DROPERIDOL PANPHARMA droperidol 2.5 mg/1 mL solution for injection, ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

droperidol, Quantity: 2.5 mg/mL

Available from:

Panpharma Australia Pty Ltd

INN (International Name):

Droperidol

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Intravenous

Units in package:

5 ampoules, 10 ampoules, 50 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Anaesthesia Droperidol Panpharma 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 Panpharma 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: Clear colourless solution packaged in an amber glass ampoule; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-05-17

Patient Information leaflet

Droperidol Panpharma
Version 1.1
Page 1 of 3
DROPERIDOL PANPHARMA
CONTAINS EITHER 0.5 MG/ML OR 2.5 MG/ML DROPERIDOL_ _
_droperidol _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common
questions about
Droperidol Panpharma . It
does
not contain all the available
information. It does not take the
place
of talking to your doctor.
All medicines have risks and
benefits.
Your doctor has weighed
the risks of
you being given
Droperidol Panpharma
against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR
DOCTOR
.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DROPERIDOL
PANPHARMA IS USED FOR
Droperidol Panpharma 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 THIS
MEDICINE
HAS BEEN PRESCRIBED
FOR 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 PANPHARMA
_WHEN YOU MUST NOT BE _
_GIVEN IT_
YOU SHOULD NOT BE GIVEN
DROPERIDOL PANPHARMA 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:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue
or
other parts of the body

rash, itching or hives on the
skin.
DROPERIDOL PANPHARMA 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
�

Summary of Product characteristics

Product Information
Droperidol Panpharma (0.5 mg/mL and 2.5 mg/mL)
Page 1
______________________________________________________________________________________________________________________________
PRODUCT INFORMATION
Droperidol Panpharma
0.5 mg/mL and 2.5 mg/mL
NAME OF THE MEDICINE
Droperidol Panpharma 1.25 mg/2.5 mL (0.5 mg/mL)
Droperidol Panpharma 2.5 mg/1 mL and 5.0 mg/2.0 mL (2.5 mg/mL)
The structure formula of droperidol is shown below:
Active ingredient:
Droperidol
Chemical name:
1-[1-[4-(4-fluorophenyl)-4-oxobutyl]-1,2,3,6-tetrahydropyridin-4-
yl]-1,3-dihydro-2_H_-benzimidazol-2-one
Molecular formula:
C
22
H
22
FN
3
O
2
Molecular weight:
379.42
CAS registry number:
548-73-2
DESCRIPTION
Droperidol Panpharma contains either 0.5 mg/mL or 2.5 mg/mL droperidol
as the active
ingredient. The excipients are water for injections, mannitol and
tartaric acid. Sodium
hydroxide is also present to adjust the pH to 3.4 ± 0.2.
Droperidol
is
a
cream-coloured,
light-sensitive,
crystalline,
hygroscopic
substance,
slightly soluble in water and alcohol, and soluble in aqueous
solutions with pH <4.
PHARMACOLOGY
PHARMACOLOGY IN ANIMALS
Droperidol is a neuroleptic drug of the butyrophenone group that also
includes haloperidol.
It produces general quiescence and a reduced responsiveness to
environmental stimuli
in several animal species. There is little or no effect in respiration
or myocardial
Product Information
Droperidol Panpharma (0.5 mg/mL and 2.5 mg/mL)
Page 2
______________________________________________________________________________________________________________________________
contractile force, heart rate, and cardiac output in dogs.
The blood pressure is lowered, in part as a direct vasodilator effect
and in part
because
of
adrenergic
blockade.
Droperidol
markedly
reduces
the
ability
of
apomorphine to produce emesis in dogs. It is effective in protecting
rats against
experimentally
induced traumatic shock and in protecting dogs against adrenaline-
induced ventricular arrhythmias.
PHARMACOLOGY IN HUMANS
Droper