EXAMPLE PROTOCOL FOR ADMINISTRATION OF THE
B: General Exclusion Criteria for Community
(i) Naltrexone as described in this protocol is for use
• As for community lofexidine protocol.
as adjunctive prophylactic therapy in the preventionof relapse to opioid drug misuse following planned
(iv) The CDAT consultant should be contacted
community opiate detoxification with lofexidine.
to advise on an appropriate relapse preventionmeasures if any of these exclusion criteria
(ii) The inclusion criteria are as for the community
lofexidine detoxification protocol. In addition thepatient will be required to give informed consent
(v) Patients will be assessed by the Community Drug
and Alcohol Team before admission. Patients not
for the prescription of naltrexone, following a pre-detoxification clinical assessment of suitability.
wishing to receive naltrexone will not be excluded
This assessment will be accompanied by agreed
(iii) Exclusion criteria for treatment under the
A: Naltrexone Specific Exclusion Criteria.
• A history of sensitivity to naltrexone.
(i) A qualified medical doctor will be required to
• Concurrent acute hepatitis or liver failure.
prescribe naltrexone as described in this protocol.
• Concurrent elevation of AST or other
(ii) A qualified nurse will be required to administer
transaminases by greater than two-fold
naloxone and naltrexone as described in this
above the upper limit of the normal range.
protocol.The nurse must be qualified to administermedication and basic measures in the case of an
• Concurrent pregnancy or breast feeding.
• Concomitant use of illicit opiates during
(iii) The patient’s general practitioner will be
responsible for continuing naltrexone prescriptionfollowing completion of detoxification.
• Detoxification with methadone or other
• The commencement of naltrexone in the
community must always be preceeded by
administration of a naloxone challenge.
Names of all medicines to be administered under
Naltrexone hydrochloride & Naloxone
hydrochloride, both PoM.
• The challenge will be administered by the
STAGE A: NALOXONE CHALLENGE
All patients for whom commencement of naltrexone is
planned in the community should receive a naloxonechallenge immediately before commencement of
• Complete Short Opiate Withdrawal Scale.
• Give 0.4mg naloxone hydrochloride IM.
a. Day of naloxone challenge.
• Complete Short Opiate Withdrawal Scale at
For patients detoxifying from heroin only, naloxone
challenge may be administered on day 4 (Thursday) if the following conditions are met:
• Observe for a further 15 minutes.
• The patient was not using any other opiate
drug in combination with heroin, in the period
leading up to commencement of detoxification.
IF ANY INCREASE IN WITHDRAWAL HAS
BEEN OBSERVED OVER THIS PERIOD,
• On-site urine screens have been negative for
DO NOT PROCEED FURTHER.
opiates and methadone on all of days 1 to 4
Discuss the case with the CDAT consultant.
(Monday to Thursday week 1) of the
For all other patients naloxone challenge should be
• At 30 minutes give a further 0.4mg naloxone
administered on day 8 (Monday of week 2) if the
hydrochloride IM only if there has been no
significant increase in withdrawal symptoms.
• On-site urine screens have been consistently
• Complete the Short Opiate Withdrawal Scale
negative since and including day 3 (Wednesday
at 45 minutes.
of week 1) of the detoxification.
• Observe for a further 15 minutes.
If the above conditions are not met for administration
of naloxone challenge, the case should be discussed with
IF ANY INCREASE IN WITHDRAWAL HAS
BEEN OBSERVED OVER THIS PERIOD, DO
NOT PROCEED FURTHER. Discuss the case
with the CDAT consultant.
If there was no significant reaction to the administration
of naltrexone over the first one hour, then progress to B.
• The naloxone challenge should occur at the
patient’s GP Surgery, by previous arrangement
with the GP, or at the CDAT base. The patient’s
care coordinator should arrange this in advance
of the detoxification occurring.
• Easy access to emergency resuscitation
equipment must be ensured before giving
the naloxone challenge.
STAGE B: NALTREXONE ADMINISTRATION
• Administer naltrexone 25mg (half a tablet)
orally once immediately following successful
completion of the naloxone challenge.
1. ‘As required’ lofexidine should be administered by
titrating against the short opiate withdrawal scale
• Naltrexone 50mg orally once daily from day
as described in the lofexidine protocol.
2. The CDAT consultant should be informed in all
Withdrawal symptoms should be monitored by use of
cases of markedly increased opiate withdrawal
the ‘Short Opiate Withdrawal Scale’. Lofexidine may be
following naltrexone administration. In rare cases
administered on an ‘as required’ basis as stated within
where delirium or vomiting supervene, the patient
the lofexidine protocol, for opiate withdrawal symptoms
associated with naltrexone administration.
1. Naltrexone should not be commenced if the AST
Anaphylaxis occurring in response to IM
is greater than approximately two times normal
This should be treated as for any other anaphylacticreaction. Resuscitation equipment and emergency
2. All patients receiving naltrexone should have baseline
medication must be available at the GP surgery in
liver function studies and then repeat tests once a
which naloxone induction will take place. Immediate
month for the first 4 to 6 months. Patients with
medical advice should be sought from a GP on-site
baseline liver abnormalities should be tested every
2 weeks for up to 6 weeks before going on to a oncea month frequency.
Anaphylaxis is characterised by the rapid onset ofhypotension, tachycardia, and collapse.There may
3. Naltrexone should be discontinued if the AST rises
to greater than 3 times normal unless some other
also be bronchospasm and laryngeal oedema.
4. Naltrexone may possibly induce a depressive disorder
in some patients after days or weeks of use – the
Lay the patient flat and raise their feet
continued prescription of naltrexone should bereviewed in such cases.
1 in 1000 solution IM
• Chlorpheniramine 10-20mg IV, given slowly
over 1 minute, can be a useful adjunct, but
should only be given after adrenaline has
already been given.
Immunization Division, Texas Department of Health 1100 West 49th St., Austin, TX 78756 (800) 252-9152 (512) 458-7544 fax Pertussis Case Track Record FINAL STATUS : NETSS CASE # : Patient’s Name: ______________________________________________________ Reported By: ___________________________________________ Address: _________________________________________________________
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