4.0 Central Nervous System

4.1.1 Hypnotics - for short term use only

Try to avoid. If needed, use for 1-3 days only. Do not give on discharge from hospital. Hypnotics are only licensed for short term use. On specialist advice only, some patients with long term psychiatric problems may require long term use.

GREEN      Temazepam

tablets 10mg

elixir 10mg/5mL

AMBER      Nitrazepam

tablets 5mg

oral suspension 2.5mg/5mL

GREEN       Zopiclone tablets 3.75mg, 7.5mg

GREEN       Zolpidem tablets 5mg, 10mg - in line with NICE TA 77- short term use only.  RED           Melatonin 2mg MR tablets - for use in ICU only

Chloral Hydrate for paediatric sedation

RED           Chloral hydrate liquid 500mg/5mL

Melatonin [Circardin® tablets]  See Shared Care Guideline

Melatonin PR tablets, off license use, for the treatment of sleep disorders in children with neurodevelopmental disorders. The long term safety and efficacy of melatonin is unclear.

AMBER Shared Care    Melatonin 2mg [Circardin® prolonged release tablets] [off label use]

                                                                                                                                                                           

Melatonin in the Treatment of Rapid Eye Movement [REM] Sleep Behaviour Disorder [RBD] in Parkinson's Disease

and Lewy Body Dementia

Melatonin prolonged release tablets [Circardin®] are suitable for prescribing in primary care following initiation or

recommendation by a specialist when clonazepam is not considered appropriate.

AMBER        Melatonin prolonged release tablets 2mg  [Circardin® prolonged release tablets]

Sodium oxybate for treatment of narcolepsy with cataplexy in adults (under expert supervision) RED              Sodium oxybate 500mg/mL oral solution [Xyrem®]                      Specialist medicine                                                                   CCG Commissioned Blueteq form required

4.1.2 Anxiolytics

Use at lowest dose for shortest time possible. Long term use should be avoided except on specialist advice.  Chlordiazepoxide is also used in a reducing dose regimen for the management of acute alcohol withdrawal. 

GREEN      Chlordiazepoxide

capsules 5mg, 10mg

GREEN      Diazepam

tablets 2mg, 5mg, 10mg

syrup 2mg/5mL

injection 10mg/2mL

suppositories 10mg

GREEN      Lorazepam tablets 1mg

RED           Lorazepam injection 4mg/mL

Schizophrenia NICE Clinical Guidelines 2009

These guidelines relate to adults (18 years and older). For information on early detection and intervention, and for recommendations on psychological and psychosocial interventions, see the full guidance.

Treatment and management

First and acute episodes of schizophrenia

¤   Urgently refer anyone presenting with psychotic symptoms in primary care to and appropriate specialist team.

¤   If a GP needs to start antipsychotics they should they should have experience in treating and managing                               schizophrenia.

¤   Use an oral antipsychotic for people with newly diagnosed schizophrenia

¤   Decide which drug to use together with the patient, and carer if appropriate*

¤   Consider the benefits and risks of each antipsychotic including the relative potential of each to cause side                            effects, such as:

>  Extrapyramidal effects e.g.akathisia,

>   metabolic effects e.g.weight gain

>   unpleasant subjective experience

* NB - This guidance replaces NICE TA43 which recommended atypical antipsychotics first-line;      this recommendation no longer stands.

Prescribing  

• Start with a dose at the lower end of the licensed range and titrate upwards slowly within the dose range in the BNF or Summary of Products Characteristics (SPC)
  
• Do NOT use a loading dose of an antipsychotic
  
• Carry out a trial at the optimum dose for 4-6 weeks
  
• Do NOT prescribe regular combined antipsychotics, except for short periods (e>g> when changing medication).
• Review prn antipsychotics regularly e.g. weekly, and check whether the dose taken has increased above the maximum in the BNF/SPC. 

Maintenance treatment

Do NOT use intermittent dosing strategies unless the patient will not accept continuous maintenance treatment or if it is contraindicated.

Depot/long-acting injectable antipsychotics

¤     Use depot/long-acting injectable antipsychotics when;

> the patient would prefer this after an acute episode,

> avoiding covert non-adherence to medication is a clinical priority.

¤     When starting treatment:

>  consider the preferences and attitudes of the patient towards regular intramuscular injections and their                             delivery (e.g. home visits, location of clinics)                     >  consider the benefits and risk of each antipsychotic,

>  initially use a small test dose as in the BNF/SPC

Monitoring

Link to Suggested Monitoring Requirements of High Risk Drugs

Pre-treatment

An electrocardiogram (ECG) is needed if:

¤   specified in the SPC

¤   there is a personal history of cardiovascular disease,

¤   cardiovascular risk is identified e.g. hypertension,

¤   the person is admitted as an inpatient.

During treatment       ¤   Record the indications, expected benefits and risks, and expected time-frame for a change in symptoms and for              side effects to occur.       ¤   Justify and record reasons for doses outside the range specified in the BNF/SPC.       ¤   Monitor and record the following regularly throughout treatment, but especially during titration:                      ¤   efficacy, including changes in symptoms and behaviour,                      ¤   side effects,                      ¤   adherence,                      ¤   physical health.       ¤   Record the rationale for continuing, changing or stopping medication and the effects of such changes.

Cautions and counselling 

Discuss the following with the patient:

¤     any non-prescribed treatments including complementary therapies,

¤     prescription and non-prescription medicines,

¤    use of alcohol, tobacco and illicit drugs.

Inadequate response to treatment

¤   Review the diagnosis.

¤   Check adherence to antipsychotics.

¤   Review psychological treatments.

¤   Consider other causes of non-response.

Use clozapine if symptoms have not responded adequately despite sequential use of at least two different antipsychotics, including a non-clozapine second-generation antipsychotic.

If there is inadequate response to clozapine, follow the steps above then check clozapine levels before adding a second antipsychotic to augment clozapine. Choosing a drug that does not compound the side effects of clozapine. An adequate trial of augmentation may need to be up to 8 to 10 weeks.

Withdrawal

• inform the patient of the high risk of relapse if medication is stopped within 1-2 years.
  
• if withdrawing antipsychotic medication do so gradually.
  
• Regularly monitor for signs and symptoms of relapse for at least 2 years after withdrawal.  

DEPRESSION

Mild depression

Antidepressants are not recommended for the initial treatment of mild depression, because the risk-benefit ratio is poor. However where mild depression persists after other interventions, or is associated with psychosocial and medical problems, consider the use of an antidepressant.

Moderate depression

Offer antidepressant medication to all patients routinely, before psychological interventions.

Choice of drug

Discuss the choice of an antidepressant with the patient including side effect profile, discontinuation symptoms, any potential interactions with other medication including herbal medicines and the individual perception of previous treatment and its effect.

When an antidepressant is to be prescribed in routine care it should be a generic SSRI because they are as effective as tricyclic antidepressants and their use is less likely to be discontinued due to side effects. Fluoxetine or citalopram should be used first line because they are generally associated with fewer discontinuation/withdrawal symptoms.

Changing therapy

Treatment should be continued for a minimum of 4 weeks (6 weeks in the elderly) before considering that it is ineffective. If a partial response has occurred reassess response after a further six weeks. If there is no response check compliance and consider changing drug.

Duration of therapy

Continue antidepressant therapy for at least 6 months after remission. For patients who have had two or more depressive episodes in the recent past, and who have experienced significant functional impairment during the episodes, continue therapy for two years.

Prescribing in older adults

When prescribing in older adults the dose prescribed should be age appropriate taking into account the physical health and concomitant medication. Side effects should be monitored closely when prescribing in older adults.

Augmentation of an Antidepressant Regime   The following recommendations are made for augmentation of an antidepressant regime under a specialist mental  health team:        ¤    The drugs that can be used to augment an antidepressant are lithium, an anti-psychotic such as aripiprazole,               olanzapine, quetiapine or risperidone, or another antidepressant such as mianserin or mirtazapine.        ¤    Consideration must be given to the potential increase in side effects.        ¤    When prescribing lithium the monitoring of lithium should be undertaken as per the Trust guidelines        ¤    When prescribing lithium the monitoring of lithium should be undertaken as per the Trust guidelines        ¤    The following drugs should not be used to augment and antidepressant regime: - buspirone, carbamazepine,                 lamotrigine, valproate pindolol and thyroid hormones.        ¤    Benzodiazepines should only be used concurrently with an antidepressant for a maximum of 2 weeks.

GENERALISED ANXIETY DISORDER

Consider offering:

¤    Support and information

¤    Problem solving

¤    Benzodiazepines for 2-4 weeks maximum

¤    Sedative antihistamines e.g. hydroxyzine

Pharmacological Treatment

¤    Before prescribing consider age, previous response to treatment, risk of deliberate self-Harm or accidental                      overdose, patient preference and cost effectiveness.

¤    Offer an SSRI unless otherwise indicated (Paroxetine and escitalopram have a license for GAD)

¤    If one SSRI is not suitable or there is no improvement after 12 weeks then offer another SSRI

¤    Minimise side effects by starting low and titrating slowly

¤    Long term treatment and doses at the upper end of the dose range may be required.

¤    Review efficacy and side effects after 2 weeks then at 4,6 and 12 weeks.

¤    If treatment is long term then review at 8-12 week intervals.

¤    Follow SPCs for specific monitoring

¤    If improvement after 12 weeks then continue treatment for 6 months then slowly taper off over an extended

period.

¤    If no improvement after 12 weeks then consider a different intervention OR venlafaxine up to a maximum of

75mg. NB venlafaxine  is contra-indicated in patients with an identified very high risk of serious cardiac

ventricular arrhythmia , or those with uncontrolled hypertension.  Venlafaxine should be used with caution in

patients with established cardiac disease that may increase the risk of ventricular arrhythmias (e.g. recent

myocardial infarction). Regular measurement of blood pressure is recommended for patients receiving

venlafaxine.

¤    If no improvement after two interventions review and if appropriate offer referral to specialist mental health

service.

Pregabalin - AMBER - initiation by LSCFT specialist clinician [Position Statement]  Prescribing of Pregabalin in primary care for the treatment of Generalised Anxiety Disorder can be continued provided  that the treatment is initiated by a specialist and that certain prior criteria have been met. See Position Statement

Click here for The Joint Formulary for Psychotropic Medication (LCFT)

PANIC DISORDER

¤   Offer an SSRI licensed for panic disorder, unless otherwise indicated  (citalopram, paroxetine and escitalopram)

¤   If SSRI not suitable or no response after 12 weeks consider clomipramine or imipramine

¤   Benzodiazepines, sedating antihistamines and antipsychotics should NOT be prescribed for panic disorder

¤   Review efficacy and side effects after 2 weeks then at 4, 6 and 12 weeks.

¤   Long term treatment and doses at the upper end of the dose range may be required.

¤   If treatment is long term then review at 8-12 week intervals.

¤   Follow SPCs for specific monitoring

¤   If no improvement after two interventions review and if appropriate offer referral to specialist mental health                     services.

BUSPIRONE        ¤   The evidence for buspirone is equivocal and its use is NOT recommended by NICE.        ¤   Buspirone should not be used in patients with epilepsy, severe renal impairment (defined as creatinine                 clearance of 20 ml/minute or below, or a plasma creatinine above 200 micromoles/litre) or in patients with             severe hepatic disease.        ¤   Buspirone is licensed for short term use. Any patients initiated on buspirone by specialist mental health              services and discharged to primary care should have buspirone stopped after two months of   treatment             unless otherwise specified.  Information from the manufacturer of buspirone indicates patients aren't             likely to suffer from withdrawal after stopping buspirone.

Stopping or reducing antidepressants

All patients prescribed antidepressants should be informed that, although the drugs are not associated with tolerance or craving, discontinuation symptoms may occur on stopping, missing doses or, occasionally, on reducing the dose of the drug. These symptoms are usually mild and self-limiting (in which case monitor and reassure) but occasionally can be severe. Cessation of therapy should be managed over a minimum of 4 weeks.

4.3.1 Tricyclic and related antidepressant drugs

Tricyclics should be used only where SSRIs have proved ineffective. Care should be taken with their use because of potential cardiotoxicity and also toxicity in overdose. Lofepramine is an appropriate first choice. In the elderly, start with low dose and increase cautiously.

Sedative

GREEN       Amitriptyline

tablets 10mg, 25mg, 50mg

liquid 25mg/5mL

GREEN       Clomipramine capsules 10mg, 25mg, 50mg

AMBER       Doxepin capsules 25mg, 50mg

(LCFT)

Less sedative

GREEN       Imipramine (Nocturnal enuresis ONLY)

tablets 10mg, 25mg

syrup 25mg/5mL

BLACK         Imipramine is not recommended for use in depression or neuropathic pain

GREEN       Lofepramine

tablets 70mg suspension 70mg/5mL  Trazodone  Trazodone is licensed for use in depressive illness, particularly where sedation is required. It is related to the tricyclic   anti-depressants.  GREEN               Trazodone                             capsules 50mg, 100mg                                 tablets 150mg GREEN               Trazodone oral solution SF 50mg/5mL [For titration/dose reduction  and patients with swallowing  restricted use  difficulties]

Dosulepin (dothiepin) is not recommended by NICE due to its association with ischaemic heart disease, cardiac arrhythmias and fatalities following overdose.

4.3.3 Selective serotonin re-uptake inhibitors (SSRI)

SSRIs selectively inhibit reuptake of serotonin. NICE recommend that the initial choice of antidepressant should be an SSRI that is available as a generic drug (currently citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline). Locally fluoxetine, citalopram and sertraline are primarily recommended as first and second line choices.

Fluoxetine has a higher propensity for drug interactions although it is less likely to cause a withdrawal reaction. Fluoxetine has shown to have a favourable balance of risks and benefits for the treatment of depressive illness in under 18's. Citalopram is an alternative first line SSRI which may be better tolerated and has fewer drug interactions than most other SSRIs. Sertraline is the SSRI of choice in ischaemic heart disease.

Consider that fluoxetine, fluvoxamine and paroxetine have a higher propensity for drug interactions. Paroxetine is associated with a higher risk of discontinuation symptoms. However, all SSRIs can precipitate such withdrawal symptoms - consult the BNF for tailoring of dose recommendations, do not stop treatment abruptly. 

First & Second Line

GREEN      Fluoxetine                     capsules 20mg                           dispersible tablets 20mg                       (for patients unable to swallow standard capsules)                    liquid 20mg/5mL  GREEN      Citalopram tablets 10mg, 20mg         GREEN      Sertraline tablets 50mg, 100mg

Escitalopram in depression

In the NICE guidance for managing depression (Oct 2009) the NICE committee examined the benefits of prescribing escitalopram. For escitalopram they concluded that the evidence showed only a small advantage over other antidepressants and this was not considered clinically important. There was a small economic advantage over three other antidepressants but this was considered by the committee to have limitations and was insufficient to make a specific recommendation.

Escitalopram: Major Depressive Illness Escitalopram should be reserved for patients with major depressive illness only [As per product license] GREEN            Escitalopram tablets 5mg, 10mg, 20mg  restricted use             MHRA Drug Safety Update - Citalopram and escitalopram: QT interval prolongation

Alternatives - see notes above

GREEN              Paroxetine tablets 20mg, 30mg

Escitalopram in generalised anxiety disorder

See notes on generalised anxiety disorder above.

GREEN              Escitalopram tablets 5mg, 10mg, 20mg

Daily selective serotonin re-uptake inhibitors (SSRIs) in the treatment of premature ejaculation (PE)

Daily SSRI's may be used as an option to treat acquired PE but only after psychotherapy and management of the causative problem have failed to resolve the issue.

Patients should be referred to the psychosexual service in order to determine if a daily SSRI would be an appropriate treatment option.

AMBER            Daily SSRIs for the treatment of PE

4.3.4 Other antidepressant drugs

Third line only

Mirtazapine

Mirtazapine can very rarley cause blood disorders - Patients should be advised to report any fever, sore throat, stomatitis or other signs of infection during treatment. Blood count should be performed and the drug stopped immediatley if blood dyscrasia suspected. Can also increase appetite and weight gain, and cause anti-cholinergic side effects such as dry mouth and postural hypotension. Nausea, vomiting, dizziness, agitation, anxiety, and headache are most common features of withdrawal if treatment stopped abruptly or if dose reduced markedly; dose should be reduced over several weeks.

GREEN              Mirtazapine                             tablets 15mg, 30mg, 45mg                              orodispersable tablets 15mg, 30mg, 45mg (only for those with swallowing difficulties)

Venlafaxine Take into account the toxicity in overdose for people at serious risk of suicide and be aware that venlafaxine is associated with a greater risk of death in overdose. When prescribing antidepressants other than an SSRI take into account the increased likelihood of the patient stopping treatment because of side effects and the need to increase the dose gradually with venlafaxine, duloxetine and tricyclic antidepressants. Treatment with venlafaxine should be initiated under specialist supervision/recommendation when used at 300mg/day or above. It is contra-indicated in patients with an identified very high risk of serious cardiac ventricular arrythmia (e.g. those with a significant left ventricular dysfunction, NYHA Class III/IV), or those with uncontrolled hypertension. Venlafaxine should be used with caution in patients with established cardiac disease that may increase the risk of ventricular arrhythmias (e.g. recent myocardial infarction). Regular measurement of blood pressure is recommeded for patients receiving venlafaxine.   GREEN             Venlafaxine                            tablets/capsules m/r 75mg, 150mg, 225mg, 300mg, 375mg                                  tablets 37.5mg, 75mg           Vortioxetine  Vortioxetine is recommended as an option for the treatment of major depression episodes in adults by NICE TA367     Where the condition has responded inadequately to 2 antidepressants within the current episode.  GREEN             Vortioxetine (Brintellix®)                            tablets 5mg, 10mg, 20mg   Duloxetine for depression - prescribe by brand name only

When prescribing antidepressants other than an SSRI take into account the increased likelihood of the patient stopping treatment because of side effects and the need to increase the dose gradually venlafaxine, duloxetine and tricyclic antidepressants. Consider the specific cautions, contra-indications and monitoring requirements for duloxetine. Regular measurement of blood pressure is recommended for patients receiving duloxetine.

AMBER                Duloxetine (Cymbalta®) capsules 30mg, 60mg

L-Tryptophan  For initiation by a consultant psychiatrist only, in treatment resistant depression.  Please see shared care guideline here SHARED CARE    L-Tryptophan tablets 500mg

Other specialists interventions initiated by specialist mental health teams only:

MAOIs phenelzine - AMBER with ongoing specialist review

Antidepressants with lithium augmentation - AMBER with ongoing specialist review

Other antidepressants which may be initiated by LCFT are as follows:

AMBER                Mianserin       (LCFT)                  tablets 10mg, 30mg AMBER                Moclobemide  (LCFT)                  tablets 150mg, 300mg AMBER                Reboxetine  (LCFT)                  tablets 4mg

Treatment of diabetic neuropathic pain with duloxetine - prescribe by brand name only.

Duloxetine is to be prescribed for diabetic neuropathic pain when the use of tricyclic antidepressants are inappropriate, not tolerated or ineffective.  Withdraw other antidepressants before initiating duloxetine.  Prescribe by brand name only. Treatment should be reviewed after two weeks to assess tolerability, and then after two months to assess response – additional response after this time is unlikely. See new drug review for full recommendations - click here to access it.

GREEN                Duloxetine (Cymbalta®) capsules 30mg, 60mg

Agomelatine  (BLACK traffic Light) Agomelatine should only be initiated and prescribing continued by a consultant psychiatrist from Lancashire Care Trust, for those patients who had tried other antidepressant treatments, including where possible the NICE recommended options for the management of treatment refractory depression. GPs should not be asked to pick up prescribing of agomelatine. All requests should be directed through the Pharmacy Dept of Lancashire Care Foundation Trust initially for authorisation. Patients must be monitored for symptoms suggesting hepatic dysfunction. Liver function tests must be performed in all patients: at initiation of treatment, and then after six weeks, twelve weeks and twenty four weeks. Thereafter liver function tests should be checked when clinically indicated.   Click here for the Joint Formulary for Psychotropic Medication LCFT.

Methylphenidate, dexamfetamine and atomoxetine should be used for Attention Deficit Hyperactivity Disorder only in accordance with the NICE and local shared care guidelines. These three medicines are for initiation in secondary care by specialists with a specific interest in ADHD.

NICE guidance 

Treatment and management

Drug treatment for children, you people and adults with attention deficit hyperactivity disorder (ADHD) should always be:

>     Part of a comprehensive treatment plan that includes psychological, behavioural and educational or occupational           needs

>     initiated by a healthcare professional with expertise in ADHD following a comprehensive assessment

Do NOT start drug treatment for ADHD in children, young people or adults in primary care.

After dose titration and stabilisation by a specialist, GPs can continue prescribing and monitoring drug treatment under the shared care arrangements.

If a child or young person is currently receiving drug treatment but has not been assessed in secondary care, then refer to a specialist in ADHD.

Pre-school children

Drug treatment is NOT recommended.

School-age children and young people with moderate ADHD and moderate impairment

Drug treatment is NOT indicated first-line.

Reserve drug treatment for those with:

>     moderate levels of impairment who have refused non-drug interventions

>     persistent significant impairment following a parent-training/education programme or group psychological                        treatment

School-age children and young people with severe ADHD and severe impairment

First-line: drug treatment as follows:

>     methylphenidate for ADHD without significant co-morbidity or with co-morbid conduct disorder

>     methylphenidate or atomoxetine in the presence of tics, Tourette's syndrome, anxiety disorder, stimulant misuse           or risk of stimulant dviersion.

Second-line: atomoxetine if methylphenidate is ineffective at the maximum tolerated dose or is poorly tolerated.

Third-line: dexamfetamine if no response to maximum tolerated doses of methylphenidate or atomoxetine.

Guanfacine

Children and adolescents 6 -17 years of age for whom stimulants are not suitable, not tolerated or have been shown to

be ineffective. Specialist initiation - see New Medicine Recommendation

SHARED CARE       Guanfacine

                                1mg, 2mg, 3mg, 4mg prolonged-release tablets

Adults with ADHD

First-line: methylphenidate (unlicensed).

OR atomoxetine (unlicensed) if there are concerns about drug misuse and diversion.

Second-line: atomoxetine or dexamfetamine (unlicensed) if methylphenidate is ineffective or cannot be tolerated.

Do NOT use antipsychotics for ADHD in children, young people or adults.

Monitoring

The responsibility for carrying out routine monitoring is outlined in the shared care protocol.

For all drugs monitor:

>     Height (children and young people) - every 6 months.

>     Weight - 3 and 6 months after the start of treatment, then every 6 months.

>     Heart rate and blood pressure - before and after each dose change and every 3 months.

Cautions and counselling

Atomoxetine

Warn parents/carers/adult patients about the potential for:

>     Suicidal thinking and self harm

>     Liver damage (rare) SHARED CARE        Atomoxetine                                   capsules 10mg, 18mg, 25mg, 40mg, 60mg      SHARED CARE       Dexamfetamine                                   tablets 5mg    SHARED CARE       Methylphenidate                                   tablets 5mg, 10mg, 20mg

Prolonged release methylphenidate formulations, should be considered second line and used for patients requiring methylphenidate in the morning and afternoon when administration of a midday dose is problematic or inappropriate.  The pharmacokinetic profile of each brand of prolonged release formulation differs from those of other prolonged release formulations of methylphenidate, and they cannot be considered to be interchangeable.  As such, prolonged release methylphenidate preparations should be prescribed by brand name.  

SHARED CARE       Methylphenidate

prolonged release tablets 18mg, 27mg, 36mg, 54mg (Concerta XL®)

prolonged release capsules 10mg, 20mg, 30mg  (Equasym XL®)

prolonged release capsules 10mg, 20mg, 30mg, 40mg (Medikinet XL®)                                        prolonged release tablets 18mg, 27mg, 36mg, 54mg (Xaggitin®XL)

prolonged release tablets 16mg, 27mg, 36mg, 54mg (*Delmosart®XL)

* cost-effective brand, for use in paediatrics

prolonged release tablets 18mg, 27mg,  36mg, 54mg (Xenidate XL®)

                 Shared care protocols are available  click here.  .  

Modafinil

The European Medicines Agency has recommended that the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy, and that it should no longer be used for the treatment of excessive sleepiness associated with obstructive sleep apnoea or chronic shift work sleep disorder.

On the basis of the available data, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of this medicine only outweighed the risks in the therapeutic indication narcolepsy. For all other indications the Committee found that the risks outweighed the benefit shown in clinical trials. Therefore, the Committee concluded that all other indications should be withdrawn from the marketing authorisations of these medicines.

AMBER                    Modafinil (initiation by consultant neurologist only)                                    tablets 100mg, 200mg   RED     Solriamfetol (Sunosi)                                                                           ICS/CCG Commissioned Blueteq required NICE TA758   Solriamfetol is recommended as an option for treating excessive daytime sleepiness in adults with                         narcolepsy with or without cataplexy. This is only if modafinil and either dexamfetamine or methylphenidate                         have not worked well  enough or are not suitable.   Lisdexamfetamine (young children and Young adults) For use by ELCAS and some Consultant Paediatricians in the treatment of ADHD in children and adults (only in complex patients who meet two specific criteria - SEE BELOW)  AMBER                    Lisdexamfetamine   SHARED CARE        capsules 20mg, 30mg, 40mg, 50mg, 60mg, 70mg (Elvanse®)           >   extenuating circumstances exist which mean that a patient would not reliably receive all the required doses              of dexamfetamine throughout the day and requires a once daily dose of lisdexamfetamine to support adherence.       >    treatment has been agreed through the internal governance arrangements of the trust   Lisdexamfetamine (Adults) For use as an option as part of a treatment programme for ADHD in adults AMBER                   Lisdexamfetamine   SHARED CARE       capsules 20mg, 30mg, 40mg, 50mg, 60mg, 70mg (Elvanse® Adult)    Click here to link to the shared care guideline

These drugs should be prescribed in accordance with NICE guidelines.

4.5.1  Anti-obesity drugs acting on the gastro-intestinal tract

GREEN      Orlistat

tablets 120mg

These drugs should only be used when the cause of vomiting is known.  Drug treatment for vertigo is often not the most effective management strategy, and long treatment should generally be avoided. 

Antihistamines

GREEN      Cyclizine

tablets 50mg

GREEN       Doxylamine and pyridoxine 10mg/10mg tablets (Xonvea®)                     (Indicated in the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative                      management. Suitable for initiation in Primary or Secondary care)

Phenothiazines and related drugs

Symptomatic relief of nausea from underlying disease, drug treatment, and Ménière’s disease.

Caution: prochlorperazine may cause dystonic reactions in the elderly.

GREEN      Prochlorperazine

tablets 5mg

buccal tablets 3mg

syrup 5mg/5mL

suppositories 5mg

injection 12.5mg/mL

GREEN      Levomepromazine (methotrimeprazine)

tablets 25mg*

injection 25mg/mL

* 25mg tablet to be quartered for 6mg dose

BLACK        Levomepromazine tablets 6mg

For the prevention and treatment of post operative nausea and vomiting:

RED           Droperidol injection 2.5mg/mL

Domperidone and metoclopramide

Symptomatic relief of nausea from underlying disease or drug treatment. Avoid use of metoclopramide in children and

those under 20 years of age because of risk of dystonic reactions.

 **New updated advice for Domperidone**

Following a European review, the Medicines and Healthcare products Regulatory Agency (MHRA) is advising that domperidone should not be used by people who have serious underlying heart conditions. It should only be used in the relief of symptoms of nausea and vomiting and at the lowest effective dose for the shortest possible duration.     Adults should take no more than three 10mg tablets per day.                                                                                                         Domperidone should no longer be used to treat other conditions such as heartburn, bloating or relief of stomach discomfort. 

MHRA Drug Safety Update 2019: Domperidone for nausea and vomiting: lack of efficacy in children; reminder of

contraindications in adults and adolescents

MHRA Drug Safety Update - Domperidone: risks of cardiac side effects

GREEN      Domperidone

tablets 10mg

suspension 5mg/mL

GREEN      Metoclopramide

tablets 10mg

syrup 5mg/mL

injection 10mg/2mL

Use of domperidone as a galactogogue during breastfeeding or expressing breastmilk

Domperidone as a galactogogue aids the initiation and maintenance of breast milk supply to meet the needs of a baby receiving breast milk, when non-drug methods have failed. A health professional should be involved in any decision to use domperidone. Domperidone is most likely to be needed for mothers whose babies are on the neonatal unit.

See Infant feeding manual guidance  [page 16]

GREEN     Domperidone 10mg tablets

5HT3 antagonists

Nausea and vomiting

GREEN       Ondansetron

tablets 4mg, 8mg

injection 8mg/4mL

RED            Ondansetron  See MHRA Drug Safety Update January 2020                                (Off licence use in hyperemesis, consultant initiation only)                      tablets 4mg, 8mg                      injection 8mg/4mL

Second line

RED           Granisetron

tablets 1mg

injection 1mg, 3mg

For post-operative nausea and vomiting in adults (not licensed for use in children) – see PONV guidelines.

RED           Dolasetron

injection 12.5mg/0.625mL     Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy RED         Netupitant/palonosetron capsules (Akynzeo®)                  oncology use only

Aprepitant

Aprepitant is a neurokinin 1 receptor antagonist, is licensed for the prevention of acute and delayed nausea and

vomiting associated with cisplatin-based cytotoxic chemotherapy; it is given with dexamethasone and a

5HT3 antagonist. such as ondansetron.  Cancer network guidelines specify when this medicine can be given, and these

should be followed at all times.  They are available online, click here to access them.

RED           Aprepitant

capsules 80mg, 125mg

For vestibular disorders and hypersalivation

GREEN      Hyoscine hydrobromide

injection 400 microgram

tablets (sublingual) 300 microgram

AMBER      Glycopyrronium Liquid 1mg/5mL* (prescribe as Colonis Pharma Ltd brand)                     (Tablets removed from formulary due to cost effectiveness of liquid June 2017)                     *Use: Hypersalivation in adults and children [Non-Parkinson's disease]                     *Use: Hypersalivation/Sialorrhoea in adults with Parkinson's Disease

Other drugs for Ménière’s disease

GREEN      Betahistine

tablets 8mg, 16mg

GREEN      Cinnarizine

tablets 15mg

4.7 Analgesics

When an analgesic strategy is being formulated, reference should be made to a patient's previous experience of pain, analgesics used, any adverse effects and preferences. Renal function and age must also be considered.                         The concept of a balanced or multi model approach to pain management should be employed. Using analgesics with different modes of action improves analgesia and decrease the risk of adverse effects.

Analgesia Ladder

The choice of analgesia should be guided by the principles outlined below.

Analgesia should be prescribed appropriate to the pain intensity.

DO NOT GIVE MORE THAN ONE OPIOID DRUG SIMULTANEOUSLY UNLESS DIRECTED BY A PAIN SPECIALIS

4.7.1 Non-opioid analgesics

For mild to moderate pain relief. Suitable for pain in musculoskeletal conditions.

GREEN       Paracetamol  [Consider OTC/Self care]                      tablets 500mg,  soluble tablets 500mg                                 suspension 120mg/5m, 250mg/5mL                    suspension SF 500mg/5mL (Rosemont) [for patients with swallowing difficulties]                    suppositories 125mg, 250mg, 500mg

For short term use as advised by acute pain team or anaesthetists only  RED           Paracetamol intravenous infusion 10mg/mL 100mL vial

Non-steroidal Anti-inflammatory Drugs  Ibuprofen, Naproxen, Diclofenac        for preparations see section 10.1.1

Compound analgesic preparations (containing opioids)

These preparations should not be used routinely.  Patients should be given the individual components where possible to allow titration of dose.

Where these preparations are used, they should be for short term use only, for relief of moderate pain.

GREEN      Co-codamol 8/500 (codeine 8mg + paracetamol 500mg) [Consider OTC/Self care]                      tablets 8/500, tablets dispersible 8/500

GREEN      Co-codamol 30/500 (codeine 30mg + paracetamol 500mg)                     tablets 30/500, tablets effervescent 30/500

GREEN      Co-dydramol (dihydrocodeine 10mg + paracetamol 500mg)                     tablets 10/500

BLACK       Nefopam tabelts - ELHE Position Statement

4.7.2 Opioid analgesics

Used for relief of moderate to severe pain. Suitable for pain of visceral origin.

GREEN      Codeine phosphate                     tablets 15mg, 30mg, 60mg                    syrup 25mg/5mL

GREEN      Dihydrocodeine                     tablets 30mg                    elixir 10mg/5mL

GREEN      Tramadol                     capsules 50mg                    tablets prolonged release* 100mg, 150mg, 200mg                      *prescribe as Marol® PR tablets - more cost effective than capsules MR                    capsules m/r 100mg, 150mg, 200mg (prescribe as Marol® Tablets PR as above)

(M/R preparations should be prescribed in favour of standard release if there is a risk of abuse or diversion)

RED           Tramadol injection 100mg/2mL (Theatre Recovery only)

GREEN      Morphine sulfate                    tablets 10mg, 20mg, 50mg [Sevredol®]                    oral solution 10mg/5mL, 100mg/5mL [Oramorph®]                    injection 10mg/mL, 15mg/mL, 30mg/mL

capsules m/r  10mg, 30mg, 60mg, 100mg, 200mg [Zomorph®]                    tablets m/r  5mg, 10mg, 15mg, 30mg, 60mg, 200mg [MST®]

(Modified release tablets and capsules should be prescribed by brand name)

The onus is on the prescriber to take adequate steps to assure safe and cost effective choices.

RED           Morphine syringe 100mg/50mL

GREEN      Diamorphine (ongoing supply problems contact pharmacist for advice)                     injection 5mg, 10mg, 30mg, 100mg, 500mg

GREEN      Pethidine                     injection 50mg/mL, 100mg/2mL GREEN      Fentanyl matrix patches 12, 25, 50, 75,100 micrograms/hr                      Matrifen®, Mezolar®, Fencino®, Opiodur®

(Fentanyl matrix patches should be prescribed by brand name to minimise the risk of reservoir patches                      being accidentally supplied)

N.B. This formulary does not specify which brand to prescribe because procurement costs are frequently changing.

The onus is on the prescriber to take adequate steps to assure safe and cost effective choices.

For guidance on the use of fentanyl patches in care homes - click here

AMBER     Oxycodone Hcl modified-release tablets*                                   tablets m/r 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg (Oxypro®MR tablets, Longtec®)                    * Oxypro®MR tablets is the cost-effective branded generic to options for prolonged-release oxycodone.                  [East Lancashire Hospital Trust use 'Oxylan®'' MR - please note this is similar in name to Oxypro®MR AMBER     Oxycodone Liquid 5mg/5mL - 2nd line to capsules  AMBER     Oxycodone Concentrated oral solution 10mg/mL - Palliative Care Use Only  AMBER     Oxycodone Injection 10mg/mL - Palliative Care Use Only when morphine is unsuitable

RED           Methadone (see section 4.10 for use in opiate addiction)                     mixture 1mg/mL (some brands are unlicensed for use in analgesia)                    tablets 5mg                    injection 10mg/mL

GREEN       Buprenorphine                     sublingual tablets 200microgram, 400microgram                    Please note: Buprenorphine oral lyophilisate (Espranor®) is RED traffic Light and  should only be prescribed by                       The Specialist Substance Misuse Service.  (see section 4.10 for use in opiate addiction)   AMBER      Buprenorphine transdermal  weekly patches                      (Butec®) 5, 15, 10, 20 micrograms/hour / (Sevodyne®) 5, 10, 20micrograms/hr                     Preferred brands for all patients  AMBER      Buprenorphine transdermal 96 hourly patches                      (Bupeaze®) 35, 52.5, 70 micrograms/hour - preferred  brand for all patients

Please note the difference in duration of action between the patches. BuTrans require changing every seven days whilst Transtec are a 96 hour patch which will require changing twice weekly. Ensure that the dosage interval prescribed is approriate for the product prescribed in order to prevent either unnecessary changing of patches or potentially leaving patients unmedicated.

Strong Opioids: Treatments of choice

Chronic Pain  Morphine is the first line strong opioid in management of severe chronic pain, in combination with non-opioid and adjuvant therapies.                                                                                                                                                                             Oxycodone and topical agents (Fentanyl / Buprenorphine patches) should be considered as second line agents, for patients intolerant or contraindicated of morphine.

Post Operative Pain   Various agents and regimens are used according to treatment pathway and prescribing is restricted to secondary care, although patients may be discharged on limited course of high potency opioid. Choices are in accordance with the Acute Post Operative Analgesic Prescribing Guidelines and Oxycodone Guideline for Orthopaedic Patients.                                     For prescribing after discharge from hospital, patients should be stepped down to lower potency analgesics or            pre admission regimens should be reinstated after careful consideration of the new analgesic requirement.

Palliative Care   Morphine is the first line strong opioid in palliative care, by oral or parenteral route.   Oxycodone and topical agents (Fentanyl / Buprenorphine patches) should be considered as second line agents, for  patients intolerant or contraindicated of morphine.

Use of Alfentanil  Pain in patients with renal failure or intolerable side effects from other opioids. It is an alternative to other opioids   such as morphine, oxycodone and diamorphine, particularly in patients with renal failure. It should only be used as a   continuous subcutaneous infusion and on the advice of Specialist Palliative Care.     AMBER  Alfentanil solution for injection 1mg/2mL                                   solution for injection 5mg/1mL  See Syringe Pump Policy ELHT

Actions recommended in NPSA/2008/RRR05

Reducing Dosing Errors with Opioid Medicines

This guidance applies when the following opioid medicines are prescribed, dispensed or  administered: buprenorphine,

diamorphine, dipipanone, fentanyl, hydromorphone, meptazinol, methadone, morphine, oxycodone, papaveretum and pethidine.

When opioid medicines are prescribed, dispensed or administered, in anything other than acute emergencies, the

healthcare practitioner concerned, or their clinical supervisor, should:

>      Confirm any recent opioid dose, formulation, frequency of administration and any other analgesic medicines

prescribed for the patient. This may be done for example through discussion with the patient or their

representative (although not in the case of treatment for addiction), the prescriber or through medication records.

>       Ensure where a dose increase is intended, that the calculated dose is safe for the patient (e.g. for oral morphine or

oxycodone in adult patients, not normally more than 50% higher than the previous dose).

>     Ensure they are familiar with the following characteristics of that medicine and formulation: usual starting dose,                frequency of administration, standard dosing increments, symptoms of overdose, common side effects.

Healthcare organisations should ensure local medicines and prescribing policies, including Standard operating

Procedures, are reviewed to reflect this guidance.

Prescribing Fentanyl Patches

Fentanyl patches may differ between brands depending on the type of patch used (matrix or reservoir) and it may

not be suitable to switch patients from one type to the other. For this reason we recommend that only matrix

patches are used across the health economy for all patients.

Matrix transdermal patches consist of a protective film (to be removed prior to application of the patch) and two

functional layers: one self-adhesive matrix layer containing fentanyl and a carrier film impermeable to water.

Matrix patches differ from reservoir patches by the way that the drug is carried. Reservoir patches have a reservoir

filled with the fentanyl in a gel or solution form which is released into the body through a membrane. Matrix patches

hold the drug in an adhesive layer which is distributed evenly throughout the patch and so are considered to be a more

safe delivery method as there is no chance of the fentanyl leaking.

Method of administration

The patches should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arm (in

young children, the upper back is the preferred location to apply the patch, this is to minimize the potential of the child

removing the patch).

Hair at the application site (hairless area is preferred) should be clipped (not shaved) prior to system application. If the

site requires cleansing prior to application of the patch, this should be done with water. Soaps, oils, lotions, alcohol or

any other agent that might irritate the skin or alter its characteristics should not be used. The skin should be completely dry before application of the patch.

Since the transdermal patch is protected outwardly by a waterproof covering foil, it may also be worn when taking a

shower.

The patch should be attached as soon as the pack has been opened. Following removal of the protective layer, the

transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making

sure that the contact is complete, especially around the edges. The patches should be worn continuously for 72 hours

after which it should be replaced with a new patch. A new transdermal patch should always be applied to a different

site from the previous one. The same application site may be re-used only after an interval of at least 7 days.

If residues remain on the skin after removal of the patch, these can be cleaned off with soap and plenty of water. In no

case should alcohol or other solvents be used for cleansing as these could penetrate the skin due to the effect of the

patch.

The transdermal patch should not be divided, as no data are available with regard to this.

Safe use and disposal of used patches

Patients with fever should be regularly monitored for increased side effects as increased absorption is possible.

Patients should be advised to avoid exposing application site to external heat, for example a hot bath or a sauna.

The manaufacturers recommend use only in opioid tolerant patients due to risk of respiratory depression in strong

opioid naive patients.

Patients should be counselled on safe use, correct administration, disposal, strict adherence to dosage instructions, and

the symptoms and signs of opioid overdosage.

Significant quantities of fentanyl remain in the patches even after use. Used patches should be folded with the adhesive

surfaces inwards and due to safety and environmental reasons, discarded safely or whenever possible returned to the

pharmacy.

4.7.3 Neuropathic pain

Duloxetine (Cymbalta®) – see section  4.3.4

Gabapentin – see section 4.8.1

Pregabalin

Pregabalin should only be used in patients who are unresponsive, unsuitable or intolerant of therapy with tricyclic anti-depressants, gabapentin and first line analgesics.  Pregabalin should always be prescribed as a twice daily dose as this is the most cost effective regimen.  Response to therapy should be regularly assessed, and therapy stopped in patients who are unresponsive.

[For prescribing in Generalised Anxiety Disorder, AMBER specialist initiation with criteria, see section 4.3]

GREEN     Pregabalin                     capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg BLACK      Pregabalin Liquid GREEN     Alzain® (cost effective option)                   capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg GREEN     Axalid ® (cost effective option)                  capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg

Note: Licensed indications may vary. Check SPCs to inform decisions made with individual patients.

Capsaicin

Cautions  Avoid contact with eyes, and inflamed or broken skin. Hands should be washed immediately after use. Not for use  under tight bandages. Avoid taking a hot shower or bath just before or after applying capsaicin -burning sensation  enhanced Side-effects  Transient burning sensation can occur during initial treatment, particularly if too much cream is used, or if the  frequency of administration is less than 3–4 times daily.

GREEN         * Capsaicin cream 0.025% [Zacin®] (for osteoarthritis of the hand and knee only- NOT for back pain)                       For general musculoskeletal pain advise to purchase a rubefacient product]  [Consider OTC/Self care]   AMBER        Capsaicin cream 0.075% [Axsain®] (for post herpetic neuralgia & painful diabetic neuropathy)

Lidocaine Plasters

Lidocaine patches should only be initiated by specialists in the management of postherpetic neuralgia. These are chronic pain consultants and consultant neurologists. They should only be used for the management of post herpetic neuralgia where other available treatments (e.g. TCA’s, gabapentin/pregabalin, capsaicin cream) have been used, are inappropriate or not tolerated. Lidocaine patches have not demonstrated sufficient benefits in terms of efficacy or comparative effectiveness to warrant wider use at this stage.   If no benefit has been seen after 2-4 weeks, treatment should be stopped.  Assess possibility of reducing number of plasters, or increasing time between plasters on a regular basis.

AMBER       Lidocaine patches 5% for postherpetic neuralgia                      (2nd line only after other options  have been used.)  AMBER       Lidocaine patches 5%  as a final option in palliative care.

RED             Lidocaine patches 5% for all indications other than postherpetic neuralgia.

Lidocaine plasters for Allondynia and/or hyperalgesia and dysesthesia Lidocaine patches are recommmended only if unresponsive to or intolerant of other neuropathic agents in  NICE/ELMMB guidelines , and treatment is  prescribed by clinicians who specialise in control of pain. Prescribing should  not be transferred to Primary Care   RED            Lidocaine patches 5% for Allondynia and/or hyperalgesia and dysesthia (unlicensed use)

4.7.4 Antimigraine drugs

Guidelines for the management of migraine - see Appendix 1.

4.7.4.1 Treatment of the acute migraine attack

Analgesics - for preparations see section 4.7.1 Nausea - domperidone (section 4.6) may be helpful.

First Line Options  GREEN      Sumatriptan                     tablets 50mg     GREEN     Sumatriptan 3 mg/0.5 ml solution for injection in pre-filled pen                   nasal spray10mg/ 0.1mL unit dose                    Sumatriptan nasal spray 20mg/0.1mL unit dose                         injection (subcutaneous) 6mg/0.5mL syringe

GREEN      Zolmitriptan                       Orodispersable tablets 2.5mg

Second Line options  Patients often warrant a trial of different oral triptans due to individual variability in response, and prescribers should choose a second line product with their patient based on efficacy, tolerability, formulation and cost.

4.7.4.2 Prophylaxis of migraine

Factors which trigger attacks should be sought. Therapy should be reviewed at 6 monthly intervals as long term prophylaxis with these drugs is undesirable.

Amitriptyline is unlicensed for migraine but may be usefully prescribed at a dose of 10mg at night, increasing to a maintenance dose of 50-150mg at night.

Sodium valproate (unlicensed) is no longer recommended.  This is due to the availability of licensed anti-convulsants (e.g. topiramate) and also the teratogenic risk associated with its use in pregnancy (e.g. unplanned pregnancy).

GREEN      Amitriptyline (unlicensed) tablets 10mg, 25mg, 50mg

GREEN      Pizotifen                     tablets 500 micrograms, 1.5mg                                 elixir 250 micrograms/5mL

GREEN      Propranolol capsules m/r 80mg                    Propranolol capsules m/r 160mg

GREEN      Topiramate capsules NICE CG150 (see section 4.8 for use in epilepsy [AMBER])

RED           Flunarizine tablets 5mg, 10mg (Sibelium®) Specialist use only RED    Galcanezumab [Emgality 120mg/1mL solution for injection p/f pens] NICE TA659  Galcanezumab is recommended as an option for preventing migraine in adults, only if:                          >  they have 4 or more migraine days a month                          >  at least 3 preventive drug treatments have failed and                          >  the company provides it according to the commercial arrangement                                                                                                                                 CCG Commissioned Blueteq form required   RED    Erenumab [Aimovig] NICE TA682  Erenumab is recommended as an option for preventing migraine in adults, only if:      > they have 4 or more migraine days a month      > at least 3 preventive drug treatments have failed      > the 140mg dose of erenumab is used and      > the company provides it according to the commercial arrangement  Stop erenumab after 12 weeks of treatment if:      > in episodic migraine  [less than 15 headache days a month] the frequency does not reduce by at least 50%      > in chronic migraine [15 headache days a month or more with at least 8 of those having features of migraine] the          frequency does not reduce by at least 30%             Treatment of chronic migraine   RED           Botulinum Toxin A (use of brand with lowest acquisition cost) injection               CCG Commissioned   NICE TA260  Recommended as an option for the prophylaxis of headaches in adults with chronic migraine )defined as headaches                         on at least 15 days per month of which at least 8 days are with migraine):                           ° that has not responded to at least three prior pharmacological prophylaxis therapies and                            ° whose condition is appropriately managed for medication overuse.   RED           Fremanezumab solution for injection [Ajovy® 225mg/1.5ml]            CCG Commissioned BlueTeq form required NICE TA631  Recommended as an option for preventing migraine in adults, only if:                           º the migraine is chronic, that is, 15 or more headache days a month for more than 3 months with at least of those                              having features of migraine                           ° at least 3 preventative drug treatments have failed and                            ° the company provides it according to the commercial arrangement

4.8.1 Control of epilepsy

All patients with epilepsy need specialist assessment, generally before therapy is started. Use of newer agents should follow NICE guidance.

Updated advice on brand prescribing in the treatment of epilepsy (Nov 2013)/Drug Safety Update November 2017 

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance to prescribers, pharmacists and patients in relation to anti-epileptic drugs (AEDs). This follows a review by the Commission on Human Medicines (CHM) which looked at the evidence on patients switching between different manufacturers' products of particular AEDs. CHM concluded that whilst there was no clear evidence of harm associated with switching products, an effect in some drugs, for some drugs, could not be completely ruled out.

The potential effects of switching may include a loss of seizure control or the occurrence of side effects, or both. These risks can be associated with switching between a branded originator and a generic product, and between different generic products.

CHM advised that AEDs could be classified into three categories. These categories aim to help prescribers and patients whether it is necessary to maintain continuity of supply of a specific manufacturer's product

Category 1

For these drugs doctors are advised to ensure that their patient is maintained on a specific manufacturer's product.

The AEDs in this category are: phenytoin, carbamazepine, phenobarbital, primidone

Category 2

For these drugs the need for continued supply of a particular manufacturer's product should be based on clinical

judgement and consultation with patient and/or carer taking into account factors such as seizure frequency and

treatment history.

The AEDs in this category are: valproate, lamotrigine, perampanel, retigabine, rufinamide, clobazam, clonazepam, oxcarbazepine, eslicarbazepine, zonisamide, topiramate.

Category 3

For these drugs it is usually unnecessary to ensure that patients are maintained on a specific manufacturer's product

unless there are specific concerns such as patient anxiety, and risk of confusion or dosing errors.

The AEDs in this category are: levetiracetam, lacosamide, tigabine, gabapentin, pregabalin, ethosuximide, vigabatrin

When evaluating whether continuity of supply should be maintained for category 2 or 3 medicines, it would be appropriate to consider:          > perception by patients of differences in supply, for example differences in product presentations        > co-morbid autism, mental health issues or special education needs.   It is clinically appropriate to maintain an individual  on a specific manufacturers' product, prescribe either by specifying  brand prescribe either by specifying  brand name or by using the generic drug name and name of manufacturer.

The newer antiepileptic drugs gabapentin, lamotrigine, levetiracetam, topiramate and zonisamide, within  their licensed indications, are recommended for the management of epilepsy in people who have not benefited from

treatment with the older antiepileptic drugs such as carbamazepine or sodium valproate, or for whom the older

antiepileptic drugs are unsuitable because:

• there are contraindications to the drugs
  
• they could interact with other drugs the person is taking (notably oral contraceptives)
  
• they are already known to be poorly tolerated by the individual
  
• the person is a woman of childbearing potential
  

Careful adjustment of dose is needed, starting low and increasing gradually until seizures are controlled or there are adverse effects. Therapy with two or more antiepileptics concurrently should only be used when monotherapy with several alternative drugs has proved ineffective.

Sodium Valproate - Risk of abnormal pregnancy outcomes- MHRA alert Jan 2015

https://www.gov.uk/drug-safety-update/medicines-related-to-valproate-risk-of-abnormal-pregnancy-outcomes

Link to Valproate Safety Implementation Group (VSIG)

[link to resources and recent updates]

Valproate is associated with a dose-dependent risk of abnormal pregnancy outcomes, whether taken alone or in combination with other medicines. Data suggest that when valproate is taken for epilepsy with other medicines, the risk of abnormal pregnancy outcomes is greater than when valproate is taken alone.

The risk of congenital malformations is approximately 10 % while studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development.

Given these risks, valproate for the treatment of epilepsy or bipolar disorder should not be used during pregnancy and in women of child-bearing potential unless clearly necessary ie in situations where other treatments are ineffective or not tolerated.

Carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant. If you decide to prescribe valproate to a woman of child-bearing potential, she must use effective contraception during treatment and be fully informed of the risks for the unborn child if she becomes pregnant during treatment with valproate.

Older anti-epileptics

AMBER     Carbamazepine (Tegretol®)                    tablets 100mg, 200mg, 400mg to reach stable dose                          then convert to tablets m/r 200mg, 400mg                          liquid 100mg/5mL                       suppositories 125 mg

AMBER     Clobazam (only for epilepsy, endorse script SLS)                    tablets 10mg

AMBER     Clonazepam (Rivotril®) tablets 500mcg                           Clonazepam 0.5mg/5mL oral suspension (Rosemont)

AMBER     Ethosuximide capsules 250mg (Epesri®)  [PRESCRIBE BY BRAND] AMBER      Oral solution SF  250mg/5mL  [paediatric use only]

AMBER     Phenytoin (Epanutin®)                    tablets chewable 50mg                            suspension 30mg/5mL

AMBER     Phenytoin Sodium (Flynn Hardcaps®)                    capsules 25mg, 50mg, 100mg

AMBER     Sodium valproate (Epilim®)                    tablets e/c 200mg, 500mg                     tablets m/r 200mg, 300mg, 500mg                             tablets crushable 100mg                          liquid 200 mg/5mL      RED           Sodium Valproate injection 400mg

Episenta®  Episenta® capsules (prolonged release sodium valproate) are also available for use, and are especially helpful for those  patients with swallowing difficulties. They are given once daily, as capsules or sachets which can be opened and put on  soft food if required, without chewing.  Like other valproate preparations when used for epilepsy, they should be  prescribed by brand name.

AMBER     Sodium valproate (Episenta ® )                     capsules m/r 150mg, 300mg AMBER    Phenobarbital                    tablets 15mg, 30mg, 60mg

RED          Phenobarbital elixir [all strengths]

Newer anti-epileptics

AMBER     Gabapentin  AMBER     Lamotrigine (Lamictal®)                     tablets 25mg, 50mg     AMBER     Levetiracetam (prescribe generically)                     tablets 250mg, 500mg, 1g                            oral solution (sugar free) 100mg/mL  RED           Levetiracetam Conc for solution for injection 500mg/5ml [Keppra®] [Epilepsy] AMBER     Levetiracetam Conc for solution for injection 500mg/5ml [Keppra®] Specialist Palliative Care use                    A list of Community Pharmacies who stock specialist palliative care drugs can be accessed here

AMBER     Topiramate                    tablets 25mg, 50mg, 100mg, 200mg                      sprinkle capsules 15mg, 25mg, 50mg                            Topiramate oral suspension 20mg/mL - paediatric use only  [Rosemont pharmaceuticals] AMBER     Zonisamide (Zonegran®)                                capsules 25mg, 50mg, 100mg AMBER     Zonisamide oral solution 100mg/5mL [paediatric use only] AMBER     Lacosamide (Vimpat®)                             tablets 50mg, 100mg, 150mg 200mg                       syrup 10mg/mL     RED           intravenous infusion 10mg/mL  AMBER     Oxcarbazepine (Trileptal®)                    tablets f/c 150mg . 300mg, 400mg                        suspension 300mg/5mL

Brivaracetam  Adjunctive therapy in the treatment of partial-onset seizures with or without secondary  generalisation in adult,  adolescent and children from 4 years of age with epilepsy. AMBER     Brivaracetam (Briviact®)                    tablets 10mg, 25mg, 50mg, 75mg, 100mg                   oral solution 10mg/1ml   Please note: Unlicensed use in children under the age of 4 years - initiated on advise of specialist or tertiary centre.  RED           Brivaracetam (Briviact®)                    tablets 10mg, 25mg, 50mg, 75mg, 100mg                   oral solution 10mg/1ml

ED          Cenobamate [Ontozry®: tablets 100mg, 150mg, 25mg, 50mg]        NICE TA753  Recommended as an option for treating focal onset seizures with or without secondary seizures in                            adults with drug-resistant epilepsy that has not been adequately controlled with at least w anti-seizure                           medicines. It is only recommended if:                           >    it is used as an add-on treatment, after at least 1 other add-on treatment has not controlled                                  seizures, and                           >    treatment is started in a tertiary epilepsy service

RED          Cannabidiol with clobazam [Epidyolex®]                                                              NHS England Commissioned NICE TA614 - Cannabidiol with clobazam is recommended as an option for treating seizures associated with Dravet                          syndrome in  people aged 2 years and older, only if:                         >  the frequency of convulsions is checked every 6 months, and cannabidiol is topped if the frequency has                              not fallen by at least 30% compared with the 6 months before starting treatment.                         >  the company provides cannabidiol according to the commercial arrangement

Eslicarbazepine actetate  For adjunctive therapy in adults with focal (partial onset) seizures with or without secondary generalisation, only for  refractory patients in whom standard adjunctive treatment is inefffective or not tolerated. Treatment should only be considered following referral to or discussion with a tertiary care specialist

AMBER      Eslicarbazepine acetate (Zebininx®)                        tablets 800mg

Perampanel  For use only as an option when other treatment options recommended by NICE CG137 have been tried or fully   considered in the treatment of partial-onset seizures with or without secondarily generalised seizures in people with   epilepsy aged 12 years and over.

AMBER       Perampanel (Fycompa®)                      tablets f/c 2 mg, 4 mg, 6 mg, 8 mg,10 mg, 12 mg

Rufinamide  Rufinamide should only be initiated or recommended by a specialist in the management of Lennox-Gastaut Syndrome (LGS) and other forms of epilepsy, after which prescribing may be passed to the primary care prescriber. Adequate  advice on dose titration should be provided in every case. It should be used as a fourth line adjunctive therapy, usually in a combination with one or more of the following  medicines; sodium valproate (unlicensed), topiramate or lamotrigine.  Women of child-bearing potential taking rufinamide should be advised to use two forms of safe and effective contraception. Hypersensitivity syndrome - Serious hypersensitivity syndrome has developed especially in children and upon initiation of therapy; consider withdrawal if rash or signs or symptoms of hypersensitivity syndrome develop.  Warn patients to seek immediate medical attention if signs or symptoms of hypersensitivity develop.

AMBER     Rufinamide (Inovelon®)                     tablets 100mg, 200mg, 400mg       Infantile Spasms  AMBER     Vigabatrin sachets 500mg Stiripentol to treat Dravet Syndrome in combination with Sodium Valproate and clobazam. For use under specialist advice only  RED          Stiripentol (Diacomit®)                   250mg, 500mg capsules Stiripentol as adjunctive therapy of refractory generalised tonic-clonic seizures in patients over the age of 18 years  who were previously diagnosed with severe myoclonic epilepsy in infancy (Dravet syndrome) whose seizures are not  adequately controlledwith clobazam and valproate. RED*         Stiripentol (Diacomit®)                    250mg, 500mg capsules   * Red Traffic Light (for all ages) for continuation of treatment of patients who have previously received the drug during     childhood under the NHSE standard contract for paediatric neurosciences - neurology.    NOT to be newly initiated in adults.     Medicine to be supplied by the hospital for the duration of the treatment course.    Primary care initiaion or continuation of treatment is not recommended.

4.8.2 Drugs used in status epilepticus Guidelines for the management of status epilepticus - see Appendix 2   Lorazepam is the drug of choice for initial use. RED           Clonazepam (specialist use)                     injection 1mg/1mL GREEN      Diazepam                     injection (emulsion) 5mg/mL                    rectal tubes 5mg, 10mg RED           Lorazepam injection 4mg/mL  AMBER     Midazolam buccal liquid 5mg/mL (Buccolam®)  Prefilled oral syringes, sugar free AMBER     *Midazolam maleate oromucosal solution 10mg/mL  (Epistatus®)   Pre-filled oral syringe SF [1mL]                   *(licensed for use in children and adolescents  aged 10 to less than 18 years)   Transfer to new Licensed Buccal Midazolam 5mg/ml (Buccolam▼): Guidance for Practitioners is available here  RED           Paraldehyde injection (intramuscular or rectal use)  RED           Phenytoin sodium injection 250mg/5mL

All material in this section is aimed at health care professionals, but is information currently held in the

public domain, members of the public seeking advice on medicine-related matters are advised to speak

with their GP, pharmacist, nurse or contact NHS111 Service

Email: info.elmmb@nhs.net

Copyright© 2016 2020 East Lancashire Medicines Management Board   All rights reserved.  Disclaimer/Terms and conditions

4.9.1 Dopaminergic drugs used in parkinsonism

Levodopa with a dopa-decarboxylase inhibitor is the treatment of choice for patients disabled by idiopathic Parkinson's disease. Therapy should be initiated with low doses, gradually increased. Final dose may be a compromise between mobility and side-effects.

GREEN      Co-beneldopa  (benserazide/levodopa)

dispersible tablets 25/100 (Madopar 125®)

capsules m/r 25/100 (Madopar CR 125®)

GREEN      Co-careldopa (carbidopa/levodopa)

tablets 10/100 (Sinemet-110®), 25/250 (Sinemet-275®)

tablets 25/100 (Sinemet-Plus®)

tablets m/r 25/100 (Sinemet Half CR®), 50/200 (Sinemet CR®)

GREEN      Selegiline oral lyophilisates 1.25mg (Zelapar®)

Other dopaminergic drugs

In Parkinson’s disease pramipexole is seen as the dopamine agonist of choice in the movement disorders clinic, with

cabergoline and ropinirole also seen as useful. Dose titration by GPs should be carried out in line with specialist nurse

or clinician recommendations after the initial prescription.

AMBER     Amantadine capsules 100mg & syrup 50mg/5mL

AMBER     Apomorphine injection (APO-go®)       Click here for shared care agreement

AMBER     Cabergoline tablets 1mg, 2mg, 4mg

AMBER     Entacapone tablets 200mg

AMBER     Pramipexole (generic only) 88mcg, 180mcg, 350mcg, 700mcg

AMBER     Pramipexole MR preparations (generic only)                   260mcg, 520mcg, 1.05mg, 1.57mg, 2.1mg, 2.62mg, 3.15mg                       (MR preparations are only for use only when there are compliance issues)

AMBER     Rasagiline tablets 1mg

AMBER     Ropinirole tablets 250micrograms, 1mg, 2mg, 5mg

Starter pack (42 x 0·25 mg, 42 x 0·5 mg, 21 x 1 mg).

Follow-on pack (42 x 0·5 mg, 42 x 1 mg, 63 x 2 mg).

AMBER     Ropinirole prolonged release, once daily tablets

2mg, 4mg, 8mg.

AMBER     Levodopa /carbidopa/ entacapone

Stalevo®, Stanek® tablets 50/12.5/200

Stalevo®, Stanek® tablets 100/25/200

Stalevo®,  Stanek® tablets 150/37.5/200

AMBER    *Sastravi®  tablets - NB: secondary care use only, who will prescribe and label generically.                   *Primary Care Prescribers to issue as Stanek® or Stalevo®

AMBER     Entacapone tablets 200mg

RED            Tolcapone tablets –   Requires intensive LFT monitoring. AMBER     Opicapone (Ongentys®) 50mg hard capsules   Note: Opicapone is recommended as a second line catechol-o-methyltransferase inhibitor in adult patients with Parkinson's disease with 'end of dose' motor fluctuations who cannot be stabilised on levodopa/DDCI inhibitors and who fail to respond to or are intolerant of entacapone, where tolcapone is being considered.

BLACK      Safinamide (Xadago®) 50mg and 100mg film-coated tablets

Click here to access New Medicines Recommendation

Rotigotine patches Rotigotine has shown inferiority to ropinirole and should not be used in preference to other dopamine agonists unless  such alternatives are not suitable (e.g. compliance issues, need for social care to administer other oral therapies,  dysphagia), not tolerated (GI disturbance), or ineffective. Rotigotine is recommended for use only within its licensed  indications (i.e. both early and late stage Parkinson’s disease, as monotherapy or in combination).  Rotigotine requires  dose titration.   Dose in early stage Parkinson’s disease, initiated at 2mg/24hr and patients should be initially prescribed a dose  titration (starter pack) to ensure that the patient reaches the optimum dose of 6mg/day or 8mg/day (maximum dose)  within 1 month.  Therapy should then be continued at this dose by the primary care prescriber unless the patient  suffers side effects, where dose reduction to 4mg/day or 6mg/day should be considered.    Dose in advanced stage Parkinson’s disease with fluctuations, initiated at 4mg/24hr and increased weekly by  2mg/24hr weekly to maximum 16mg/24hr.   Prescribing responsibility may be passed to primary care prescribers following the specialist’s initial prescription, but  response to treatment and the need for continued therapy should be continuously monitored for by the specialist

AMBER     Rotigotine patches 2mg, 4mg, 6mg, 8mg & starter pack

4.9.1.1 Dopaminergic drugs used in restless leg syndrome

Diagnosis of restless legs syndrome (RLS) can be made if all of the following four criteria are met:

• a need to move the legs, usually accompanied or caused by uncomfortable, unpleasant sensations in the legs,
  
• symptoms are exclusively present or worsen during periods of inactivity/rest,
  
• symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues,
  
• symptoms are generally worse or exclusively occur in the evening or during the night 

Guidelines on the management of restless leg syndrome in primary care can be accessed here

Once a diagnosis has been made, the patients severity of symptoms should be scored using the International Restless Leg Syndrome (IRLS) rating scale. See appendix II.

Other secondary cases should be referred to a specialist for diagnosis (e.g. renal failure). Dopamine agonists are not licensed for the management of secondary RLS, only idiopathic RLS. Try to avoid drugs that can exacerbate symptoms (CNS stimulants, diuretics, tricyclic antidepressants, calcium antagonists, phenytoin). 

Patients with paroxsysmal RLS should be offered advice on sleep hygiene and other non-pharmacological measures which will reduce symptoms in some patients.  Should these measures fail, pramipexole may be offered on a ‘when required’ basis in line with the recommendations below.

Patients with moderate to severe RLS (as rated on the IRLS scale, 15 to 40 points) should also be offered sleep hygiene advice and non-pharmacological measures. Patients may consequently be offered treatment with pramipexole, which may be initiated by any prescriber for the treatment of restless leg syndrome (RLS) in line with the product licence and the following recommendations;

• To be initiated in patients with primary (idiopathic) RLS only
  
• serum ferritin should be checked to exclude iron deficiency as a cause. If ferritin <20mcg/L then oral iron supplementation should be offered initially

Pramipexole – 1st Line Choice

• Treatment should be initiated at pramipexole 125micrograms/day. Many patients respond to this dose within 1 week. Dose increases to pramipexole 125micrograms/day and pramipexole 500micrograms/day should be undertaken in 1 week intervals only where necessary. Maximum dose of pramipexole 750micrograms/day should rarely be required.  The dose should be taken 2-3 hours before bedtime. [Doses stated relate to pramipexole dihydrochloride]

• Patients should be counselled that treatment with a dopamine agonist can in some patients exacerbate symptoms, or cause them to appear earlier in the day (augmentation). Some patients see a rebound in symptoms on cessation of treatment. Relapse rates with long term treatment are also unknown at this stage. Dopamine agonists can also cause sudden hypersomnia - patients should also be warned of this overwhelming sensation of sleepiness occurring with little or no warning, and the need to exercise caution when driving or operating machinery. They are also rarely associated with pathological gambling. 
  
• Treatment should be reviewed at 3 months and stopped if little or no benefit seen. Patients should be referred where there is neurological comorbidity (if this requires assessment or seriously impedes diagnosis), failure of response to two dopamine agonists, or augmentation occurs.

GREEN      Generic Pramipexole dihydrochloride  tabelts 125 micrograms, 250 micrograms

Ropinirole – 2nd Line Choice

Ropinirole may only be initiated for the treatment of RLS where the use of pramipexole is inappropriate, not tolerated or ineffective. Efficacy data for the licence for ropinirole comes from those patients with an IRLS score of 24 or above (rather than 15 or above with pramipexole); dose titration is slower than with pramipexole and costs more at the average dose. Starter packs are available for initial dose titration up to 0.5mg/day.

GREEN      Ropinirole

tablets 0.25mg, 0.5mg, 2mg & ‘starter pack’

4.9.2 Antimuscarinic drugs used in parkinsonism

Less effective than levopoda in idiopathic Parkinson's disease, but often supplement its action. Patients with mild symptoms, particularly tremor, may be treated with antimuscarinics alone initially. Prolonged use may cause cognitive impairment.

GREEN      Trihexyphenidyl (benzhexol)                     tablets 2mg, 5mg GREEN      Procyclidine                     tablets 5mg                    syrup 2.5mg/5mL, 5mg/5mL                    injection 10mg/2mL     Trihexphenidyl liquid  Use in dystonic symptoms in children with neurodevelopment conditions AMBER      Trihexphenidyl liquid

4.9.3 Drugs used in essential tremor, chorea, tics and related disorders

Haloperidol is used for motor tics and choreas, propranolol and primidone for essential tremor and tetrabenazine to control movement disorders e.g. Huntington's Chorea.  Riluzole should be used as per NICE guidelines to treat the amytrophic lateral sclerosis form of motor neurone disease.

RED             Botulinum A toxin (Consultant only)

injection 100units  (Botox®)

injection 500units  (Dysport®)

injection 200units (Xeomin®) 2nd line option when intolerance to Dysport® or Botox®

[Brands are not interchangeable]

AMBER       Clonidine tablets 25 micrograms

GREEN       Haloperidol - see section 4.2.1

AMBER       Primidone tablets 250mg (unlicensed)

GREEN       Propranolol -see section 4.7.4.2

AMBER      Riluzole tablets 50mg (Consultant Neurologist  initiation only)

Shared Care

AMBER      Tetrabenazine tablets 25mg RED            Botulinum neurotoxin type A (Xeomin® 50unit, 100unit, 200unit powder for solution for injection)                     [excessive salivation and drooling) caused by neurological conditions in adults]              CCG Commissioned, BlueTec Form     Infantile Haemangiomas  see section 13

Alcohol dependence

Acamprosate should only be initiated following advice from the drug and alcohol team, or other specialist.

AMBER        Acamprosate tablets e/c 333mg

Nalmefene to be supplied via a locally commissioned specialist service in conjunction with continuos psychosocial support. NICE TAG325

RED                Nalmefene  tablets f/c 18mg

Disulfiram is used as an adjunct in the treatment of alcohol dependence (under specialist supervision)

AMBER          Disulfiram tablets 200mg 

Chlordiazepoxide is used in treatment of alcohol withdrawal by Specialist Service only

RED                Chlordiazepoxide capsules 5mg, 10mg

Nicotine Replacement Therapy (NRT)

NRT should not be prescribed by GPs. Individuals  wishing to stop smoking should be referred to a local stop smoking service  East Lancashire Stop Smoking Service can be contacted on 0800 328 6297 or visit the NHS Quit Squad Patients can self-refer directly to a stop smoking service provider <click here>  For Blackburn with Darwen contact Blackburn with Darwen Stop Smoking Service.   T: 01254 682037    E: quitsmoking@blackburn.gov.uk    Click here to access the Position Statement on GP Prescribing of NRT

RED     Nicotine replacement therapy Bupropion  Bupropion (Zyban®) is contra-indicated in patients with a history of seizures or of eating disorders, or who are experiencing acute withdrawal from alcohol or benzodiazepines. Refer to prescribing information for full contra- indications and interactions. Use in line with NICE guidance.

GREEN      Bupropion tablets m/r 150mg

Varenicline  Please note: Varenicline (Champix®) 0.5mg and 1mg tablets are unavailable until further notice - see position statement Varenicline should only be prescribed on the direct advice of a smoking cessation adviser.

¤       Patients presenting to their GP requesting varenicline should be referred to a smoking cessation adviser to

help the patient choose the most appropriate smoking cessation product.  This may not be varenicline.

¤       Varenicline should be used where the use of nicotine replacement therapy (NRT) is not tolerated, ineffective

or inappropriate.  Varenicline has not been compared with NRT, although it has been shown to be superior to

bupropion (Zyban®).

¤       Smoking cessation, with or without pharmacotherapy, has been associated with the exacerbation of

underlying psychiatric illness (e.g. depression). Care should be taken with patients with a history of psychiatric

illness and patients should be advised accordingly.

¤       There is no clinical experience with varenicline in patients with epilepsy.  Patients should be advised of this,

and explicit consent should be obtained if they wish to receive varenicline.

¤       Varenicline should only be used within its licensed indications, and prescribed for smokers who commit to a

target stop date and who smoke >10 cigarettes (or equivalent) per day.

¤       The smoker should be offered regular follow up and advice to aid smoking cessation at at least 2 weekly

intervals through the smoking cessation service.

¤       An initial supply should be for 2 weeks using the ‘starter pack’.  This can then be followed up by a second 2

week supply at the full dose.  A third and fourth prescription of 4 weeks supply should be issued only if the

smoker demonstrates a continuing attempt to stop smoking.  The GP will be contacted at these points to

confirm that these further prescriptions should be issued and that the patient is  still being followed up by the

smoking cessation service.

¤       Patients should only be treated for an initial 12 week course of varenicline until further NICE guidance on the

cost-effectiveness of an additional 12 weeks treatment is available.  In addition, there are no current criteria to

select which patients should receive an additional 12 weeks therapy.

¤       At the end of therapy patients should be advised to taper the dose rather than abruptly stop therapy, as there

is some evidence of an increase in smoking rates and withdrawal symptoms following abrupt withdrawal.

¤       For  example, instead of the last week of 1mg twice daily dosing, this could be decreased to 0.5mg twice daily

for two weeks, then stop.  [This regime is not based on trial data, but on pharmacokinetics]

¤       The concomitant use of varenicline and NRT after the quit date is not recommended.

MHRA Advice for healthcare professionals:

• Patients and their family or care-givers should be made aware of the possibility that trying to stop smoking might cause symptoms of depression.

• Patients who are taking varenicline who develop suicidal thoughts or behaviour should stop their treatment and contact their doctor immediately.

• Varenicline should be discontinued immediately if agitation, depressed mood, or changes in behaviour are observed that are of concern for the doctor, patient, family or care-giver.

• Patients with serious psychiatric illness did not participate in the premarketing studies of varenicline, and the safety and efficacy of varenicline in such patients has not been established. Care should be taken when prescribing varenicline to patients who have a history of psychiatric illness.

GREEN      Varenicline*

tablets 0.5mg, 1mg and ‘starter pack’

Prescribing should only be initiated on the direct advice of a smoking cessation adviser and should be linked

to specialist behavioural management support.    *Please note: Varenicline (Champix®) 0.5mg and 1mg tablets are unavailable until further notice - see position statement

Opioid dependence

These products should only be initiated following advice from the drug and alcohol team, or other specialist.

CSM Advice - As a result of reports linking methadone and the risk of QT interval prolongation prescribers are advised

to carefully monitor the following patients whilst taking methadone:

º          Patients with heart or liver disease

º        Patients with electrolyte abnormalities

º       Patients receiving concomitant treatment with CYP 3A4 inhibitors (eg macrolides, azole antifungals,

diltiazem, verapamil and some anti-HIV protease inhibitors)

º         Concomitant treatment with drugs which cause QT interval prolongation

º          Patients requiring more than 100mg methadone per day

AMBER      Methadone (see section 4.7.2 for use in analgesia)

mixture 1mg/mL

mixture 1mg/mL S/F (sugar free)

oral concentrate 10mg/mL, 20mg/mL (care in prescribing and dispensing due to different

strengths – only dispense after further diluting with Methadose® diluent)

RED            Injection 50mg/2ml, 50mg/mL RED            Tablets  5mg

AMBER     Buprenorphine (see section 4.7.2 for differing product used in analgesia)

sublingual tablets 400microgram, 2mg, 8mg.

RED           Buprenorphine oral lyophilisate 2mg, 8mg (Specialist Substance Misuse service only)

AMBER      Lofexidine

tablets 200 microgram

AMBER      Naltrexone

                   tablets 50mg 

Refer to latest NICE guidance, TAG217, March 2011 (updated May 2016).  Only specialists should initiate treatment after formal assessment including tests of cognitive, global and behavioural functioning and the likelihood of the patient to comply with therapy. GPs may be asked to take over prescribing once an appropriate maintenance dose has been reached and the patient has been demonstrated to benefit from therapy. Patients continuing on treatment should be assessed every six months in secondary care.  

AMBER                Generic Donepezil (1st line use)

tablets and orodispersible tablets 5mg, 10mg

NB Orodispersible tablets should be reserved for use in those with swallowing difficulties only.

(Dispersible tablets are more cost effective compared to liquid preparations)

AMBER                Galantamine modified release tablets 8mg, 16mg, 24mg  (alternative 2nd line option)                               Preferred formulary choices are Gatalin XL tablets,  Luventa XL tablets                               (Prescribe by brand)                              (Please note  standard release tablets or liquid preparations are not approved for use in EL & BwD CCG and should not be prescribed in Primary Care)

AMBER                Rivastigmine (2nd line choice)

capsules 1.5mg, 3mg, 4.5mg

solution 10mg/5mL

patches 4.6mg/24 hours, 9.5mg/24 hours

NB patches should be reserved for those patients who are unable to tolerate or swallow an AChEI.

AMBER                 Memantine (3rd line choice)

tablets 10mg, 20mg

oral solution 10mg/mL

orodispersible tablets 10mg, 20mg

A prescribing information sheet for these drugs can be found here