Dothep

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Dothiepin hydrochloride

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

DOTHEP

_contains the active ingredient dothiepin hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dothep.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Dothep against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT WITH YOUR MEDICINE.
You may need to read it again.
WHAT DOTHEP IS USED
FOR
Dothep is used to treat depression.
Dothep 25 mg capsules can be used
at any stage in the treatment of
depression. However, the higher
strength Dothep 75 mg tablets are
approved only for the maintenance
treatment of depression (after your
symptoms have improved).
Dothep belongs to a group of
medicines called tricyclic
antidepressants (TCAs). TCA
medicines work by correcting the
imbalance of certain chemicals in the
brain. These chemicals, called
amines, are involved in controlling
mood. By correcting this imbalance,
TCAs can help relieve the symptoms
of depression.
 ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DOTHEP HAS
BEEN PRESCRIBED FOR YOU.
 Your doctor may have prescribed
Dothep for another reason.
 DOTHEP IS NOT APPROVED FOR USE IN
CHILDREN AND ADOLESCENTS BELOW 18
YEARS OF AGE FOR THE TREATMENT OF
DEPRESSION.
 The safe use and effectiveness of
Dothep in treating depression, for
this age group, has not been
established.
 Dothep is available only with a
doctor's prescription.
BEFORE YOU TAKE
DOTHEP
_WHEN YOU MUST NOT TAKE IT_
 DO NOT TAKE DOTHEP IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
DOTHIEPIN (E.G. PROTHIADEN) OR ANY
OF THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the bo

Summary of Product characteristics

DOTHEP 
_Dothiepin hydrochloride _

PRODUCT INFORMATION 

NAME OF THE MEDICINE 

Active ingredient: 
 Dothiepin (as hydrochloride) 

Chemical name:   
3-(6H-dibenzo(b,e)-thiepin-11-ylidene) propyldimethylamine
hydrochloride

Structural formula: 

Molecular formula: C
19
H
21
NS.HCl 
Molecular Weight: 331.9 
CAS Registry No: 897-15-4 

DESCRIPTION 

Dothiepin hydrochloride is a white or faintly yellow, crystalline powder. It is freely soluble in water, in 
alcohol and in methylene chloride. 

Dothep capsules contain the following inactive excipients: lactose, povidone, sodium starch glycollate, 
lactose anhydrous, purified talc, magnesium stearate and purified water. 

PHARMACOLOGY 

Dothiepin is a
thioanalogue of amitriptyline.  It is generally equivalent to amitriptyline in antireserpine activity 
but less potent than imipramine. 

_Site  and  mode  of  Action._    The  mechanism  by  which  dothiepin  and  all  tricyclic  antidepressants  produce  an 
antidepressant effect is unknown, although the therapeutic site of action is thought to be in the CNS. Dothiepin 
possesses anticholinergic, antihistamine and central sedative properties. It has been claimed that the cause of 
depression is associated with a functional abnormality of the biogenic amines, particularly the catecholamines, in 
the  brain.    The  tricyclics  increase  the  availability  of  noradrenaline  and  5-hydroxytryptamine  at  central 
noradrenergic synapses by inhibiting their uptake from nerve endings. 

PHARMACOKINETICS 

_Absorption._  Dothiepin is well absorbed from the small intestine.  There are substantial interindividual variations 
in plasma concentrations after a single dose due to the interaction of exogenous and end