TRAXOR

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

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12-06-2024

Thành phần hoạt chất:

Sertraline hydrochloride; Sertraline (as hydrochloride)

Sẵn có từ:

Aurobindo Pharma Australia Pty Ltd

Lớp học:

Medicine Registered

Tờ rơi thông tin

                                TRAXOR 
CONSUMER MEDICINE INFORMATION 
Ver 1.1  
                                         
                                      
                                        
                          Page 1 of 5 
 
TRAXOR 50 & 100 
Sertraline (as hydrochloride) 
CONSUMER MEDICINE INFORMATION 
 
WHAT IS IN THIS LEAFLET 
 
THIS LEAFLET ANSWERS SOME COMMON 
QUESTIONS ABOUT TRAXOR. 
 
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 TRAXOR 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 TRAXOR IS USED FOR 
 
TRAXOR 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. 
 
TRAXOR 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 TRAXOR for another 
purpose. 
 
ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY TRAXOR HAS 
BEEN PRESCRIBED FOR YOU. 
This med
                                
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                                Product Information:   
TRAXOR 50 & 100 (Sertraline Tablets 50 mg & 100 mg)        
                                        
                                 
   Ver 1.3 
 
 
 
 
Page 1 of 24 
 
PRODUCT INFORMATION 
 
TRAXOR 50 (50 MG SERTRALINE TABLETS) 
TRAXOR 100 (100 MG SERTRALINE TABLETS)
 
 
NAME OF THE MEDICINE 
The active ingredient in TRAXOR is sertraline hydrochloride.   
 
H N C H
3
.H C L
C L
C L
.
 
 
 
CHEMICAL
NAME: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine 
hydrochloride. 
MOLECULAR FORMULA: C
17
H
17
Cl
2
N.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. 
 
TRAXOR is available as tablets containing 50 mg & 100
mg sertraline (as hydrochloride). 
 
TRAXOR tablets contain the following inactive
ingredients:  microcrystalline cellulose, sodium 
starch glycollate type-A, hydroxypropylcellulose, calcium hydrogen
phosphate, magnesium 
stearate, and white opadry (contains hypromellose, macrogol 400,
titanium dioxide & polysorbate 
80). 
 
PHARMACOLOGY
  
_MECHANISM OF ACTION _
Sertraline hydrochloride is an antidepressant for oral
administration. It is chemically unrelated to 
tricyclic, tetracyclic or other available antidepressant agents. 
 
The mechanism of action of sertraline is presumed to be linked
to its inhibition of central nervous 
system neuronal uptake of serotonin (5HT). Studies at clinically
relevant doses in humans 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 

                                
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