Saturday, October 1, 2016

Diflucan Intravenous Infusion





Diflucan 2mg/ml (50mg/25ml) Intravenous Infusion (IV)



Diflucan 2mg/ml (200mg/100ml) Intravenous Infusion (IV)



Fluconazole




Read all of this leaflet carefully before you start taking this medicine.



  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:



  • 1. What Diflucan IV is and what it is used for

  • 2. Before you are given Diflucan IV

  • 3. How Diflucan IV will be given to you

  • 4. Possible side effects

  • 5. How to store Diflucan IV

  • 6. Further information





What Diflucan IV is and what it is used for



Diflucan IV is one of a group of medicines called “antifungals”. The active ingredient is fluconazole.



Diflucan IV is used to treat infections caused by fungi including yeasts and. may also be used to stop you from getting a fungal infection.
The most common cause of fungal infections is a yeast called Candida.




You may be given this medicine by your doctor to treat the following types of fungal infections.



  • Genital thrush, infection of the vagina or penis.

  • Mucosal thrush, infection of the mouth or throat.

  • Skin infections - e.g. athlete's foot, ringworm, jock itch.

  • Internal (systemic) fungal infections caused by:

    • Candida and found in the blood stream, body organs (e.g.heart, lungs) or urinary tract

    • Cryptococcus, e.g. meningitis and infections of other sites such as the lungs and skin





You may also be given Diflucan IV to:



  • stop you from getting a fungal infection (if your immune system is not working properly).

  • stop an infection caused by Cryptococcus from coming back (in AIDS patients).





Before you are given Diflucan IV






Do not take Diflucan IV if you



  • have ever had an allergic reaction to:

    • any of the ingredients of Diflucan IV

    • other medicines you have taken to treat a fungal infection.
      The symptoms may include itching, reddening of the skin or difficulty in breathing.


  • are taking terfenadine (an antihistamine for allergies)

  • are taking cisapride (used for stomach upsets)




Take special care with Diflucan IV



Tell your doctor if you:



  • have liver or kidney problems

  • suffer from heart disease, including heart rhythm problems

  • have abnormal levels of potassium, calcium or magnesium in your blood




Taking other medicines



Tell your doctor, immediately if you are taking Terfenadine (an antihistamine for treating allergies) or Cisapride (used for stomach upsets) as these should not be taken with Diflucan IV.



There are some medicines that may interact with Diflucan IV. Make sure your doctor knows if you are taking any of the following medicines:



  • warfarin (or similar drugs) that thin the blood to prevent blood clots

  • medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide

  • water tablets, such as hydrochlorothiazide, used to treat fluid retention and high blood pressure

  • midazolam used to help you sleep or for anxiety

  • phenytoin (used to control epilepsy)

  • rifampicin or rifabutin (antibiotics for infections)

  • ciclosporin or tacrolimus (to prevent transplant rejection)

  • theophylline (used to control asthma)

  • astemizole (an antihistamine for treating allergies)

  • zidovudine, also known as AZT (used in HIV-infected patients)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.





Pregnancy and breast-feeding



You should not take Diflucan IV while you are pregnant or if you are breast feeding.





Driving and using machines



Treatment with Diflucan IV is unlikely to affect your ability to drive or use machinery.





Important information about some of the ingredients of Diflucan IV



Diflucan IV contains 15mmol sodium per 100ml dose. To be taken into consideration by patients on a controlled sodium diet.






How Diflucan IV will be given to you



This medicine will be given by your doctor or nurse as a slow injection (infusion) into your vein over approximately 30 minutes.Diflucan IV is supplied as a solution.
It will not be diluted it further. This medicine should not be mixed with any other drug before infusion.



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 Diflucan IV.




Adults





Genital thrush – 150mg as a single dose.


Mucosal thrush (dose depends on where the infection is located) – 50mg once daily for 7-14 days or 14-30 days. Sometimes doses are increased to 100 mg.


Fungal skin infections – 50mg once daily for 2-4 weeks (Athlete’s foot may be up to 6 weeks).


Internal fungal infections – 400mg on the first day then 200-400mg once daily for 6-8 weeks or longer if needed.


To stop you from getting fungal infections – 50-400mg once daily while you are at risk of getting an infection.


To stop infection caused by Cryptococcus from coming back – 100-200mg once daily indefinitely.






Children




4 weeks to 15 years old –


  • Mucosal infections – 3mg/kg once daily.


  • Internal fungal infections – 6-12mg/kg once daily.


  • Prevention of fungal infection – 3-12mg/kg once daily while at risk of
    getting an infection.





2-4 weeks old
– Same dose as above but given once every 2 days. A maximum dose of 12mg/kg every 2 days.



Less than 2 weeks old
– Same dose as above but given once every 3 days. A maximum dose of 12mg/kg every 3 days.





A maximum dosage of 400mg daily should not be exceeded in children.



Use of Diflucan IV for treating genital Candida infections in children under 16 years old is not recommended.





Elderly



The usual adult dose will be given unless you have kidney problems.





Patients with kidney problems



Your doctor may modify your dose, depending on your kidney function.




If you have any further questions on the use of this product, ask your doctor or pharmacist.



You will find more about Diflucan IV on the back of this leaflet.





Possible side effects



Like all medicines, Diflucan IV 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 wheezing, difficulty in breathing or tightness in chest

  • Swelling of eyelids, face or lips

  • Itching all over the body reddening of the skin or itchy red spots

  • Skin rash

  • Severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).

  • If you are an AIDS patient you are more likely to get severe skin reactions to drugs including Diflucan IV.


Very common side effects which may affect more than 1 person in 10 are listed below:



  • feeling sick

  • stomach discomfort

  • diarrhoea

  • wind

  • rash

  • headache

These undesirable effects are usually mild. If they cause you discomfort or are long lasting, check with your doctor or pharmacist.





Other side effects



  • itching

  • being sick

  • seizure

  • lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding

  • high blood levels of cholesterol, fats or salt

  • liver damage and yellowing of the skin and eyes (Jaundice)

  • hair loss

  • dizziness

  • altered sense of taste

  • change in heart rate or rhythm



If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





How to store Diflucan IV



  • Keep out of the reach and sight of children


  • Do not store above 30°C


  • Do not freeze


  • Diflucan IV will not be used after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.


  • Once open any unused infusion will be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.





Further information




What Diflucan IV contains



  • The active substance is 2mg/ml(50mg/25ml) fluconazole or 2mg/ml(200mg/100ml) fluconazole depending on which strength you have been prescribed.


  • The other ingredients are:

- Sodium chloride

- Water for injection








What Diflucan IV 50mg/25ml and 200mg/100ml intraveneous infusion looks like and contents of the pack.



  • Diflucan IV 50mg/25ml and 200mg/100ml intraveneous infusion is a clear colourless solution.

  • Diflucan IV comes in a glass vial containing a total of either 50mg or 200mg fluconazole.




Marketing Authorisation Holder and Manufacturer




Pfizer Limited

Sandwich

Kent

CT13 9NJ

United kingdom





Manufacturer




Pfizer PGM

Zone Industrielle

29 route des Industries

37530 Poce sur Cisse

France





Company contact address




Pfizer Limited

Walton Oaks

Dorking Road

Tadworth

Surrey

KT20 7NS

United Kingdom

Tel:01304616161





This leaflet was last approved in – 06 / 2008.



© - Pfizer Limited



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