DBL PROMETHAZINE HYDROCHLORIDE 50mg/2mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

promethazine hydrochloride, Quantity: 25 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: disodium edetate; sodium metabisulfite; glacial acetic acid; sodium acetate; water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

5x50mg/2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATION AS 8 January 2004: Promethazine Hydrochloride Injection BP is indicated for the following conditions: Treatment of allergic reactions such as: uncomplicated allergic conditions of the immediate type, e.g. pruritus, urticaria and angioedema, when oral therapy is impossible or contraindicated. Treatment and prevention of vomiting including: motion sickness; drug induced nausea; prevention and control of nausea and vomiting associated with certain types of anaesthesia and surgery, such as procedures with a high incidence of post-operative vomiting (e.g. gynaecological surgery, strabismus or middle ear surgery, and electroconvulsive therapy); in patients with a past history of motion sickness or post-operative vomiting; and in patients in whom avoidance of vomiting is crucial (e.g. neurosurgery and eye surgery). Promethazine has sedative effects and it is also used in: pre-operative, post-operative and obstetric (during labour) sedation.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DBL™ PROMETHAZINE HYDROCHLORIDE INJECTION BP
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING TREATED WITH DBL PROMETHAZINE HYDROCHLORIDE INJECTION
BP?
DBL Promethazine Hydrochloride Injection BP contains the active
ingredient promethazine hydrochloride. DBL Promethazine
Hydrochloride Injection BP is used to treat allergic reactions, to
relieve nausea, vomiting and dizziness and/or as a sedative.
For more information, see Section 1. Why am I being treated with DBL
Promethazine Hydrochloride Injection BP? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL PROMETHAZINE
HYDROCHLORIDE INJECTION
BP?
Do not use if you have ever had an allergic reaction to promethazine
hydrochloride, phenothiazine-derivative medicines or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
treatment with DBL Promethazine Hydrochloride Injection BP? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Promethazine Hydrochloride
Injection BP and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP GIVEN?
Your doctor will decide what dose you will receive. This depends on
your condition and other factors, such as your weight. It must
only be given by a doctor or nurse.
More instructions can be found in Section 4. How is DBL Promethazine
Hydrochloride Injection BP given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH DBL PROMETHAZINE
HYDROCHLORIDE INJECTION
BP?
THINGS YOU
SHOULD DO
•
Remind any doctor, nurse, pharmacis

Summary of Product characteristics

Version: pfpprozi10719
supersedes: Version 10.0
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION – DBL™
PROMETHAZINE HYDROCHLORIDE INJECTION
BP (PROMETHAZINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Promethazine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
EXCIPIENT(S) WITH KNOWN EFFECT
Sodium metabisulfite
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL™ Promethazine Hydrochloride Injection BP is a clear, colourless
solution of pH 5.0 to 6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL™ Promethazine Hydrochloride Injection BP is indicated for the
following conditions:
Treatment of allergic reactions such as:
•
uncomplicated allergic conditions of the immediate type, e.g.,
pruritus, urticaria and angioedema,
when oral therapy is impossible or contraindicated.
Treatment and prevention of vomiting including:
•
motion sickness;
•
drug induced nausea;
•
prevention and control of nausea and vomiting associated with certain
types of anaesthesia and
surgery,
such
as
procedures
with
a
high
incidence
of
post-operative
vomiting
(e.g.,
gynaecological surgery, strabismus or middle ear surgery, and
electroconvulsive therapy); in
patients with a past history of motion sickness or post-operative
vomiting; and in patients in
whom avoidance of vomiting is crucial (e.g., neurosurgery and eye
surgery).
Promethazine has sedative effects and it is also used in:
Version: pfpprozi10719
supersedes: Version 10.0
Page 2 of 10
•
pre-operative, post-operative and obstetric (during labour) sedation.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_ALLERGIC CONDITIONS _
_Adults:_
25 mg to 50 mg by deep intramuscular injection or slow intravenous
injection; may be
repeated within two hours if necessary. Maximum dose up to 150 mg
da