Flucasten One

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Fluconazole 150mg

Sẵn có từ:

Teva Pharma (New Zealand) Limited

INN (Tên quốc tế):

Fluconazole 150 mg

Liều dùng:

150 mg

Dạng dược phẩm:

Capsule

Thành phần:

Active: Fluconazole 150mg Excipient: Colloidal silicon dioxide Gelatin   Lactose Magnesium stearate Maize starch Methyl hydroxybenzoate   Patent blue V   Propyl hydroxybenzoate   Purified water   Sodium laurilsulfate     Titanium dioxide  

Các đơn vị trong gói:

Blister pack, 1 individual blister per carton, 1 capsule

Lớp học:

Restricted

Loại thuốc theo toa:

Restricted

Sản xuất bởi:

Mylan Laboratories Limited

Chỉ dẫn điều trị:

Flucasten One 150 mg, given orally, is indicated for vaginal candidiasis.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, 1 individual blister per carton - 1 capsules - 36 months from date of manufacture stored at or below 25°C

Ngày ủy quyền:

2010-06-15

Tờ rơi thông tin

CONSUMER MEDICINE INFORMATION
FLUCASTEN ONE
Fluconazole 150mg capsule
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Flucasten One
capsule.
It does not contain all of the available information. It does not take
the place of talking to
your pharmacist or doctor.
All medicines have risks and benefits. Your pharmacist or doctor has
weighed the risks
of you using Flucasten One capsule against the benefits they expect it
will have for you.
If you have any concerns about using this medicine, ask your
pharmacist or doctor.
KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again.
WHAT FLUCASTEN ONE CAPSULE IS USED FOR
Your Flucasten One capsule contains fluconazole. It belongs to a group
of medicines
known as antifungals.
Flucasten One is used to treat vaginal thrush infections. It works by
preventing the
growth of fungal and yeast organisms.
Flucasten One is available over the counter at a pharmacy or with a
doctor’s
prescription.
BEFORE YOU TAKE FLUCASTEN ONE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FLUCASTEN ONE IF YOU HAVE AN ALLERGY TO THE FOLLOWING:
•
ANY MEDICINE CONTAINING 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.
DO NOT TAKE FLUCASTEN ONE IF YOU ARE TAKING CISAPRIDE (a medicine used
to treat
stomach problems).
FLUCASTEN ONE IS NOT RECOMMENDED FOR CHILDREN UNDER 18 YEARS OF AGE
UNLESS
RECOMMENDED BY A DOCTOR. Safety and effectiveness in children under 18
years of age
have not been established.
Talk to your pharmacist or doctor if you are not sure whether you
should take this
medicine.
_BEFORE YOU TAKE IT _
Tell your pharmacist or doctor if you have allergies to any other
medicines, foods,
preservatives or dyes.
Tell your pharmacist or doctor if you have any oth

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
FLUCASTEN ONE
_Fluconazole 150 mg Capsules _
PRESENTATION
Size ‘1’ hard gelatin capsules with a blue body and cap. The
capsules contain white
to off white powder.
PHARMACOLOGY
_PHARMACODYNAMICS _
Fluconazole is a member of the bis-triazole class of antifungal
agents. Fluconazole is
a highly selective inhibitor of fungal cytochrome P-450 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. Interaction studies with antipyrine indicate that single
or multiple doses
of fluconazole 50 mg do not affect its metabolism.
_PHARMACOKINETICS AND METABOLISM _
Fluconazole is well absorbed and oral absorption is not affected by
concomitant food
intake. In fasted normal volunteers, peak plasma concentrations occur
between 1
and 2 hours post dose with a terminal plasma elimination half-life of
approximately
30 hours (range 20 - 50 hours). The apparent volume of distribution
approximates to
total body water. Plasma protein binding is low (11 - 12%).
Fluconazole has been found to achieve good penetration into all
tissues and body
fluids studied. The levels of fluconazole in saliva and sputum are
similar to plasma
levels.
The major route of excretion is renal, with approximately 80% of the
administered
dose appearing in the urine as unchanged medicine. About 11% of the
dose is
excreted in the urine as metabolites. The pharmacokinetics of
fluconazole are
markedly affected by reduction in renal function, however, no
adjustments in single-
dose therapy are necessary. There is an inverse relationship between
the elimination
half-life and creatinine clearance.
The long plasma elimination half-life provides the basis for single
dose therapy for
vaginal candidiasis.
There are differences in the pharmacokinetics between adults and
children, with
children after the neonatal period gene