Patient Medication Information: uses, side effects, how to take - Ditropan Syrup 1mg/mL
ABOUT THIS MEDICATION
What the medication is used for:
DITROPAN is used to relieve the symptoms of overactive bladder which include the frequent and urgent need to urinate with or without urine leakage.
What it does:
DITROPAN decreases the urgency and frequency of both incontinent episodes and voluntary urination.
When it should not be used:
You should not take DITROPAN if:
you have difficulty urinating, passing and digesting food,
or suffer from glaucoma (high pressure and pain in the eyes), or if you are at risk for these conditions;
you are allergic to oxybutynin chloride or any of the other
ingredients in DITROPAN (see What the nonmedicinal ingredients are).
What the medicinal ingredient is:
oxybutynin chloride
What the nonmedicinal ingredients are:
Tablets: calcium stearate, FD & C Blue #1 lake, lactose and microcrystalline cellulose.
Syrup: citric acid, FD & C Green #3, flavour, glycerine, methylparaben, purified water, sodium citrate, sorbitol, and sucrose.
What dosage forms it comes in:
Tablets: 5 mg
Syrup: 1 mg/mL
WARNINGS AND PRECAUTIONS
BEFORE you use DITROPAN talk to your doctor or pharmacist if:
$ you suffer from stomach problems affecting passage and
digestion of food;
$ you suffer from glaucoma (high pressure and pain in the
eyes);
- you suffer from gastroesophageal reflux or are taking drugs (such as bisphosphonates which are used to prevent bone thinning and fractures caused by osteoporosis) that can worsen esophagitis (inflammation of the tube that connects the mouth and the stomach);
$ you suffer from ulcerative colitis (inflammatory bowel disease);
$ you suffer from myasthenia gravis (a muscle weakening disease);
$ you suffer from kidney and liver problems; $ you are taking certain drugs for treatment of dementia
(such as Alzheimer’s disease);
$ you have difficulty urinating;
$ you have had a reaction to oxybutynin chloride or any of the other ingredients;
$ you are pregnant or trying to become pregnant; $ you are breast-feeding;
$ you are taking or have recently taken any other medication including medications bought without a prescription.
You should be informed of the following information when taking DITROPAN:
When administered in high environmental temperature,
DITROPAN can cause heat prostration (fever and heat stroke due to decreased sweating).
DITROPAN may produce drowsiness or blurred vision.
You should exercise caution while driving or operating machinery.
Alcohol may enhance the drowsiness caused by anticholinergic agents such as DITROPAN.
INTERACTIONS WITH THIS MEDICATION
Always tell your doctor about all medicines you are taking. Your doctor will decide if it is safe for you to use DITROPAN with other medicines. If you take any of the following medicines with DITROPAN, it may affect how well they work or increase the likelihood of side effects:
- drugs that could result in serious adverse effects if small changes in dosage occur (such as digoxin for heart problems)
- other anticholinergic drugs, used to treat a number of different medical conditions (a few examples are atropine for glaucoma or hyoscine for nausea), or drugs with similar undesired effects (such as dry mouth, constipation, drowsiness, and blurred vision)
- certain antibiotics (such as erythromycin and clarithromycin)
certain medicines for the treatment of fungal infections
(such as oral ketoconazole, itraconazole, and miconazole)
PROPER USE OF THIS MEDICATION
E:\DIT062306A.PRI.doc Page 19 of 19
Usual dose:
Adults
The usual dose is one 5 mg tablet or one teaspoon (5 mL) syrup two or three times a day. The maximum recommended dose is one 5 mg tablet or one teaspoon (5 mL) syrup four times a day.
Children Over 5 Years of Age
The usual dose is one 5 mg tablet or one teaspoon (5 mL) syrup two times a day. The maximum recommended dose is one 5 mg tablet or one teaspoon (5 mL) syrup three times a day.
Overdose:
If you take more tablets than your doctor prescribed, call your doctor or regional Poison Control Centre immediately.
Missed dose:
If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
In clinical studies with DITROPAN, the most common side effects reported by patients were dry mouth, constipation, nausea, drowsiness and dizziness.
This is not a complete list of side effects. For any unexpected effects while taking DITROPAN, contact your doctor or pharmacist.
HOW TO STORE IT
Store at 15° to 30°C in tight, light-resistant containers.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone:
toll-free fax:
By email:
866-234-2345
866-678-6789 cadrmp@hc-sc.gc.ca
By regular mail:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Health Canada
Address Locator: 0701C
Ottawa, ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals can be found at: http://www.janssen-ortho.com or by contacting the sponsor, Janssen-Ortho Inc., at: 1-800-567-3331
Janssen-Ortho Inc.
Toronto, Ontario M3C 1L9
Last revised: December 20, 2006
(Component #)
© 2006 JANSSEN-ORTHO Inc.
*All trademark rights used under license
Company Logo