Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being treated with Diflucan IV?
Diflucan IV contains the active ingredient fluconazole. It is used to treat certain
fungal and yeast infections.
2. What should I know before treatment with Diflucan IV?
Do not start treatment if you are allergic to any medicine containing fluconazole,
any of the ingredients listed at the end of this CMI, or any other similar medicines
such as miconazole, ketoconazole or clotrimazole.
Tell the doctor if you have had any allergic reaction to any antifungal, or any foods,
preservatives or dyes or any other medicines, if you are pregnant, plan to become
pregnant or are breastfeeding.
You must not be given Diflucan if you are taking certain medicines.
3. What if I am taking other medicines?
Some medicines may interfere with Diflucan IV and affect how it works.
4. How is Diflucan IV given?
Diflucan IV is given as a slow injection into the vein. The doctor will decide how
much Diflucan IV will be given to you each day and for how long. It will depend on
your condition and other factors.
5. What should I know during treatment with Diflucan IV?
Things you should do
|
Tell the doctor if you have any medical conditions, are on any medicines, or if you
are pregnant, plan to become pregnant or are breastfeeding
For more information on "Things you should do" can be found in Section 6 in the full
CMI
|
Things you should not do
|
Do not start treatment if you have ever had an allergic reaction to any medicine containing
fluconazole, any of the ingredients listed at the end of this CMI, or any other similar
medicines such as miconazole, ketoconazole or clotrimazole.
|
Looking after your medicine
|
Diflucan IV should be stored in the pharmacy or on the hospital ward.
Diflucan IV should be kept in a dry place where the temperature stays below 30°C.
|
6. Are there any side effects?
DIFLUCAN IV is generally well tolerated. Side effects may include nausea, vomiting,
abdominal pain, diarrhoea, headache, skin rash or redness and easy bruising of the
skin, seizures, signs of frequent or worrying infections such as fever, severe chills,
sore throat or mouth ulcers or change in liver function.
Fluconazole
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Diflucan IV. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about Diflucan IV
Where to find information in this leaflet:
1. Why am I being treated with Diflucan IV?
Diflucan IV is used to treat certain fungal and yeast infections.
It belongs to a group of medicines called azole antibiotics.
It works by preventing the growth of the fungal and yeast organisms causing your infection.
Ask your doctor if you have any questions about why Diflucan IV has been prescribed
for you.
Your doctor may have prescribed it for another reason.
Diflucan IV is available only with a doctor's prescription.
This medicine is not addictive.
2. What should I know before treatment with Diflucan IV?
Warnings
Do not use start treatment with Diflucan IV if you:
are allergic to fluconazole, or any of the ingredients listed at the end of this leaflet,
or any medicines related to fluconazole such as miconazole, ketoconazole or clotrimazole
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; skin rash,
itching or hives.
You must not be given Diflucan IV if you are taking any of the following medicines:
terfenadine or astemizole (a medicine used to treat allergy)
cisapride (a medicine used to treat stomach problems)
erythromycin (a medicine used to treat infections)
pimozide (a medicine used to treat mental illness)
quinidine (a medicine used to treat irregular heartbeat).
Check with your doctor if you have any:
have allergies to any foods, preservatives or dyes or any other medicines
are taking medicines for any other condition
other medical conditions
liver problems
heart problems
kidney problems
Your doctor may need to monitor the function of the liver using blood tests. Be sure
to follow the doctor's advice if regular checks on your/ your child's liver are recommended.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
DIFLUCAN IV use should be avoided during pregnancy except on doctor’s advice for severe
or life-threatening infections. Effective contraception should be used in women of
childbearing potential and should continue throughout the treatment period and for
approximately 1 week after the final dose. Your doctor can discuss with you the risks
and benefits involved.
Talk to your doctor about the need for an additional method of contraception while
being given Diflucan IV.
Diflucan IV may decrease the effectiveness of some birth control pills.
DIFLUCAN IV is not recommended for use whilst breastfeeding however your doctor can
discuss with you the risks and benefits involved.
3. What if I am taking other medicines?
Tell your doctor if you are taking any other medicines, including any medicines, vitamins
or supplements that you buy without a prescription from your pharmacy, supermarket
or health food shop.
Some medicines should not be taken with Diflucan. These are listed under Section 2. What should I know before treatment with Diflucan.
Some medicines and Diflucan IV may interfere with each other. These medicines and
some others may be affected by Diflucan IV or may affect how well it works. You may
need different amounts of your medicines, or you may need to use different medicines.
These include:
some medicines for diabetes such as glipizide, tolbutamide or glibenclamide
some antibiotics, antiviral and antifungal drugs such as rifampicin, rifabutin, zidovudine,
amphotericin B, azithromycin, saquinavir or voriconazole
some drugs used for heart problems, such as amiodarone or verapamil
some drugs used in problems with the immune system, such as ciclosporin, tacrolimus,
sirolimus or tofacitinib
some medicines used to lower cholesterol, such as atorvastatin, simvastatin or fluvastatin
abrocitinib, used to treat atopic dermatitis (atopic eczema)
cyclophosphamide, vincristine, vinblastine, olaparib or ibrutinib, used to treat certain
types of cancers
tolvaptan, used to treat low levels of sodium in your blood or for kidney problems
halofantrine, used to treat malaria
warfarin, used to stop blood clots
phenytoin, used to treat epilepsy
prednisone, used to treat inflammation or suppress the immune system
theophylline, used to treat asthma
some benzodiazepines such as midazolam
lemborexant, used to treat insomnia or sleeping difficulties
ivacaftor, used to manage cystic fibrosis
lurasidone, used to manage schizophrenia
hydrochlorothiazide, used for treating fluid problems
the contraceptive pill (birth control pill)
carbamazepine, used in the treatment of epilepsy and bipolar disorder
NSAIDS such as naproxen, diclofenac and celecoxib
Vitamin A
opioid pain killers such as alfentanil, fentanyl and methadone
losartan, used for treating high blood pressure
antidepressants such as amitriptyline and nortriptyline.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Diflucan IV.
4. How is Diflucan IV given?
How much will be given
Diflucan IV is usually infused slowly into a vein.
Diflucan IV will only be given by a doctor or nurse. Your doctor will decide how much
DIFLUCAN IV you will be given each day.
How long will Diflucan IV need to be given?
The amount of Diflucan IV you receive, and the length of your treatment, will depend
on your body weight and kidney function. It will also depend on how quickly the infection
is brought under control.
After a while, the injection may be stopped and you may begin to receive Diflucan
capsules or oral suspension by mouth.
Follow the instructions provided by your/your child's doctor carefully.
If too much Diflucan IV is given
Because Diflucan IV is given to you by a health professional, overdose is unlikely
to arise.
However, if you are concerned that you may have been given too much DIFLUCAN IV you
may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know during treatment with Diflucan IV?
Things you should do
If you are a woman of childbearing potential, talk to your doctor about the need for
an additional method of contraception while being given Diflucan IV.
Diflucan IV may decrease the effectiveness of some birth control pills.
If you suffer from HIV or have a weakened immune system and develop a rash while being
given Diflucan IV, tell your doctor immediately.
If this rash worsens, Diflucan IV may need to be stopped.
Remind any doctor, dentist, or pharmacist you visit that you are using Diflucan IV.
Things you should not do
Do not start treatment if you have ever had an allergic reaction to any medicine containing
fluconazole, any of the ingredients listed at the end of this CMI
Driving or using machines
Be careful when driving vehicles or operating machinery as occasional dizziness or
seizures may occur.
Drinking alcohol
No information available
Looking after your medicine
Your hospital pharmacy will store the Diflucan IV.
Diflucan IV should be kept in a dry place where the temperature stays below 30°C.
When to discard your medicine
Discard any medicine that has passed the expiry date.
This medicine should only be used for one patient on one occasion only.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
|
What to do
|
Allergy or reaction related:
swelling of the face, lips or tongue
difficulty in swallowing or breathing
asthma, wheezing, shortness of breath
Skin changes:
yellowing of the skin or eyes, also called jaundice
sudden or severe itching, skin rash, hives
bleeding or bruising more easily than normal
reddish or purplish blotches under the skin
flaking of the skin
Changes to urine:
dark urine and light-coloured bowel movements (cholestasis)
Signs of frequent or worrying infections such as:
fever, severe chills, sore throat or mouth ulcers
Other:
fainting, seizures or fits
fast or irregular heartbeat
increased sweating.
|
Call your/your child's doctor immediately, or go to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you/your child experience,
you can report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Diflucan IV contains
Active ingredient
|
Fluconazole
|
Other ingredients
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Sodium chloride 0.9% solution
|
Do not take this medicine if you are allergic to any of these ingredients.
What Diflucan IV looks like
Diflucan IV is a clear, colourless solution and comes in clear glass vials of 50 mL
and 100 mL.
Australian Registration Number:
Aust R 47461 – 100 mg/ 50 mL
AUST R 47462 – 200 mg/ 100 mL
Who distributes Diflucan IV
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in September 2024
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