ZINDACLIN clindamycin (as clindamycin phosphate) 1% topical gel tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clindamycin phosphate, Quantity: 1.188 % w/w

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Clindamycin phosphate

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: propylene glycol; sodium hydroxide; purified water; hyetellose; ethanol; zinc acetate

Administration route:

Topical

Units in package:

15 g, 30 g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zindaclin is indicated for the treatment of acne vulgaris, particularly forms in which comedones, papules and pustules predominate.

Product summary:

Visual Identification: White translucent gel; Container Type: Tube; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-09-27

Patient Information leaflet

ZINDACLIN
®
1%W/W CLINDAMYCIN (_AS CLINDAMYCIN PHOPSHATE_)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Important
information
you
should
read
before
you
use
Zindaclin.
Please read this leaflet carefully
before
you
use
Zindaclin.
It
contains
a
summary
of
the
information
about
your
medicine.
If
you
have
any
questions
about
Zindaclin,
please
ask
your
doctor
or
pharmacist.
Keep
the
leaflet
with
the
medicine
–
you
may
need
to
read it again.
REMEMBER
This medicine is only for you.
Only a doctor can prescribe it
for you. Never give it to other
people. It may harm them, even
though
their
symptoms
may
seem to be the same as yours.
WHAT IS ZINDACLIN USED FOR?
Zindaclin is used to treat acne
(spots).
Zindaclin
contains
clindamycin
phosphate which breaks down
in the skin to clindamycin which
is
an
antibiotic.
Zindaclin
reduces the number of bacteria.
This will help to stop the pores
becoming
blocked
and
new
spots
forming.
Zindaclin
may
also help to reduce the redness
of the spots you already have.
As
with
other
products
it
will
take some time before you see
your acne improving.
Acne is an extremely common
skin
condition.
During
adolescence
grease
glands
in
the skin produce extra grease in
response to normal amounts of
sex hormones in your body and
this can cause blocked pores
(i.e.
blackheads).
When
this
happens the pores are invaded
by bacteria.
This produces chemicals which
go into deeper parts of the skin
to produce red spots filled with
pus. In some people acne starts
or continues after adolescence.
BEFORE YOU USE ZINDACLIN
_Is _
_there _
_any _
_reason _
_for _
_not _
_being given Zindaclin? _
_ _
Make sure it is safe for you to
use Zindaclin.
_If you answer ‘YES’ to any of _
_the following questions, or you _
_are not sure, please tell your _
_doctor or pharmacist. _
•
Have you ever had a
rash or other allergic
reaction to Zindaclin,
any of its ingredients
(listed
above)
or
lincomycin
(another
antibiotic)? An allergic
reaction may include
a
rash,
red
skin,
itching,
swelling
or
breathing difficulties.

Summary of Product characteristics

110919 Zindaclin PI v2
Page 1 of 7
ZINDACLIN: PRODUCT INFORMATION
NAME OF THE DRUG:
_ _
Clindamycin phosphate
Clindamycin phosphate is a water soluble ester of the semi-synthetic
antibiotic produced by a 7(S)-
chloro-substitution of the 7(R)hydroxyl group and phosphorylation of
the C(2)-OH group of the
parent antibiotic lincomycin. It is a white to off-white, odourless,
hygroscopic, crystalline powder,
found to be soluble in water, slightly soluble in dehydrated alcohol,
sparingly soluble in acetone,
and practically insoluble in chloroform and ether.
The chemical name for clindamycin phosphate is methyl
7-chloro-6,7,8-trideoxy -6-(1-methyl-
_trans_
-4-propyl-
L
-2-pyrrolidinecarboxamido)-1-thio-
L
-
_threo_
-(-D-
_galacto_
-octopyranoside-2-
_O_
-
dihydrogen
phosphate).
It
has
a
molecular
weight
of
504.96,
and
the
molecular
formula
is
C
18
H
34
ClN
2
0
8
PS
OH
OH
O
SCH
3
HO
O
OH
H
O
H
H
H
H
H
H
C
3
H
7
CH
3
N
C
NH
CH
3
C
C
H
H
Cl
H
H
O
H
P
H
CAS Number: 24729-96-2
DESCRIPTION:-
White, translucent gel. 1g of gel contains 11.88mg clindamycin
phosphate equivalent to 10.00mg
clindamycin (1% w/w).
Excipients:
Propylene
glycol,
Purified
water,
Ethanol
96%,
Zinc
acetate
dihydrate,
Hydroxyethylcellulose, Sodium hydroxide 30% (w/w)
PHARMACOLOGY:-
_PHARMACODYNAMICS _
_ _
Pharmacotherapeutic group: Antiinfectives for treatment of acne ATC
code: D10A F01
ZINDACLIN contains clindamycin phosphate which is hydrolysed in the
skin to the active
constituent clindamycin. Clindamycin is a lincosamide antibiotic with
primarily bacteriostatic
110919 Zindaclin PI v2
Page 2 of 7
action against Gram positive aerobes and wide range of anaerobic
bacteria.
_In vitro_
, Clindamycin
MIC was 0.4 µg/mL against
_P.acnes_
. Cross resistance has been shown between clindamycin and
erythromycin.
When clindamycin phosphate is applied cutaneously, clindamycin is
found in comedone samples at
sufficient levels to be active against most strains of
Propionibacterium (
_P. acnes_
). It thus reduces
the number of surface and follicular
_P.acnes,_
one of th