Formulary Chapter 4: Central nervous system - Full Chapter
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Chapter Links... |
MHRA Drug Safety Alert (Feb 2015): Drugs and driving: blood concentration limits set for certain drugs |
NENC Palliative and End of Life Care Symptom Control Guidelines |
NICE NG62: Cerebral palsy in under 25s: assessment and management |
TEWV - Medicines Optimisation – Interactive Guide |
TEWV Guidelines |
TEWV Safe Transfer of Prescribing Guidance |
Details... |
04.01 |
Hypnotics and anxiolytics |
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Hypnotics should not be prescribed for more than 10 nights without being reviewed. Use in the elderly is discouraged. Nitrazepam is no longer included in the formulary for use as a hypnotic |
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Melatonin
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Formulary
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- First line: melatonin 1mg and 5mg modified release tablets in line with licensed indications only.
- Second line: melatonin 1mg, 2mg, 3mg, 4mg and 5mg tablets (crushed if necessary).
- Third line: melatonin 1mg/1ml oral solution - 1st choice for patients unable to tolerate solid dose formulations. Consilient Health formulation to be used as it is alcohol and propylene glycol free
Approved Indications
Melatonin can be used to facilitate the induction of sleep, and increase the duration of sleep on the advice of an appropriate secondary care specialist, in the following situations:
1) Visually impaired or blind people with disturbed sleep wake cycles. ![Green plus](../images/TrafficLightsGreenPlus.gif) 2) Delayed sleep phase syndrome and other circadian rhythm disorders.![Green plus](../images/TrafficLightsGreenPlus.gif) 3) Children with neurological or behavioural disorders including: ![Amber](../images/TrafficLightsAmberV2.gif)
- Attention deficit hyperactivity disorder (ADHD).*
- Chronic sleep onset insomnia.*
- Neurodevelopmental disabilities (e.g. involving delayed brain maturation, sensory dysfunction - especially visual and dysfunction of sleep centres).*
4) Treatment of children and young adults with chronic fatigue syndrome / myalgic encephalomyelitis who have sleep difficulties (as recommended in NICE clinical guideline no. 53).* ![Amber](../images/TrafficLightsAmberV2.gif) 5) Prior to examinations such as a sleep encephalogram (EEG) in children and sedation prior to scans in paediatric oncology. ![Green plus](../images/TrafficLightsGreenPlus.gif) 6) Patients with REM sleep behaviour disorder (RBD) - e.g. associated with degenerative conditions such as Parkinson’s disease or dementia, as a second line treatment to clonazepam. ![Green plus](../images/TrafficLightsGreenPlus.gif) 7) To improve nocturnal sleep in critically ill patients (to aid weaning from mechanical ventilation) ![Green plus](../images/TrafficLightsGreenPlus.gif)
*Note that for indications 3 and 4 in children and young people melatonin is classified as an ‘amber’ drug and therefore subject to formal shared care guidance. Please follow relevant link below for the most recent guideline.
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Tees, Esk and Wear - Melatonin Shared Care Guideline
North of Tyne, Gateshead and North Cumbria - Melatonin for the management of Sleep – Wake Disorders in Children and Young People
North of Tyne, Gateshead and North Cumbria - Melatonin Deprescribing Guideline (March 2022)
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Temazepam
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First Choice
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04.01.01 |
Zaleplon, Zolpidem and Zopiclone |
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Zolpidem
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Formulary
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MHRA Drug Safety Update (May 2014): Zolpidem: risk of drowsiness and reduced driving ability
NICE TA77: Zaleplon, zolpidem and zopiclone for the management of insomnia
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Zopiclone
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Formulary
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- To be used in accordance with NICE criteria
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NICE TA77: Zaleplon, zolpidem and zopiclone for the management of insomnia
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04.01.01 |
Chloral and derivatives |
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Chloral Hydrate
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Formulary
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MHRA Drug Safety Update (Oct 2021): Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
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Chloral Hydrate 500mg in 5ml mixture
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Formulary
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MHRA Drug Safety Update (Oct 2021): Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
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04.01.01 |
Clomethiazole (Chlormethiazole) |
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Clomethiazole
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Formulary
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- Alcohol withdrawal - chlordiazepoxide is preferred in the management of alcohol withdrawal.
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Promethazine Hydrochloride
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Formulary
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Daridorexant (Quviviq® )
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Formulary
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- 25mg and 50mg tablets
- Approved for the treatment long-term insomnia in line with NICE via NHS Sleep Clinic at
- South Tees Hosptials NHS Foundation Trust; and
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- First 3 months treatment to be provided by secondary care followed by a review and a further 1 month supply if appropriate before prescribing is handed over to primary care
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NICE TA922: Daridorexant for treating long-term insomnia
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Sodium Oxybate 500mg/1ml oral solution (Xyrem®)
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Formulary
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- Approved for the treatment of narcolepsy with cataplexy in children age 7 years and above only in accordance with NHS England clinical commissioning policy.
- The Northern (NHS) Treatment Advisory Group recommends the use of sodium oxybate in adult patients who have received and benefited from treatment with sodium oxybate as commissioned by NHS England. i.e. continuing treatment for those >19 years old.
- The Northern (NHS) Treatment Advisory Group also recommends sodium oxybate for use in adults who have not received it as a child as per the RMOC criteria, noting that may sometimes be used in combination with other agents.
- The following criteria for use in adults who have not received sodium oxybate as child apply:
- Patients presenting with narcolepsy with cataplexy according to International Classification of sleep disorders 3 (ICSD) criteria for Narcolepsy Type 1 AND
- Patients ≥ 19 years old AND
- Where patients have co-morbidities, which are also affecting sleep, these should be managed and adequately treated (for example moderate to severe obstructive sleep apnoea or restless legs syndrome) AND
- Failure to respond to non-pharmacological treatments consisting of behavioural and environmental adaptations, for example planned naps AND
- Inadequate response (within 3 months) to, or intolerable adverse effects from, or contra-indicated use of, more than one stimulant for narcolepsy, and more than one anticataplectic agent AND
- Assessed as being able to benefit from sodium oxybate via a specialist sleep centre.
- Sodium oxybate is generally considered as a final treatment option for patient
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Clinical Commissioning Policy: Sodium oxybate for symptom control of narcolepsy with cataplexy (children and adolescents aged 7 until 19 years)
NTAG - Treatment Appraisal Decision Summary - Sodium Oxybate
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04.01.01 |
Pitolisant |
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Benzodiazepines should not be used as an anxiolytic for more than 4 weeks without being reviewed. Use in the elderly is discouraged. |
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Pregabalin
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Formulary
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MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy
MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression
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Diazepam
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First Choice
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- Diazepam 2mg tablets: are the preferred strength in primary care.
- Diazepam 10mg tablets: should no longer be used.
- Diazepam 10mg in 2ml injection: only approved for use in epilepsy (see section 4.8.2).
- Diazepam 2 mg/5ml oral solution: swallowing difficulties
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Chlordiazepoxide
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Formulary
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Lorazepam
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Formulary
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MHRA Drug Safety Update (October 2007): Lorazepam: reduction of recommended maximum daily dose
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Buspirone Hydrochloride
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Formulary
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04.01.02 |
Meprobamate |
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04.02 |
Drugs used in psychoses and related disorders |
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04.02.01 |
Antipsychotic Drugs |
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For more information on prescribing antipsychotics in primary care see the North of Tyne, Gateshead and North Cumbria APC Information leaflet prepared by CNTW or the TEWV Medicines Optimisation Interactive Guide (as appropriate):
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Benperidol
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Formulary
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- Approved for the control of deviant antisocial sexual behaviour
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04.02.01 |
First Generation Antipsychotic Drugs |
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Chlorpromazine
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Formulary
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Haloperidol
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Formulary
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Palliative Care
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MHRA Drug Safety Update Dec 2021: Haloperidol (Haldol): reminder of risks when used in elderly patients for the acute treatment of delirium
NICE NG10: Violence and aggression: short-term management in mental health, health and community settings
TEWV Rapid Tranquilisation Policy
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Perphenazine
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Formulary
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Sulpiride
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Formulary
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Zuclopenthixol
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Formulary
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Flupentixol (Flupenthixol)
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Alternatives
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Levomepromazine (Methotrimeprazine)
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Alternatives
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For use in palliative care.
- Levomepromazine 25mg in 1ml injection is approved for use in palliative care.
- Note: Methotrimeprazine / Levomepromazine 6mg tablets are
unlicense
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Trifluoperazine
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Alternatives
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04.02.01 |
Second Generation Antipsychotic Drugs |
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Risperidone
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Formulary
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- Note: risperidone orodispersible tablets should only be used in situations where the plain tablets are unsuitable.
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MHRA Drug Safety Update (Nov 2013): Risperidone and paliperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery
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Amisulpride
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Formulary
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Aripiprazole
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Alternatives
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- Approved for schizophrenia in people aged 15 to 17 years in line with NICE.
- Approved for moderate to severe manic episodes in young people aged 13 and older with bipolar I disorder NICE.
- Aripriprazole 10mg & 15mg orodispersible tablets are approved for doses over 5mg for those patients who have difficulty swallowing.
- Aripiprazole 1mg in 1ml oral solution is only for doses of 5mg or less, or when titrating patients on doses of increments of less than 5mg, in patients who have difficulty swallowing tablets.
- To be used in accordance with NICE criteria.
- Note: Aripiprazole 7.5mg/ml IM Injection is approved for use in rapid tranquilisation in patients with acute psychosis.
NTW use only.
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NICE TA213: Aripiprazole for the treatment of schizophrenia in people aged 15 -17 years
NICE TA292: Bipolar disorder (children) - aripiprazole
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Clozapine
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Alternatives
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- First choice in patients with treatment-resistant schizophrenia.
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MHRA Drug Safety Alert (Oct 2017): Clozapine: reminder of potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus
MHRA Drug Safety Update (Aug 2020): Clozapine and other antipsychotics: monitoring blood concentrations for toxicity
North East and North Cumbria ICB - Clozapine supporting guidance for primary care
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Lurasidone (Latuda®)
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Alternatives
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- 18.5mg, 37mg and 74mg tablets
- Approved for the treatment of schizophrenia in adults and adolescents aged 13 years and over
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NTAG - Lurasidone Treatment Appraisal: Decision Summary
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Olanzapine
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Alternatives
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- Olanzapine orodispersible tablets should only be used in situations where the plain tablets are unsuitable.
- Olanzapine orodispersible tablets and injection are also approved for 2nd/3rd- line use in the management of delirium in critical care patients
unlicensed indication. ![Green plus](images/TrafficLightsGreenPlus.gif)
- 10 mg injection
- for rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate.
- for delirium at end of life
- 210mg, 300mg & 405mg powder and solvent for suspension for long-acting injection (as olanzapine embonate monohydrate)
![Red](images/TrafficLightsRedV2.gif)
- approved for the treatment of schizophrenia in adults within secure psychiatric services
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Quetiapine
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Alternatives
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- 25mg, 100mg, 150mg 200mg & 300mg tablets
![Green plus](images/TrafficLightsGreenPlus.gif)
- 50mg, 200mg, 300mg & 400mg prolonged release tablets
- Prolonged release tablets are approved for use in patients who require an outside carer to administer their medicines, and for short term use when rapid dose titration is considered important e.g. where its use might avoid the need to admit the patient to hospital.
- Quetiapine 20mg/ml Oral Suspension (Rosemont) - CNTW only
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04.02.02 |
Antipsychotic depot injections |
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Zuclopenthixol Decanoate
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First Choice
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CNTW
TEWV
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Aripiprazole (Abilify Maintena®)
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Alternatives
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CNTW
TEWV
- NTAG approved for the treatment of schizophrenia as per its licensed indication and as outlined in the Guidance on the Use of Antipsychotic Long-acting Injections in the North of England.
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Aripiprazole (Abilify Maintena®, Otsuka Pharmaceuticals) long acting injection for schizophrenia
TEWV Shared Care Guidelines for Aripiprazole
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Flupentixol Decanoate
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Alternatives
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CNTW
TEWV
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Haloperidol Decanoate
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Alternatives
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CNTW
TEWV
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Paliperidone
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Alternatives
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CNTW
TEWV
- NTAG approved for the treatment of schizophrenia as per its licensed indication and as outlined in the Guidance on the Use of Antipsychotic Long-acting Injections in the North of England.
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Paliperidone long acting injection (Xeplion®) and Paliperidone 3 monthly injection (Trevicta®) Janssen-Cilag for schizophrenia.
TEWV Paliperidone LAI – Shared Care Guidelines
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Risperidone (Risperdal Consta®)
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Alternatives
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CNTW
TEWV
- Only for use by psychiatrists in accordance with NTAG guidelines.
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Zuclopenthixol Acetate (Clopixol Acuphase®)
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Alternatives
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- For short-term use by NTW.
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Olanzapine Embonate (ZypAdhera®)
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Alternatives
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04.02.03 |
Drugs used for mania and hypomania |
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Other anticonvulsant drugs are used in the management of bipolar disorders e.g. Lamotrigine for the depressive phase. Such use is ‘off-licence’. |
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Lamotrigine
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Formulary
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Olanzapine (oral)
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Formulary
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Quetiapine
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Formulary
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Risperidone (oral)
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Formulary
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MHRA Drug Safety Update (Nov 2013): Risperidone and paliperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery
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04.02.03 |
Antipsychotic drugs |
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04.02.03 |
Carbamazepine |
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Carbamazepine
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Formulary
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Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) |
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Sodium valproate 200mg, 300mg, and 500mg tablets (Epilim Chrono®)
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Formulary
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- Sodium valproate 200mg, 300mg, and 500mg (Epilim Chrono®) tablets are approved for the prevention and treatment of manic episodes associated with bipolar disorder (
unlicensed indication). May be useful in patients unresponsive to lithium.
Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) ![Amber](images/TrafficLightsAmberV2.gif)
Black Triangle in females
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
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Valproate medicines: Pregnancy Prevention Programme materials
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Valproic Acid (Depakote®) (Semisodium valproate)
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Formulary
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- Licensed alternative to sodium valproate MR tablets.
Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) ![Amber](images/TrafficLightsAmberV2.gif)
▼Black Triangle in females
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
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Valproate medicines: Pregnancy Prevention Programme materials
Local Shared Care guideline in TEWV to support Valproate Pregnancy Prevention Programme
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Lithium Carbonate
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Formulary
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North of Tyne, Gateshead and North Cumbria - Lithium Shared Care Guideline
South Tyneside & Sunderland APC Shared Care Guideline - Lithium
TEWV Guidelines on Safe Lithium Prescribing and Shared Care
TEWV Safety guidance: Lithium on admission to an acute hospital ward
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Lithium Citrate
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Formulary
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North of Tyne, Gateshead and North Cumbria - Lithium Shared Care Guideline
TEWV Guidelines on Safe Lithium Prescribing and Shared Care
TEWV Safety guidance: Lithium on admission to an acute hospital ward
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04.03 |
Antidepressant drugs |
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04.03.01 |
Tricyclic and related antidepressant drugs |
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04.03.01 |
Tricyclic antidepressants |
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Amitriptyline
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First Choice
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Imipramine
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Formulary
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Lofepramine
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Formulary
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- Safer than amitriptyline in overdosage, but not as effective.
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Clomipramine
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Alternatives
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04.03.01 |
Related antidepressants |
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Trazodone
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First Choice
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- Trazodone is widely used off-license for night sedation and behavioural symptoms of dementia.
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04.03.02 |
Monoamine-oxidase inhibitors |
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Phenelzine
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Formulary
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- For use on advice from psychiatrists only.
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Moclobemide
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Formulary
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- For use on advice from psychiatrists only.
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04.03.03 |
Selective serotonin re-uptake inhibitors |
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Citalopram
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First Choice
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- Please note maximum doses
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MHRA Drug Safety Update (Dec 2014): Citalopram and escitalopram: QT interval prolongation
MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
MHRA Drug Safety Update (July 2016): Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use
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Fluoxetine
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First Choice
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- 20mg capsules
- 20mg dispersible tablets
- first choice for patients unable to use the capsules
- 20mg/5ml oral solution
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MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
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Paroxetine
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First Choice
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MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
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Sertraline
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First Choice
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- 25mg, 50mg, 100mg, 150mg & 200mg tablets
- 100mg/5ml concentrate for oral solution (Thame)
- Approved for patients who are unable to take a solid dose form or who require small doses
- Must be diluted prior to use. Please refer to SPC for list of specified drinks
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MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
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Escitalopram
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Formulary
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MHRA Drug Safety Update (Dec 2014): Citalopram and escitalopram: QT interval prolongation
MHRA Drug Safety Update (Jan 2021): SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
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04.03.04 |
Other antidepressant drugs |
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These drugs are for use in patients not responding adequately to first-line treatments. |
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Agomelatine
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Alternatives
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- NETAG approved for the treatment of depression only following an adequate trial of at least three alternative antidepressant drugs at maximally tolerated doses (as described by NICE and as stated in the BNF).
- Prescribing and monitoring should be initiated by specialist mental health physicians. After a minimum of 12 weeks, prescribing may be transferred to primary care.
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MHRA Drug Safety Update (Dec 2014): Agomelatine (Valdoxan): risk of liver toxicity
North East and North Cumbria ICB: Agomelatine – Prescribing and Monitoring in Adults: Information for Primary Care
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Duloxetine
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Alternatives
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- For use on advice of psychiatrists as a third-line antidepressant - but only for use in patients who cannot tolerate high-dose (>150mg daily) venlafaxine, or patients with hypertension, established CHD or other cardiovascular risk factors which would make the use of high-dose venlafaxine undesirable.
- Also approved for third-line use (after drugs such as the tricyclic antidepressants and gabapentin) in the treatment of neuropathic pain on the advice of pain specialists.
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Mirtazapine
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Alternatives
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- Orodispersible mirtazapine tablets should only be prescribed for use when other formulations are unsuitable (more expensive).
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Reboxetine
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Alternatives
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- Not licensed in the elderly
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Venlafaxine
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Alternatives
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- For patients on doses of 300mg/day or more.
![Green Traffic Light](images/TrafficLightsGreenplus.gif)
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TEWV Depression medication pathway for adults
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Vortioxetine
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Alternatives
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- Only approved for use in accordance with NICE guidance.
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NICE TA367: Vortioxetine for treating major depressive episodes
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04.04 |
CNS stimulants and other drugs used for attention deficit hyperactivity disorder |
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Methylphenidate
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Formulary
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- Please prescribe by brand name
- Approved for ADHD and the treatment of narcolepsy in adult and paediatrics.
- Approved for improving working memory and processing speed following neurocognitive damage secondary to brain injury from; a brain tumour and its associated treatment (e.g. hydrocephalus and radiotherapy) or neurotoxic chemotherapy.
- 5mg & 10mg tablets
- 5mg, 10mg, 20mg, 30mg and 40mg m/r capsules (Medikinet® XL)
- 10mg, 20mg & 30mg m/r capsules (Equasym® XL)18mg, 27mg & 36mg m/r tablets (Xaggitin® XL)
- Existing patients who are prescribed Concerta® XL should be reviewed and switched to Xaggitin® XL as appropriate
- Xaggitin® XL is bioequivalent to Concerta® XL
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North of Tyne, Gateshead and North Cumbria - Methylphenidate for Narcolepsy Shared Care Guidance (March 2023)
North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Adults
North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Children and Young People
North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Methylphenidate secondary to brain injury
South Tyneside & Sunderland APC Shared Care Guidance - Methylphenidate, Dexamfetamine, Lisdexamfetamine and Atomoxetine for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults
South Tyneside & Sunderland APC Shared Care Guidance - Methylphenidate, Dexamfetamine, Lisdexamfetamine, Atomoxetine and Guanfacine for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children and Young People
TEWV ADHD prescribing algorithm in adults
TEWV ADHD prescribing algorithm in Children & Young People
TEWV Methylphenidate Shared Care Guideline
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Atomoxetine
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Formulary
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- 10mg, 18mg, 25mg, 40mg, 60mg, 80mg & 100mg capsules
- 4mg/1ml oral solution - approved for patients with more complex needs e.g. younger patients and those with swallowing difficulties.
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North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Adults
North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Children and Young People
TEWV Atomoxetine Shared Care Guideline
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Dexamfetamine
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Formulary
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- 5mg, 10mg and 20mg tablets
- ADHD
- Narcolepsy
- Doses up to 60mg daily
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North of Tyne, Gateshead and North Cumbria - Dexamfetamine for Narcolepsy
North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Adults
North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Children and Young People
TEWV Shared Care Guidelines: Dexamfetamine
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Lisdexamfetamine
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Formulary
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- 20mg, 30mg, 40mg, 50mg, 60mg & 70mg capsules
- For third line use and specialist initiation. Should only transferred to GPs after at least three month stable symptom control
- Approved for the treatment of ADHD in adults
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North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Adults
North of Tyne, Gateshead and North Cumbria Shared Care Guideline - Attention Deficit Hyperactivity Disorder (ADHD) in Children and Young People
TEWV Shared Care Guidelines: Lisdexamfetamine
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Modafinil
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Formulary
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- Approved for:
- treatment of patients with narcolepsy
- treatment of idiopathic hypersomnia
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MHRA Drug Safety Update (Nov 2020): Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy
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Solriamfetol (Sunosi®)
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Formulary
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- 75mg and 150mg tablet
- Approved for treating excesive daytime sleepiness caused by narcolepsy in line with NICE
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NICE TA758: Solriamfetol for treating excessive daytime sleepiness caused by narcolepsy
NICE TA777: Solriamfetol for treating excessive daytime sleepiness caused by obstructive sleep apnoea (Not Recommended)
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Pitolisant (Wakix®)
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Alternatives
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- Approved for use in patients with narcolepsy who experience psychomotor side effects with modafinil and dexamfetamine.
- To be used in line with NTAG
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NICE TA776: Pitolisant hydrochloride for treating excessive daytime sleepiness caused by obstructive sleep apnoea
NTAG - Treatment Appraisal Decision Summary - Pitolisant (Wakix®) for the treatment of narcolepsy with or without cataplexy in adults.
NTAG - Pitolisant for Narcolepsy Treatment Pathway
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Guanfacine (Intuniv®)
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Alternatives
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- 1mg, 2mg, 3mg & 4mg prolonged release tablets
- Approved for use in children and adolescents when 1st line stimulants and atomoxetine are contraindicated or ineffective.
- Can also be prescribed in primary care by GPs in adults who started treatment in childhood and wish to continue, for whom stimulants are not suitable, not tolerated or have been shown to be ineffective under specialist supervision
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Methylphenidate, Dexamfetamine, Lisdexamfetamine and Atomoxetine for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults
TEWV ADHD prescribing algorithm in adults
TEWV Guanfacine Shared Care Guideline
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04.05 |
Drugs used in the treatment of obesity |
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04.05.01 |
Anti-obesity drugs acting on the gastro-intestinal tract |
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Liraglutide (Saxenda®)
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Formulary
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Saxenda®![](../images/blacktriangle.gif) ![Red](../images/TrafficLightsRedV2.gif)
- Approved as an option for managing overweight and obesity alongside a reduced-calorie diet and increased physical activity in adults in line with NICE and providing:
- it is prescribed in secondary care by a specialist multidisciplinary tier 3 weight management service; and
- the company provides it according to the commercial arrangement
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NICE TA664: Liraglutide for managing overweight and obesity
|
Orlistat
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
|
MHRA Drug Safety Update (March 2014): Orlistat: theoretical interaction with antiretroviral HIV medicines
|
04.05.02 |
Centrally acting appetite suppressants |
|
|
04.06 |
Drugs used in nausea and vertigo |
|
|
Droperidol
|
Formulary
|
|
|
Granisetron
|
Formulary
|
|
|
Metoclopramide INJECTION
|
Formulary
|
|
|
Nabilone
|
Formulary
|
|
|
Ondansetron INJECTION
|
Formulary
|
|
MHRA Drug Safety Alert (Jul 2013): Ondansetron for intravenous use: dose-dependent QT interval prolongation
MHRA Drug Safety Update (Jan 2020): Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy
|
|
|
04.06 |
Vomiting during pregnancy |
|
|
04.06 |
Postoperative nausea and vomiting |
|
|
|
04.06 |
Other vestibular disorders |
|
|
04.06 |
Cytotoxic chemotherapy |
|
|
|
|
|
Cinnarizine
|
Formulary
|
|
|
Cyclizine
|
Formulary
|
|
|
Promethazine Hydrochloride (Phenergan)
|
Formulary
|
|
|
04.06 |
Phenothiazines and related drugs |
|
|
Prochlorperazine
|
Formulary
|
- Note: Buccastem® 3mg tablets are only approved for the treatment of nausea associated with migraine when the oral route cannot be used due to vomiting.
|
|
04.06 |
Domperidone and metoclopramide |
|
|
Metoclopramide
|
Formulary
|
- Please refer to MHRA advice
|
Metoclopramide: risk of neurological adverse effects
|
Domperidone
|
Unlicensed
|
- Approved for use as a galactagogue to re-establish breastfeeding on specialist advice and following a cardiovascular risk assessment in light of MHRA advice.
|
MHRA Drug Safety Alert (May 2014): Domperidone: risk of cardiac side effect
MHRA Drug Safety Update (Dec 2019): Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescents
|
|
Ondansetron
|
First Choice
|
- The cheapest available formulation should be used.
- Ondansetron 4mg and 8mg oro-dispersible tablets/films are approved for the treatment of post-operative nausea and vomiting in patients who do not require IV access or are nil by mouth
|
MHRA Drug Safety Update (Jan 2020): Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy
|
Palonosetron
|
Alternatives
|
- Only approved for the second line treatment of chemotherapy induced nausea vomiting only.
|
|
Netupitant & Palonosetron (Akynzeo®)
|
Alternatives
|
- To be used in accordance with Northern England Strategic Clincial Cancer Network (NCCN) Guidelines
|
|
04.06 |
Neurokinin receptor antagonist |
|
|
Aprepitant
|
Formulary
|
- For the prevention of chemotherapy induced nausea and vomiting (CINV) in high risk patients in accordance with North of England Cancer Network: CINV Guidelines in adult oncology and haematology patients
|
Chemotherapy Induced Nausea and Vomiting (CINV) Anti-emetic Guidelines
|
Fosaprepitant
|
Formulary
|
- For the prevention of chemotherapy induced nausea and vomiting (CINV) in high risk patients in accordance with North of England Cancer Network: CINV Guidelines in adult oncology and haematology patients
|
Chemotherapy Induced Nausea and Vomiting (CINV) Anti-emetic Guidelines
|
|
Cannabidiol (Epidyolex®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- 100mg/1mL oral solution
- Approved for use in combination with clobazam for treating seizuires associated with Dravet syndrome in people aged 2 years and older
- Approved for use in combination with clobazam for treating seizures associated with Lennox-Gastaut syndrome
|
NICE TA614: Cannabidiol with clobazam for treating seizures associated with Dravet syndrome
NICE TA615: Cannabidiol with clobazam for treating seizures associated with Lennox–Gastaut syndrome
|
04.06 |
Hyoscine |
|
|
Hyoscine Hydrobromide (tablets/patches)
|
Formulary
|
- For the management of excessive secretions where tablets are unsuitable.
|
|
04.06 |
Other drugs for Ménière's disease |
|
|
Betahistine Dihydrochloride
|
Formulary
|
|
|
|
|
|
|
|
04.07.01 |
Non-opioid analgesics and compound analgesic preparations |
|
|
Paracetamol
|
First Choice
|
- Paracetamol 500mg tablets / soluble tablets
- Paracetamol 1gram injection for IV infusion
- NoTGhdNC: approved for limited short-term use where oral and rectal routes cannot be used and NSAIDs are not appropriate in paediatric areas only, the 50ml formulation should be stocked.
- Paracetamol suppositories
- Licensed preparations include 60mg,125mg, 250mg, and 500mg suppositories are available in primary care.
unlicensed preparations include 15mg, 30mg, 60mg, 120mg, 240mg, and 500mg. These are used in NUTH.
|
|
Naproxen tablets
|
Formulary
|
|
|
Ibuprofen
|
Alternatives
|
|
MHRA Drug Safety Update (June 2015): High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk
|
Aspirin
|
Alternatives
|
|
|
Diclofenac
|
Alternatives
|
- Oral diclofenac is restricted to short-term use for post operative pain.
- If long-term use is required diclofenac is only approved for 4th line treatment (see below):
- Ibuprofen low dose – first line treatment.
- Naproxen low dose – second line treatment.
- Naproxen high dose – third line treatment.
- Diclofenac – fourth line treatment.
|
MHRA Drug Safety Update (Dec 2007): NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
MHRA Drug Safety Update (Jan 2015): Cox-2 selective inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs): Cardiovascular safety.
MHRA Drug Safety Update (June 2013): Diclofenac: new contraindications and warnings
MHRA Drug Safety Update (Oct 2012): Non-steroidal anti-inflammatory drugs (NSAIDs): cardiovascular risks
|
|
04.07.01 |
Compound analgesic preparations |
|
|
|
While Co-codamol 8/500 is commonly used, no advantages over paracetamol have been substantiated. The low dose of codeine may be enough to cause opioid side-effects (in particular, constipation) and can complicate the treatment of overdose, yet may not provide significant additional relief of pain. Use is therefore discouraged. |
|
04.07.02 |
Opioid analgesics |
|
|
|
NENC ICB DOES NOT support the routine long-term prescribing (greater than 3 months) of opioids or the use of high dose opioids (higher than 120 mg/day of oral morphine equivalent) for non-cancer, persistent pain in adults. |
|
Codeine
|
Formulary
|
First line
Second line
The following codeine preparations are unlicensed and approved for use:
- 30 mg suppositories.
- codeine 2mg, 3mg, 6mg, 15mg;
- codeine 30mg in 1ml injection
![CD](images/CD.jpg)
|
MHRA Drug Safety Update (Dec 2014): Codeine for analgesia: restricted use in children because of reports of morphine toxicity
MHRA Drug Safety Update (Dec 2014): Codeine: very rare risk of side-effects in breastfed babies
|
Morphine
|
Formulary
|
- Tablets - 10mg, 20mg, 50mg (Sevredol®)
- MR capsules - 10mg, 30mg, 60mg, 100mg, 200mg (Zomorph®)
- MR tablets - 5mg, 10mg, 15mg, 30mg, 60mg, 100mg, 200mg (MST®)
- Oral solution - 10mg in 5ml
- Injection - 10mg/ml, 15mg/ml, 20mg/ml, 30mg/ml
- Zomorph® is the preferred M/R formulation.
Note: the following preparations are also approved for use:
- morphine 5mg in 1ml injection
unlicensed
- 10mg in 1ml preservative free injection
unlicensed
- 2mg in 5ml epidural
unlicensed
- 100 micrograms/1 ml oral solution. For use in neonates.
unlicensed
- 50mg in 50ml PCA injection
|
|
Alfentanil
|
Formulary
|
- Palliative care use
- 500micrograms in 1ml [ST&S], 1mg in 2ml, 5mg in 10ml & 5mg in 1ml injection ampouless - approved for initiation by specialists in palliative care
- All non-palliative care indications
![Red](images/TrafficLightsRedV2.gif)
|
|
Diamorphine
|
Formulary
|
Unlicensed intranasal diamorphine is approved for use in children for the relief of severe pain due to clinically suspected limb fractures, burns and significant fingertip injuries. Appropriate risk assessments are to be conducted by each organisation in order to determine formulation of choice (e.g. ampoules or intranasal spray).
- Note: intranasal diamorhine
|
|
Ketamine
|
Formulary
|
|
|
Tramadol
|
Alternatives
|
- 50mg capsules, 50mg dispersible tablets & 100mg/2ml injection
- Only approved for use as a second-line weak opioid analgesic for use in patients where treatment with possible alternatives such as paracetamol, NSAIDs, and codeine is insufficiently effective, not tolerated or considered unsuitable for other reasons.
- Note: modified release tramadol is not approved or recommended.
|
|
Buprenorphine
|
Alternatives
|
- 200microgram sublingual tablets
- 300microgram in 1ml injection
- Buprenorphine patches (Preferred brand - Butec®) are approved for use in palliative care when fentanyl 12 microgram/hr transdermal patches exceed the patient’s analgesic requirements.
|
|
Fentanyl
|
Alternatives
|
- 12, 25, 50, 75 & 100 microgram/hour transdermal patches
- Prescribe by brand. Mezolar® has replaced Matrifen® as the first choice brand. Patients who currently use Matrifen® can continue to do so if managing well.
- Fentanyl sublingual tablets (Abstral®) NoTGhdNC
only for patients experiencing incident pain during radiotherapy, restricted to palliative care use only
- Fentanyl sublingual tablets (Abstral®) CD&TV
for breakthrough / rescue pain relief in palliative care
- nasal spray
- approved for use in children during diamorphine shortage with appropriate local governance arrangements
|
MHRA Drug Safety Update (Oct 2018): Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children
MHRA Drug Safety Update (Sep 2020): Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patients
Transdermal fentanyl – MHRA Drug Safety Update (July 2014): Transdermal fentanyl “patches”: reminder of potential life threatening harm from accidental exposure, especially in children
|
Hydromorphone
|
Alternatives
|
|
|
Methadone
|
Alternatives
|
The following preparations are approved:
- 5mg tablets;
- 5mg in 5ml mixture DTF & 5mg in 5ml sugar free solution
- 20mg in 1ml concentrated oral solution (
unlicensed)
- 10mg in 1ml injection
|
|
Oxycodone
|
Alternatives
|
- Approved only for use in patients who are intolerant of morphine.
![Green](images/TrafficLightsGreenV2.gif)
- Note: Oxycodone 50mg in 1ml injection is also approved for use, but is restricted to controlled circumstances in palliative patients following risk assessment by individual organisations.
![Green Traffic Light](images/TrafficLightsGreenplus.gif)
- Approved for use as part of Enhanced Recovery After Surgery (ERAS) as part of multi-modal enhanced recovery pathway following hip and knee surgery
![Red](images/TrafficLightsRedV2.gif)
- The OxyPro® branded generic is preferred (most cost effective option).
- The oral solution should be used instead of immediate release tablets.
|
|
Pethidine
|
Alternatives
|
|
|
Tapentadol
|
Alternatives
|
- Approved for use by chronic pain specialist in adults with severe pain who have been screened for a neuropathic element to their pain and are uncontrolled or experiencing GI side effects on existing therapy.
|
MHRA Drug Safety Update (Jan 2019): Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines
|
Dihydrocodeine
|
Alternatives
|
- Note: the use of dihydrocodeine 30mg tablets & 10mg in 5ml oral solution is no longer recommended for regular use. Codeine is the preferred weak opioid analgesic.
- Dihydrocodeine is only approved for use in breast feeding mothers immediately postdelivery/ c-section where adequate pain relief has not been achieved using paracetamol and NSAIDs. Patients requiring contunation of dihydrocodeine following discharge (post delivery/c-section) can have dihydrocodeine prescribed in primary care (for short-term use only).
|
|
|
|
|
|
04.07.02 |
Breakthrough pain |
|
|
|
04.07.02 |
Other |
|
|
04.07.03 |
Neuropathic pain |
|
|
|
Prescribing of gabapentinoids to treat persistent non-neuropathic pain is NOT routinely recommended
Note: other drugs such as Ketamine (see section 15.1.1) may also be advised by pain/palliative care specialists in the management of neuropathic pain. |
|
Amitriptyline
|
First Choice
|
|
|
Gabapentin
|
Second Choice
|
- For use in the treatment of neuropathic pain
- Gabapentin is also approved for hospital use as an adjunct to other treatment in the management of peri/post-operative pain.
unlicensed
- GPs should not be asked to prescribe gabapentin for this unlicensed indication.
- Approved for intractable itch with severe burns
![Green plus](images/TrafficLightsGreenPlus.gif)
|
MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression
|
Pregabalin
|
Second Choice
|
- Pregabalin is restricted to use in the management neuropathic pain as a second choice where treatment with gabapentin has been unsuccessful or not tolerated.
|
MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy
MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression
|
Nortriptyline
|
Formulary
|
|
|
Carbamazepine
|
Alternatives
|
- Restricted use in treatment of trigeminal neuralgia only.
|
|
Duloxetine
|
Alternatives
|
- For third-line use (after drugs such as the tricyclic antidepressants and gabapentin) in the treatment of neuropathic pain on the advice of pain specialists.
|
|
Phenytoin
|
Alternatives
|
|
|
|
04.07.03 |
Trigeminal neuralgia |
|
|
04.07.03 |
Postherpetic neuralgia |
|
|
Capsaicin
|
Formulary
|
- Qutenza® cutaneous patch approved for the treatment of neuropathic pain as fourth line agent for neuropathic pain and in line with the attached regionally agreed pathway.
![Red](images/TrafficLightsRedV2.gif)
- 0.075% cream (Axsain®) approved for post hepatic neuralgia and peripheral diabetic neuropathy
![Green plus](../images/TrafficLightsGreenPlus.gif)
|
NTAG - Treatment Appraisal Decision Summary - Capsaicin (Qutenza)
NTAG Pathway for the use of Qutenza (Capsaicin 8%) in the Neuropathic Pain Patient Group
|
Lidocaine 5% medicated plasters (700mg lidocaine/plaster)
|
Formulary
|
- For use in the treatment of post-herpetic neuralgia only, on the advice of pain specialists and subject to an appropriate trial of efficacy in each individual patient.
|
Co Durham & Tees Valley APC – Advice on prescribing Lidocaine Patches in Primary Care
|
04.07.03 |
Chronic facial pain |
|
|
04.07.04 |
Antimigraine drugs |
|
|
|
04.07.04.01 |
Treatment of the acute migraine attack |
|
|
Rizatriptan
|
Formulary
|
|
|
|
Paracetamol
|
Formulary
|
|
|
Ibuprofen
|
Formulary
|
|
MHRA Drug Safety Update (June 2015): High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk
|
Naproxen tablets
|
Formulary
|
|
|
Aspirin
|
Formulary
|
|
|
Diclofenac
|
Formulary
|
|
MHRA Drug Safety Update (Dec 2007): NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
MHRA Drug Safety Update (Jan 2015): Cox-2 selective inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs): Cardiovascular safety.
MHRA Drug Safety Update (June 2013): Diclofenac: new contraindications and warnings
MHRA Drug Safety Update (Oct 2012): Non-steroidal anti-inflammatory drugs (NSAIDs): cardiovascular risks
|
04.07.04.01 |
5HT1 agonists |
|
|
Sumatriptan
|
First Choice
|
|
|
Zolmitriptan 2.5mg tablets
|
Alternatives
|
|
|
Frovatriptan
|
Alternatives
|
|
|
04.07.04.01 |
Ergot alkaloids |
|
|
04.07.04.01 |
Anti-emetics |
|
|
Metoclopramide
|
Formulary
|
- Used to help promote absorption of analgesics.
|
MHRA Drug Safety Update Alert (Aug 2013): Metoclopramide: risk of neurological adverse effects
|
04.07.04.01 |
Other drugs for migrane |
|
|
04.07.04.02 |
Prophylaxis of migraine |
|
|
Pizotifen
|
Formulary
|
|
|
Metoprolol
|
Formulary
|
|
|
Propranolol
|
Formulary
|
|
|
Topiramate
|
Formulary
|
- MHRA Drug Safety Update (July 2022): Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure
|
|
Clonidine
|
Formulary
|
- Clonidine is not generally recommended for migraine prophylaxis; may aggravate depression/cause insomnia.
|
|
Eptinezumab (Vyepti®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- 100mg/1ml concentrate for solution for infusion
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
|
NICE TA871: Eptinezumab for preventing migraine
|
Erenumab (Aimovig®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- 70mg/1ml and 140mg/1ml solution for injection (pre-filled pens)
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
|
NICE TA682: Erenumab for preventing migraine in adults
|
Fremanezumab (Ajovy®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- 225mg/1.5ml solution for injection (Pre-filled pens/syringes)
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
|
NICE TA764: Fremanezumab for preventing migraine
|
Galcanezumab (Emgality®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- 120mg/1ml injection
- Approved for the prevention of chronic migraine in adults in line with NICE only if
- they have 4 or more migraine days a month
- at least 3 preventative drug treatments have failed
|
NICE TA659: Galcanezumab for preventing migraine
|
Rimegepant (Vydura®)
|
Formulary
|
- 75mg oral lyophilisates
- Approved for preventing migraine in line with NICE
- First three month's supply from secondary care followed by 12 week review and then transfer to primary care with a 4 week prescription to allow for handover
- Approved for treating migraine in line with NICE
![Green](../images/TrafficLightsGreenV2.gif)
|
NICE TA906: Rimegepant for preventing migraine
NICE TA919: Rimegepant for treating migraine
|
Botulinum Toxin Type A
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
|
NICE TA260: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine
|
Amitriptyline
|
Unlicensed
|
|
|
Imipramine
|
Unlicensed
|
|
|
Sodium valproate
|
Unlicensed
|
- Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) are also approved for use in those who have difficulty swallowing sodium valproate tablets. MR granules may be more convenient to use than large volumes of liquid formulations.
Black Triangle in Females
Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) ![Amber](images/TrafficLightsAmberV2.gif)
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
|
Valproate medicines: Pregnancy Prevention Programme materials
|
04.07.04.03 |
Cluster headache |
|
|
|
Lithium carbonate
|
Unlicensed
|
- Lithium should be prescribed by brand name.
|
Lithium Shared Care Guideline (Amber)
|
Lithium citrate
|
Unlicensed
|
- Lithium should be prescribed by brand name.
|
Lithium Shared Care Guideline (Amber)
|
|
|
|
04.08.01 |
Control of epilepsy |
|
|
|
The MHRA recommend that patients on certain antiepileptic drugs remain on the same brand where possible. In order to help decide which anti-epileptics may or may not be switched the MHRA have classified anti-epileptics in to 3 categories.
Category 1 - the patient should be maintained on a specific manufacturer’s product (carbamazepine, phenobarbital and phenytoin)
Category 2 - 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 (clobazam, clonazepam, eslicarbazepine acetate, lamotrigine, oxcarbazepine, perampanel, retigabine, rufinamide, sodium valproate, topiramate, and zonisamide).
Category 3 - usually unnecessary to ensure that patients are maintained on a specific manufacturer’s product unless there are specific reasons such as patient anxiety and risk of confusion or dosing errors (acetazolamide, brivaracetam, ethosuximide, gabapentin, lacosamide, levetiracetam, pregabalin, stiripentol, and vigabatrin). |
|
Acetazolamide (Category 3)
|
Formulary
|
|
|
Brivaracetam (Category 3)
|
Formulary
|
- Approved for use as adjunctive therapy in patients with severe/intractable partial onset seizures e.g. a sezuire frequency of 1 per week following failure of first-line adjunctive therapy. Response must be assessed within 3-6 months before transferring prescribing to primary or stopping treatment, as appropriate.
|
|
Cannabidiol (Epidyolex®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- 100mg/1mL oral solution
- Approved for use in combination with clobazam for treating seizuires associated with Dravet syndrome in people aged 2 years and older
- Approved for use in combination with clobazam for treating seizures associated with Lennox-Gastaut syndrome
- Approved as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over - in line with NICE TA873.
|
NICE TA614: Cannabidiol with clobazam for treating seizures associated with Dravet syndrome
NICE TA615: Cannabidiol with clobazam for treating seizures associated with Lennox–Gastaut syndrome
NICE TA873: Cannabidiol for treating seizures caused by tuberous sclerosis complex
|
Carbamazepine (Category 1)
|
Formulary
|
- Carbamazepine 200mg and 400mg MR tablets (Tegretol® retard) are available on consultant request for those in whom conventional carbamazepine has been shown to be unsuitable
![Green Traffic Light](images/TrafficLightsGreenplus.gif)
|
|
Carbamazepine Suppositories
|
Formulary
|
|
|
Clobazam (Category 2)
|
Formulary
|
|
|
Clonazepam (Catergory 2)
|
Formulary
|
- Clonazepam 500microgram in 5ml sugar-free oral solution is also approved
unlicensed
|
|
Eslicarbazepine (Category 2)
|
Formulary
|
- Approved for use by specialists only in those patients for whom intolerance of carbamazepine is a major concern and when use of this agent is more cost effective than alternatives available.
|
|
Ethosuximide
|
Formulary
|
|
|
Fenfluramine (Fintepla®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
Oral solution: 2.2mg/mL
|
NICE TA808: Fenfluramine for treating seizures associated with Dravet syndrome
|
Gabapentin (Category 3)
|
Formulary
|
- Note: gabapentin 250mg in 5ml is also approved
unlicensed.
|
MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression
|
Lacosamide (Category 3)
|
Formulary
|
- Only approved on advice from consultant neurologists, in patients that are refractory to treatment with other drugs.
|
|
Lamotrigine (Category 2)
|
Formulary
|
|
|
Levetiracetam (Category 3)
|
Formulary
|
|
|
Oxcarbazepine (Category 2)
|
Formulary
|
|
|
Perampanel (Category 2)
|
Formulary
|
- NETAG approved for partial (focal) seizure epilepsy only when other treatment options recommended by NICE have been tried or fully considered.
|
NTAG - Perampanel (Fycompa®) for epilepsy
|
Phenobarbital (Category 1)
|
Formulary
|
|
|
Phenobarbital INJECTION
|
Formulary
|
|
|
Phenytoin (Category 1)
|
Formulary
|
- Note: phenytoin 30mg in 5ml suspension (base) – 90mg (15ml) is equivalent to one 100mg phenytoin sodium capsule 250mg in 5ml injection (sodium salt).
|
|
Piracetam
|
Formulary
|
|
|
Pregabalin (Category 3)
|
Formulary
|
- Approved for specialist advice in the management of treatment resistant epilepsy.
- Also approved as a second line agent for General Anxiety Disorder. Although treatment can be given 2-3 times daily, it is more cost effective to give as a twice daily dose.
|
MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy
MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression
|
Primidone
|
Formulary
|
|
|
Rufinamide (Category 2)
|
Formulary
|
- Approved for limited use as a second or third-line treatment in patients with Lennox-Gastaut syndrome and related encephalopathies.
- Should only be used on the advice of paediatric neurologists and other neurologists specialising in the treatment of epilepsy.
|
|
Sodium Valproate (Category 2)
|
Formulary
|
- Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) - for possible use in those who have difficulty swallowing sodium valproate tablets. May be more convenient to use than large volumes of liquid formulations.
- Valproate▼ must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP)
![Amber](images/TrafficLightsAmberV2.gif)
▼ BLACK TRIANGLE IN FEMALES
Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP)
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
|
Valproate medicines: Pregnancy Prevention Programme materials
Local Shared Care guideline in TEWV to support Valproate Pregnancy Prevention Programme
|
Sodium Valproate▼ Injection
|
Formulary
|
Valproate must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP)
For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:
MHRA Drug Safety Updates (valproate)
|
|
Stiripentol (Category 3)
|
Formulary
|
- For use as adjunctive therapy of refractory generalised tonicclonic seizures in children with severe myoclonic epilepsy in infancy.
|
|
Tiagabine
|
Formulary
|
|
|
Topiramate (Category 2)
|
Formulary
|
|
|
Vigabatrin (Category 3)
|
Formulary
|
|
North of Tyne, Gateshead and North Cumbria - Vigabatrin Shared Care Guideline
|
Zonisamide (Category 2)
|
Formulary
|
- For use only in patients that are refractory to treatment with other drugs on the recommendation of a specialist
- Use in children is
unlicensed.
|
|
|
04.08.01 |
Partial seizures with or without secondary generalisation |
|
|
04.08.01 |
Generalised seizures |
|
|
04.08.01 |
Carbamazepine and Oxcarbazepine |
|
|
|
04.08.01 |
Gabapentin and pregabalin |
|
|
|
|
|
|
04.08.01 |
Phenobarbital and other barbiturates |
|
|
|
|
|
|
04.08.01 |
Tiagabine |
|
|
|
|
|
|
04.08.01 |
Benzodiazepines |
|
|
|
Cenobamate (Ontozry®)
|
Formulary
|
- 12.5mg, 25mg, 50mg, 100mg, 150mg and 200mg tablets
- Approved for treating focal onset seizure in epilepsy in line with NICE
- Patients will be stabilised by the epilepsy specialist prior to transfer to the GP for continuation. This will usually be after 3 months of treatment.
|
NICE TA753: Cenobamate for treating focal onset seizures in epilepsy
|
04.08.02 |
Drugs used in status epilepticus |
|
|
Diazepam
|
Formulary
|
|
|
Midazolam
|
Formulary
|
- Buccolam® 5mg in 1ml alcohol-free buccal solution, and Buccolam® 2.5mg, 5mg, 7.5mg and 10mg prefilled oral syringes are approved as first choice for status epilepticus in children aged 3 months to 18 years.
- Epistatus® 10mg in 1ml oromucosal solution pre-filled oral syringes is approved for use in the treatment of epileptic seizures in infants under 3 months and adults over 18 years of age. This use is off-label Injection solutions (section 15.1.4) can also be given buccally
|
MHRA Letters sent to healthcare professionals (January 2018): Buccolam (midazolam) – risk of inhalation/ingestion of tip cap of prefilled plastic syringes.
|
Phenobarbital Sodium
|
Formulary
|
|
|
Clonazepam
|
Alternatives
|
- For initiation by neurologists only.
|
|
Lorazepam
|
Alternatives
|
- For initiation by neurologists only.
- Lorazepam 2mg/ml suspension & 4mg/ml suspension are also approved but are
unlicensed.
- Buccal administration of lorazepam suspensions are only approved for use in paediatrics in children with status epilepticus in whom buccal midazolam, rectal paraldehyde or rectal diazepam are ineffective.
![Red Traffic Light](images/TrafficLightsRedV2.gif)
|
|
Phenytoin sodium 250mg in 5ml injection
|
Alternatives
|
- For initiation by neurologists only.
|
|
Paraldehyde rectal liquid
|
Unlicensed
|
- For initiation by neurologists only.
|
|
04.08.03 |
Febrile convulsions |
|
|
Paracetamol
|
Formulary
|
Paracetamol suppositories
unlicensed preparations include 15mg, 30mg, 60mg, 120mg, 240mg, and 500mg. These are used in NUTH.
- Licensed preparations include 60mg, 125mg, 250mg, and 500mg suppositories are available in primary care.
|
|
04.09 |
Drugs used in parkinsonism and related disorders |
|
|
|
|
04.09.01 |
Dopaminergic drugs used in Parkinsons disease |
|
|
Cabergoline
|
Formulary
|
|
|
Foslevidopa/foscarbidopa (Produodopa®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- foslevidopa 240mg/foscarbidopa 12mg in 1ml solution for infusion
- Approved for the treatment advanced Parkinson’s with motor symptoms in adults in line with NICE and NHSE Specialised Commissioning Policy
|
NICE TA934: Foslevodopa–foscarbidopa for treating advanced Parkinson’s with motor symptoms
|
Levidopa/carbidopa Intestinal Gel (Duodopa®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- levidopa 20mg/carbidopa 5mg intestinal gel
- Approved for the treatment of Parkinson's disease
|
|
Pergolide
|
Formulary
|
|
|
Pramipexole (restless legs)
|
Formulary
|
|
|
Safinamide
|
Alternatives
|
- 50mg and 100mg tablets
- Approved for use in Parkinson's Disease patients on levodopa who are having motor fluctuations affecting their quality of life as an alternative to rasagiline.
|
|
04.09.01 |
Dopamine receptor agonists |
|
|
Apomorphine
|
Formulary
|
- 5mg/1ml (20ml) solution for infusion for infusion pumps & 10mg/1ml (3ml) solution for injection cartridges (Dacepton®) - NEW PATIENTS
- 30mg/3ml solution for injection (APO-go®) - Patients commenced on treatment prior to July 2022 can continue on APO-go® (including 50mg/10ml solution for infusion pre-filled syringes for infusion pumps)
- Apomorphine 10mg lozenges are also approved (RVI)
Unlicensed
|
County Durham Shared Care Guidelines: Apomorphine
MHRA Drug Safety Update (April 2016): Apomorphine with domperidone: minimising risk of cardiac side effects
North of Tyne, Gateshead and North Cumbria - Apomorphine - Shared Care Guidance
South Tyneside & Sunderland APC Shared Care Guideline - Apomorphine injection or infusion for Parkinson’s disease
Tees Valley Shared Care Guidelines: Apomorphine
|
Bromocriptine
|
Formulary
|
|
|
Pramipexole
|
Formulary
|
- Approved for second line use in Parkinson's disease.
|
|
Ropinirole
|
Formulary
|
- Ropinirole once daily formulation is only approved for use in Parkinson’s disease patients with proven compliance.
![Green plus](../images/TrafficLightsGreenPlus.gif)
- Approved for first line use in patients with restless legs syndrome.
![Green](images/TrafficLightsGreenV2.gif)
|
|
Rotigotine (Parkinsons)
|
Formulary
|
- For use on the advice of specialists in the treatment of Parkinson's disease. Mainly for use in patients who have difficulty with swallowing.
- Approved for second line use in patients with restless legs syndrome.
|
|
|
Co-Beneldopa
|
Formulary
|
|
|
Co-Careldopa
|
Formulary
|
|
|
Co-Careldopa and Entacapone
|
Formulary
|
|
|
04.09.01 |
Monoamine-oxidase-B inhibitors |
|
|
Rasagiline
|
Formulary
|
|
|
Selegiline Hydrochloride
|
Formulary
|
|
|
04.09.01 |
Catachol-O-methyltransferase inhibitors |
|
|
Entacapone
|
First Choice
|
|
|
Opicapone
|
First Choice
|
|
|
Tolcapone
|
Alternatives
|
|
|
04.09.01 |
Amantadine |
|
|
Amantadine
|
Formulary
|
- For use on the advice of neurologists.
|
|
04.09.01 |
Mild to moderate dementia in Parkinsons disease |
|
|
04.09.02 |
Antimuscarinic drugs used in parkinsonism |
|
|
Orphenadrine
|
Formulary
|
|
|
Procyclidine
|
Formulary
|
|
|
Trihexyphenidyl (Benzhexol)
|
Formulary
|
|
|
04.09.03 |
Drugs used in essential tremor, chorea, tics, and related disorders |
|
|
Botulinum Toxin Type A (Botox®)
|
Formulary
|
- Botox also approved for use in paediatric patients with severe bladder over- activity and neuropathic bladder who have not responded to other treatment.
- Prescribe by brand name.
|
|
Botulinum Toxin Type A (Dysport®)
|
Formulary
|
|
|
Botulinum Toxin Type A (Vistabel®)
|
Formulary
|
- Restricted to use in private patients receiving aesthetic treatment.
- Prescribe by brand name.
|
|
Botulinum Toxin Type A injection (Xeomin ® )
|
Formulary
|
- 50, 100 & 200 unit powder for solution for injection
- Approved for the treatment of chronic sialorrhoea in line with NICE
- Similar potency to Botox®, and may be less expensive (depending on price agreements/ contracts), but not licensed for the full range of indications.
- Prescribe by brand name.
|
NICE TA605: Xeomin (botulinum neurotoxin type A) for treating chronic sialorrhoea
|
Botulinum Toxin Type B (NeuroBloc®)
|
Formulary
|
|
|
Riluzole
|
Formulary
|
- 50mg tablets; 50mg orodispersible tablets (Emylif); 5mg/1ml oral suspension
- Approved for motor neurone disease in line with NICE.
- Note: riluzole orodispersible film and oral suspension approved only when other preparations (including crushing tablets) are not suitable.
|
NENC Shared Care Protocol - riluzole for patients in adult services
NICE TA20: Motor neurone disease - riluzole
Shared Care Guideline
|
Tetrabenazine
|
Formulary
|
- For use on the advice of neurologists.
|
|
Memantine
|
Formulary
|
- Approved for use as last line drug after other alternatives have been considered, in the treatment of congenital and acquired nystagmus.
|
|
04.09.03 |
Torsion dystonias and other involuntary movements |
|
|
04.09.04 |
Restless leg syndrome |
|
|
04.10 |
Drugs used in substance dependence |
|
|
|
|
|
04.10.01 |
Alcohol dependence |
|
|
Acamprosate
|
Formulary
|
- COUNTY DURHAM
acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
|
|
Chlordiazepoxide
|
Formulary
|
- COUNTY DURHAM
acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
|
|
Disulfiram
|
Formulary
|
- COUNTY DURHAM
acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
|
|
Nalmefene
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
- COUNTY DURHAM
acamprosate, chlordioazepoxide, disulfiram & nalmefene prescribing should be retained within the commissioned service within County Durham.
|
NICE TA325: Nalmefene for reducing alcohol consumption in people with alcohol dependence
|
Naltrexone (alcohol dependence)
|
Formulary
|
|
|
|
|
04.10.02 |
Nicotine dependence |
|
|
Bupropion Hydrochloride
|
Formulary
|
- RAG status as per local commissioning arrangements
- MHRA Drug Safety Update (Nov 2020): Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs
- Resistant depression
![Red](images/TrafficLightsRedV2.gif)
|
|
Nicotine
|
Formulary
|
- The following nicotine replacement treatments are approved:
- Nicotine gum - 2mg & 4mg sugar-free chewing gum (Nicorette® is the gum of choice).
- Nicotine 16 hour patch - 10mg, 15mg, and 25mg/16 hour patches (Nicorette® Invisi).
- Nicotine 24 hour patch - 7mg & 14mg, and 21mg /24 hour patches (Nicotinell® is the patch of choice as potential savings to be made).
- Nicotine lozenges - 2mg and 4mg lozenges (Niquitin® is the lozenge of choice), 1.5mg and 4mg mini lozenges (NiQuitin® Minis Lozenges).
- Nicotine 2mg sublingual tablets.
- Nicotine inhalator - 15mg cartridges for use in inhalator.
- Nicotine oromucosal spray - Nicorette® Quickmist 1mg per dose.
- North Cumbria - Smoking Cessation is commissioned separately through community pharmacies and should not be prescribed on FP10's
- Newcastle/Gateshead - Local Authority smoking cessation programme should be used. NRT should not routinely be prescribed on FP10
|
|
Varenicline
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
- RAG status as per local commissioning arrangements.
|
NICE TA123: Varenicline
|
|
04.10.03 |
Opioid dependence |
|
|
Buprenorphine 400 microgram, 2mg, and 4mg sublingual tablets
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
- In the treatment of substance misuse the 400microgram strength should be prescribed as Subutex® to avoid a product licensed for pain relief being supplied
|
|
Buprenorphine and Naloxone (Suboxone®)
|
Formulary
|
|
|
Lofexidine (BritLofex®)
|
Formulary
|
South Tyneside and Sunderland only
|
|
Methadone
|
Formulary
|
- Methadone 5mg in 5ml oral solution and 5mg in 5ml sugar free solution are both approved for the management of opioid dependence in line with NICE.
CD&TV and ST&S
|
|
Naltrexone 50 mg tablets (Nalorex®)
|
Formulary
|
- Approved for the management of opioid dependence in detoxified formerly opioid-dependent people in line with NICE.
- Also approved NoTGhdNC for use in reducing agitation and/ or selfinjurious behaviour in patients with learning disabilities or autism (
unlicensed indication). Treatment must be initiated by an appropriate hospital specialist.
|
NICE TA115: Drug misuse - naltrexone
|
|
04.10.03 |
Opioid substitution therapy |
|
|
Buprenorphine (Buvidal®)
|
Alternatives
|
- 8mg/0.16ml 16mg/0.32ml, 24mg/0.48ml, 32mg/0.64ml, 64mg/0.18ml, 96mg/0.27ml, 128mg/0.36ml 160mg/0.45ml prolonged-release solution for injection (pre-filled syringes).
- Approved for the treatment of opioid dependance in adults and adolescents aged 16 years and over, by substance misuse service providers, in line with NTAG and RMOC guidance.
|
NTAG - Buprenorphine prolonged release injection for opioid dependence
|
|
04.10.03 |
Adjunctive therapy and symptomatic treatment |
|
|
04.10.03 |
Opioid-receptor antagonists |
|
|
|
|
Only specialists in the care of patients with dementia (psychogeriatricians and certain neurologists) should initiate treatment.
|
|
Donepezil
|
First Choice
|
- Only approved for use in accordance with NICE guidance.
|
NICE TA217: Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease
|
Galantamine
|
Alternatives
|
- Only approved for use in accordance with NICE guidance.
- The oral solution is only approved for limited short-term use in the management of hospital patients who are unable to swallow tablets/ capsules. It is not for use in patients whose dementia is so severe that they can no longer swallow tablets.
|
NICE TA217: Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease
|
Memantine
|
Alternatives
|
- Only approved for use in accordance with NICE guidance.
|
NICE TA217: Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease
|
Rivastigmine
|
Alternatives
|
- Only approved for use in accordance with NICE guidance.
- Rivastigmine patches are approved for patients unable to tolerate treatment with oral rivastigmine due to nausea and vomiting, and for patients requiring treatment with an acetylcholinesterase inhibitor who are unable to take oral medication e.g. due to swallowing difficulties or ‘nil by mouth’ prior to surgery.
|
NICE TA217: Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease
|
|
|
|
|
|
Dehydrated alcohol 100% BP for Injection
|
Formulary
|
- Approved for intrathecal neurolysis treatment of intractable pain due to cancer in terminally ill patients
|
|
Inotersen (Tegsedi®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- Approved as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis in line with NICE
|
NICE Highly specialised technologies 9: Inotersen for treating hereditary transthyretin amyloidosis
|
Patisiran (Onpattro®)
|
Formulary
![High Cost Medicine](images/HCDicon.gif)
|
- 10mg vial
- Approved for the treatment of hereditary transthyretin amyloidosis in adults with stage 1 and stage 2 polyneuopathy in line with NICE
|
NICE Highly specialised technologies 10: Patisiran for treating hereditary transthyretin amyloidosis
|
Phenol 5% in Glycerol Injection
|
Formulary
|
- Approved for intrathecal neurolysis treatment of intractable pain due to cancer in terminally ill patients
|
|
Vutrisiran (Amvuttra®)
|
Formulary
|
- Approved as an option for treating hereditary transthyretin-related amyloidosis in adults with stage 1 or stage 2 polyneuropathy - in line with NICE TA868.
- Summer 2023 - Only one centre in London commissioned to provide this drug for patients in England.
|
NICE TA868: Vutrisiran for treating hereditary transthyretin-related amyloidosis
|
.... |
Key |
|
|
Cytotoxic Drug
|
|
Controlled Drug
|
|
High Cost Medicine
|
|
NHS England |
|
Homecare |
|
CCG |
|
Traffic Light Status Information
Status |
Description |
![Red](images/TrafficLightsRedV2.gif)
|
Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
![Amber](images/TrafficLightsAmberV2.gif)
|
Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
![Green plus](images/TrafficLightsGreenPlus.gif)
|
Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
![Green](images/TrafficLightsGreenV2.gif)
|
Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
![Black](images/TrafficLightsBlackV2.gif)
|
NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
![Brown](images/TrafficLightsBrownV2.gif)
|
UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
![Not Recomended](images/TrafficLightsBlueNR.gif)
|
NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
|
|
|