PIL
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
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SPC
ditropan-ccsdsv2-piv8-d1-17jan13
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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
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