IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
OXYBUTYNIN EXTENDED-RELEASE - ORAL
COMMON BRAND NAME(S): Ditropan XL
USES: This is a long-acting form of oxybutynin that is used to treat overactive bladder and urinary conditions. It relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination. Oxybutynin belongs to a class of drugs known as antispasmodics. This medication is also used to treat children 6 years of age and older who have an overactive bladder due to certain nerve disorders (e.g., spina bifida).
HOW TO USE: Take this medication by mouth, usually once a day, or as directed by your doctor. It may be taken with or without food. The dosage is based on your medical condition and response to therapy. The length of treatment is determined by your doctor who may suggest periodic trials off the drug to evaluate whether you still need to be taking it. Swallow this medication with the help of liquids. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: Dry mouth, drowsiness, headache, dizziness, nausea, vomiting, upset stomach, stomach pain, constipation, diarrhea, blurred vision, dry eyes, unusual taste in mouth, dry/flushed skin, stuffy nose, and cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. To relieve dry eyes, use artificial tears or other eye lubricants. Consult your pharmacist for further advice. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (e.g., stimulant-type with stool softener). For certain products of this drug, an empty tablet shell may appear in your stool. This is harmless. Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: decreased sexual activity, difficulty urinating, fast/pounding heartbeat, signs of kidney infection (e.g., burning/painful/frequent urination, lower back pain, fever), mental/mood changes, swelling of arms/legs/ankles/feet, vision problems (including eye pain). Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, stomach/intestinal blockage (e.g., persistent nausea/vomiting, prolonged constipation). A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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. 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 taking 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active internal bleeding, untreated/uncontrolled glaucoma (narrow-angle), severe blockage/slowed movement of stomach/intestines (e.g., gastric retention, paralytic ileus), decreased bladder emptying activity (urinary retention). Before using this medication, tell your doctor or pharmacist your medical history, especially of: bladder disease (e.g., bladder outflow blockage), certain muscle disease (myasthenia gravis), heart disease (e.g., congestive heart failure, coronary artery disease, arrhythmias), high blood pressure, liver disease, kidney disease, loss of mental abilities (dementia), certain nervous system disorder (autonomic neuropathy), enlarged prostate gland (benign prostatic hypertrophy-BPH), stomach/intestinal disease (e.g., acid reflux disease, hiatal hernia, ulcerative colitis), severe throat/stomach/intestinal narrowing (strictures), overactive thyroid (hyperthyroidism). This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. This drug may increase the risk for heatstroke because it causes decreased sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic drugs (e.g., atropine, glycopyrrolate, scopolamine ), other antispasmodic drugs (e.g., clidinium, dicyclomine, propantheline), certain anti-Parkinson's drugs (e.g., benztropine, trihexyphenidyl), belladonna alkaloids, bisphosphonate drugs (e.g., alendronate, etidronate, risedronate), drugs affecting liver enzymes that remove oxybutynin from your body (such as azole antifungals-including ketoconazole, macrolide antibiotics-including erythromycin, cimetidine, rifamycins-including rifabutin, St. John's wort, certain anti-seizure medicines-including carbamazepine), potassium tablets/capsules, pramlintide. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., phenobarbital), medicine for sleep (e.g., zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine or tricyclics such as amitriptyline), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: delirium and paralysis.
NOTES: Do not share this medication with others.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised June 2010. Copyright(c) 2010 First Databank, Inc.