Oxytrol

DRUG DESCRIPTION

OXYTROL, oxybutynin transdermal system, is designed to deliver oxybutynin continuously and consistently over a 3- to 4-day interval after application to intact skin.

OXYTROL is available as a 39 cm? 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 (interindividual 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-diethylamino2-butynyl 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.

Transdermal System Components

OXYTROL (oxybutynin transdermal) is a matrix-type transdermal system 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 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 (oxybutynin transdermal) system. (Not to scale)
Side View

Side view of the OXYTROL system - Illustration

Top View

Top view 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 any of these serious side effects:

  • fever with hot, dry skin;
  • uneven heart rate;
  • pain, burning, or other difficulty when urinating; or
  • severe itching, burning, or blistering that does not clear up within several hours after removing the skin...

Read All Potential Side Effects and See Pictures of Oxytrol »

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.

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, severe blockage/slowed movement of the stomach/intestines (e.g., gastric retention, paralytic ileus), certain bladder problems (urinary retention), uncontrolled glaucoma (narrow-angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (bladder outflow obstruction), certain...

Read All Potential Precautions of Oxytrol »


Oxytrol Consumer (continued)

SIDE EFFECTS: Skin redness/itching/irritation at the application site, dry mouth, drowsiness, dizziness, blurred vision, headache, weakness, nausea or constipation 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 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).

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: vision problems, difficulty urinating, signs of kidney infection (e.g., burning/painful/frequent urination, lower back pain), fast/irregular heartbeat, mental/mood changes, fever, flushed/hot/dry skin.

Tell your doctor immediately if any of these rare but very serious side effects occur: eye pain, signs of stomach/intestinal blockage (e.g., severe stomach pain, persistent nausea/vomiting, severe 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 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.

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, severe blockage/slowed movement of the stomach/intestines (e.g., gastric retention, paralytic ileus), certain bladder problems (urinary retention), uncontrolled glaucoma (narrow-angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (bladder outflow obstruction), certain muscle disease (myasthenia gravis), stomach/intestinal disease (e.g., acid reflux, hiatal hernia, ulcerative colitis, intestinal atony), heart problems (e.g., coronary artery disease, congestive heart failure, arrhythmias), high blood pressure, liver disease, kidney disease, loss of mental abilities (dementia), overactive thyroid (hyperthyroidism), enlarged prostate, certain nervous system disorder (autonomic neuropathy).

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 medication can cause decreased sweating. Avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities since heatstroke may occur.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side 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 medication passes into breast milk. Consult your doctor before breast-feeding.


Oxytrol Patient Information Including Side Effects

Brand Names: Oxytrol

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

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

What is oxybutynin transdermal (Oxytrol)?

Oxybutynin reduces muscle spasms of the bladder and urinary tract.

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

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

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 any of these serious side effects:

  • fever with hot, dry skin;
  • uneven heart rate;
  • pain, burning, or other difficulty when urinating; or
  • severe itching, burning, or blistering that does not clear up within several hours after removing the skin patch.

Less serious side effects may include:

  • mild skin itching, burning, redness, or discoloration where a patch was worn;
  • dizziness, drowsiness, weakness;
  • blurred vision;
  • dry mouth;
  • warmth, tingling, or redness under your skin;
  • nausea, vomiting, stomach pain;
  • constipation or diarrhea;
  • dry eyes;
  • stuffy nose;
  • back pain;
  • feeling restless; or
  • sleep problems (insomnia).

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 transdermal (Oxytrol)?

Do not use this medication if you are allergic to oxybutynin, or if you have uncontrolled glaucoma, a blockage in your stomach or intestines, or if you are unable to urinate.

Oxybutynin can cause blurred vision, drowsiness, or dizziness. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid drinking alcohol. It can increase some of the side effects of oxybutynin.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids to keep yourself hydrated while you are using oxybutynin.

Do not expose the oxybutynin transdermal patch to sunlight. It should be worn under clothing.

Related Drug Centers
  • Oxytrol


Related Drugs Index: