TRANXENE CAPSULE 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CLORAZEPATE DIPOTASSIUM

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

N05BA05

Dosage:

5 mg

Pharmaceutical form:

CAPSULE

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Authorization date:

1988-05-21

Patient Information leaflet

QUALITATIVE AND QUANTITATIVE COMPOSITION
Dipotassium clorazepate................................. 5mg
Excipients: potassium carbonate, talc.
PHARMACEUTICAL FORM
Capsule
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
•  Reactional  anxiety,  in  particular  adaptation  disorders 
with anxious mood and post-traumatic anxiety.
•  Adjunctive therapy for anxiety in neuroses (in particular 
hysteria, hypochondria, phobia).
•  Anxiety  associated  with  severe  or  painful  somatic 
disorders.
•  Generalized anxiety.
•  Anxiety attack.
•  Prevention and treatment of delirium tremens.
•  Alcohol withdrawal.
Panic disorder does not constitute an indication.
POSOLOGY AND METHOD OF ADMINISTRATION
DURATION
Treatment should be as short as possible and the patient 
should be reassessed regularly and the need for continued 
treatment  should  be  evaluated,  especially  in  case  the 
patient  is  symptom  free.  In  most  patients,  the  overall 
duration  of  treatment  should  not  exceed  4  to  12  weeks, 
including the period of dose tapering (see section “Special 
warnings and special precautions for use”).
•  Reactional  anxiety,  adjunctive  therapy  for  anxiety  in 
neuroses,  anxiety  associated  with  severe  or  painful 
somatic  disorders:  4  to  12  weeks,  including  dose 
tapering.
•  Generalized  anxiety:  long  term  treatment  upon 
specialist’s advice.
•  Anxiety attacks: short term treatment
•  Prevention  and  treatment  of  _delirium  tremens_:  a  few 
days.
•  Alcohol  withdrawal:  treatment  lasting  3  to  6  weeks 
surrounding the withdrawal period.
Treatment should always be tapered off gradually.
DOSE
In  all  cases,  treatment  must  be  started  with  the  lowest 
recommended dose. The maximum daily dose of 90 mg 
per day