UROXATE TABLET 100MG

देश: मलेशिया

भाषा: अंग्रेज़ी

स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

सक्रिय संघटक:

FLAVOXATE HYDROCHLORIDE

थमां उपलब्ध:

IMEKS PHARMA SDN. BHD.

INN (इंटरनेशनल नाम):

FLAVOXATE HYDROCHLORIDE

पैकेज में यूनिट:

500 Tablets; 100 Tablets

द्वारा बनाया गया:

Sriprasit Pharma Co. Ltd.

सूचना पत्रक

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
UROXATE TABLET 100MG
Flavoxate Hydrochloride (100 mg)
1
WHAT IS IN THIS LEAFLET
1.
What UROXATE is used for
2.
How UROXATE works
3.
Before you use UROXATE
4.
How to use UROXATE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of UROXATE
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT UROXATE IS USED FOR
UROXATE is used to relieve symptoms of
painful
urination,
urgent
need
to
urinate,
increased frequency of urination especially
in
the
night,
lower
abdomen
pain
and
inability to control urine flow, which may be
due to inflammation of the bladder, prostate
gland or urinary tract.
HOW UROXATE WORKS
UROXATE
contains
the
active
ingredient
Flavoxate
hydrochloride.
It
works
by
preventing and relieving muscle spasms and
thus inhibiting bladder contractions in the
urinary
tract
in
addition
to
reducing
associated pain.
BEFORE YOU USE UROXATE_ _
-
_When you must not use it_
Do not take UROXATE if you:
• are allergic to flavoxate hydrochloride or
any other ingredients in the formulation.
• have stomach or intestinal obstruction.
• have bleeding in your stomach or intestine.
• have achalasia (a rare disorder that causes
difficulty swallowing).
•
have problems in completely empty your
bladder (urinary retention).
• have glaucoma (increased pressure in eye).
• are suffering from a condition that causes
muscle weakness (myasthenia gravis).
-
_Before you start to use it _
Tell your doctor if you have allergies to any
other
medicines,
foods,
preservatives
or
dyes.
Talk to your doctor if you:
• are suffering from kidney problems.
UROXATE is not recommended for use in
children below 12 years of age.
_If you are not sure whether you should start _
_taking this medicine, talk to your doctor. _
-
_Taking other medicines _
Inform your doctor or pharmacist if you are
taking or if you have recently taken any other
medicines,
including
medicines
obtained
without a prescription.
Some
medicines
and
UROXATE
may
int

उत्पाद विशेषताएं

CONTENT
Each UROXATE Tablet contains 100 mg Flavoxate hydrochloride.
DESCRIPTION
White round biconvex film-coated tablet embossed with “SPS” on one
side and plain on the other.
PHARMACODYNAMICS
Flavoxate hydrochloride is an antispasmodic selective to the urinary
tract. The mechanism of action involves intracellular cyclic AMP
accumulation
and
calcium
blocking
activity.
It
inhibits
bladder
contractions induced by various agonists or by electrical stimulation
and inhibits the frequency of bladder voiding contractions. It
increases
bladder
volume
capacity,
reduces
the
threshold
pressure
and
micturition pressure. Flavoxate does not significantly affect cardiac
or
respiratory functions.
PHARMACOKINETICS
There are very limited published reports on the pharmacokinetic data
on flavoxate hydrochloride. In a single study of 11 normal male
subjects,
the
time
to
onset
of
action
is
55
minutes
after
oral
administration. Peak plasma concentration was observed at 112
minutes and 57% of the flavoxate hydrochloride was excreted via the
kidneys within 24 hours in this particular study. It has also been
reported that 10-30% of a 100 mg dose is excreted in urine within 6
hours after oral administration.
INDICATIONS
UROXATE is used as an antispasmodic to provide symptomatic relief
of
dysuria,
urgency,
nocturia,
suprapubic
pain,
frequency
and
incontinence
that
may
occur
in
patients
with
cystitis,
prostatitis,
urethritis, urethrocystitis and urethrotrigonitis.
RECOMMENDED DOSAGE
Adults and children over 12 years old: One or two 100 mg tablets to
be taken three or four times daily. The dose may be reduced
with
improvement in symptoms.
CONTRAINDICATIONS
UROXATE is contraindicated in patients who have hypersensitivity to
flavoxate hydrochloride or to any of the excipients, gastrointestinal
obstructive
conditions
or
ileus,
gastrointestinal
haemorrhage,
achalasia, urinary retention, glaucoma and myasthenia gravis.
WARNINGS AND PRECAUTIONS
Since the renal clearance of the active metabolite accounts more than
50% of the dose, renal impairm