OZOLE fluconazole 50 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluconazole, Quantity: 50 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Fluconazole

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: maize starch; lactose monohydrate; colloidal anhydrous silica; sodium lauryl sulfate; magnesium stearate; patent blue V; purified water; titanium dioxide; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OZOLE (fluconazole) capsules, given orally, are indicated for the following conditions: - 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 acute phase of cryptococcal meningitis. - Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with AIDS. - Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. - Secondary prophylaxis of oropharyngeal candidiasis in patients with HIV infection. - 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 infecctions. Until such data are available, amphotericin B remains the drug of choice. - Vaginal candidiasis, when topical therapy has failed. - Treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therpy is not a practical treatment option. Usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks.

Product summary:

Visual Identification: Blue/white hard gelatin, self locked capsules of size '4' imprinted with 'RANBAXY' in black edible ink on both cap and body containing white to off white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-10-06

Patient Information leaflet

OZOLE
_Fluconazole Capsules _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OZOLE (fluconazole
capsules).
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 taking OZOLE
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING/TAKING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with this medicine.
You may need to read it again.
WHAT OZOLE IS USED
FOR
OZOLE contains fluconazole.
Fluconazole belongs to a group of
medicines called azole antibiotics,
used to treat fungal infections. The
most common cause of such
infections is a fungus called Candida.
Your doctor would have prescribed
OZOLE for one or more of the
following:
•
Treatment of fungal infections of
the mouth (oral thrush), throat, or
food pipe by Candida in patients
who have suppressed immunity
•
Treatment of fungal infections of
the skin (such as those involving
groin, area between the toes) not
responding to local antifungal
application therapy
•
Treatment of serious internal
fungal infections caused by
Candida (such as those involving
blood, urinary tract, lungs or
other body organs) in patients
who are unable to tolerate
intravenous antifungal therapy
with amphotericin B
•
Treatment of fungal infections of
the brain caused by a fungus
Cryptococcus (a condition called
cryptococcal meningitis) in
patients not tolerating intravenous
antifungal therapy with
amphotericin B
•
Treatment of vaginal fungal
infections (vaginal thrush) when
local antifungal application
therapy has failed
•
To prevent fungal infections (if
your immune system is not
working properly)
•
To prevent cryptococcal
meningitis infections in patients
with AIDS and/or HIV infection
Your doctor may prescribe OZOLE
for another reason. Ask your doctor
if you have any questions about why
OZOLE has been prescribed for you.
There i

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
OZOLE (FLUCONAZOLE) CAPSULES
1 NAME OF THE MEDICINE
Fluconazole
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluconazole is a member of the bis-triazole class of antifungal
agents.
Fluconazole is a white crystalline powder, slightly soluble in water,
freely soluble in methanol.
OZOLE
(fluconazole)
capsules
contain
50,
100
and
200
mg
of
the
active
ingredient,
fluconazole.
Excipient with known effect: lactose monohydrate. For the full list of
excipients, see section
6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Ozole is available as:
Blue/ white hard gelatin, self locked capsules of size '4' imprinted
with ‘RANBAXY' in black
edible ink on both cap and body containing white to off white powder,
containing 50 mg of
Fluconazole.
Blue/ white hard gelatin, self locked capsules of size '2' imprinted
with ‘RANBAXY' in black
edible ink on both cap and body containing white to off white powder,
containing 100 mg of
Fluconazole.
Purple/ white hard gelatin, self locked capsules of size '0' imprinted
with ‘RANBAXY' in black
edible ink on both cap and body containing white to off white powder,
containing 200 mg of
Fluconazole.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OZOLE (fluconazole) capsules, given orally, are indicated for the
following conditions:
-
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.
Ozole_PI_V4_30 Nov 18
Page 1 of 23
-
Maintenance therapy to prevent relapse of cryptococcal meningitis in
patients with
AIDS.
-
Treatment
of
oropharyngeal
and
oesophageal
candidiasis
in
AIDS
and
other
immunosuppressed patients.
-
Secondary prophylaxis of oropharyngeal candidiasis in patients with
HIV infection.
-
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
amp