Batrafen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ciclopirox 8%

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Ciclopirox 8%

Dosage:

8 %

Pharmaceutical form:

Nail lacquer

Composition:

Active: Ciclopirox 8% Excipient: Butyl ester of PVM/MA copolymer Ethyl acetate Isopropyl alcohol Nitrogen

Units in package:

Bottle, glass, 1x1.5g, 1.5 g

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 1x1.5g - 1.5 g - 24 months from date of manufacture stored at or below 25°C protect from light 6 months opened stored at or below 25°C protect from light - Bottle, glass, 1x3g - 3 g - 36 months from date of manufacture stored at or below 25°C protect from light 6 months opened stored at or below 25°C protect from light

Authorization date:

1993-04-22

Patient Information leaflet

BATRAFEN CMI LAQ NZ  
#17673v6.0 
Page 1  

Batrafen
®
 Nail Lacquer 
(bat-rar-fen)

_CICLOPIROX _
_(SICK-LOW-PIR-ROCKS)_
_ _
CONSUMER MEDICINE INFORMATION (CMI) 

BATRAFEN CMI LAQ  
#17673v6.0 
Page 2  
_ _
WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Batrafen Nail 
Lacquer. 
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 or pharmacist 
has weighed the risks of you using it 
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 BATRAFEN NAIL 
LACQUER IS USED FOR 
Batrafen Nail Lacquer is a nail 
lacquer that is painted onto the 
fingernails or toenails. Batrafen Nail 
Lacquer contains ciclopirox, which is 
an antifungal agent. Batrafen Nail 
Lacquer is used to treat fungal 
infections of the fingernails and 
toenails. 
Fungal nail infections are hard to 
treat and a full cure depends on 
several factors, including how badly 
damaged the nail is. While Batrafen 
Nail Lacquer can cure the fungal 
infection, it cannot repair the damage 
and so a full cure can be expected in 
less than one in three people. 
ASK YOUR DOCTOR OR PHARMACIST IF 
YOU HAVE ANY QUESTIONS ABOUT WHY 
IT HAS BEEN RECOMMENDED FOR YOU. 
BEFORE YOU USE IT 
_WHEN YOU MUST NOT USE IT _
DO NOT USE BATRAFEN NAIL LACQUER 
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 BATRAFEN NAIL LACQUER 
TO A CHILD OR ADOLES

Summary of Product characteristics

_Batrafen DS LAQ_
_ _
_#78118v1.0 Page _
_1 _
_ _

DATA SHEET 
BATRAFEN NAIL LACQUER 
NAME OF MEDICINE 
Ciclopirox 8% Nail Lacquer 
PRESENTATION 
Batrafen Nail Lacquer contains 80mg/g (8%) of the active
ingredient ciclopirox.  Ciclopirox is 
6-cyclohexyl-1-hydroxy-4-methyl-2-(1H) pyridone (C
12
H
17
NO
2
).  MW: 207.3. 
The chemical structure is shown below: 

CAS 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. 
The lacquer is composed of butyl ester of
PVM/MA copolymer, ethyl acetate and propyl alcohol.  
The excipients ethyl acetate and propyl alcohol are solvents
that vaporise after application. 
Batrafen Nail Lacquer is a clear, slightly yellow solution. 
USES 
ACTIONS 
Ciclopirox is a broad spectrum antimycotic with a high penetrating
power.  It has a fungicidal effect 
on dermatophytes, yeasts, moulds and other fungi. 
Ciclopirox is the free acid of ciclopiroxolamine.  Ciclopirox has
an identical spectrum of activity to 
ciclopiroxolamine.  Ciclopirox is a hydroxypyridone
derivative that is structurally unrelated to the 
imidazole derivatives or other antifungals. 
Ciclopirox has several mechanisms of action including chelation
of polyvalent metal cations 
(e.g. Fe
3+
 and Al
3+
).  It thus inhibits the metal-dependent enzymes,
including those responsible for 
the degradation of peroxides within fungal cells. 
Batrafen Nail Lacquer has been developed for the treatment of
fungal infections of the nails.  The 
active ingredient ciclopirox penetrates the nail plate and reaches
the fungal pathogen within 
48 hours of application. 
PHARMACOKINETICS 
Glucuronidation is the main metabolic pathway for ciclopirox,
which is excreted