Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
oxybutynin, Quantity: 36 mg
Theramex Australia Pty Ltd
Oxybutynin
Drug delivery system, transdermal
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
Topical
8 patches per carton, 2 patches per carton
(S4) Prescription Only Medicine
OXYTROL is indicated for the treatment of overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms.
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
Licence status A
2007-05-10
OXYTROL ® O X Y T R O L ® v e r s i o n 2 . 0 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 Citiți documentul complet
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 Citiți documentul complet