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Ditropan XL

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Ditropan XL

DITROPAN XL®
(oxybutynin chloride) Extended Release Tablets

DRUG DESCRIPTION

DITROPAN XL® (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL® Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers.

Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3•HCl. Its structural formula is:

DITROPAN XL® (oxybutynin chloride) Structural Formula Illustration

Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis.

DITROPAN XL® also contains the following inert ingredients: cellulose acetate, hypromellose, lactose, magnesium stearate, polyethylene glycol, polyethylene oxide, synthetic iron oxides, titanium dioxide, polysorbate 80, sodium chloride, and butylated hydroxytoluene.

System Components and Performance

DITROPAN XL® uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the push layer to expand. This expansion pushes the suspended drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of DITROPAN XL® depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.

What are the possible side effects of oxybutynin (Ditropan, Ditropan XL, Urotrol)?

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

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

  • hot, dry skin and extreme thirst;
  • severe stomach pain or constipation;
  • blurred vision, eye pain, or seeing halos around lights;
  • pain or burning when you urinate; or
  • urinating less than usual or not at all.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Ditropan XL »

What are the precautions when taking oxybutynin chloride extended release tablets (Ditropan XL)?

Before taking 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active internal bleeding, untreated/uncontrolled glaucoma (narrow-angle), severe blockage/slowed movement of stomach/intestines (e.g., gastric retention, paralytic ileus), decreased bladder emptying activity (urinary retention).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bladder disease (e.g., bladder outflow...

Read All Potential Precautions of Ditropan XL »

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

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Ditropan XL - User Reviews

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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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