Ditropan

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oxybutynin hydrochloride

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

DITROPAN
1
DITROPAN 
DIT-RO(H)-PAN)
_oxybutynin hydrochloride (oxy-BEAUT-in-in HIGH-dro(h)-CLOR-ride)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ditropan. 
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist. 
All medicines have risks and
benefits.   Your doctor or pharmacist
has weighed the risks of you taking
Ditropan against the benefits they
expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again. 
WHAT DITROPAN IS USED
FOR
Ditropan is used to decrease the
urgency and the frequency of
urination. Ditropan works by
relaxing the bladder smooth muscle
and helps to decrease muscle spasm.
This delays the initial desire and the
urge to urinate. 
Your doctor may have prescribed
Ditropan for another reason. 
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
DITROPAN HAS BEEN PRESCRIBED FOR
YOU. 
There is no evidence that Ditropan is
addictive. 
This medicine is available only with
a doctor's prescription. 
Ditropan is not recommended for use
in children under the age of 5 years,
as there have been no studies of its
effects in children. 
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DITROPAN IF YOU HAVE
AN ALLERGY TO DITROPAN OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET. 
DO NOT TAKE DITROPAN IF YOU HAVE: 
*
angle closure glaucoma or
shallow anterior chamber -
disorders of the eye
*
partial or complete intestinal
blockage; stomach, intestinal or
large bowel problems including
colitis (inflammation of the
colon) 
*
myasthenia gravis -  a disease of
the muscles
*
urinary tract blockage
*
severe bleeding
DO NOT TAKE DITROPAN IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT. 
The safety of the use

Summary of Product characteristics

ditropan-ccsdsv2-piv8-d1-17jan13

 1

PRODUCT INFORMATION 
DITROPAN
_ _
NAME OF THE MEDICINE 
Each tablet contains oxybutynin hydrochloride 5 mg. 

The chemical structure of oxybutynin hydrochloride is the following: 

CAS: 1508-65-2 
DESCRIPTION 
Oxybutynin hydrochloride is 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride.  
It  is  a  white  crystalline  solid  (MW  393.9),  which  is  readily  soluble  in  water  and  acids,  but 
relatively insoluble in alkalis. 
PHARMACOLOGY 
Oxybutynin hydrochloride exerts a direct antispasmodic effect on smooth muscle and inhibits 
the  muscarinic  action  of  acetylcholine  on  smooth  muscle.    Oxybutynin  hydrochloride  exhibits 
four to ten times the antispasmodic potency of atropine, but only one fifth of the anticholinergic 
activity  of  atropine  on  the  rabbit  detrusor  muscle.    No  blocking  effects  occur  at  skeletal 
neuromuscular junctions or autonomic ganglia (antinicotinic effects). 
Ditropan  relaxes  bladder  smooth  muscle.    In  patients  with  conditions  characterised  by 
involuntary  bladder  contractions,  cystometric  studies  have  demonstrated  that  Ditropan 
increases  bladder  (vesical)  capacity,  diminishes  the  frequency  of  uninhibited  contractions  of 
the  detrusor  muscle,  and  delays  the  initial  desire  to  void.    Ditropan  thus  decreases  urgency 
and the frequency of both incontinent episodes and voluntary urination. 
CLASS  
Antispasmodic, anticholinergic.

PHARMACOKINETICS 
Oxybutynin  hydrochloride  is  readily  absorbed  (peak  plasma  concentration  in  approx.  1  hour) 
and  rapidly  eliminated  (plasma  half  life  about  2  hours).    Absolute  bioavailab