Zoloft

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

Sertraline hydrochloride

Sẵn có từ:

Pfizer Australia Pty Ltd

Lớp học:

Medicine Registered

Tờ rơi thông tin

ZOLOFT
®

_Sertraline (sir-tra-leen) hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zoloft.
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 risks of
you taking Zoloft 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 need to read it again.
WHAT ZOLOFT IS USED
FOR
Zoloft is used to treat depression and
conditions called obsessive
compulsive disorder (OCD), panic
disorder, social phobia (social
anxiety disorder) and premenstrual
dysphoric disorder (PMDD).
PMDD affects some women in the
days before their period. PMDD is
different from premenstrual
syndrome (PMS). The mood
symptoms (anger, sadness, tension,
etc) in PMDD are more severe than
in PMS and affect the woman's daily
activities and relationships with
others.
Zoloft belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs). They are
thought to work by blocking the
uptake of a chemical called serotonin
into nerve cells in the brain.
Serotonin and other chemicals called
amines are involved in controlling
mood.
Your doctor, however, may prescribe
Zoloft for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZOLOFT HAS
BEEN PRESCRIBED FOR YOU.
Zoloft should not be used in children
and adolescents under the age of 18
years for the treatment of any
medical condition other than
obsessive compulsive disorder
(OCD). The safety and efficacy of
Zoloft for the treatment of medical
conditions (other than OCD) in this
age group has not been satisfactorily
established.
For the treatment of OCD, Zoloft is
not recommended for use in children
under the age of 6, as the safety and
efficacy in children of this age group
has not been established.
This medicine is only available with

Đặc tính sản phẩm

Version: pfpzolot10513 
Supersedes: pfpzolot10413 

Page 1 of 25 
PRODUCT INFORMATION 
ZOLOFT
Ò
 (SERTRALINE HYDROCHLORIDE) 
NAME OF THE MEDICINE 
ZOLOFT Sertraline (as hydrochloride) 50 mg
and 100 mg capsules. 
ZOLOFT is an antidepressant for oral
administration  and contains the active ingredient sertraline 
hydrochloride.
 Sertraline hydrochloride  is chemically unrelated to tricyclic, tetracyclic or other 
available antidepressant agents. 
The structural formula of sertraline hydrochloride is shown
below: 

Chemical name: 
(1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-
naphthalenamine hydrochloride 
Molecular formula: 
C
17
H
17
NCl
2
.HCl 
Molecular weight: 
342.7 
CAS Registry Number: 
79559-97-0. 
DESCRIPTION 
Sertraline hydrochloride is a white crystalline powder that
is slightly soluble in water and isopropyl 
alcohol and sparingly soluble in ethanol. 
ZOLOFT is supplied for oral administration as film
coated tablets containing sertraline 
hydrochloride equivalent to 50  and  100 mg sertraline and the following inactive ingredients: 
cellulose  –  microcrystalline, calcium hydrogen phosphate,
hydroxypropyl cellulose, sodium starch 
glycollate, magnesium stearate, white Opadry, clear Opadry. 
Version: pfpzolot10513 
Supersedes: pfpzolot10413 

Page 2 of 25 
PHARMACOLOGY 
PHARMACODYNAMICS 
The mechanism of action of sertraline is presumed to be linked
to its inhibition of CNS neuronal 
uptake of serotonin (5HT).
 Studies at clinically relevant doses in man have demonstrated
that 
sertraline blocks the uptake of serotonin into human platelets.
 _In vitro_  studies in animals also 
suggest that sertraline is a potent and
selective inhibitor of neuronal serotonin reuptake and
has only 
very weak effects on noradrenaline and
dopamine neuronal reuptake.  _In vitro_ studies have shown 
that ser