ASPEN FLUCONAZOLE fluconazole 200mg/100mL solution for injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluconazole, Quantity: 200 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Fluconazole

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

10 x 100mL bags

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fluconazole Injection is indicated for the following conditions but should be used only when fluconazole cannot be administered orally: 1. Treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. Note: Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. 2. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). 3. Treatment of oropharyngeal and oesophageal candidiasis in patients with AIDS and other immunosuppressed patients. 4. Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. 5. Serious and life-threatening Candida infections in patients who are unable to tolerate amphotericin B. Note: It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life-threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice.

Product summary:

Visual Identification: Clear and colourless solution.; Container Type: Bag; Container Material: PVC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-05-11

Patient Information leaflet

ASPEN FLUCONAZOLE – Consumer Medicine Information
Page 1 of 3
ASPEN FLUCONAZOLE INJECTION
_fluconazole _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASPEN
FLUCONAZOLE injection. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given ASPEN
FLUCONAZOLE injection against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE._ _
You may need to read it again.
WHAT ASPEN
FLUCONAZOLE
INJECTION IS USED FOR
ASPEN FLUCONAZOLE contains
fluconazole as the active ingredient
and 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 THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor’s prescription.
There is no evidence that it is
addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN ASPEN
FLUCONAZOLE INJECTION IF YOU
HAVE AN ALLERGY TO:

fluconazole

medicines related to fluconazole
such as miconazole,
ketoconazole or clotrimazole

any of the ingredients listed at
the end of this leaflet.
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; rash,
itching or hives on the skin.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU ARE TAKING OTHER
MEDICINES CALLED CISAPRIDE OR
TERFENADINE. TELL YOUR DOCTOR IF
YOU ARE TAKING CISAPRIDE OR
TERFENADINE.
YOU MUST NOT BE GIVEN THIS
MEDICINE AFTER THE EXPIRY DATE
PRINTED ON THE PACK OR IF THE
PACKAGING IS TORN

Summary of Product characteristics

ASPEN FLUCONAZOLE – Product Information
Page 1 of 15
PRODUCT INFORMATION
ASPEN FLUCONAZOLE
INJECTION FOR INTRAVENOUS INFUSION
NAME OF THE MEDICINE
Non proprietary name: Fluconazole injection for intravenous infusion
Chemical name:
2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-propan-2-ol
Molecular formula: C
13
H
12
F
2
N
6
O
Molecular weight: 306.3
CAS registry number 86386-73-4
The chemical structure of fluconazole is shown below:
DESCRIPTION
Fluconazole is a white to off-white crystalline powder which is
sparingly soluble in water
and saline.
ASPEN FLUCONAZOLE Injection for Intravenous Infusion is a clear,
colourless solution.
The 2mg/mL strength is available in bags containing 100mg/50mL,
200mg/100mL and
400mg/200mL. The active ingredient is fluconazole and the excipients
are sodium chloride
and water for injections.
It is formulated in a 0.9% sodium chloride solution, with each 100mg
(50mL) bag containing
7.5mmol of Na
+
and Cl
-
, each 200mg (100mL bag) containing 15mmol of Na
+
and Cl
-
and
each 400mg (200mL) bag containing 30mmol Na
+
and Cl
-
. This should be considered in
patients on a sodium or fluid restricted diet.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Fluconazole, a member of the triazole class of antifungal agents, is a
potent and selective
inhibitor of fungal enzymes necessary for the synthesis of ergosterol.
ASPEN FLUCONAZOLE – Product Information
Page 2 of 15
Fluconazole is a highly selective inhibitor of fungal cytochrome P450
sterol C-14 alpha-
demethylation. Mammalian cell demethylation is much less sensitive to
fluconazole
inhibition. The subsequent loss of normal sterols correlates with the
accumulation of 14
alpha-methyl sterols in fungi and may be responsible for the
fungistatic activity of
fluconazole.
Fluconazole 50mg daily given for up to 28 days has been shown not to
affect corticosteroid
levels or adrenocorticotrophic hormone (ACTH) stimulated response in
healthy female
volunteers. Plasma oestradiol levels and urinary free cortisol levels
were decreased with
little effe