Oxytrol Medication Information:
Oxytrol medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.
Oxytrol 36 mg
Oxytrol patches 36 mg
What is OXYTROL?
OXYTROL is a transdermal system (skin patch) to treat overactive bladder. OXYTROL delivers the medicine slowly and constantly through your skin and into your bloodstream for the 3 or 4 days that you wear the patch.
Overactive bladder makes it hard to control when you urinate (pass water). Overactive bladder can make you urinate more often (increased frequency) or make you feel the need to urinate often (urgency). Overactive bladder can also lead to accidental urine loss (leaking or wetting oneself).
What are the ingredients for Oxytrol of OXYTROL?
OXYTROL contains the same active medicinal ingredient (oxybutynin) as oxybutynin tablets and syrup. The oxybutynin in OXYTROL is dissolved in the thin layer of adhesive that sticks the patch to your skin. This layer contains acrylic adhesive and triacetin in addition to the oxybutynin medicinal ingredient. A second layer, on top of the adhesive layer, is made of a polyester/ethylene-vinyl acetate film. This outer layer protects the adhesive drug layer from moisture and damage when you are wearing the patch. The unused OXYTROL System also contains a third layer made of siliconized polyester which you will peel off and discard before applying your patch.
Who should not use OXYTROL?
Do not use OXYTROL if you have the following medical conditions:
Urinary retention. Your bladder does not empty or does not empty completely when you urinate.
Gastric retention. Your stomach empties slowly or incompletely after a meal.
Uncontrolled narrow-angle glaucoma (high blood pressure in your eye). Tell your doctor if you have glaucoma or a family history of glaucoma.
Pregnancy or breastfeeding. Tell your doctor if you are pregnant, or become pregnant, or are breastfeeding. OXYTROL may not be right for you.
Allergy to oxybutynin or the inactive ingredients in OXYTROL. See What are the ingredients of OXYTROL? If you have had allergies to medical tape products or other skin patches, tell your doctor.
If you have certain other medical conditions, use OXYTROL with caution. Tell your doctor about all your medical conditions, especially if you have any of the following:
Bladder obstruction (blockage)
Gastrointestinal obstruction (blockage in the digestive system)
Ulcerative colitis (inflamed bowels)
Myasthenia gravis (nerve weakness)
Reduced gastrointestinal motility (chronic constipation)
Gastric reflux disease (heartburn) or esophagitis (inflamed esophagus, the tube between your mouth and stomach), and/or if you are taking drugs that may worsen esophagitis such as biphosphonates (a type of bone loss preventing drug)
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and supplements. Some of them may cause problems if you take OXYTROL. Also OXYTROL may affect how some of them work.
What should I avoid while using OXYTROL?
Do not expose the patch to sunlight. Therefore wear it under clothing.
What are the possible side effects for Oxytrol of OXYTROL?
You may see mild redness at the site when a patch is removed. This redness should disappear within several hours after removing the patch. If uncomfortable irritation or excessive itchiness continues, tell your doctor.
Oxybutynin may cause sleepiness or blurred vision, so be careful when driving or operating machinery. In addition, sleepiness may be increased by drinking alcohol (beer, wine or hard liquor). Oxybutynin therapy has also been associated with skin rash, painful urination, nausea, abdominal pain, back pain, and fatigue.
Since oxybutynin treatment may decrease sweating, you may overheat or have fever or heat stroke if you are in warm or hot temperatures.
The most common side effects of OXYTROL are skin reactions where the patch is put on. These include itching and redness. Other side effects include dry mouth, constipation, abnormal vision and headache. If you take other medicines that cause dry mouth, constipation, or sleepiness, OXYTROL can increase those effects.
These are not all the side effects of OXYTROL. For a complete list, ask your doctor or pharmacist.
How should I use OXYTROL?
(See package insert for illustrations.) Put on a new patch of OXYTROL 2 times a week (every 3 to 4 days) according to your doctor's instructions. Wear the patch all the time until it is time to apply a new one. Wear only 1 patch of OXYTROL at a time. Try to change the patch on the same 2 days each week. Your package of OXYTROL has a calender checklist printed on the back to help you remember your schedule. Mark the schedule you plan to follow. Always change OXYTROL on the 2 days of the week you mark on the calender.
Put the patch on a clean, dry and smooth (fold-free) area of skin on your abdomen (stomach area), hips or buttocks (as shown in the picture). 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 1 week. You may wish to try different locations when using OXYTROL to find the locations that are most comfortable for you and where clothing will not rub against it.
Each patch is sealed in its own protective pouch. When you are ready to put on the OXYTROL patch, tear open the pouch and remove the patch. Apply the patch to your skin right away. Do not keep or store the patch outside the sealed pouch.
The sticky adhesive side of the patch is covered by 2 strips of overlapping protective liner. Remove the first piece of the protective liner and place the patch, adhesive face down, firmly on to the skin.
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 move off the patch. Apply firm pressure over the surface of the patch with your fingers to make sure the patch stays on. 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.
Contact with water when you are bathing, swimming, showering or exercising will not change the way that OXYTROL works. However, try to avoid rubbing the patch area during these activities.
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. You should then put on a new patch in a different area, but 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 and continue to follow your original application schedule.
When changing OXYTROL, remove the old patch slowly and carefully avoid damaging the skin. Once off, fold the patch in half with the sticky sides together and insert the used patch into the newly opened pouch of the replacement system. Since the patch will still contain some oxybutynin, throw it away so that it cannot be accidentally worn or swallowed by another person, especially a child, or a pet.
Gently washing the application site with warm water and a mild soap should 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 excess residue. Rings of adhesive that become dirty may require 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.
Store at room temperature, 25°C. Temporary storage between 15 and 30°C is also permitted. Keep OXYTROL and all medications in a safe, secure place and out of the reach of children.
Information for the Patient
Oxybutynin acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In patients with overactive bladder, characterized by detrusor muscle instability or hyperreflexia, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction. Oxybutynin thus decreases urinary urgency and the frequency of both incontinence episodes and voluntary urination.
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The R-isomer of oxybutynin shows greater selectivity for the M3 and M1 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue). The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in in vitro studies.
OXYTROL (oxybutynin transdermal system) is designed to deliver oxybutynin continuously and consistently over a 3 to 4-day time interval after application to intact skin. The OXYTROL system has a skin contact surface area of 39 cm2 and contains 36 mg of oxybutynin.
Oxybutynin is transported across intact skin and into the systemic circulation by passive diffusion across the stratum corneum. The average daily dose of oxybutynin absorbed from the 39 cm2 OXYTROL system is 3.9 mg. The average (SD) nominal dose, 0.10 (0.02) mg oxybutynin per cm2 surface area, was obtained from analysis of residual oxybutynin content of systems worn over a continuous 4-day interval during 303 separate occasions in 76 healthy volunteers. Following application of the first OXYTROL 3.9 mg/day system, oxybutynin plasma concentrations increase for approximately 24 to 48 hours reaching average maximum concentrations of 3 to 4 ng/mL. Thereafter, steady concentrations are maintained for up to 96 hours. Absorption of oxybutynin is bioequivalent when OXYTROL is applied to the abdomen, buttocks or hip.
OXYTROL is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
The concomitant use of oxybutynin with other anticholinergic drugs or with other agents that produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Pharmacokinetic studies with patients concomitantly receiving cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g. ketoconazole, itraconazole, and miconazole) or macrolide antibiotics (e.g. erythromycin and clarithromycin), have not been performed.
Of the total number of patients in the clinical studies of OXYTROL, 49% were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
OXYTROL should be used with caution in patients with hepatic or renal impairment.
OXYTROL should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (see Contraindications).
It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OXYTROL is administered to a nursing woman.
OXYTROL (Oxybutynin Transdermal System) has a low potential for abuse. Oxybutynin is an anticholinergic compound with a well known safety and efficacy profile. The compound does not possess characteristics commonly associated with drugs of dependence liability or abuse, such as those with euphoric, central nervous system (CNS) depressant, or stimulant action.
The safety and efficacy of OXYTROL in pediatric patients have not been established.
Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment. Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence) or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.
The safety of OXYTROL administration to women who are or who may become pregnant has not been established. Therefore, OXYTROL should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.
OXYTROL should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see Contraindications). OXYTROL, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.
OXYTROL should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
OXYTROL is a matrix-type transdermal system composed of 3 layers. 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.
Each 39 cm2 system imprinted with “OXYTROL 3.9" contains: 36 mg oxybutynin for nominal delivery of 3.9 mg oxybutynin per day when dosed in a twice weekly regimen. Patient Calendar Boxes of 8 systems and 24 systems. Boxes of 8 systems for use as physician samples. Store at room temperature at 15 to 30°C. Protect from moisture and humidity. Do not store outside the sealed pouch. Apply immediately after removal from protective pouch. Discard used OXYTROL in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.
OXYTROL is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.
OXYTROL is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
No data supplied by the manufacturer.
The safety of OXYTROL was evaluated in a total of 417 patients who participated in two Phase III clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in Phase I and Phase II trials. In the two pivotal studies, (Study 1 and Study 2; see Clinical Studies section of the Product Monograph), a total of 246 patients received OXYTROL during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received OXYTROL for at least 24 weeks and at least 36 weeks, respectively.
No deaths were reported during treatment. No serious adverse events related to treatment were reported.
Adverse events reported in the pivotal trials are summarized in Table 1 and Table 2.
Table 1: OXYTROL
|Adverse Eventa|| Placebo |
| OXYTROL (3.9 mg/day) |
|Application Site Pruritus||8||6.1||21||16.8|
|Application Site Erythema||3||2.3||7||5.6|
|Application Site Vesicles||0||0.0||4||3.2|
Table 2: OXYTROL
|Adverse Eventa|| Placebo |
| OXYTROL (3.9 mg/day) |
|Application Site Pruritus||5||4.3||17||14.0|
|Application Site Erythema||2||1.7||10||8.3|
|Application Site Rash||1||0.9||4||3.3|
|Application Site Macules||0||0.0||3||2.5|
Other adverse events reported by >1% of OXYTROL-treated patients, and judged by the investigator to be possibly, probably or definitely related to treatment include: abdominal pain, nausea, flatulence, fatigue, somnolence, headache, flushing, rash, application site burning and back pain.
Most treatment-related adverse events were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of OXYTROL-treated patients in Study 1 and by 5.0% of OXYTROL-treated patients in Study 2.
Treatment-related adverse events that resulted in discontinuation were reported by 11.2% of OXYTROL-treated patients in Study 1 and 10.7% of OXYTROL-treated patients in Study 2. Most of these were secondary to application site reaction. In the two pivotal studies, no patient discontinued OXYTROL treatment due to dry mouth.
In the open-label extension, the most common treatment-related adverse events were: application site pruritus, application site erythema and dry mouth.
Overdosage using OXYTROL (oxybutynin transdermal system) is unlikely. Each 39 cm2 system contains 36 mg oxybutynin and delivers 3.9 mg/day when attached to the skin. Thus, 36 mg oxybutynin would be the maximum dose possible if a system were inadvertently taken internally. In terms of transdermal application, if an entire box of 24 systems were applied simultaneously and worn for 24 hours, the resulting dose would be 93.6 mg.
Case reports of oral overdose with oxybutynin chloride indicate that doses of this magnitude should resolve with withdrawal of exposure and supportive care. Overdose with oral oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oral oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, following by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients recovered fully with symptomatic treatment.
In the event of a possible overdose, the transdermal system(s) should be removed immediately and medical attention sought. Plasma concentrations of oxybutynin and N-desethyloxybutynin decline within 1 to 2 hours after removal of transdermal system(s). If an overdose is suspected, patients should be monitored until symptoms resolve.
The recommended starting dose is one 3.9 mg/day system applied twice weekly (every 3 to 4 days).
OXYTROL should be applied to dry, intact skin on the abdomen, hip or buttock. Apply immediately after removal from the protective pouch. A new application site should be selected with each new OXYTROL system to avoid re-application to the same site within 7 days.