TOPICIL 1% SOLUTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CLINDAMYCIN PHOSPHATE

Available from:

SCHMIDT BIOMEDTECH SDN BHD

INN (International Name):

CLINDAMYCIN PHOSPHATE

Units in package:

28ml mL

Manufactured by:

DOUGLAS MANUFACTURING LTD

Summary of Product characteristics

TOPICIL
™
CLINDAMYCIN PHOSPHATE 1% TOPICAL SOLUTION USP
EQUIVALENT TO 1%W/V CLINDAMYCIN
PRESENTATION
A clear 1% alcoholic solution of clindamycin in
a 28 mL clear glass bottle with a dab-o-matic
top.
TOPICIL™
solution
contains
39.25%w/v
isopropyl alcohol.
THERAPEUTIC PROPERTIES
Clindamycin
phosphate
is
inactive
in-vitro,
however, rapid in-vivo hydrolysis releases the
active
clindamycin.
Clindamycin
has
in-vivo
activity against all isolates of Propionibacterium
acnes and activity has been demonstrated in
comedones from acne patients. It appears that
topical administration of clindamycin can also
reduce free fatty acid levels on the skin.
PHARMACOKINETICS
Clindamycin
is
absorbed
through
the
skin
after
multiple
applications
with
serum
concentrations being in the range 0-3 ng/mL.
This
represents
only
0.2%
of
the
peak
concentration
achieved
after
oral
administration of a 150 mg capsule. It has also
been shown that there is no accumulation after
multiple oral doses. Absorbed clindamycin is
widely distributed, however, it does not appear
in the CSF even in the presence of inflamed
meninges.
The
biological
half-life
is
approximately 2.5 hours although this may be
increased in the presence of severely reduced
renal
function.
Clindamycin
is
eliminated
by
metabolism to inactive metabolites.
Less than 0.25% of a dose is recovered in the
urine as clindamycin.
INDICATIONS
Treatment
of
moderate
to
severe
acne
unresponsive to non-antibiotic therapy.
ADVERSE EFFECTS
Adverse effects have been reported rarely with
topical clindamycin but include: dry skin, oily
skin,
skin
irritation,
contact
dermatitis,
eye
stinging,
gram
negative
folliculitis
and
GI
disturbances or abdominal pain occasionally
associated
with
diarrhoea,
bloody
diarrhoea
and
colitis
(including
pseudomembranous
colitis).
Since
clindamycin
may
be
absorbed
after
topical
administration,
the
following
effects
should also be noted since they have occurred
after
oral
or
parenteral
administration:
hypersensitivity
reactions
such
as
maculopapular rash and urticaria or er