Droperidol 0.5 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Droperidol

Available from:

Sintetica GmbH

ATC code:

N05AD08

INN (International Name):

Droperidol

Pharmaceutical form:

Solution for injection

Therapeutic area:

droperidol

Authorization status:

Not marketed

Authorization date:

2023-07-17

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DROPERIDOL 0.5 MG/ML SOLUTION FOR INJECTION
droperidol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Droperidol is and what it is used for
2.
What you need to know before you are given Droperidol
3.
How you will be given Droperidol
4.
Possible side effects
5.
How to store Droperidol
6.
Contents of the pack and other information
1.
WHAT DROPERIDOL IS AND WHAT IT IS USED FOR
DROPERIDOL
is a solution for injection containing the active substance
droperidol, which is used:
-
to prevent you feeling sick (nausea) or vomiting
-
when you wake up after an operation (primarily used in adults and, as
a second line, in
children [2 to 11 years] and adolescents [12 to 18 years]) or
-
in adults when you receive morphine-based painkillers after an
operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DROPERIDOL
YOU MUST NOT BE GIVEN DROPERIDOL IF YOU:
-
are allergic (hypersensitive) to droperidol, or any of the other
ingredients of this medicine
(listed in section 6)
-
are
allergic
to
a
group
of
medicines
used
to
treat
psychiatric
disorders,
called
butyrophenones, e.g. haloperidol, triperidol, benperidol, melperone,
domperidone
-
or anyone in your family have an abnormal electrocardiogram (ECG)
heart tracing
-
are taking any medicine that can affect the ECG (see section Other
medicines and
Droperidol)
-
have low levels of potassium or magnesium in your blood
-
have a pulse rate of less than 55 beats per minute (the doctor or
nurse will check this), o

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00CRF7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Droperidol 0.5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution contains 0.5 mg droperidol (1.25 mg/2.5
ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution, free from visible particles.
pH: 3.0–3.8
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Prevention and treatment of post-operative nausea and vomiting (PONV)
in adults and, as second line, in children
(2 to 11 years) and adolescents (12 to 18 years).

Prevention of nausea and vomiting induced by morphine and derivatives
during post-operative patient controlled
analgesia (PCA) in adults.
Certain precautions are required when administering droperidol: see
sections 4.2, 4.3, and 4.4.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
Prevention and treatment of post-operative nausea and vomiting (PONV).
_Adults: _0.625 mg to 1.25 mg (1.25 to 2.5 ml).
_Elderly (over 65 years): _0.625 mg (1.25 ml).
_Renal/hepatic impairment: _0.625 mg (1.25 ml).
_Children (2 to 11 years) and adolescents (12 to 18 years): _10 to 50
microgram/kg (up to a maximum of 1.25 mg).
_Children (below the age of 2 years): _not recommended.
For prevention of PONV, antiemetics are indicated in patients at
moderate and high risk. The risk should be assessed using
standard accepted scales or scores, such as the Modified APFEL Score.
Administration of Droperidol is recommended 30 minutes before the
anticipated end of surgery. Repeat doses may be given
every 6 hours as required.
In adults, prevention of early vomiting and late nausea may be
improved by doses above 0.75 mg, but not greater than 1.25
mg.
In adults and children, higher doses are associated with increased
risk of sedation and drowsiness.
Prevention of nausea and vomiting induced by morphine and derivatives
during post-operative patient-controlled analgesia
(PCA