OXYTROL oxybutynin 3.9 mg/day transdermal drug delivery system

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

oxybutynin, Quantity: 36 mg

Beschikbaar vanaf:

Theramex Australia Pty Ltd

INN (Algemene Internationale Benaming):

Oxybutynin

farmaceutische vorm:

Drug delivery system, transdermal

Samenstelling:

Excipient Ingredients: triacetin; ethyl acetate; povidone; 2-ethylhexyl acrylate; hexamethylene glycol dimethacrylate; cyclohexane; dilauroyl peroxide; isopropyl alcohol; dimeticonol; methicone; dibutyltin diacetate; heptane; toluene; aminoethylaminopropyl trimethoxysilane; polyethylene terephthalate; ethylene/vinyl acetate copolymer

Toedieningsweg:

Topical

Eenheden in pakket:

8 patches per carton, 2 patches per carton

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

OXYTROL is indicated for the treatment of overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms.

Product samenvatting:

Visual Identification: Patch, translucent with text "OXYTROL 3.9 mg/day" and packaged in a heat sealed sachet; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Licence status A

Autorisatie datum:

2007-05-10

Bijsluiter

OXYTROL
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details. [Include if
applicable]
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine. [Include if
applicable]
1.
WHY AM I USING OXYTROL
®
?
Oxytrol® contains the active ingredient Oxybutynin. Oxytrol
®
is used for the treatment for overactive bladder.
For more information, see Section 1. Why am I using Oxytrol®? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OXYTROL
®
?
Do not use if you have ever had an allergic reaction to Oxytrol
®
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Oxytrol®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Oxytrol
®
and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE OXYTROL
®
?
•
One new OXYTROL
®
patch should be applied two times a week (every three to four days)
according to your doctor's
instructions. Wear only one patch of OXYTROL
®
at a time.
More instructions can be found in Section 4. How do I use Oxytrol®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OXYTROL
®
?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Oxytrol
®
.
•
If you become pregnant while you are being treated with this medicine,
tell your doctor immediately
•
Keep all of your doctor's appointments so that your progress can be
checked.
DRIVING
OR USING
MACHINES
•
This medicine may cause ti

Productkenmerken

Theramex Australia Pty Ltd Version 1.1 1
AUSTRALIAN PI – OXYTROL
® (OXYBUTYNIN) TRANSDERMAL DRUG
DELIVERY SYSTEM
1
NAME OF THE MEDICINE
Oxybutynin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytrol® is available as a 39 cm
2
patch containing 36 mg of oxybutynin.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
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 triacetin.
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
Theramex Australia Pty Ltd Version 1.1 2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oxytrol® is indicated for the treatment of overactive bladder with
symptoms of urinary frequency, urgency
or incontinence or any combination of these symptoms.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Oxytrol® should be applied to dry, intact skin on the abdomen, hip,
or buttock. A new application site should
be selected with each new patch to avoid re-application to the same
site within 7 days. The dose of Oxytrol®
is one (3.9 mg/day) patch applied twice weekly (every 3 to 4 days).
Details on use of the patch are explained
in the pack insert that should be dispensed with the product.
Apply immediately after remova