TACROLIMUS ACT tacrolimus 5 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tacrolimus, Quantity: 5 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Tacrolimus

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: hypromellose; titanium dioxide; ethanol absolute; Gelatin; purified water; magnesium stearate; lactose; croscarmellose sodium; methyl chloride; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

50 capsules in blister pack, 10 capsules in blister pack, 100 capsules in blister pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children

Product summary:

Visual Identification: Pink / Pink hard gelatin capsules, size "4" imprinted with "TCR" on cap & "ABZ 5" on body containing white to off white granular powder.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-05-27

Patient Information leaflet

TACROLIMUS ACT
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2015- Page: 1 of 4
TACROLIMUS ACT
(TACROLIMUS CAPSULES 0.5 MG, 1 MG AND 5 MG)
_Tacrolimus (as monohydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Tacrolimus ACT. 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
Tacrolimus ACT against the
benefits this medicine is expected
to have for you.
If you have any concerns about
using Tacrolimus ACT ask your
doctor or pharmacist.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT TACROLIMUS
ACT 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.
Tacrolimus ACT stops this
attack; it is very important to take
Tacrolimus ACT 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
Tacrolimus ACT.
Tacrolimus ACT contains the
active ingredient tacrolimus,
which is an immunosuppressive
agent.
Your doctor may have prescribed
Tacrolimus ACT for another
reason. Ask your doctor if you
have any questions about why
this medicine has been
prescribed for you.
BEFORE YOU TAKE
TACROLIMUS ACT
_WHEN YOU MUST NOT USE IT _
Do not use Tacrolimus ACT if
• you have an allergy to
tacrolimus, other macrolides
(these are antibiotics of the
erythromycin family - trade
names are Eryc, EES, Klacid,
Zithromax, Rulide and Biaxsig)
or any of the ingredients
contained in the capsules. See
‘Product

Summary of Product characteristics

Tacrolimus ACT (Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg) Version 1.0
-2015- Page 1 of 21
PRODUCT INFORMATION
TACROLIMUS ACT
(TACROLIMUS CAPSULES 0.5 MG, 1 MG AND 5 MG)
NAME OF THE MEDICINE
Tacrolimus (as monohydrate)
_[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 109581-93-3
DESCRIPTION
Tacrolimus
appears
as
white
crystals
or
a
crystalline
powder,
very
soluble
in
methanol, and chloroform, freely soluble in acetone and ethanol and
practically
insoluble in hexane and water. Tacrolimus is obtained by fermentation
as a single
enantiomer but exists in tautomeric equilibration in aqueous solution.
Tacrolimus ACT capsules also contain hypromellose, croscarmellose
sodium, lactose
anhydrous and magnesium stearate. The capsule shell contains gelatin,
water-purified
and titanium dioxide and a dye (iron oxide yellow (E172) for 0.5 mg
capsules and
iron oxide red (E172) for 5 mg capsules). The capsules also have a
trace of TekPrint
SW-9008 black ink (ARPING Number: 2328), which contains shellac,
propylene
glycol, ammonia, iron oxide black and potassium hydroxide.
PHARMACOLOGY
Tacrolimus ACT (Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg) Version 1.0
-2015- Page 2 of 21
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