PHARMACOR TACROLIMUS tacrolimus 1 mg capsule bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
17-08-2016
Summary of Product characteristics
(SPC)
17-08-2016
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
tacrolimus monohydrate
Available from:
Pharmacor Pty Ltd
INN (International Name):
tacrolimus monohydrate
Patient Information leaflet
________________________________________________________________________________________________
Pharmacor Tacrolimus CMI v0316
1
PHARMACOR TACROLIMUS
_TACROLIMUS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
_ _
This
leaflet
answers
some
common
questions
about
PHARMACOR
TACROLIMUS
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
PHARMACOR
TACROLIMUS
against
the
benefits this medicine is expected to have
for you.
If
you
have
any
concerns
about
using
PHARMACOR
TACROLIMUS
ask
your
doctor or pharmacist.
Keep this leaflet with your medicine. You
may need to read it again._ _
_ _
WHAT PHARMACOR
TACROLIMUS IS USED FOR
You have been given a new transplanted
liver or kidney, lung or heart from another
person
because
your
own
was
no
longer
healthy. Your body recognises that this new
organ is different from your organs and will
try to reject it by attacking it in the same
way that it would attack germs that enter
your body. This could make you become ill
again.
PHARMACOR
TACROLIMUS
stops
this
attack;
it
is
very
important
to
take
PHARMACOR TACROLIMUS
given to you
by your doctor regularly so that your new
liver,
kidney,
lung
or
heart
will
not
be
attacked or rejected.
If you have been taking other medicines for
this purpose, but are still feeling unwell,
your doctor may change your treatment and
begin
giving
you
PHARMACOR
TACROLIMUS.
PHARMACOR
TACROLIMUS
contains the
active
ingredient
tacrolimus,
which
is
an
immunosuppressive agent.
Your
doctor
may
have
prescribed
PHARMACOR
TACROLIMUS
for
another
reason. Ask your doctor if you have any
questions about why this medicine has been
prescribed for you.
BEFORE YOU USE PHARMACOR
TACROLIMUS
WHEN YOU MUST NOT USE IT
Do not use
PHARMACOR TACROLIMUS
if
you have an allergy to tacrolimus,
other
macrolides
(these
are
antibiotics
of
the
erythromycin
family – trade names are Eryc, EES,
Klacid,
Zithromax,
Rul
Read the complete document
Summary of Product characteristics
Product Information – 0316
Page 1 of 17
AUSTR 209266;209267;209268;209270;209272;209274
PHARMACOR PTY LIMITED
PHARMACOR TACROLIMUS
(TACROLIMUS CAPSULES 0.5 MG, 1 MG, 5 MG)
PRODUCT INFORMATION
NAME OF THE MEDICINE
Tacrolimus
_[3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-_
_
5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a_-hexadecahydro-5,19-dihydroxy-3-
[
2-
(4- hydroxy-
3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-
tetramethyl-8- (2-propenyl)-15,19-epoxy-3H-pyrido
[
2,1-c] [1,4] oxaazacyclotricosine-
1,7,20,21(4H,23H)- tetrone, monohydrate.
Molecular Formula: C
44
H
69
NO
12
.H
2
O
Molecular Weight: 822.03. CAS 104987-11-3
DESCRIPTION
Tacrolimus appears as white to off white powder, soluble in acetone,
chloroform and
ethyl acetate, insoluble in water. Tacrolimus is obtained by
fermentation as a single
enantiomer but exists in tautomeric equilibration in aqueous solution.
Pharmacor Tacrolimus capsules also contain hypromellose,
croscarmellose sodium, lactose
anhydrous and magnesium stearate. The capsule shell contains gelatin,
water, sodium lauryl
sulfate, titanium dioxide and colorants (ferric oxide yellow E172 for
0.5 mg capsules, and ferric
oxide red E172 for 5 mg capsules). The capsules have a trace of
printing ink (that used in the
0.5 mg and 1 mg capsules contains shellac and ferric oxide red E172;
that used in the 5 mg
capsule contain shellac, potassium hydroxide, titanium dioxide).
PHARMACOLOGY
Product Information – 0316
Page 2 of 17
AUSTR 209266;209267;209268;209270;209272;209274
Tacrolimus is a macrolide lactone with potent _in vitro _and _in vivo
_immunosuppressive activity.
Studies suggest that tacrolimus inhibits the formation of cytotoxic
lymphocytes which are
regarded as being primarily responsible for graft rejection.
Tacrolimus suppresses T-cell
activation
and
T-helper-cell-dependent
B-cell
proliferation,
as
well
as
the
formation
of
lymphokines such as interleukins-2 and -3 and gamma-interferon and the
expression of the
interleukin-2 receptor.
Read the complete document
