Oxytrol Patch

Oxytrol is a patch containing oxybutynin that is placed on the abdomen, hips, or buttocks once every 3 to 4 days to reduce muscle spasms of the bladder and urinary tract. Oxytrol transdermal skin patches are used to treat symptoms of overactive bladder such as frequent or urgent urination, incontinence (urine leakage), and increased nighttime urination.

The active ingredient, oxybutynin, is dissolved in the thin layer of adhesive that sticks the patch to your skin. The Oxytrol skin patch delivers the medicine slowly and constantly through your skin and into your bloodstream for the 3 or 4 days that you wear the patch.

Oxytrol was FDA-approved on February 26, 2003.

You should not use Oxytrol if you have uncontrolled narrow-angle glaucoma, a blockage in your stomach or intestines, or if you are unable to completely empty your bladder.

You should not use Oxytrol if you are allergic to oxybutynin, or if you have:

• untreated or uncontrolled narrow-angle glaucoma;
• a stomach disorder causing delayed emptying; or
• if you are unable to completely empty your bladder.

Oxytrol is not approved for use by anyone younger than 18 years old.

To make sure Oxytrol is safe for you, tell your doctor if you have:

• trouble emptying your bladder (or you have a weak stream of urine);
• an enlarged prostate;
• a stomach disorder such as hiatal hernia, gastroesophageal reflux disease (GERD), or slow digestion;
• an intestinal disorder, such as ulcerative colitis;
• bowel obstruction, constipation;
• glaucoma;
• myasthenia gravis; or
• liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

Common Oxytrol side effects may include:

• redness, itching, or mild skin irritation where a patch was worn;
• dizziness, drowsiness;
• dry mouth;
• dry eyes, blurred vision; or
• constipation, diarrhea, decreased urination.

Serious side effects

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

Stop using this medicine and call your doctor at once if you have:

• little or no urination;
• severe constipation;
• confusion, hallucinations;
• vomiting, severe heartburn or upper stomach pain;
• pain or burning when you urinate; or
• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

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.

Use Oxytrol exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets.

• Do not take by mouth. Oxytrol is for use only on the skin.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

• Open the sealed pouch and remove the protective liner. Apply the Oxytrol patch to a clean, dry area on your stomach, hip or buttock. Avoid skin that is irritated or damaged, or skin that has been treated with oil or lotion. Avoid placing the patch on a skin area that will be rubbed by a waistband or tight clothing.
• Press the Oxytrol patch firmly into place with your fingers. You may leave the patch on while bathing, showering, or swimming.
• If an Oxytrol patch falls off, try sticking back into place. If it does not stick well, put on a new patch and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.

Leave the Oxytrol patch in place and wear it for 3 to 4 days. You should change the patch twice per week (such as every Sunday and Thursday). Use a calendar to help you keep a steady patch-changing schedule.

• Choose a different place on your skin to wear the patch each time you put on a new one. Do not use the same skin area twice within 7 days.
• Do not wear more than one Oxytrol patch at a time. Using extra skin patches will not make the medicine more effective. Do not divide or cut the patch into pieces. Damaged patches should not be used.
• Use baby oil or mild soap and water to remove any adhesive residue that stays on your skin. Avoid using harsh soaps, alcohol, nail polish remover, or other solvents that could irritate your skin.
• After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

The Oxytrol patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

If you forget to change a skin patch on your scheduled day, replace the patch as soon as you remember. Wear the new patch until your next regular patch-changing day. Do not apply two patches at the same time and do not change your patch-changing schedule.

If a patch falls off, try sticking back into place. If it does not stick well, put on a new patch and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include warmth, tingling, fever, irregular heartbeats, feeling restless, vomiting, and little or no urinating.

Do not expose the Oxytrol skin patch to sunlight. It should be worn under clothing.

Drinking alcohol can increase certain side effects of oxybutynin.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

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

Avoid getting this medicine in your eyes. If contact does occur, rinse with water.

Avoid applying lotions, powders, or oils to the skin you plan to treat with Oxytrol. These other skin products can make it harder for your skin to absorb oxybutynin, and it may not work as well.

Using Oxytrol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines, especially:

• an antidepressant;
• cold or allergy medicine that contains an antihistamine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
• medicine to treat an overactive bladder; or
• bronchodilator asthma medication.

This list is not complete. Other drugs may interact with oxybutynin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Store Oxytrol at room temperature between 68°F to 77°F (20°C to 25°C). Do not store outside the sealed pouch. Keep in a dry place.

Safely throw away used Oxytrol patches in the household trash. Be careful to prevent accidental exposure to children or pets.

Keep out of the reach of children

Active ingredients: oxybutynin Inactive ingredients: flexible polyester/ethylene-vinyl acetate film, acrylic adhesive, triacetin, siliconized polyester film.

Abbvie Inc.