synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.zotepineMonitor Closely (2)oxybutynin decreases levels of zotepine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. oxybutynin decreases levels of zotepine by pharmacodynamic antagonism. Use Caution/Monitor. >10% Dry mouth (21-71%) Constipation (7-15%) Somnolence (2-14%) Nausea (2-12%) 1-10% Asthenia (6-10%) Dizziness (6-10%) Headache (6-10%) Blurred vision (6-10%) Dry eyes (6-10%) Diarrhea (6-10%) Nausea (6-10%) Pain (6-10%) Rhinitis (6-10%) <1% Anorexia Fluid retention Hot flush Dysphonia Dysphagia Frequent bowel movements Chest discomfort Thirst Frequency Not Defined Cycloplegia Impairment of mental alertness Memory impairment Mydriasis Tachycardia QT prolongation Postmarketing reports Hallucinations Confusion Delirium Urinary tract infection Palpitations Nasal congestion Hypertension Concomitant use with carbamazepine Vomiting Drowsiness Unsteadiness Slurred speech Nystagmus Contraindications Hypersensitivity Gastric or urinary obstruction or retention, paralytic ileus, severe ulcerative colitis Uncontrolled narrow-angle glaucoma Relative contraindications: Myasthenia gravis, tachycardia secondary to cardiac insufficiency or thyrotoxicosis Cautions Caution in controlled angle-closure glaucoma; mild-to-moderate ulcerative colitis, hyperthyroidism; partial obstructive uropathy; benign prostatic hyperplasia Caution in hepatic or renal impairment May increase risk of heat prostration during hot weather May cause memory loss Angioedema necessitating hospitalization and emergency medical treatment has occurred with first or subsequent doses of oral oxybutynin; if angioedema develops, oxybutynin-containing products should be discontinued and appropriate therapy promptly provided Caution with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention May aggravate symptoms of decreased gastrointestinal motility in patients with autonomic neuropathy Caution with GERD and/or those taking drugs that can cause or exacerbate esophagitis (eg, bisphosphonates) Caution with myasthenia gravis because of decreased cholinergic activity Caution with other anticholinergics (antimuscarinics); may increase risk for xerostomia, constipation, headache, dizziness, and blurred vision Somnolence reported with oxybutynin-containing products; use caution with activities requiring mental alertness May aggravate Parkinson disease symptoms Hallucinations or confusion may occur; monitor May exacerbate symptoms of heart failure, hypertension, and/or cardiac arrhythmias; use with caution May aggravate symptoms of dementia in patients cholinesterase inhibitors; use with caution Use with caution in patients with hiatal hernia The use of the extended release formulation has been associated (rare) with symptoms of obstruction in patients with known stricture/narrowing of the GI tract Before using over the counter product, consider other causes of frequent urination, including early pregnancy, diabetes, and other serious conditions; contact healthcare provider if symptoms do not improve with 2 weeks of initial use Avoid use in patients with myasthenia gravis because of decreased cholinergic activity; if experiencing exacerbation of symptoms of myasthenia gravis, oxybutynin-containing product should be discontinued and appropriate therapy promptly provided Pregnancy There are no studies with topical or oral oxybutynin use in pregnant women to inform a drug associated risk for birth defects or miscarriage; no adverse developmental outcomes observed in animal reproduction studies when administered to pregnant rats and rabbits during organogenesis at approximately 50 and 1 times, respectively, the maximum human dose based on body surface area Lactation There is no information on presence of drug in human milk, effects on breastfed child, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from the underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Exerts antispasmodic and antimuscarinic effects on smooth muscle; delays desire to void, increases bladder capacity, and decreases uninhibited contraction; decreases frequency and urgency Absorption Bioavailability: 6% (~1.5-2 times higher for extended-release) Onset: 30-60 min Peak effect: 3-6 hr Duration: 6-10 hr Peak plasma time: <1 hr (immediate-release); 12 hr (extended release) Peak plasma concentration: Immediate-release, 3.6 ng/mL (R-) and 7.8 ng/mL (S-); extended-release, 1 ng/mL (R-) and 1.8 ng/mL (S-) Distribution Vd: 193 L Metabolism Metabolized in liver and gut by CYP3A4; converted to active metabolite N-desethyloxybutynin (DEO) by GI metabolic pathways, which are bypassed in transdermal delivery, resulting in lower DEO ratio Metabolites: DEO (active) Elimination Half-life: 2-3 hr (immediate-release); 12-13 hr (extended-release) Excretion: Urine BRAND FORM. UNIT PRICE PILL IMAGE Oxytrol transdermal- 3.9 mg/24 hr transdermal systemOxytrol transdermal- 3.9 mg/24 hr transdermal systemGelnique transdermal- 10 % (100 mg/gram) gelGelnique transdermal- 10 % (100 mg/gram) gelCopyright © 2010 First DataBank, Inc.Print Patient Educationoxybutynin transdermal OXYBUTYNIN - TRANSDERMAL (OX-i-BUE-ti-nin) COMMON BRAND NAME(S): Oxytrol USES: Oxybutynin is used to treat an overactive bladder. By relaxing the muscles in the bladder, oxybutynin improves symptoms such as the inability to control urination (incontinence), feeling that one has to urinate (urgency), and having to go to the bathroom often (frequency). This medication belongs to the class of drugs known as antispasmodics.This medication is not recommended for use in children younger than 5 years of age. Consult your doctor for more information.Unless otherwise directed by your doctor, the over-the-counter product should only be used by adult women who have symptoms of overactive bladder for at least 2 months.For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you. HOW TO USE: If you are taking the over-the-counter product to self treat, read all directions on the product package before taking this medication. If your doctor has prescribed this medication, read the Patient Information Leaflet if available from your pharmacist before you start using oxybutynin and each time you get a refill. If your doctor has prescribed this medication, take it as directed. If you have any questions, consult your doctor or pharmacist.Apply one patch to your skin as directed by your doctor, usually every 3 to 4 days. If you are self-treating, apply one patch to your skin every 4 days. Follow the dosing schedule carefully.Remember to remove the old patch before applying a new patch.Apply the new patch to a different area of skin to prevent skin irritation. Do not apply a patch to the same area within 7 days.Before applying the patch, wash the area you will be using for the patch gently and thoroughly with soap and water. Rinse and dry with a clean dry towel.Do not open the sealed pouch container until you are ready to apply the patch. Open the pouch and remove the protective liner from the patch to expose the adhesive. Apply the patch to an area of clean, dry, smooth skin on the stomach (abdomen), hips, or buttocks. Press firmly to be sure the patch stays on. Apply to an area of skin that is under clothing and protected from sunlight. Avoid applying the patch on your waistline, since tight clothing may rub the patch off, or on areas where sitting may loosen it. Do not apply the patch to oily/red/cut/irritated/broken skin or skin covered with lotion or powder. Do not cut the patch into smaller sizes unless otherwise directed.Contact with water (such as swimming, bathing) will not change the way the patch works. Avoid rubbing the patch area during these activities.If the area around the patch becomes red, itchy, or irritated, try a new site. If irritation continues or becomes worse, tell your doctor promptly.If the patch falls off, reapply it or apply a new patch to a new area and continue on your same schedule.When it is time to apply a new patch, remove the old one and dispose of it properly in the trash. Fold the sticky sides of the patch together and throw it away where it cannot be accidentally worn or swallowed by others, especially a child or pet.The length of treatment is determined by your doctor, who may have you stop using the medication sometimes to see if you still need to use it.Use this medication regularly to get the most benefit from it. To help you remember, try to always change the patch on the same 2 days of the week. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Tell your doctor if your condition lasts or gets worse. If you are self-treating, tell your doctor if your condition does not improve after 2 weeks. If you think you may have a serious medical problem, get medical help right away. 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 last or get worse, tell your doctor or pharmacist promptly.To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.If your doctor has directed you to use this medication, remember that your doctor 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 right away if you have any serious side effects, including: vision problems (including eye pain), difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, lower back pain), fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations), fever, flushed/hot/dry skin, signs of stomach/intestinal blockage (such as nausea/vomiting that doesn't stop, severe stomach pain, severe constipation).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: active internal bleeding, blockage/slowed movement of the stomach/intestines (such as gastric retention, paralytic ileus), certain bladder problems (urinary retention, bladder outflow obstruction, stress incontinence), glaucoma (narrow-angle), a certain muscle disease (myasthenia gravis), liver disease, high blood pressure, heart problems (such as coronary artery disease, congestive heart failure, arrhythmias), stomach/intestinal disease (such as acid reflux, hiatal hernia, ulcerative colitis, intestinal atony), kidney disease, loss of mental abilities (dementia), enlarged prostate, overactive thyroid (hyperthyroidism), a certain nervous system disorder (autonomic neuropathy), Parkinson's disease.In addition, before you self treat with this medication, tell your doctor if you have any of these signs of a more serious condition: signs of a bladder/kidney infection (such as burning/pain when you urinate, fever, pink/bloody urine), signs of diabetes (such as increased thirst, dizziness/fainting, vision changes, increased urination, wounds that are slow to heal).This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may make you sweat less, making you more