DBL PROMETHAZINE HYDROCHLORIDE

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Promethazine hydrochloride

Available from:

Hospira Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

DBL™

Promethazine Hydrochloride Injection CMI

Page  1 
DBL™

PROMETHAZINE HYDROCHLORIDE 
INJECTION BP 

_ _
Promethazine hydrochloride _(Proe-METH-a-zeen) _
_ _
CONSUMER MEDICINE INFORMATION

_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _

WHAT IS IN THIS LEAFLET 

This leaflet answers some 
common questions about DBL™

Promethazine Hydrochloride 
Injection BP (Promethazine).  It 
does not contain all the available 
information. 
It does not take the place of 
talking to your doctor and 
pharmacist. 

All medicines have risks and 
benefits.  Your doctor has 
weighed the risks of you being 
given DBL™

Promethazine 
Hydrochloride Injection BP 
against the benefits they expect it 
will have for you.   

IF YOU HAVE ANY CONCERNS ABOUT 
BEING GIVEN THIS MEDICINE, ASK 
YOUR DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET IN A SAFE 
PLACE.  You may need to read it 
again. 

WHAT DBL™

PROMETHAZINE 
HYDROCHLORIDE 
INJECTION BP IS USED 
FOR 

This medicine is used to treat  
•  allergic reactions,  
•  to relieve nausea, vomiting 
and dizziness 
•  as a sedative (to help people 
go to sleep and control their 
anxiety) before and after 
surgery, and during labour. 

This medicine belongs to a group 
of antihistamines called 
phenothiazines (_fen-oh-THY-ah-_
_zines)_.  It works by preventing the 
effects of histamine in the body. 

ASK YOUR DOCTOR IF YOU HAVE 
ANY QUESTIONS ABOUT WHY THIS 
MEDICINE HAS BEEN PRESCRIBED 
FOR YOU. 
Your doctor may have prescribed 
it for another reason.

This medicine is not addictive  

It is available only with a doctor’s 
prescription.

BEFORE YOU ARE GIVEN 
DBL™

PROMETHAZINE 
HYDROCHLORIDE 
INJECTION BP 
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _

YOU MUST NOT BE GIVEN 
PROMETHAZINE IF YOU HAVE AN 
ALLERGY TO: 
•  any medicine containing 
promethazine hydrochloride 
•  any other

Summary of Product characteristics

Product Information - Australia 

Version 8.0 
Page 1

DBL™

PROMETHAZINE HYDROCHLORIDE INJECTION BP 

NAME OF THE MEDICINE 
Promethazine hydrochloride 

S
N
N
CH
3
CH
3
H
3
C
.HCl

CAS Reg. No. 58-33-3.  C
17
H
20
N
2
S.HCl.  M. wt. 320.9. 

DESCRIPTION 
DBL™ Promethazine Hydrochloride Injection BP is a clear, colourless
solution of pH 5.0 to 6.0.  
Each mL of the solution contains 25.0 mg promethazine hydrochloride,
0.10 mg disodium edetate, 
1.30 microlitre glacial acetic acid, 27.2 mg sodium acetate and 1.32
mg sodium metabisulfite in water 
for injections. 

PHARMACOLOGY 
Promethazine is a phenothiazine derivative with potent antihistaminic
and sedative-hypnotic effects.  
It also has antiemetic, antivertigo, anti-motion sickness,
anticholinergic effects and local anaesthetic 
actions. 

Antihistamines competitively and reversibly antagonise the effects
of histamine at the H
1
-receptor 
sites on effector cells which are responsible for vasodilatation,
increased capillary permeability, flare 
and itch reactions in the skin, and to some extent for contraction
of smooth muscle in the bronchi and 
gastrointestinal tract. 

The precise mechanism of the CNS effects of promethazine is unknown.
 The sedative effects may 
involve antagonism at central histamine, serotonin and acetylcholine
receptors, or central alpha 
adrenergic stimulation.  However, paradoxical CNS stimulation
may occur, especially in children, and 
at high doses may be attributable to antimuscarinic activity.  The
antiemetic, anti-motion sickness and 
antivertigo effects of promethazine are possibly a result of central
anticholinergic actions on the 
vestibular apparatus and the integrative vomiting centre and
medullary chemoreceptive trigger zone of 
the midbrain. 

The anticholinergic (antimuscarinic) actions of promethazine provide a
drying effect on the oral and 
nasal mucosa. 

PHARMACOKINETICS 
Promethazine is well absorbed from parenteral site