OXYBUTYNIN WINTHROP oxybutynin hydrochloride 5mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxybutynin hydrochloride

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

oxybutynin hydrochloride

Patient Information leaflet

OXYBUTYNIN WINTHROP
1
OXYBUTYNIN WINTHROP
_Oxybutynin Hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Oxybutynin
Winthrop.
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
Oxybutynin Winthrop 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 OXYBUTYNIN
WINTHROP IS USED FOR
Oxybutynin Winthrop is used to
decrease the urgency and the
frequency of urination. Oxybutynin
Winthrop 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
Oxybutynin Winthrop for another
reason. Ask your doctor if you have
any questions about why Oxybutynin
Winthrop has been prescribed for
you.
There is no evidence that
Oxybutynin Winthrop is addictive.
This medicine is available only with
a doctor's prescription.
Oxybutynin Winthrop 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
OXYBUTYNIN WINTHROP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OXYBUTYNIN WINTHROP
IF YOU HAVE AN ALLERGY TO
OXYBUTYNIN WINTHROP OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
DO NOT TAKE OXYBUTYNIN WINTHROP
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 OXYBUTYNIN WINTHROP
IF YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
The safety of the use of Oxybutynin
Winthrop in women who are

Summary of Product characteristics

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PRODUCT INFORMATION
OXYBUTYNIN WINTHROP
NAME OF THE MEDICINE
Each tablet contains oxybutynin hydrochloride 5mg.
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.
The excipients contained in each tablet are calcium stearate,
microcrystalline cellulose,
anhydrous lactose and brilliant blue FCF aluminium lake.
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).
Oxybutynin Winthrop relaxes bladder smooth muscle. In patients with
conditions characterised
by involuntary bladder contractions, cystometric studies have
demonstrated that Oxybutynin
Winthrop
increases
bladder
(vesical)
capacity,
diminishes
the
frequency
of
uninhibited
contractions of the detrusor muscle, and delays the initial desire to
void. Oxybutynin Winthrop
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
bioavailability after oral
dosing has been reported to be about 6%. Oxybutynin hydrochloride
undergoes significant
first pass metabolism. Very little unchanged drug or metabolites are
detected in the urine
suggesting the importance of biliary excretion.
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