Apo-Ciclopirox

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ciclopirox 8%{relative}

Available from:

Apotex NZ Ltd

INN (International Name):

Ciclopirox 8% w/w

Dosage:

8% w/w

Pharmaceutical form:

Nail lacquer

Composition:

Active: Ciclopirox 8%{relative} Excipient: Ethyl acetate Gantrez ES-435 Isopropyl alcohol

Units in package:

Bottle, glass, 9 mL; fill volume, 6.6 mL

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

PCAS Finland Oy

Therapeutic indications:

APO-CICLOPIROX is indicated for the topical treatment of fungal infections of the nails, caused by dermatophytes, yeasts or moulds, including tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporumcanis, candidiasis due to Candida albicans and tinea (pityriasis) versicolor due to Malassezia furfur.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 9 mL; fill volume - 6.6 mL - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2008-10-22

Patient Information leaflet

New Zealand Consumer Medicine Information
APO-CICLOPIROX
_CICLOPIROX USP _
8% w/w Nail Lacquer (Topical Solution)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Ciclopirox.
This leaflet answers some common questions about Apo-Ciclopirox. 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 using
Apo-Ciclopirox against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT APO-CICLOPIROX IS USED FOR
Apo-Ciclopirox contains ciclopirox, which is an antifungal agent.
Apo-Ciclopirox is
used to treat fungal infections of the nails, caused by dermatophytes,
yeasts or
moulds, including tinea pedis, tinea cruris and tinea corporis.
Your doctor may have prescribed Apo-Ciclopirox for another reason.
Ask your doctor if you have any questions about why Apo-Ciclopirox has
been
prescribed for you.
BEFORE YOU USE APO-CICLOPIROX
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE APO-CICLOPIROX IF YOU ARE ALLERGIC TO IT OR ANY OF THE
INGREDIENTS
LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic
reaction include skin
rash, itching, shortness of breath or swelling of the face, lips or
tongue, which may
cause difficulty in swallowing or breathing.
DO NOT GIVE APO-CICLOPIROX TO A CHILD.
DO NOT USE IT IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. It may
affect
your developing baby if you use it during pregnancy.
DO NOT USE IT IF YOU ARE BREAST-FEEDING OR PLANNING TO BREAST-FEED.
Apo-Ciclopirox
may pass into breast milk and there is a possibility your baby may be
affected.
DO NOT USE IT AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. If you
use it after
the expiry date has passed, it may not work as well.
DO NOT USE IT IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING.
If you are not sure whether

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-CICLOPIROX
1.
APO-CICLOPIROX (8% W/W NAIL LACQUER)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CICLOPIROX 8% W/W
Chemical Structure:
Chemical Name: 6-cyclohexyl-1-hydroxy-4-methyl-2-(1H) pyridine.
Empirical Formula: C
12
H
17
NO
2
Molecular Weight: 207.3
CAS No.: 29342-05-0
Ciclopirox is a white to slightly yellowish-white, crystalline powder
which is odourless to almost
odourless. It is freely soluble in dichloromethane and ethanol 96%,
very soluble in chloroform, soluble
in ether and slightly soluble in water. The pKa value is 7.2.
Excipient(s) with known effect
APO-CICLOPIROX is lactose free and gluten free.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
APO-CICLOPIROX 8% w/w nail lacquer is a clear, colourless to slightly
yellowish solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-CICLOPIROX is indicated for the topical treatment of fungal
infections of the nails, caused by
dermatophytes, yeasts or moulds, including tinea pedis, tinea cruris
and tinea corporis due to
_Trichophyton _
_rubrum_,
_Trichophyton _
_mentagrophytes_,
_Epidermophyton _
_floccosum_
and
_Microsporumcanis_, candidiasis due to _ Candida albicans_ and tinea
(pityriasis) versicolor due to
_Malassezia furfur_.
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 9
APO-CICLOPIROX
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULTS
1.
Before starting treatment, remove any loose nail or nail pieces using
nail clippers or nail files. If
you have diabetes or problems with numbness in your toes or fingers,
talk to your doctor before
trimming your nails or removing any nail pieces.
2.
Apply APO-CICLOPIROX every other day for the first month (bedtime is
best) to all affected nails
with the applicator brush provided. Application may be reduced to not
less than twice weekly in the
second month of treatment and to once weekly from the third month of
treatment. Apply APO-
CICLOPIROX evenly over the entire nail and the skin right around the
nail. Wh