情報リーフレット
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
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製品の特徴
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
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