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Oxytrol

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Oxytrol

OXYTROL®
(oxybutynin) Transdermal System

DRUG DESCRIPTION

OXYTROL (oxybutynin) Transdermal System is designed to deliver oxybutynin over a 3- to 4day interval after application to intact skin. OXYTROL is available as a 39 cm² system containing 36 mg of oxybutynin. OXYTROL has a nominal in vivo delivery rate of 3.9 mg oxybutynin per day through skin of average permeability (inter-individual variation in skin permeability is approximately 20%).

Oxybutynin is an antispasmodic, anticholinergic agent. Oxybutynin is administered as a racemate of R- and S-isomers. Chemically, oxybutynin is d, l (racemic) 4-diethylamino-2butynyl phenylcyclohexylglycolate. The empirical formula of oxybutynin is C22H31NO3. Its structural formula is:

OXYTROL® (oxybutynin) Structural Formula Illustration

Oxybutynin is a white powder with a molecular weight of 357. It is soluble in alcohol, but relatively insoluble in water.

OXYTROL is a matrix-type transdermal system composed of three layers as illustrated in Figure 1. Layer 1 (Backing Film) is a thin flexible polyester/ethylene-vinyl acetate film that provides the matrix system 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, USP. Layer 3 (Release Liner) is two overlapped siliconized polyester strips that are peeled off and discarded by the patient prior to applying the matrix system.

Figure 1: Side and top views of the OXYTROL system. (Not to scale)

Side and top views of the OXYTROL system - Illustration

What are the possible side effects of oxybutynin transdermal (Oxytrol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using oxybutynin transdermal and call your doctor at once if you have a serious side effect such as:

  • fever with hot, dry skin;
  • uneven heart rate;
  • pain or burning when you urinate;
  • urinating less than usual or not at all; or
  • severe itching, burning, or blistering that does not clear up within several hours after removing the skin patch.

Less serious...

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What are the precautions when taking oxybutynin transdermal (Oxytrol)?

Before using oxybutynin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: active internal bleeding, blockage/slowed movement of the stomach/intestines (such as gastric retention, paralytic ileus), certain bladder problems (urinary retention, bladder outflow obstruction, stress incontinence), glaucoma (narrow-angle), a certain muscle disease (myasthenia gravis), liver disease, high blood pressure, heart problems (such as coronary artery disease, congestive heart failure, arrhythmias),...

Read All Potential Precautions of Oxytrol »

Last reviewed on RxList: 10/18/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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