Oxytrol

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Oxybutynin 36mg

Fáanlegur frá:

Teva Pharma (New Zealand) Limited

INN (Alþjóðlegt nafn):

Oxybutynin 36 mg

Skammtar:

3.9 mg/24h

Lyfjaform:

Transdermal patch

Samsetning:

Active: Oxybutynin 36mg Excipient: Duro-Tak 87-2888 Acrylic Adhesive Backing film. Scotchpak 9739 Release Liner (Grade 10393 S 3 CL PET 4400B/000) Triacetin

Einingar í pakka:

Sachet, (Barex/Al) LDPE/paper laminate, 2 patches

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Siegfried Evionnaz SA

Ábendingar:

The treatment of overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms.

Vörulýsing:

Package - Contents - Shelf Life: Sachet, (Barex/Al) LDPE/paper laminate - 2 patches - 36 months from date of manufacture stored at or below 25°C. (Do not refrigerate, do not freeze) - Sachet, (Barex/Al) LDPE/paper laminate - 8 patches - 36 months from date of manufacture stored at or below 25°C. (Do not refrigerate, do not freeze).

Leyfisdagur:

2006-04-05

Upplýsingar fylgiseðill

OXYTROL
®
1
OXYTROL
®
_Oxybutynin (Ox-y-BEWT-ee-nin) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the
OXYTROL
®
transdermal drug
delivery system (patch). 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 being given OXYTROL®against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT OXYTROL
® IS
USED FOR
OXYTROL®is a transdermal patch
that is a treatment for overactive
bladder. It delivers the active
ingredient, oxybutynin, through your
skin and into your bloodstream.
Overactive bladder makes it hard to
control when you urinate (pass
water). Overactive bladder can make
you urinate more often (increased
frequency) or make you feel the need
to urinate often (urgency). Overactive
bladder can also lead to accidental
urine loss (leaking or wetting
oneself).
The active ingredient in
OXYTROL®, oxybutynin, is
dissolved in the thin layer of adhesive
that sticks the patch to your
skin. OXYTROL®delivers the
medicine slowly and constantly
through your skin and into your
bloodstream for the three or four
days that you wear the patch.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is only available with a
doctor's prescription.
Care should be taken when driving or
operating machinery as this medicine
may cause sleepiness or blurred
vision.
There is not enough information to
recommend the use of this medicine
for children under the age of 18 years.
BEFORE YOU ARE GIVEN
OXYTROL
®
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE OXYTROL®IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
oxybutynin
•
any of the ingredients listed at

Vara einkenni

OXYTROL
®
TRANSDERMAL DRUG DELIVERY SYSTEM
NAME OF MEDICINE
Oxybutynin
The structure of oxybutynin 4-(diethylamino)but-2-ynyl
(RS)-2-cyclohexyl-2-hydroxy-
2-phenylacetate is given below. Oxybutynin is an antispasmodic,
anticholinergic
agent, and is administered as a racemate of R- and S-isomers. The
molecular weight
of the compound is 357.49 and the
CAS number is 5633-20-5.
Oxybutynin is a white
powder, soluble in alcohol, but relatively insoluble in water.
DESCRIPTION
Oxytrol
®
is a transdermal drug delivery system designed to deliver oxybutynin
continuously and consistently over a 3 to 4 day interval after
application on to intact
skin. Oxytrol
®
is available as a 39 cm
2
patch containing 36 mg of oxybutynin.
Oxytrol
®
has a nominal _in vivo_ delivery rate of 3.9 mg oxybutynin per day.
TRANSDERMAL PATCH COMPONENTS
Oxytrol
®
is a matrix-type transdermal patch composed of three layers as
illustrated in
Figure 1 below. Layer 1 (Backing Film) is a thin flexible
polyester/ethylene-vinyl
acetate film that provides the matrix patch with occlusivity and
physical integrity and
protects the adhesive/drug layer. Layer 2 (Adhesive/Drug Layer) is a
cast film of
acrylic adhesive containing oxybutynin and glycerol triacetate. Layer
3 (Release
Liner) is two overlapped siliconized polyester strips that are peeled
off and discarded
by the patient prior to applying the matrix patch.
FIGURE 1: Side and top views of Oxytrol
®
. (Not to scale)
SIDE VIEW
TOP VIEW
_PHARMACOLOGY _
The free base form of oxybutynin is pharmacologically equivalent to
oxybutynin
hydrochloride. Oxybutynin acts as a competitive antagonist of
acetylcholine at
postganglionic muscarinic receptors, resulting in relaxation of
bladder smooth
muscle. In patients with conditions characterised by involuntary
detrusor
contractions, cystometric studies have demonstrated that oxybutynin
increases
maximum urinary bladder capacity and increases the volume to first
detrusor
contraction. Oxybutynin thus decreases urinary urgency and the
frequency of both
incontinence