DROPERIDOL LUPIN droperidol 5 mg/2 mL solution for injection glass ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

droperidol, Quantity: 5 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Droperidol

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: mannitol; tartaric acid; sodium hydroxide; water for injections

Administration route:

Intravenous, Intramuscular

Units in package:

10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Anaesthesia Droperidol Droperidol Lupin is indicated to produce tranquillisation and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures for premedication, induction, and as an adjunct in the maintenance of general and regional anaesthesia in neuroleptanalgesia in which Droperidol Lupin Injection is given concurrently with a narcotic analgesic, to aid in producing tranquillity and decreasing anxiety and pain.,Psychiatry The management of severe agitation, hyperactivity, or aggressiveness in psychotic disorders, including schizophrenic reaction and the manic type of manic depressive illness, or in disturbed states, such as some types of acute brain syndrome and in nonpsychotic acute excitation states.

Product summary:

Visual Identification: DROPERIDOL 5 mg/2ml solution for injection is a sterile liquid in brown 2mL glass ampoules containing 5 mg Droperidol.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-03-06

Patient Information leaflet

1
DROPERIDOL SXP
_contains the active ingredient droperidol_
_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
DROPERIDOL SXP injection.
It does not contain all of 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 being given
DROPERIDOL SXP injection
against the benefits they
expect it will have for you.
If you have any concerns about
being given this medicine, talk
to your doctor.
Keep this leaflet. You may need
to read it again.
WHAT DROPERIDOL SXP
IS USED FOR
DROPERIDOL SXP injection is a
tranquilliser used to:

calm patients before
surgery

reduce nausea and
vomiting which may occur
with anaesthesia

help produce or maintain
anaesthesia

help reduce anxiety and
pain when used with
strong pain killers during
surgery

help manage severe
agitation, aggression and
over-activity.
Ask your doctor if you have any
questions about why it has
been given to you.
Your doctor may have
prescribed it for another
reason.
There is not enough
information to recommend the
use of this medicine for
children under the age of 2
years.
BEFORE YOU ARE GIVEN
DROPERIDOL SXP
WHEN YOU MUST NOT BE
GIVEN IT
You should not be given
DROPERIDOL SXP injection if
you have an allergy to:

any medicine containing

droperidol

any of the ingredients
listed at the end of this
leaflet

any other similar
medicines such as
haloperidol.
Some of the symptoms of an
allergic reaction may include
skin rash, itching or hives,
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing, wheezing or
shortness of breath.
Droperidol SXP injection should
not be given if you have:

severe drowsiness and
slowness as a result of
brain disease or damage

Parkinson’s disease

pheochromocytoma, a
type of tumour, which
causes high blood pressure

a rare heart disorder
known as QT prolongation.
Sometimes this runs in

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
DROPERIDOL SXP (DROPERIDOL) INJECTION
_ _
1. NAME OF THE MEDICINE
Droperidol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Droperidol SXP injection contains the active ingredient droperidol.
Droperidol SXP injection comes in two strengths and contains either
2.5 mg/1 mL or 5.0 mg/2 mL of
droperidol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Droperidol SXP 2.5 mg/1 mL solution for injection is a sterile liquid
in brown 1 mL glass ampoules containing
2.5 mg droperidol.
Droperidol SXP 5 mg/2 mL solution for injection is a sterile liquid in
brown 2 mL glass ampoules containing 5
mg droperidol.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
ANAESTHESIA
Droperidol SXP Injection is indicated to produce tranquillisation and
to reduce the incidence of nausea and
vomiting in surgical and diagnostic procedures; for premedication,
induction, and as an adjunct in the
maintenance of general and regional anaesthesia; in neuroleptanalgesia
in which Droperidol SXP Injection is
given concurrently with a narcotic analgesic, to aid in producing
tranquillity and decreasing anxiety and pain.
PSYCHIATRY
The management of severe agitation, hyperactivity, or aggressiveness
in psychotic disorders, including
schizophrenic reaction and the manic type of manic depressive illness,
or in disturbed states, such as some
types of acute brain syndrome and in nonpsychotic acute excitation
states.
4.2. DOSE AND METHOD OF ADMINISTRATION
Dosage should be individualised. Some of the factors to be considered
in determining the dose are age, body
weight, physical status, underlying pathological condition, use of
other drugs, type of anaesthesia to be used
and the surgical procedure involved.
Vital
signs
should
be
monitored
routinely.
To
minimise
the
risk
of
ventricular
arrhythmia,
an
electrocardiograph (ECG) should be performed and examined for evidence
of QT prolongation before any
operation commences. ECG monitoring should continue during the
surgical procedure and sub