Oxytrol

What is Oxytrol used for?

Oxytrol is a prescription medicine that is used to treat an overactive bladder. Oxytrol may be given to you for other reasons.

Description

OXYTROL (oxybutynin transdermal system) is designed to deliver oxybutynin over a 3- to 4-day 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-2-butynyl phenylcyclohexylglycolate. The empirical formula of oxybutynin is C22H31NO3. Its structural formula is:

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.

Before taking Oxytrol, tell your doctor:

• If you are allergic to Oxytrol; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Bowel block, glaucoma, myasthenia gravis, slow moving GI (gastrointestinal) tract, or trouble passing urine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Oxytrol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Oxytrol?

• Tell all of your health care providers that you take Oxytrol. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Oxytrol affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help with dry mouth. See a dentist often.
• A very bad reaction called angioedema has happened with Oxytrol. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if you have any of these signs.
• If you are 65 or older, use Oxytrol with care. You could have more side effects.
• Some forms of Oxytrol may not be for use in all ages of children. If you have questions, talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

What are the side effects of Oxytrol that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Very bad dizziness or passing out.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Feeling agitated.
• Mood changes.
• Fever.
• Not sweating during activities or in warm temperatures.
• Trouble passing urine.
• Very bad belly pain.
• Muscle weakness.

What are some other side effects of Oxytrol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Blurred eyesight.
• Headache.
• Upset stomach.
• Diarrhea or constipation.
• Dry mouth.
• Trouble sleeping.
• Feeling nervous and excitable.
• Irritation where Oxytrol is used.
• Redness.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Oxytrol?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Store in pouch until ready for use.
• Use right after opening.
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Instructions for Use

OXYTROL
(OKSEE TROLE)
(oxybutynin transdermal system)

Read this Instructions for Use that comes with your OXYTROL before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

Where to apply OXYTROL:

• Put the patch on a clean, dry, and smooth (fold-free) area of skin on your abdomen (stomach area), hips or buttocks. See Figure A.
• Avoid your waistline area, since tight clothing may rub against the patch.
• The areas you choose should not be oily, damaged (cut or scraped), irritated (rashes) or have any other skin problems.
• Do not put OXYTROL on areas that have been treated with oils, lotions, or powders that could keep the patch from sticking well to your skin.
• When you put on a new patch, use a different area of skin from the most recent patch site. You may find it useful to change the site from one side of your body to the other.
• Do not use the same area for the patch for at least 7 days. You may choose to try different sites when using OXYTROL to find the sites that are most comfortable for you and where clothing will not rub against it.

Figure A

How to apply OXYTROL:

Step 1.

• Each patch is sealed in its own protective pouch. See Figure B.
• When you are ready to put on your OXYTROL patch, tear open the pouch and remove the patch.
  See Figure C.

Figure B

Figure C

Step 2.

• The sticky adhesive side of the patch is covered by 2 strips of overlapping protective liner. See Figure D.
• Remove the first piece of the protective liner and place the patch, adhesive face down, firmly onto the skin. See Figure E.

Figure D

Figure E

Step 3.

• Bend the patch in half and gently roll the remaining part onto your skin using the tips of your fingers. As you roll the patch in place, the second piece of the protective liner should come off the patch. See Figure F.
• Apply firm pressure over the surface of the patch with your fingers to make sure the patch stays on. See Figure G.
• When putting on the patch, avoid touching the sticky adhesive side.
• Touching the adhesive may cause the patch to fall off early.
• Throw away the protective liners.
• If the patch partly or completely falls off, press it back in place and continue to follow your application schedule.
• If the patch does not stay on, throw it away. Put on a new patch on a different area of skin, and continue to follow your original application schedule.
• If you forget to change your patch after 3 or 4 days, remove the old patch, put on a new patch in a different area of skin and continue to follow your original application schedule.

Figure F

Figure G

How to remove Oxytrol:

• When changing your OXYTROL patch, remove the old patch slowly and carefully to avoid damaging your skin.
• After the old patch is removed, fold it in half with the sticky sides together.
• The patch will still contain some oxybutynin. Throw the patch away so that it cannot be worn or swallowed by another person, child, or pet.
• Gently wash the application site with warm water and a mild soap to remove any adhesive that stays on your skin after removing the patch.
• A small amount of baby oil may also be used to remove any adhesive remaining on your skin. Rings of adhesive that become dirty may need a medical adhesive removal pad that you can get from your pharmacist.
• Alcohol or other dissolving liquids (nail polish remover or other solvents) may cause skin irritation and should not be used.

Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL