Fluconazole 2mg/Ml Solution For Infusion
Fluconazole 2mg/ml Solution for Infusion
The following information is intended for medical or healthcare professionals
For single use only.
Discard any remaining
Although further dilution is unnecessary, fluconazole intravenous infusion is compatible with the following administration fluids:
a. Dextrose 20%
b. Ringer's solution
c. Hartmann's solution
d. Potassium chloride in dextrose
e. Sodium bicarbonate 4.2%
f. Normal saline (0.9%) Recommended method of administration:
Fluconazole intravenous infusion does not require dilution prior to administration. If necessary, the solution may be infused through an existing administration set containing one of the compatible fluids listed above using a suitable 'Y' connection. Mixing with other drugs prior to infusion is not recommended. Fluconazole intravenous infusion may be infused through an existing line with one of the above listed fluids. No specific incompatibilities have been noted, although mixing with any other drug prior to infusion is not recommended.
Y
Package leaflet: Information for the user
Fluconazole 2mg/ml Solution for Infusion
The name of your medicine is Fluconazole 2 mg/ml Solution for Infusion, which will be called Fluconazole Infusion throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Fluconazole Infusion is and what it is
2. What you need to know before you take Fluconazole Infusion
3. How to take Fluconazole Infusion
4. Possible side-effects
5. How to store Fluconazole Infusion
6. Contents of the pack and other information
What Fluconazole Infusion is and what it is used for
Fluconazole is one of a group of medicines called "antifungals". The active substance is fluconazole. Fluconazole Infusion is used to treat infections caused by fungi and may also be used to stop you from getting candidal infection. The most common cause of fungal infections is a yeast called Candida. Adults
You might be given this medicine by your doctor to treat the following types of fungal infections:
• Cryptococcal meningitis - a fungal infection in
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract
• Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth.
You might also be given Fluconazole Infusion to:
• stop cryptococcal meningitis from coming back
• stop mucosal thrush from coming back
• stop you from getting an infection caused by Candida (if your immune system is weak and not working properly).
Children and adolescents (0 to 17 years old)
You might be given this medicine by your doctor to treat the following types of fungal infections:
• Mucosal thrush - infection affecting the lining of the mouth, throat
• Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract
• Cryptococcal meningitis - a fungal infection in
You might also be given Fluconazole Infusion to:
• stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)
• stop cryptococcal meningitis from coming back. 3 What you need to know before you
take Fluconazole infusion
Do not take Fluconazole Infusion:
• If you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing
• If you are taking astemizole, terfenadine (antihistamine medicines for allergies)
• If you are taking cisapride (used for stomach
• If you are taking pimozide (used for treating mental illness)
• If you are taking quinidine (used for treating heart arrhythmia)
• If you are taking erythromycin (an antibiotic for treating infections)
Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking Fluconazole Infusion
• If you have a liver or kidney problem
• If you suffer from heart disease, including heart rhythm problems
• If you have abnormal levels of potassium, calcium or magnesium in your blood
• If you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).
Ketoconazole is known to cause adrenal insufficiency (a condition in which the adrenal glands do not produce adequate amounts of steroid hormones), and this could also although rarely seen be applicable to fluconazole.
Other medicines and Fluconazole Infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) or erythromycin (an antibiotic for treating infections) as these should not be taken
with Fluconazole Infusion (see section: "Do not take Fluconazole Infusion”).
There are some medicines that may interact with Fluconazole 2 mg/ml Intravenous Infusion. Make sure your doctor knows if you are taking any of the following medicines:
• rifampicin or rifabutin (antibiotics for infections)
• alfentanil, fentanyl (used as anaesthetic)
• amitriptyline, nortriptyline (used as anti-depressant)
• amphotericin B, voriconazole (anti-fungal)
• medicines that thin the blood to prevent blood clots (indanedione, warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used for treating fits)
• nifedipine, isradipine, amlodipine felodipine and losartan (for hypertension - high blood pressure)
• ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
• cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating
• halofantrine (used for treating malaria)
• statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels
• methadone (used for pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• vitamin A (nutritional supplement)
• hydrochlorothiazide (a 'water pill')
• amiodarone (used for treating heart problems). Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this
Driving and using machines
When driving vehicles or using machines it should be taken into account that occasionally dizziness or fits may occur.
Fluconazole Infusion contains Sodium chloride
Fluconazole 2 mg/ml Intravenous Infusion contains 9 mg of sodium chloride per ml of solution (e.g. 25 ml vial contains 225 mg of sodium chloride and 100 ml vial contains 900 mg). This may make the infusion unsuitable to people on a low sodium diet. If you are unsure about whether you are on this type of diet, please consult your nurse or doctor.
£3 How to take Fluconazole infusion
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This medicine is given by your doctor or nurse as a slow injection (infusion) into your vein.
The usual doses of this medicine for different infections are below. Check with your doctor or nurse if you are not sure why you are being given fluconazole.
Adults
|
Condition |
Dose |
|
To treat cryptococcal |
400 mg on the first day then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if needed. Sometimes doses are increased up to 800 mg |
|
To stop cryptococcal meningitis from coming |
200 mg once daily until you are told to stop |
|
coccidioidomycosis |
200 mg to 400 mg once daily from 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800 mg |
|
To treat internal fungal infections caused by Candida |
800 mg on the first day then 400 mg once daily until you are told to stop |
|
To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth |
200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop |
|
To treat mucosal thrush -dose depends on where the infection is located |
50 mg to 400 mg once daily for 7 to 30 days until you are told to stop |
|
To stop mucosal infections affecting the lining of mouth, throat |
100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection |
|
To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly) |
200 mg to 400 mg once daily while you are at risk of getting an infection |
A
Use in children and adolescents Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children posology).
Children to 11 years old
The maximum dose for children is 400 mg daily The dose will be based on the child's weight in kilograms.
Daily dose
Mucosal thrush and throat infections caused by Candida - dose and duration depends on the severity of the infection and on where the infection is located
3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day)
Cryptococcal meningitis or 6 mg to 12 internal fungal infections kg of body caused by Candida
mg per weight
To stop children from 3 mg to 12
getting an infection caused kg of body by Candida (if their immune system is not working properly)
mg per weight
Use in children of 3 to 4 weeks of age:
The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.
Doctors sometimes prescribe different doses to these. Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Patients with kidney problems
Your doctor may change your dose, depending on your kidney function.
If you receive more Fluconazole Infusion than you should
If you are concerned that you may have been given too much Fluconazole Infusion, tell your doctor or nurse immediately. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour).
If a dose of Fluconazole Infusion has been forgotten
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.
If you stop taking Fluconazole Infusion
If you have any further questions on the use of this
medicine, ask your doctor or nurse.
[4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
• A few people develop allergic reactions although serious allergic reactions are rare. If you get any of the following symptoms, tell your doctor immediately. Sudden wheeziness, difficulty in breathing or tightness of the chest
• Swelling of eyelids, face or lips
• Itching all over the body reddening of the skin or itchy red spots
• Severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).
Fluconazole may affect your liver. The signs of liver problems include:
• Loss of appetite
• Vomiting
• Yellowing of your skin or the whites of your eyes (jaundice).
If any of these happen, stop taking Fluconazole Infusion and tell your doctor immediately.
Other side effects
Additionally, if any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Common side effects which may affect up to 1 in 10 people in 100 are listed below:
• Headache
• Stomach discomfort
• Feeling sick
• Vomiting
• Increases in blood tests of liver function
• Rash.
Uncommon side effects which may affect up to 1in 100 people are listed below:
• Reduction in red blood cells which can make skin pale and cause weakness or breathlessness
• Decreased appetite
• Inability to sleep
• Feeling drowsy
• Fit
• Dizziness
• Sensation of spinning, tingling, pricking or
numbness
• Changes in sense of taste
• Constipation
• Difficult digestion
• Wind
• Dry mouth
• Muscle pain
• Liver damage and yellowing of the skin and eyes (jaundice)
• Wheals
• Blistering (hives)
• Itching
• Increased sweating
• General feeling of being unwell
Rare side effects which may affect 1 in 1,000 people
are listed below:
• Lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding
• Red or purple discoloration of the skin which may be caused by low platelet count
• Other blood cell changes
• Blood chemistry changes (high blood levels of cholesterol, fats)
• Low blood potassium
• Shaking
• Abnormal electrocardiogram (ECG)
• Change in heart rate or rhythm
• Liver failure
• Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
What Fluconazole Infusion contains
The active substance is fluconazole.
Each ml contains 2 mg of fluconazole.
Other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide and water for injections. What Fluconazole Infusion looks like and contents of the pack:
Fluconazole Infusion is a clear colourless solution Type I glass vials: 25 ml, 50 ml and 100 ml. Marketing Authorization Holder and Manufacturer
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG, United Kingdom. Manufacturer
Pharmathen S.A, 6 Dervenakion str., 15351 Pallini Attikis, Athens, Greece.
This leaflet was last revised in January 2016 PL 00289/1569 |POM |
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
[5 How to store Fluconazole Infusion
Your doctor or pharmacist will know how to store Fluconazole Infusion.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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