Xydep

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

XYDEP
®

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

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xydep.
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 Xydep 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 XYDEP IS USED
FOR
Xydep 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.
Xydep 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
Xydep for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY XYDEP HAS
BEEN PRESCRIBED FOR YOU.
Xydep 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
Xydep for the treatment of medical
conditions (other than OCD) in this
age group has not been satisfactorily
established.
For the treatment of OCD, Xydep 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
a doctor's

Đặc tính sản phẩm

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PRODUCT INFORMATION 
XYDEP

 (SERTRALINE HYDROCHLORIDE) 
NAME OF THE MEDICINE 
XYDEP Sertraline (as
hydrochloride) 50 mg and 100 mg capsules. 
XYDEP  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. 
XYDEP  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. 
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_ 
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studies  in  animals  also  suggest  that  sertraline  i