Ditropan XL

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; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using oxybutynin and call your doctor at once if you have any of these serious side effects:

  • hot, dry skin and extreme thirst;
  • severe stomach pain or constipation;
  • pain or burning when you urinate; or
  • urinating less than usual or not at all.

Less serious side effects may include:

    ...

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 »


Ditropan XL Consumer (continued)

SIDE EFFECTS: Dry mouth, drowsiness, headache, dizziness, nausea, vomiting, upset stomach, stomach pain, constipation, diarrhea, blurred vision, dry eyes, unusual taste in mouth, dry/flushed skin, stuffy nose, and cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. To relieve dry eyes, use artificial tears or other eye lubricants. Consult your pharmacist for further advice.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (e.g., stimulant-type with stool softener).

For certain products of this drug, an empty tablet shell may appear in your stool. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual activity, difficulty urinating, fast/pounding heartbeat, signs of kidney infection (e.g., burning/painful/frequent urination, lower back pain, fever), mental/mood changes, swelling of arms/legs/ankles/feet, vision problems (including eye pain).

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, stomach/intestinal blockage (e.g., persistent nausea/vomiting, prolonged constipation).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 blockage), certain muscle disease (myasthenia gravis), heart disease (e.g., congestive heart failure, coronary artery disease, arrhythmias), high blood pressure, liver disease, kidney disease, loss of mental abilities (dementia), certain nervous system disorder (autonomic neuropathy), enlarged prostate gland (benign prostatic hypertrophy-BPH), stomach/intestinal disease (e.g., acid reflux disease, hiatal hernia, ulcerative colitis), severe throat/stomach/intestinal narrowing (strictures), overactive thyroid (hyperthyroidism).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug may increase the risk for heatstroke because it causes decreased sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Ditropan XL Patient Information Including Side Effects

Brand Names: Ditropan, Ditropan XL, Urotrol

Generic Name: oxybutynin (oral) (Pronunciation: OX i BUE ti nin)

  • What is oxybutynin (Ditropan XL)?
  • What are the possible side effects of oxybutynin (Ditropan XL)?
  • What is the most important information I should know about oxybutynin (Ditropan XL)?
  • What should I discuss with my healthcare provider before using oxybutynin (Ditropan XL)?
  • How should I use oxybutynin (Ditropan XL)?
  • What happens if I miss a dose (Ditropan XL)?
  • What happens if I overdose (Ditropan XL)?
  • What should I avoid while using oxybutynin (Ditropan XL)?
  • What other drugs will affect oxybutynin (Ditropan XL)?
  • Where can I get more information?

What is oxybutynin (Ditropan XL)?

Oxybutynin reduces muscle spasms of the bladder and urinary tract.

Oxybutynin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased night-time urination.

Oxybutynin may also be used for other purposes not listed in this medication guide.

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

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 and call your doctor at once if you have any of these serious side effects:

  • hot, dry skin and extreme thirst;
  • severe stomach pain or constipation;
  • pain or burning when you urinate; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth;
  • dry eyes, blurred vision;
  • mild constipation;
  • diarrhea;
  • nausea, mild stomach pain or upset;
  • dizziness, drowsiness, weakness;
  • headache;
  • sleep problems; or
  • runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oxybutynin (Ditropan XL)?

You should not use this medication if you are allergic to oxybutynin, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using oxybutynin, tell your doctor if you have glaucoma, liver or kidney disease, an enlarged prostate, myasthenia gravis, ulcerative colitis, a blockage in your stomach or intestines, or a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Oxybutynin can decrease perspiration and you may be more prone to heat stroke.

Oxybutynin can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

There are many other medicines that can interact with oxybutynin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, extreme thirst, severe stomach pain or constipation, pain or burning when you urinate, or if you stop urinating.

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