Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Oxybutynin 36mg
Teva Pharma (New Zealand) Limited
Oxybutynin 36 mg
3.9 mg/24h
Transdermal patch
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
Sachet, (Barex/Al) LDPE/paper laminate, 2 patches
Prescription
Prescription
Siegfried Evionnaz SA
The treatment of overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms.
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).
2006-04-05
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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument