ZOLPIDEM-GA Zolpidem tartrate 10mg tablet blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

zolpidem tartrate

थमां उपलब्ध:

Amneal Pharma Australia Pty Ltd

INN (इंटरनेशनल नाम):

zolpidem tartrate

सूचना पत्रक

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ZOLPIDEM-GA
_Zolpidem tartrate _
_ _
CONSUMER MEDICINE INFORMATION
WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH UNUSUAL AND POTENTIALLY
DANGEROUS BEHAVIOURS WHILST
APPARENTLY ASLEEP. THESE HAVE INCLUDED SLEEP WALKING, DRIVING MOTOR
VEHICLES AND OTHER BIZARRE
BEHAVIOURS. SOME MEDICINES MAY INTERACT WITH ZOLPIDEM AND PARTICULAR
CAUTION IS NEEDED WITH
OTHER DRUGS THAT MAY ALSO ACT ON THE BRAIN; BEFORE YOU TAKE ZOLPIDEM
REFER TO THE "TAKING OTHER
MEDICINES" SECTION BELOW OR ASK YOUR DOCTOR OR PHARMACIST. YOU MUST
NOT DRINK ALCOHOL WHEN YOU
TAKE ZOLPIDEM. DO NOT TAKE ZOLPIDEM FOR MORE THAN 4 WEEKS. IF YOUR
SLEEP PROBLEMS CONTINUE,
CONSULT YOUR DOCTOR.
WHAT IS IN THIS LEAFLET?
This leaflet answers common
questions about ZOLPIDEM-
GA. 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 has
weighed the risk of taking
ZOLPIDEM-GA against the
benefits it is expected to 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 want to
read it again.
WHAT IS ZOLPIDEM-GA USED
FOR?
ZOLPIDEM-GA is a prescription
medicine that your doctor has
prescribed for you. Do not
share it with anyone.
ZOLPIDEM-GA is the brand
name of a medicine called
Zolpidem tartrate.
ZOLPIDEM-GA is used to
initiate sleep in those with
sleeping difficulties, also called
insomnia. The cause of sleeping
problems should be known, if
possible. The causes should be
treated before ZOLPIDEM-GA,
or any hypnotic is prescribed.
IT SHOULD NOT BE USED FOR MORE
THAN 4 WEEKS AT A TIME.
Continuous long term use is not
recommended unless advised
by your doctor.
THE USE OF ZOLPIDEM-GA
MAY LEAD TO DEPENDENCE ON
THE MEDICINE.
ZOLPIDEM-GA has a different
chemical structure to any other
sleeping tablet that is currently
available in Australia.
ZOLPIDEM-GA works by
binding to special sites in the
brain which produce sleep.
Your doctor will have explained
why you are be

उत्पाद विशेषताएं

Zolpidem-GA PI v2 101006 marketed
Page 1 of 13
PRODUCT INFORMATION (MARKETED)
ZOLPIDEM-GA TABLETS
WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH POTENTIALLY DANGEROUS COMPLEX
SLEEP-
RELATED BEHAVIOURS WHICH MAY INCLUDE SLEEP WALKING, SLEEP DRIVING AND
OTHER BIZARRE
BEHAVIOURS. ZOLPIDEM IS NOT TO BE TAKEN WITH ALCOHOL. CAUTION IS
NEEDED WITH OTHER
CNS DEPRESSANT DRUGS. LIMIT USE TO FOUR WEEKS MAXIMUM UNDER CLOSE
MEDICAL
SUPERVISION.
NAME OF THE MEDICINE
ZOLPIDEM-GA
Name of the active ingredient: zolpidem tartrate
Its chemical name is 2-(4-methylphenyl)-N,N,6-trimethylimidazo [1,2,a]
pyridine-3-acetamide
hemitartrate.
Its molecular formula is C
42
H
48
N
6
O
8
. MW is 764.9. CAS numbers are 99294-93-6 (zolpidem
tartrate) and 82626-48-0 (zolpidem free base).
DESCRIPTION
Zolpidem tartrate is a white to off white colourless, crystalline
powder, sparingly soluble in
water. Each tablet contains zolpidem tartrate 10 mg with lactose,
microcrystalline cellulose,
hypromellose, sodium starch glycollate and magnesium stearate. The
coating on the tablets
consists of hypromellose, titanium dioxide and macrogol 400.
PHARMACOLOGY
PHARMACODYNAMICS
Zolpidem tartrate belongs to the imidazopyridine group of compounds
and is structurally
unrelated to other hypnotic agents. Zolpidem tartrate selectively
binds the omega-1 receptor
subtype (also known as the benzodiazepine-1 subtype) which is the
alpha unit of the GABA-
A
receptor
complex.
Whereas
benzodiazepines
non-selectively
bind
all
three
omega
receptor
subtypes,
zolpidem
tartrate
preferentially
binds
the
omega-1
subtype.
The
modulation of the chloride anion channel via this receptor leads to
the specific sedative
Zolpidem-GA PI v2 101006 marketed
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effects demonstrated by zolpidem tartrate i.e. the preservation of
deep sleep (stage 3 and 4
slow wave sleep). These effects are reversed by the benzodiazepine
antagonist flumazenil.
In animals: The selective binding of zolpidem tartrate to omega-1
receptors may explain the
virtual absence at hypnotic doses of myorelaxant and anti-c