LOZANOC itraconazole 50 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

itraconazole, Quantity: 50 mg

Available from:

Mayne Pharma International Pty Ltd

INN (International Name):

Itraconazole

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: sodium starch glycollate type A; titanium dioxide; brilliant blue FCF; hypromellose phthalate; silicon dioxide; magnesium stearate; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

60, 15, 7, 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Superficial mycoses: LOZANOC is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and Pityriasis versicolor. Systemic mycoses: Lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. Consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see PHARMACOLOGY).

Product summary:

Visual Identification: light blue opaque capsule with i-50 printed in black on the cap; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-16

Patient Information leaflet

LOZANOC
®
50MG CAPSULES
1
LOZANOC
® 50MG CAPSULES
_itraconazole _
CONSUMER MEDICINE INFORMATION
WARNING: LOZANOC HAS A HIGHER ABSORPTION THAN OTHER ITRACONAZOLE
CAPSULES. ONE CAPSULE OF LOZANOC 50 MG IS
THERAPEUTICALLY EQUIVALENT TO ONE 100 MG CAPSULE OF CONVENTIONAL
ITRACONAZOLE CAPSULES. LOZANOC 50MG CAPSULES AND
CONVENTIONAL ITRACONAZOLE 100MG CAPSULES ARE NOT INTERCHANGEABLE.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LOZANOC
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 LOZANOC
Capsules against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING LOZANOC CAPSULES, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LOZANOC
®
CAPSULES ARE USED FOR
LOZANOC Capsules are used to
treat certain fungal infections which
include the following:
•
persistent infections of the nails,
skin, hands, feet or groin;
•
persistent candida (yeast)
infections of the vagina;
•
eye infections which have not
responded to other treatment or
which may be affecting vision;
•
candida (yeast) infections of the
mouth or throat in patients with
lower resistance to disease;
•
generalised infections.
LOZANOC works by killing or
stopping the growth of the fungus
that causes the 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 reason.
BEFORE YOU TAKE
LOZANOC
® CAPSULES
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LOZANOC CAPSULES
IF:
•
you have an allergy to
LOZANOC Capsules or any of
the ingredients (see Product
Description at the end of this
Leaflet).
•
you have a condition called heart
failure (also called congestive
heart failure or CHF),
LOZANOC could make it worse.
•
you are pregnant or may become
pregnant.
If there is a chance yo

Summary of Product characteristics

v 4.0
1
AUSTRALIAN PRODUCT INFORMATION
LOZANOC (ITRACONAZOLE) CAPSULES
1.
NAME OF THE MEDICINE
Itraconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in LOZANOC is itraconazole. LOZANOC is available
as capsules
containing 50 mg of suprabioavailable itraconazole.
Itraconazole is a synthetic triazole antifungal agent.
For the full list of excipients, see
_section 6.1 List of Excipients_
.
3.
PHARMACEUTICAL FORM
LOZANOC are powder-filled capsules consisting of a blend of
itraconazole spray-dried
powder and excipients, encapsulated into hard gelatin capsules.
The capsules are light blue with
_i-_
50 printed in black on the cap.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Superficial mycoses
LOZANOC is indicated – if external treatment is not effective or not
appropriate – for the
treatment of the following fungal infections: dermatomycoses (e.g.
tinea corporis, tinea
cruris, tinea pedis, tinea manus, onychomycosis) and pityriasis
versicolor.
Systemic mycoses
LOZANOC is indicated for the treatment of systemic mycoses, such as
candidiasis,
aspergillosis, and histoplasmosis.
WARNING: LOZANOC HAS A HIGHER BIOAVAILABILITY THAN OTHER ITRACONAZOLE
CAPSULES.
ONE CAPSULE OF LOZANOC 50 MG IS THERAPEUTICALLY EQUIVALENT TO ONE 100
MG CAPSULE
OF CONVENTIONAL ITRACONAZOLE CAPSULES. THE RECOMMENDED DOSE FOR
LOZANOC IS
THEREFORE HALF THE RECOMMENDED DOSE FOR CONVENTIONAL ITRACONAZOLE
CAPSULES.
LOZANOC 50 MG CAPSULES AND CONVENTIONAL ITRACONAZOLE 100 MG CAPSULES
ARE NOT
INTERCHANGEABLE.
v 4.0
2
Consideration should be given to official guidance on the appropriate
use of antimycotic
agents, and to the discussion of the pharmacodynamic properties (see
_section 5.1 _
_Pharmacodynamic Properties_
).
4.2.
DOSE AND METHOD OF ADMINISTRATION
LOZANOC is for oral administration and can be taken with or without
food.
One capsule of LOZANOC 50 mg is therapeutically equivalent to one 100
mg capsule of
conventional itraconazole capsules. The recommended dose for LOZANOC
is therefore half
the recommended dose fo