Download Guidelines for the use of zuclopenthixol acetate

Guidelines for the use of zuclopenthixol acetate
(Clopixol Acuphase®) injection
Version 3.1
(Updated monitoring form dated November 2016)
GUIDELINE REPLACED
RATIFYING COMMITTEE
DATE RATIFIED
NEXT REVIEW DATE
EXECUTIVE SPONSOR
ORIGINAL AUTHOR
REVIEWED / UPDATED BY
Version 3
Drugs and Therapeutics Group
August 2018
Executive Medical Director
Jed Hewitt – Chief Pharmacist
Helen Manuell – Lead Pharmacist (ESx)
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Guidelines for the use of zuclopenthixol acetate
(Clopixol Acuphase®) Injection
Introduction
In the past, Acuphase has often been too widely and possibly inappropriately
used, sometimes without full regard being given to the fact that it is a potentially
hazardous and toxic preparation with very little published information to support
its use. Indeed, the Cochrane Library concludes that there is inadequate data
on Acuphase and no convincing evidence to support its use in acute psychiatric
emergency. So far as possible, it should therefore be reserved for the minority
of patients who have a prior history of previous use and good response, with
use defined in an advance directive.
Similarly, as a general rule Clopixol Acuphase should not be used for Rapid
Tranquillization unless such practice is also in accordance with an advance
directive.
Normally, Acuphase should never be considered as a first-line drug for Rapid
Tranquillization as its onset of action will often not be rapid enough in these
circumstances. In addition, the administration of an oil-based injection carries
very high risk in a highly agitated patient.
Acuphase should never be administered:
 In an attempt to hasten the antipsychotic effect of other therapy
 To a patient who is physically resistant, due to risk of intravasation
Acuphase should never be used for patients:
 Who will accept oral antipsychotic medication
 Who are antipsychotic naïve
 Who are known to be sensitive to extrapyramidal side effects
 Who are unconscious
 Who are pregnant or are breast-feeding
 Who are known to have cardiac disease or renal or hepatic impairment

Use outside the inpatient setting is not recommended, as the patient will
require close monitoring over a full 24-hour period.
Licensed Use.
Acuphase is licensed as “initial treatment of acute psychoses, including mania
and exacerbation of chronic psychoses, particularly where a duration of effect
of 2-3 days is desirable”.
It is important to recognise that onset of action is not as rapid as may be
believed or required, particularly where rapid tranquillization is needed.
Therefore, Acuphase should only be used after an acutely psychotic patient
has required repeated injections of short-acting antipsychotics such as
haloperidol or olanzapine, and/or sedative drugs such as lorazepam, and
these have not been effective. (Unless there is an advance directive for its
use).
Further to this, Acuphase should be given only when enough time has
elapsed to fully assess the response to previously injected drugs, ie. at least
15 minutes after IV injections and at least 60 minutes after those administered
intramuscularly.
Consideration should be given to zuclopenthixol plasma levels reaching a
peak approximately 24-36 hours after administration of an Acuphase dose.
Caution must therefore be applied if consideration is being given to the
administration of a short-acting psychotropic IM injection during treatment with
Acuphase, as excessive sedation and/or aggravated adverse events may
occur if the patient is exposed to high plasma levels of multiple drugs.
Dose
Acuphase is licensed at a dose of 50mg to 150mg, (1-3ml), repeated if
necessary after 2 or 3 days. (Some patients may need an additional injection
between 1 and 2 days after the first, although at least 24 hours should be left
between doses). The maximum dose per injection for an elderly patient is
100mg (2ml).
For all patients the accumulated dosage must not exceed 400mg, (or 4
injections), within a 2-week period.
Acuphase should not be viewed as a course of treatment and the patient
should be carefully reviewed before each dose is prescribed / administered.
The maximum licensed duration ensures that a treatment plan is put in place
for the patient. More frequent administration or a more prolonged treatment
period is not within the terms of the Product License and should only occur in
very exceptional circumstances.
The patient must be carefully monitored after each injection and a specific
recording sheet is available for this purpose and should be retained in the
patient’s notes following completion. The exact monitoring frequency is shown
on the recording sheet. (See appendix).
If used to good effect and the patient feels that they may benefit from its use
in the future, then consideration should be given to the preparation of an
advance directive.
Onset and Duration of Action
Sedative effects of Acuphase usually begin to appear within 2 hours of injection
and may not reach a peak for another 24 to 36 hours. Significant effects may
last for up to 72 hours although full elimination of the drug may not be complete
for 7 days.
Cross-Reference
This guidance document should be read in conjunction with the Trust Rapid
Tranquillisation Policy.
References.



Summary of Product Characteristics – Clopixol Acuphase. Lundbeck Ltd, August 2015
th
The Maudsley Prescribing Guidelines, 12 Edition, 2015.
The Psychotropic Drug Directory 2014. Stephen Bazire.
Helen Manuell
Lead Clinical Pharmacist
August 2015
Appendix 1
ZUCLOPENTHIXOL ACETATE (ACUPHASE) PHYSICAL OBSERVATION CHART
Patient name
Ward
Date of birth
Tim e m onitoring initiated:
Tim e m onitoring stopped:
MEWS
TIME (24 hour)
36
42
48
40
3
3
39
3
38.5
3
38.5
3
38
3
38
3
37.5
2
37.5
2
37
0
37
0
36
35
0
1
36
35
0
1
34
3
34
3
≥200
3
190
2
180
2
170
2
160
1
150
1
140
1
130
0
120
0
110
0
100
0
90
1
80
1
70
3
60
3
50
3
40
3
140 >
3
130
3
120
3
110
2
100
1
90
0
80
0
70
0
60
0
50
40
1
3
≥ 30
3
21-29
2
17-20
0
12-16
0
10-11
1
9
2
≤8
Respirations
3
Temperature
≥200
3
190
3
180
3
170
3
160
3
150
3
140
3
130
3
120
3
110
3
3
2
0
0
0
2
3
100
90
80
70
60
50
40
Systolic BP
Diastolic BP
140
3
130
3
120
3
110
2
100
1
90
0
80
0
70
0
60
0
50
40
1
3
Pulse
≥ 30
3
21-29
2
17-20
0
12-16
0
10-11
1
9
2
≤8
3
Respirations
97-100
0
9 7 - 10 0
0
94-96
0
94-96
0
≤ 93
3
≤ 93
3
O xyge n S a t ura t io n
Aw ake and active
Aw ake and calm
A s le e p but ro us a ble
Asleep and U nr esp o nsive
Temperature
30
Diastolic (Blood Pressure)
(60-89)
24
Pulse
18
Respiratory Rate
12
SPO₂
SYSTOLIC Blood Pressure
(100-139)
Pulse
(51 - 100)
6
3
Pulse
Respirations
(12 - 20)
2
39
Systolic BP
Diastolic BP
SPO₂
1
40
Temperature
Conscious
Level
0
If patient is stable (total scores of 0 -1) consider discontinuing observations.
Temperature
(36.1 - 37.4 °C)
Observations (HOURS)
Oxygen Saturatio n
A
A
R
U
0
0
2
3
Concious
Level
DATE
C o ns c io us Le v e l
Co nscio us Level
H ydra t e d- Y e s ( 0 ) o r N o ( 2 )
Hydrated
TOTAL MEWS
Initial
TOTAL MEWS
Initial
Instructions:
Zuclopenthixol acetate should ONLY be used in exceptional circumstances.
It must not be routinely consided as an option in Rapid Tranquillization.






Use this chart to record patient monitoring undertaken during a single episode of zuclopenthixol acetate (Acuphase)
If patient consents to physical examinations, ALL observations on this chart should be recorded.
If patient refuses observations, record as R. Respiration rate and consciousness should still be recorded.
Signs of dehydration include dry mouth, UTIs, poor skin condition or reduced quantity of liquids comsumed
Monitor at least hourly for the first 2 hours (especially if given with IM lorazepam) then every 6 hours.
Continue monitoring for a minimum of 48 hours and longer if the patient remains unstable.