during or shortly
after treatment has ended.
Be aware that superinfections may occur.
This is a new infection resulting from the invasion of bacteria resistant to
flucloxacillin. FLUCLOXIN should be discontinued and another therapy commenced.
FLUCLOXIN 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 FLUCLOXIN.
FLUCLOXIN should not be mixed with blood products or other fluids
containing protein.
- probenecid - a medicine used to treat gout (excess uric acid in the
blood). Probenecid may increase the concentration of flucloxacillin in the
body. This can be of benefit in the treatment of some infections. - 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. - oestrogen containing oral contraceptives - Using FLUCLOXIN while on
contraceptives may decrease the effectiveness of the contraceptive. Use an
alternative or additional method of contraception while on a course of
FLUCLOXIN. - aminoglycosides - If FLUCLOXIN and an aminoglycoside are to be used
simultaneously, the two antibiotics should not be mixed together.
Your doctor and pharmacist may have more information on medicines to be
careful with or to avoid while taking this medicine
How to use FLUCLOXIN 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 FLUCLOXIN injection
Your doctor will decide the dose by factoring in your medical condition and
age.
The usual dose is as follows:
Adults
Intramuscular - muscle tissue
250 mg every 6 hours
Slow intravenous injection (I.V.) - direct access to a vein
250 mg to 1 g every 6 hours
Intrapleural - the membrane (pleura) surrounding the lungs and the
chest cavity
250 mg once daily
Intraarticular - within a joint
250 mg to 500 mg once daily
How to use FLUCLOXIN injection
Your doctor, nurse, caregiver or yourself will make the FLUCLOXIN 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.
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 inject directly into muscle
tissue or they (not yourself) may inject directly into the infusion
tubing, pleura or joints.
The solution for injection must be used immediately or within 72 hours when
stored at 5°C.
If pain is experienced during intramuscular injection, a sterile solution of
lignocaine 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 FLUCLOXIN
Things you must do
If you develop a rash, hay fever, breathing difficulties or swelling, stop
taking FLUCLOXIN 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 FLUCLOXIN tell your doctor.
If you are about to start taking a new medicine tell your doctor and
pharmacist that you are taking FLUCLOXIN.
Things you must not do
Do not stop taking FLUCLOXIN or lower the dosage without checking with your
doctor. You should take the full course of FLUCLOXIN even if you feel well or
the infection may reappear.
Do not give FLUCLOXIN to anyone else, even if they have the same condition as
you.
Do not take FLUCLOXIN 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 FLUCLOXIN immediately and seek medical treatment.
See your doctor immediately if you or your care-giver notice the following:
- nausea
- vomiting
- diarrhoea
- itchy rash
- discolouration of the skin
- wheezing
- jaundice (yellow skin)
- tiredness
- 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 FLUCLOXIN. Do this even if there are no signs of discomfort
or poisoning.
Storage
Store FLUCLOXIN in a cool place protected from light and moisture.
Do not store FLUCLOXIN 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 FLUCLOXIN in the original pack it is provided in until it is time to use
it. The solution for injection must be used immediately.
Keep FLUCLOXIN 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
250 mg injection: Type III glass vials containing a white powder for
reconstitution and labelled with the appropriate content of flucloxacillin.
500 mg injection: Type III glass vials containing a white powder for
reconstitution and labelled with the appropriate content of flucloxacillin.
1 g injection: Type III glass vials containing a white powder for
reconstitution and labelled with the appropriate content of flucloxacillin.
All strengths of FLUCLOXIN come in packs of 5 vials.
Needles for injection are purchased separately.
Diluents
FLUCLOXIN injection is compatible with the following infusion fluids for a
period not exceeding 1 hour at room temperature: Dextrose 5%, Dextrose/Saline,
Hartman's Ringers, 0.9% sodium chloride, dextrans.
FLUCLOXIN injection is stable when reconstituted in water for injection for
at least 72 hours when stored at 5°C.
It is compatible with the following infusion fluids for up to 72 hours when
stored at 5°C: Dextrose 5%, 0.9% sodium chloride and dextrose/saline.