ORIVATE (OXYTROL) INDICATIONS
Orivate (oxybutynin) reduces muscle spasms of the bladder and urinary tract.
Orivate transdermal skin patch is used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased nighttime urination.
Orivate may also be used for purposes not listed in this medication guide.
ORIVATE (OXYTROL) INSTRUCTIONS
Use Orivate exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Orivate comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
To use the Orivate patch, open the sealed pouch and remove the protective liner. Apply the transdermal patch to a clean, dry area on your stomach, hip or buttock. Avoid skin that is oily, irritated, or damaged. Avoid placing the patch on a skin area that will be rubbed by a waistband or tight clothing.
Press the Orivate patch onto the skin and press it down firmly with your fingers. Make sure the patch is well sealed around the edges. When properly applied, the patch should stay on while swimming or bathing.
Leave the Orivate patch in place and wear it for 3 to 4 days. You should change the patch twice per week. Each time you apply a new patch, choose a different skin area on your stomach, hip, or buttock. Do not apply a patch to the same skin twice within one week.
Try to change your Orivate patch on the same two days each week (such as every Sunday and Thursday). There is a calendar printed on the package of this medication to help you establish a steady patch-changing schedule.
If the patch falls off, try sticking it back on. If it does not stay on, replace it with a new one and wear it until your next regular patch-changing day. Do not change your schedule, even if you apply a new patch to replace one that has fallen off.
After removing an Orivate patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.
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.
The Orivate patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test. Keep the Orivate patch in its sealed pouch until you are ready to use it.
ORIVATE (OXYTROL) STORAGE
ElderlyThe elimination half-life is increased in the elderly. Therefore, a dose of 2.5mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5mg two times a day to obtain a clinical response provided the side effects are well tolerated.
Children (under 5 years of age):Not recommended.
Children (over 5 years of age):Neurogenic bladder instability: the usual dose is 2.5mg twice a day. This dose may be titrated upwards to 5mg two or three times a day to obtain a clinical response provided the side effects are well tolerated. Nocturnal enuresis: the usual dose is 2.5mg twice a day. This dose may be titrated upwards to 5mg two or three times a day to obtain a clinical response provided the side effects are tolerated. The last dose should be given before bedtime.
ORIVATE (OXYTROL) STORAGE
Store this medicine at room temperature in a tightly-closed container, away from heat and light.
ORIVATE (OXYTROL) MORE INFO:
Do not use Orivate if you are allergic to oxybutynin, or if you have:
untreated or uncontrolled glaucoma;
a blockage in your digestive tract (stomach or intestines); or
if you have decreased urination or are unable to urinate.
To make sure you can safely use Orivate, tell your doctor if you have any of these other conditions:
an enlarged prostate;
an intestinal disorder, such as ulcerative colitis; or
a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion.
FDA pregnancy category B. Orivate is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether oxybutynin passes into breast milk or if it could harm a nursing baby. Do not use Orivate without telling your doctor if you are breast-feeding a baby.
Important safety information:
Before using Orivate, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by oxybutynin.
Tell your doctor about all other medicines you use, especially:
atropine (Donnatal, and others);
hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);
an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek); or
antifungal medicine such as itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend).
This list is not complete and other drugs may interact with Orivate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Get emergency medical help if you have any of these signs of an allergic reaction to Orivate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Orivate and call your doctor at once if you have a serious side effect such as:
fever with hot, dry skin;
uneven heart rate;
pain or burning when you urinate;
urinating less than usual or not at all; or
severe itching, burning, or blistering that does not clear up within several hours after removing the skin patch.
Less serious Orivate side effects may include:
mild skin itching, burning, redness, or discoloration where a patch was worn;
dizziness, drowsiness, weakness;
dry eyes, blurred vision;
warmth, tingling, or redness under your skin;
nausea, vomiting, stomach pain;
constipation or diarrhea;
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.