Ditropan XL (Janssen, 15 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

DITROPAN XL 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 XL relaxes the smooth muscle of the bladder which results in a decreased urgency and frequency of urination and episodes of urine leakage.

When it should not be used:

You should not take DITROPAN XL 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 XL (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

oxybutynin chloride

What the nonmedicinal ingredients are:

butylated hydroxytoluene, cellulose acetate, hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycol, polyethylene oxide, polysorbate 80, sodium chloride, synthetic iron oxides and titanium dioxide

What dosage forms it comes in:

extended-release tablets: 5, 10, and 15 mg

WARNINGS AND PRECAUTIONS

BEFORE you use DITROPAN XL 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 heart problems;

$ 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 XL:

• DITROPAN XL is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; you should not be concerned if you occasionally notice in your stool something that looks like a tablet.
• When administered in high environmental temperature, DITROPAN XL can cause heat prostration (fever and heat stroke due to decreased sweating).

• DITROPAN XL 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 XL.

• DITROPAN XL may cause central nervous system

  (CNS) effects (symptoms referring to changes in thinking or emotions) such as anxiety, nervousness, difficulty remembering, seeing or hearing things that are not actually there, and trouble thinking clearly or making decisions. You should watch for the signs of CNS effects, particularly in the first few months after beginning treatment or after an increase in the dose. If you experience any CNS effects, please contact your doctor immediately.

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 XL with other medicines. If you take any of the following medicines with DITROPAN XL, 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

DITROPAN XL tablets should be swallowed whole with the aid of liquids. Do not chew, divide, or crush the tablets.

DITROPAN XL may be administered with or without food.

Usual dose:

The usual starting dose of DITROPAN XL is 5 or 10 mg once daily at a consistent time each day. Dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.

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 XL, the most common side effects reported by patients were dry mouth, constipation, drowsiness, headache, blurred vision, dizziness, diarrhea and nausea.

This is not a complete list of side effects. For any unexpected effects while taking DITROPAN XL, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15 and 30°C. Protect from moisture and humidity.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada, through the Canada Vigilance Program, 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 Canada Vigilance by: toll-free telephone:

toll-free fax:

online:

email:

866-234-2345

866-678-6789

www.healthcanada.gc.ca/ medeffect

CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety & Effectiveness Information Bureau

Marketed Health Products Directorate

Health Products & Food Branch

Health Canada

Tunney’s Pasture, AL 0701C

Ottawa, ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

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: March 03, 2009