Wolverhampton Pharmacy Training 4.6.09 Lofexidine and Naltrexone in the treatment of Opiate dependence

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3. 3 ..runny eyes and nose ..yawning ..hot and cold flushing ..gooseflesh-hence ‘cold turkey’ ..fatigue ..muscular cramps and twitches ..diarrhoea ..nausea and vomiting ..musculoskeletal pain ..restlessness and sleeplessness ..anxiety, irritability and depression

4. 4 Usual time of peak Opiate withdrawal symptoms.. ..short acting Opiates (Heroin) day 2 lasting for 3 days ..low dose Methadone day 3 lasting for 5 days ..moderate dose Methadone day 5 lasting for 7 days ..high dose Methadone day 7 lasting for 9 days ..high dose Buprenorphine day 3-7 1 Withdrawal may be protracted (several months) following high dose/long term Methadone and Buprenorphine. Underlying conditions masked by Opiates may start to appear for the first time This slide re-emphasises the fact that ‘one size may not fit all’ and that a flexible protocol which takes in to account objective and subjective withdrawal symptoms based on the substance the client is withdrawing from is the best approach. PRN dosing is useful and, because BritLofex is not a CD, simple to build in to your protocol. Remember that as BritLofex has no mind altering properties, if the clients say they need more, they probably do.This slide re-emphasises the fact that ‘one size may not fit all’ and that a flexible protocol which takes in to account objective and subjective withdrawal symptoms based on the substance the client is withdrawing from is the best approach. PRN dosing is useful and, because BritLofex is not a CD, simple to build in to your protocol. Remember that as BritLofex has no mind altering properties, if the clients say they need more, they probably do.

5. 5 Effects of information on the Opiate withdrawal syndrome2 This slide highlights the importance if informing the client about what to expect from their detox and shows the beneficial effect that reassurance can have on the outcome as fear of withdrawal is recognised as a major factor for relapse.This slide highlights the importance if informing the client about what to expect from their detox and shows the beneficial effect that reassurance can have on the outcome as fear of withdrawal is recognised as a major factor for relapse.

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10. 10 THE locus ceruleus is believed to play an important role in opiate withdrawal symptomatology. It is responsible for producing 70 per cent of brain noradrenaline Noradrenaline plays a role in many of our body’s functions It helps to keep food moving smoothly through the gut It keeps the mouth and nose moist It regulates blood pressure and heart rate

11. 11 Lofexidine [Britlofex] mode of action Binds presynaptically to alpha 2 receptors located on the nerve endings of Noradrenergic neurones Acts at central and spinal level Suppresses the surge of Noradrenaline which occurs when the Opiates are stopped Minimises some but not all of the withdrawal symptoms Effective for runny eyes and nose May help agitation and insomnia

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20. 20 Many clients report that they do not think that the BritLofex is working, because they cannot feel it working. This arises because the BritLofex has prevented the withdrawal symptoms from developing, rather than the client being able to experience the BritLofex taking them away once they have already occurred. Clients should therefore be strongly reassured “that BritLofex is very effective against physical symptoms of withdrawal, and that if they were to stop it they would certainly feel a lot worse”. 1. Law F Bristol Specialist Drug Service Lofexidine Protocol 2004 BritLofex - an important point to consider This slide is extremely important. It is important that both staff and clients understand how BritLofex works. Your clients are used to taking opiates and possibly other types of substances and are therefore familiar with the desirable effects they may get from them. They will not get this effect from BritLofex as it works by blocking the opiate symptoms. It is therefore easy for them to feel that it is not working when in fact it is. They will receive no euphoric effect and this may put some clients off so it is important to reassure themThis slide is extremely important. It is important that both staff and clients understand how BritLofex works. Your clients are used to taking opiates and possibly other types of substances and are therefore familiar with the desirable effects they may get from them. They will not get this effect from BritLofex as it works by blocking the opiate symptoms. It is therefore easy for them to feel that it is not working when in fact it is. They will receive no euphoric effect and this may put some clients off so it is important to reassure them

21. 21 The dosage of Lofexidine should be titrated according to the patient's response.  Initial dosage should be 0.8mg per day in divided doses.  The dosage may be increased by increments of 0.4 to 0.8mg per day up to a maximum of 2.4mg daily. (maximum dose achieved by day 3) Maximum single dose should not exceed 4 x 0.2mg tablets (0.8mg).  In cases where no Opiate use occurs during detoxification, a duration of treatment of 7-10 days is recommended. In some cases the physician may consider longer treatment is warranted. These recommendations have been endorsed by both the Department of Health and Prison Health 1 1 Drug Misuse and Dependence UK guidelines on Clinical Management; DH2007 The MHRA has recently approved a new starting dose for Britlofex from .2mg bd increasing by .2mg to .4mg to a maximum of 2.4 mg. The new starting dose allows greater flexibility depending on the patients needs and also allows the maximum dose to be reached by day 3The MHRA has recently approved a new starting dose for Britlofex from .2mg bd increasing by .2mg to .4mg to a maximum of 2.4 mg. The new starting dose allows greater flexibility depending on the patients needs and also allows the maximum dose to be reached by day 3

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23. 23 Monitoring BritLofex Patients Should I monitor pulse? Pulse rate should be assessed frequently. exercise caution: Pulse<55 bpm or <50 bpm if baseline is 55 bpm 1 Should I monitor blood pressure? Many Units do BP measured while dose is increasing (may only be for 1 day in some areas) 1 Standard cut-off criteria : <90/50 mmHg or <80/40 mmHg if baseline is 90/50 mmHg 1 The act of monitoring BP may provide therapeutic benefits for clients and staff 2 1. Law F Bristol Specialist Drug Service Lofexidine Protocol 2004 2. Metrebian, N Mahan R, Executive Summary 2005

24. 24 Successful implementation of non-medical prescribing can result in significant improvements in access to medicines for drug misusers with reduced waiting times, increased choice of appointment times and increased throughput of clients1. Suitably qualified nurse and pharmacist prescribers can independently prescribe any licensed medicines for any medical conditions within their competences, with the exception of controlled drugs2. These may include medicines such as antidepressants, Lofexidine, Naltrexone and medicines for minor ailments2

25. 25 The ONLY licensed non-Opioid detoxification treatment Not a controlled drug No need for supervised consumption Flexibility of dosing to cover withdrawal symptoms Used with other symptomatic medication and psychosocial support Suitable for use in an in-patient, custodial or community setting Context is important Opizone™ ( Naltrexone HCl) may be initiated during or immediately after assisted withdrawal with BritLofex

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