NSFT Formulary Contents

Transcription

1 NSFT Formulary Contents Traffic Light Status... 2 Clinical Commissioning Groups... 2 Antipsychotics... 3 General Prescribing Information... 3 Typical Antipsychotics... 5 Atypical antipsychotics General Prescribing Information Mood Stabilisers General Prescribing Information Antidepressants General Prescribing Information Anxiolytics, benzodiazepines and hypnotics General Prescribing Information Drugs used in dementia General Prescribing Information Drugs used to treat ADHD General Prescribing Information Drugs used in substance misuse and alcohol use disorder Opioid replacement therapy General Prescribing Information Vitamin B Compound Strong is not recommended for use in patients with a history of excess alcohol intake and is not mentioned in NICE guidance on management of alcohol use disorder (CG 100 & CG 115) Smoking cessation General Prescribing Information Vitamins General Prescribing Information Anticoagulants General Prescribing Information Antibiotics General Prescribing Information... 50

2 Traffic Light Status Red Not recommended for routine use/not commissioned. These drugs have not been recommended for routine use at present. Red Hospital/Specialist only Drugs for which the Trust is responsible for prescribing GPs should not be expected or approached to prescribe these drugs. Amber Option for Shared Care Prescribing Drugs for which it has been deemed reasonable to approach GPs to solicit their involvement in a shared care arrangement, with the GP being asked to prescribe the drug and subject to the good practice described above. GP prescribable at request of Consultant/Specialist Drugs for which it has been deemed reasonable for GPs to prescribe outside a shared-care arrangement following recommendation by a Consultant/Specialist. Suitable for GPs to initiate and prescribe Drugs for which it has been deemed reasonable for GPs to initiate and prescribe. Non-Formulary These are drugs which are not approved for general use within NSFT. If a clinician wishes to use a non-formulary medicine as a oneoff then a non-formulary request form must be completed. Clinical Commissioning Groups Great Yarmouth and Waveney CCG (GY&W) Ipswich and East Suffolk CCG (I&ES) North Norfolk CCG (NN) Norwich CCG (N) South Norfolk CCG (SN) West Norfolk CCG (WN) West Suffolk CCG (WS) 2 P a g e

3 Antipsychotics General Prescribing Information NICE CG 178: Psychosis and schizophrenia in adults: prevention and management The choice of antipsychotic medication should be made by the service user and healthcare professional together, taking into account the views of the carer if the service user agrees. Provide information ( and discuss the likely benefits and possible side effects of each drug, including: Metabolic (e.g. weight gain and diabetes) Extrapyramidal (e.g. akathisia, dyskinesia and dystonia) Cardiovascular (e.g.prolonging the QT interval) Hormonal (e.g. raising serum prolactin levels) Other e.g. unpleasant subjective experiences. See table below for general monitoring requirements of antipsychotics. Also see the individual drugs for additional specific recommendations. Parameter/test Frequency Additional information Weight (include waist circumference and BMI if possible) Baseline, frequently for 3 months, at 1 year, then annually Not all antipsychotics are clearly associated with weight gain but monitoring is recommended nonetheless - obesity is common and physical health should be monitored for all in this Blood pressure and pulse ECG Baseline, 3 months, at 1 year then annually Baseline if Specified for individual drug A physical examination has identified specific cardiovascular risk (e.g. hypertension) patient group Quetiapine, risperidone and chlorpromazine aremore likely to be associated with postural hypotension consider additional monitoring in early stages. Monitor as per local protocol for clozapine. Ideally all patients should be offered an ECG at least annually 3 P a g e

4 There is a history of cardiovascular disease The service user is an inpatient Urea and Electrolytes Baseline then annually Full Blood Count Baseline then annually To detect chronic bone marrow suppression (small risk with some antipsychotics). Clozapine FBC monitored comprehensively as per clozapine monitoring service Blood lipids (fasting Baseline, 3 months, 1 sample if possible) Blood glucose (fasting sample if possible), HbA 1c year then annually Baseline, 3 months, 1 year then annually LFTs Baseline then annually Stop suspect drug if LFTs indicate hepatitis (transaminases x 3 normal) or functional damage (PT/albumin change). Prolactin Baseline for all, then 6 months, then annually for known prolactinelevating antipsychotics Creatine phosphokinase (CPK) Baseline, then if neuroleptic malignant syndrome (NMS) suspected First-generation antipsychotics, amisulpride, risperidone and paliperidone associated with hyperprolactinaemia. Others do not usually elevate prolactin but worth measuring if symptoms arise. NMS more likely with first-generation antipsychotics Patients with schizophrenia should have physical health monitoring (including cardiovascular disease risk assessment) at least once per year. Do not initiate regular combined antipsychotic medication, except for short periods (for example, when changing medication). Do not use High Dose Antipsychotic Therapy (HDAT) without following C112 Appendix 5 HDAT guidelines. 4 P a g e

5 For switching guidelines please refer to Psychotropic Drug Directory or or contact your ward / locality pharmacist. Switching is very patient centred; clinical judgement and previous history are crucial. Dosing in the elderly, frail and children may need to be adjusted please refer to BNF/BNFC or Summary of Product Characteristics (SmPC) for details. 1 st Generation Antipsychotics Chlorpromazine Licensed Psychotic conditions (especially paranoid), including schizophrenia, mania and hypomania. An adjunct in the short-term management of anxiety psychomotor agitation excitement, violent or dangerously impulsive behaviour. Owing to the risk of contact sensitisation, pharmacists, nurses, and other health workers should avoid direct contact with chlorpromazine; tablets should not be crushed and solutions should be handled with care. As photosensitisation may occur with higher dosages, patients should avoid direct sunlight. See table above and additionally - Lipids at baseline, 3 monthly for first year, then annually Glucose & HbA 1c at baseline, 1 month then every 6 months thereafter Flupentixol Licensed NB may vary by preparation Treatment of schizophrenia and other psychoses Treatment of depression (with or without anxiety) See table above 5 P a g e

6 Flupentixol decanoate Red Red Red Red Red Red Red Licensed The treatment of schizophrenia and other psychoses in those stabilised on oral therapy See table above Fluphenazine decanoate Red Red Red Red Red Red Red Licensed Treatment and maintenance of schizophrenic patients and those with paranoid psychoses See table above and additionally - Lipids at baseline, 3 monthly for first year, then annually Haloperidol Oral Licensed Schizophrenia: treatment of symptoms and prevention of relapse Other psychoses: especially paranoid Mania and hypomania Mental or behavioural problems such as aggression, hyperactivity and self-mutilation in the mentally retarded and in patients with organic brain damage As an adjunct to short term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour Restlessness and agitation in the elderly (not in dementia) BNF limit for oral is now 20mg a day and shortacting IM is 12mg/day (June 2014) IM is more potent than oral so oral/im prescribing is not allowed and should be prescribed separately. See table above and additionally - Pre-treatment ECG is recommended by the SPC 6 P a g e

7 Haloperidol short acting injection Red Red Red Red Red Red Red Licensed An adjunct to short term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour Follow C111: Rapid Tranquillisation Policy Monitor as required by Rapid Tranquillisation Policy Pre-treatment ECG is recommended by the SPC Haloperidol decanoate Red Red Red Red Red Red Red Licensed Long term maintenance treatment where a neuroleptic is required; for example in schizophrenia, other psychoses (especially paranoid), and other mental or behavioural problems where maintenance treatment is clearly indicated See table above and additionally - Pre-treatment ECG is recommended by the SPC Perphenazine Licensed NB may vary by preparation Schizophrenia and other psychoses, mania As an adjunct to the short term management of anxiety, severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour, Treatment of symptoms and prevention of relapse, other psychoses especially paranoid, mania and hypomania See table above and additionally - Lipids at baseline, 3 monthly for first year, then annually 7 P a g e

8 Pipotiazine palpitate Red Red Red Red Red Red Red Licensed Maintenance treatment of schizophrenia and paranoid psychoses and prevention of relapse, especially where compliance with oral medication is a problem See table above Sulpiride Licensed Acute and chronic schizophrenia Clozapine Augmentation1 (Overall effect modest) See table above and additionally - Care if egfr reduced Trifluoperazine Licensed Treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses. An adjunct in the short-term management of severe psychomotor agitation and of dangerously impulsive behaviour in, for example, mental subnormality. An adjunct in the short-term management of anxiety states, depressive symptoms secondary to anxiety, and agitation See table above and additionally - Lipids at baseline, 3 monthly for first year, then annually 8 P a g e

9 Zuclopenthixol (oral) Licensed The treatment of psychoses, especially schizophrenia See table above and additionally - Zuclopenthixol decanoate (depot injection) Red Red Red Red Red Red Red Licensed The maintenance treatment of schizophrenia and paranoid psychoses See table above Zuclopenthixol acetate Red Red Red Red Red Red Red Licensed Short term management of acute psychosis, mania or exacerbations of chronic psychosis Initial treatment of acute psychoses including mania and exacerbation of chronic psychoses, particularly where a duration of effect of 2-3 days is desirable. Do not use without following the Guidelines for the use of zuclopenthixol acetate intramuscular (IM) injection Zuclopenthixol acetate injection (Clopixol Acuphase ) Post-injection Physical Observations Record Sheet should be completed. 9 P a g e

10 2 nd Generation Antipsychotics General Prescribing Information It is advisable to monitor prolactin concentration at the start of therapy, at 6 months, and then yearly. Patients taking antipsychotic drugs not normally associated with symptomatic hyperprolactinaemia should be considered for prolactin monitoring if they show symptoms of hyperprolactinaemia (such as breast enlargement and galactorrhoea). Amisulpride Licensed Acute psychotic episodes Mixed positive and negative symptoms Predominant negative symptoms See table above and additionally - Care if egfr reduced Clozapine augmentation may allow clozapine dose reduction. Aripiprazole oral Licensed Treatment of schizophrenia in adults and in adolescents 15 years and older. Treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. Clozapine augmentation - very limited evidence of therapeutic benefit but improves metabolic parameters. See table above 10 P a g e

11 Aripiprazole rapid acting injection (RAI) Red Red Red Red Red Red Red Licensed Rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate Follow C111: Rapid Tranquillisation Policy Monitor as required by Rapid Tranquillisation Policy Aripiprazole Long Acting Injection (LAI) Red Red Red Red Red Red Red Licensed Indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. See table above Asenapine- Non Formulary Red Red Red Red Red Red Red Licensed Indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Bipolar l disorder is a chronic, typically cyclical, mood disorder. See table above 11 P a g e

12 Clozapine Red Red Red Red Red Red Red Licensed Treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics Psychotic disorders occurring during the course of Parkinson's disease, in cases where standard treatment has failed Bipolar disorder. Use licensed options first. Specialist use only. See table above and additionally - Monitor weight 3-monthly for first year, then annually Lipids at baseline, 3 monthly for first year, then Glucose & HbA 1c at baseline, 1 month then every 6 months thereafter annually Lurasidone Licensed Indicated for the treatment of schizophrenia in adults aged 18 years and over. Bipolar Disorder Notes See table above 12 P a g e

13 Olanzapine oral Licensed Schizophrenia Moderate to severe manic episode In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. Anxiety disorders Dementia & BPSD. Specialist use only. See table above and additionally - Monitor weight 3-monthly for first year, then annually Lipids at baseline, 3 monthly for first year, then annually Glucose & HbA 1c at baseline, 1 month then every 6 months thereafter Olanzapine rapid acting injection (RAI) Red Red Red Red Red Red Red Licensed Rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. To establish therapy where oral olanzapine is refused Follow C111: Rapid Tranquillisation Policy Monitor as required by Rapid Tranquillisation Policy 13 P a g e

14 Olanzapine long acting injection (LAI)- Non-Formulary Licensed Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder Special protocol / training requirement exist. Patient need to be observed for 3 hours post injection in a healthcare facility. See table above and additionally - Monitor weight 3-monthly for first year, then annually Lipids at baseline, 3 monthly for first year, then annually Glucose & HbA 1c at baseline, 1 month then every 6 months thereafter Paliperidone tablets- Non-Formulary Licensed Treatment of schizophrenia in adults and in adolescents 15 years and older. Treatment of schizoaffective disorder in adults. Paliperidone is a metabolite of risperidone but significantly (50-60 times) EXPENSIVE compared to risperidone. See table above 14 P a g e

15 Paliperidone long acting injection Red Red Red Red Red Red Red Licensed Maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Paliperidone LAI may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. Recommended initiation is with 150 mg on day 1 and 100 mg day 8, both in the deltoid muscle The third dose should be administered one month after the second initiation dose. And further maintenance dose should be monthly. See table above Quetiapine oral ( MR is non formulary) Licensed Immediate release (as Quetiapine IR. See SPC): Schizophrenia Bipolar disorder: 1. treatment of moderate to severe manic episodes in bipolar disorder 2. treatment of major depressive episodes in bipolar disorder 3. prevention of recurrence in patients with bipolar disorder, in patients whose manic or depressive episode has responded to quetiapine treatment.. As an adjunct to antidepressants in unipolar depression As an adjunct in treatment resistant depression Anxiety Disorder BPSD evidence is weak. Specialist use only or on advice from specialist. For psychosis in Parkinson s Disease. Specialist use only or on advice from specialist. For BPSD in Parkinson s Disease with Lewy Body Dementia - evidence base is weak and least effective for BPSD in other forms of dementia. Specialist use only or on advice from specialist. Using IR as once daily 15 P a g e

16 It should be prescribed as generic immediate release preparations See table above and additionally - Lipids at baseline, 3 monthly for first year, then annually Annual TFTs Risperidone oral Licensed Schizophrenia Moderate to severe manic episodes Short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to nonpharmacological approaches and when there is a risk of harm to self or others. Short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder. Longer than 6 weeks in dementia Specialist use only or on advice from specialist. Bipolar disorder (after other options have been tried as evidence is lacking) Clozapine augmentation (Evidence is very modest) As indicated in BNFc See table above Risperidone long acting injection (LAI) Red Red Red Red Red Red Red Licensed Maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics. Bipolar disorder but may worsen depressive episode Should be stored in the fridge. See table above 16 P a g e

17 Mood Stabilisers General Prescribing Information Carbamazepine Licensed Prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy. Specialist use only or on advice from specialist. Disinhibition in dementia - Specialist use only or on advice from specialist. Alcohol withdrawal Drug interactions and side effects may limit use. Significant inducer of CYP3A4 enzyme and so has many interactions, notably reducing the effects of oral contraceptives, risperidone and tricyclics Due to enzyme induction plasma levels may take a week or longer to stabilise after a dose change No evidence for plasma level relationship to therapeutic effect in non-epileptic indications Tests prior to starting treatment FBC, U&E, LFT, renal function HLA-B*1502 status in Thai/Chinese patients Weight & height if using in bipolar disorder Tests during treatment FBC, U&E, LFT - annualy Vit D/bone metabolism tests in epilepsy patients every 2-5 years Bipolar disorder FBC, LFT, U&E, TFT & weight every 6 months Plasma glucose, lipid profile (>40 yrs old), BP, weight, height yearly Lamotrigine Licensed Prevention of depressive episodes in adults with bipolar I disorder who experience predominantly depressive episodes Lamotrigine is not a mood stabiliser as such as it has no acute or long-term anti-manic activity Clearly effective for relapse prevention of bipolar depression (but not for acute bipolar depression) Epilepsy 17 P a g e Trigeminal neuralgia (often misdiagnosed as somatic depression) Specialist use only. Fast track only if initiation.

18 Needs slow dose titration (50mg/d for 2/52, then 50mg BD for 2/52; see BNF) to minimise chances of potentially fatal Stevens-Johnson syndrome and toxic epidermal necrolysis Even slower titration is needed if also taken with valproate (see BNF) or other enzyme inhibiting drugs. Slow titration is essential regardless of the indication having bipolar depression does not make the person immune from dermatological ADRs Beware of interaction with oral contraceptives when stopping or starting Shared care agreement exists Switching between formulations: Care should be taken when switching between oral formulations in the treatment of epilepsy. The need for continued supply of a particular manufacturer's product should be based on clinical judgement and consultation with the patient or their carer, taking into account factors such as seizure frequency and treatment history (see also MHRA/CHM advice) Monitor for clinical effectiveness Check interactions when new drugs are added ADRs Closely monitor and consider withdrawal if rash, fever, or other signs of hypersensitivity syndrome develop; avoid abrupt withdrawal (taper off over 2 weeks or longer) unless serious skin reaction occurs; myoclonic seizures (may be exacerbated); Parkinson's disease (may be exacerbated Blood disorders Patients and their carers should be alert for symptoms and signs suggestive of bonemarrow failure, such as anaemia, bruising, or infection. Aplastic anaemia, bone-marrow depression, and pancytopenia have been associated rarely with lamotrigine Lithium Licensed Management of acute manic or hypomanic episodes. Management of episodes of recurrent depressive disorders where treatment with other antidepressants has been unsuccessful. Prophylaxis against bipolar affective disorders. 18 P a g e

19 Control of aggressive behaviour or intentional selfharm. Refractory depression TDM required as narrow therapeutic window Trough plasma levels to be taken 12h (10-14h range acceptable) post-dose Toxic effects reliably occur at levels >1.5mmol/L. If signs of toxicity are present, stop treatment, check plasma levels, and take steps to reverse the toxicity. A concentration of >2mmol/L requires urgent treatment. Tests prior to starting treatment Lithium level (if switching from another brand/ preparation) BPAD (NICE): U&Es, serum creatinine, TFTs, FBC (if need), ECG (CVD or risk factors), weight, height. Baseline lipid profile, plasma glucose levels and BP until patient is stabilised Plasma levels one week after starting and one week after every dose change to maintain level between 0.6 and 0.8mmol/L (a level of between 0.8 and 1.0mmol/L may be appropriate in some patients) Levels should be monitored weekly until stable Ongoing Thyroid monitoring - TFTs every 6 months (more often if there is evidence of deterioration ) Renal function - Check renal function every 6 months (more often if evidence of impairment and/or deterioration, or the patient has other risk factors, such as starting ACEI, NSAIDs or diuretics) Plasma levels NICE recommend monitoring levels every 3 months once stable. Other monitoring DTB recommends annual calcium checks4. NICE and SLAM recommend monitoring weight/bmi FBC should be checked if clinically indicated 19 P a g e

20 Valproic Acid/valproate salts Licensed Semisodium valproate (Depakote ) and sodium valproate (Episenta ) are the only licensed formulation for BPAD Acute treatment of a manic episode associated with bipolar disorder where lithium is contraindicated or not tolerated. The continuation of treatment after manic episode could be considered in patients who have responded to Depakote for acute mania New Contraindication for Valproate see comments! Some sodium valproate (e.g. Epilim ) preparations are not licensed for use in BPAD Valproate salt and preparations Valproate semisodium (Depakote ) Sodium valproate (Epilim ) Sodium valproate (Episenta ) Valproic acid (Epilim Chrono ) Licensed indications Formulations Epilepsy Acute mania Mania relapse prevention No Yes Yes Tablets For oral administration in the treatment of generalised, partial or other epilepsy. All forms of epilepsy Treatment of generalised, partial or other epilepsy. No No Tablets, crushable tablets, injection, liquid, syrup Yes Yes ( Capsules, granules, injection No No CR tablets, Chronospheres The Medicines and Healthcare Products Regulatory Agency (MHRA) has BANNED valproate medicines in the UK in all women of childbearing potential who are not enrolled in a pregnancy prevention programme NSFT Valproate Toolkit cy%20-%20valproate%20toolkit%20v.2.pdf Equivalent dose of semisodium valproate (Depakote ) to sodium valproate RIBING%20GUIDELINES/Equivalent%20dose%20of%20semisodium%20valproa te%20to%20sodium%20valproate%20jan% pdf Tests prior to starting treatment LFTs, FBC (including platelet count, bleeding time and coagulation tests) and BMI NICE recommend TFTs, blood glucose, lipid profile 20 P a g e

21 (if over 40 years), weight and height. until patient is stabilised LFTs and PT periodically within first 6months of treatment Ongoing monitoring FBC (including platelet count), bleeding time and coagulation tests are recommended before surgery, and in cases of spontaneous bruising or bleeding LFTs, FBC and BMI (in those who gain weight rapidly) after 6 months Antidepressants General Prescribing Information Red Agomelatine- Non-Formulary Red Red Red Red Red Red Red Licensed Treatment of major depressive episodes in adults Take at night. Start at 25mg nocte for 2/52, increase to 50mg nocte if no response. Baseline LFTs then at 3, 6, 12 and 24 weeks. If dose increased restart monitoring. Counsel patient to look for signs of hepatotoxicity & provide booklet. Amitriptyline Licensed Symptoms of depressive illness (especially where sedation is required) Migraine prophylaxis. Neuropathic pain (side effect profile may limit use) PTSD3 Specialist use only Starting dose 75mg daily at night or in divided doses. Doses 125mg-150mg required to effectively treat depression. Use lower dose if 2D6 slow metaboliser. Use lower doses in the elderly. At clinically effective doses anticholinergic side effects may be troublesome, can minimise by starting at a low dose and titrating up slowly. 21 P a g e

22 Citalopram Licensed Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Treatment of panic disorder with or without agoraphobia. Generalised Anxiety Disorder Use Sertraline first line. Escitalopram is a licensed product and now generic. Sexual Disinhibition in dementia if at point of physical sexual aggression to others. To be backed up with SHAG scale to define and measure outcome. Specialist use only or on advice from a specialist Dementia and BPSD (rarely used). Specialist use only or on advice from a specialist. Maybe more commonly used for BPSD secondary to depression in dementia. Take in morning. Start at 20mg mane for depression, 10mg mane for anxiety with a slower titration to minimise exacerbation of symptoms. MHRA guidance restricts dose to a max of 40mg /day due to the possible risk of QTc prolongation at 60mg/day. Use with other drugs which prolong QTc is contraindicated. If using doses over 40mg/day monitor ECG pre and post dose change. Clomipramine Licensed Symptoms of depressive illness especially where sedation is required. Obsessional and phobic states. Adjunctive treatment of cataplexy associated with narcolepsy. Anxiety with obsessional features Panic Disorder Start at 10mg at bedtime, increased to mg/day for depression, max 250mg /day. Elderly max dose is 75mg daily. Use a lower dose in 2D6 slow metabolisers. Is highly serotinergic. At higher doses 150mg 300mg/day monitor ECG. 22 P a g e

23 Dosulepin- Non-Formulary Licensed Depressive illness, particularly where sedation is required Anxiety disorders NICE recommends avoiding due to high toxicity in overdose. Start at 75mg daily in divided doses or OD at bedtime increased to a max 225mg daily mg/day required for most of population for treatment of depression. If patient is suicidal limit supplies to 2/52 of 75mg/day equivalent. Duloxetine Licensed Major depressive disorder. Diabetic neuropathy, stress urinary incontinence. Generalised anxiety disorder. Other anxiety disorders Start at 60mg daily. Take in the morning to avoid sleep disturbance Cautioned with concomitant drugs which may cause bleeding. Escitalopram Licensed Major depressive episodes. Panic disorder with or without agoraphobia. Social anxiety disorder (social phobia). Generalised anxiety disorder. Obsessive-compulsive disorder Start at 10mg daily increased if necessary to 20mg/day Take in the morning to avoid sleep disturbance. For panic disorder start at 5mg daily for 7/7 then increase to 10-20mg daily. Avoid concomitant use of drugs which prolong QTc 23 P a g e

24 Fluoxetine Licensed Major depressive episodes in adults A complement to psychotherapy for the reduction of binge-eating and purging activity in Bulimia nervosa Obsessive compulsive disorder Children and Adolescents aged 8 Years and above: moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy Depression start at 20mg daily increased according to response to 60mg daily. For OCD start at 20mg daily, increase up to 60mg if necessary. Bumilia nervosa start at 60mg daily. Doses may be split, avoid giving at night as can cause sleep disturbance. Take in the morning to avoid sleep disturbance Initially may cause some exacerbation of anxiety Imipramine Licensed Depressive illness, nocturnal enuresis in children. Panic disorder Start at 75mg daily in divided doses increased slowly up to 200mg according to response (300mg in hospital patients). Up to 150mg can me taken as a single bedtime dose. Less sedative than amitriptyline. Elderly use lower doses starting at 10mg daily up to 50mg max. As tricyclic antidepressants are very toxic in overdose limit supplies in suicidal patients. Anticholinergic side effects may be troublesome. 24 P a g e

25 Lofepramine Licensed Depressive illness Start at mg daily in divided doses. Lower doses in the elderly. Due to lower risks in overdose NICE recommends Lofepramine as the tricyclic of choice. Constipation is common. Mirtazapine Licensed Major depressive illness Generalised Anxiety Disorder PTSD OCD As adjunctive treatment with SSRI (e.g. citalopram) Specialist use only. Dose for depression is 15-45mg daily taken at night. Starting at 30mg nocte will cause less sedation Monitor weight as may cause weight gain. Moclobemide Licensed Major depression. Treatment of social phobia. Other anxiety disorders A reversible inhibitor of MAO-A. Dose for depression is mg daily in a divided dose after food. Social phobia use mg daily No MAOi dietary restrictions as such but avoid large amounts of tyramine containing foods or drinks. 25 P a g e

26 Paroxetine Licensed Major depressive episode Obsessive Compulsive Disorder Panic Disorder with and without agoraphobia Social Anxiety Disorders/Social phobia Generalised Anxiety Disorder Post-traumatic Stress Disorder Doses for depression use 20-50mg daily. Start at 10mg daily in panic disorder to minimise exacerbation of symptoms. Take in the morning to avoid effects on sleep architecture. Discontinuation can be a significant problem as due to non linear kinetics blood levels drop rapidly when stopping or missing doses. Must be withdrawn very slowly. Phenelzine Licensed Depressive illness clinically characterised as 'atypical', 'non endogenous', 'neurotic' or where treatment with other antidepressants has failed Post-Traumatic Stress Disorder (PTSD). Specialist use only. Social phobia. Specialist use only. Dose 15mg tds up to 30mg tds max Requires MAOi diet advice (no cheese, marmite etc) whilst taking and care for 2 weeks after stopping. Give MAOi warning card (from pharmacy or choice & medication site) Discuss hypertensive crisis symptoms and actions. 26 P a g e

27 Sertraline Licensed Major depressive episodes Panic disorder, with or without agoraphobia. Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years Social anxiety disorder Post traumatic stress disorder (PTSD) Probably the SSRI of choice. Start at 50mg daily in depression increased up to max 200mg daily. In anxiety disorders start at the lower dose of 25mg daily and titrate slowly. May worsen anxiety symptoms initially. Tranylcypromine Licensed Depressive illness Often used when phobic symptoms present and other antidepressants have failed. Start at 10mg bd, close supervision at doses over 30mg daily. Second dose not to be taken after 3pm to avoid insomnia. Requires MAOi diet advice (no cheese, marmite etc) whilst taking and care for 2 weeks after stopping. Give MAOi warning card (from pharmacy or choice & medication site) Discuss hypertensive crisis symptoms and actions. Trazodone Licensed Anxiety, depression, mixed anxiety and depression. Dementia and BPSD. Although widely used, evidence is limited. Behavioural disturbances / agitation in dementia4 Sleep disturbance in dementia Start at 150mg daily in divided doses up to 600mg daily according to need. For anxiety start at 75mg daily increased to a maximum dose of 300mg daily. Take after food to reduce peak blood levels. Has hypnotic properties due to highly sedative antihistaminergic action. 27 P a g e

28 Tryptophan Licensed Adjunctive therapy for depression resistant to standard antidepressants. Discontinued in October 2012, but is still available as named patient only. Consultant will need to send the prescription to pharmacy. Amino acid serotonin precursor. Now no need for blood tests or OPTIMAX scheme Venlafaxine Licensed Major depressive episodes; Generalised anxiety disorder; Social anxiety disorder Panic disorder ER preparation only Start at 75mg daily increased up to max 225mg daily for anxiety, 375mg daily for depressive illness. MHRA guidance reserve as 2 nd line treatment. Contraindicated if high risk of serious cardiac arrhythmia or uncontrolled hypertension. No baseline ECG required. Monitor BP regularly. Vortioxetine Licensed Major depressive episodes in adults. Starting dose 10mg daily, adjust to 5-20mg daily Approved by NICE as 3 rd line antidepressant. Metabolised by CYP2D6 so may require dose adjustments with concomitant medication 28 P a g e

29 Anxiolytics, benzodiazepines and hypnotics General Prescribing Information Buspirone Licensed Short-term management of anxiety disorders and the relief of symptoms of anxiety with or without accompanying depression As adjunctive therapy for those with SSRI-induced sexual problems. See emc regarding hepatic and renal impairment Chlordiazepoxide Licensed For short term use 2-4 weeks Symptomatic relief of acute alcohol withdrawal Symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness Maximum dose up to 100mg daily, adjusted on an individual basis Treatment should not continue as full dose for more than 4 weeks including tapering off process Treatment lasting longer than 4 weeks. Chlordiazepoxide is the drug of choice for alcohol withdrawals as it is longer acting and more effective than shorter acting benzodiazepines such as oxazepam and lorazepam Shorter acting benzodiazepines such as oxazepam should be considered to avoid accumulation and sedation in the following groups Patients with impaired hepatic or renal function: dosage should not exceed half the adult dose and steps should be taken to ensure there is no accumulation of plasma chlordiazepoxide Contraindicated in severe hepatic insufficiency In elderly or debilitated patients, consider reducing the dose 29 P a g e

30 Clonazepam Licensed All clinical forms of epileptic disease and seizures in infants, children and adults not licensed for any psychiatric indications Experimental treatment of tardive dyskinesia.use licensed option first. Specialist use only. As adjunctive treatment of antipsychotic-induced akathisia if other strategies have failed. Mania (short term use). To control anxiety and/or agitation with aggression. BNF 74 Diazepam 5mg approximately equivalent to clonazepam 250mcg Diazepam oral Licensed The short-term relief (2-4 weeks) only, of anxiety which is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. Symptomatic treatment of acute alcohol withdrawal. 5-30mg daily in divided doses. Insomnia associated with anxiety: 5-15mg before retiring. symptoms. In the elderly the dose should be halved (emc) 30 P a g e

31 Diazepam Rectal tubes Licensed Severe or disabling anxiety and agitation; epileptic and febrile convulsions Lorazepam Oral Licensed FOR SHORT TERM (2-4 weeks only) USE (adults only) Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia or short-term organic or psychotic illness. Anxiety: 1-4mg daily in divided doses. Insomnia: 1-2mg before retiring Rapid tranquilisation Acute mania Delirium- specialist use Catatonia- specialist use The elderly may respond to lower doses (half normal adult dose or less) Lorazepam short acting injection Licensed The treatment of acute anxiety states, acute excitement or acute mania 31 P a g e

32 Nitrazepam Licensed Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime sedation is acceptable. Pregabalin Licensed Generalised Anxiety Disorder (GAD) in adults. Epilepsy Neuropathic pain Prescribe generic for GAD Promethazine Licensed Sedation and treatment of insomnia in adults (short term use) Reducing high levels of anxiety in anorexia: Specialist use only Eating Disorder unit Rapid Tranquilisation Hypnotic (oral) Promethazine short acting injection Licensed Sedation and treatment of insomnia in adults Rapid tranquilisation 32 P a g e

33 Propranolol Licensed NB May vary by formulation (m/r or IR) Relief of situational anxiety and generalised anxiety symptoms, particularly those of somatic type Akathisia Temazepam (Controlled Drug) Licensed Short-term treatment of insomnia in cases where it is severe, disabling or subjecting the individual to extreme distress. Use beyond 4 weeks. Zaleplon Licensed Treatment of patients with insomnia who have difficulty falling asleep only when the disorder is severe, disabling or subjecting the individual to extreme distress (maximum 2 weeks). Use beyond 2 weeks. Zolpidem Licensed Short-term treatment of insomnia in situations where the insomnia is debilitating or is causing severe distress (maximum 4 weeks) Use beyond 4 weeks. 33 P a g e

34 Zopiclone Licensed Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress (maximum 4 weeks). Use beyond 4 weeks. Melatonin Tablets- Licensed Non-Formulary Red Red Red Red Red Red Red Melatonin Tablets- CAMHs Shared Care Amber Amber Amber Amber Amber Amber Amber Licensed Melatonin m/r (Circadin ) is indicated as monotherapy for the short-term treatment of *primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. *Primary insomnia is sleeplessness that is not attributable to a medical, psychiatric or environmental cause. Where sleeplessness may be attributable to psychiatric cause Those under 55 years of age CAMHs Shared Care Melatonin business case for Julian Hospital was approved at TAG to be used for up to 13 weeks from initiation 34 P a g e

35 Drugs used in dementia General Prescribing Information Donepezil Tablets Amber Amber Amber Amber Amber Amber Amber Licensed Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Use in other dementias - Specialist use only. Notes See shared care and EMC for more information Galantamine Amber Amber Amber Amber Amber Amber Amber Licensed Symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. Use in other dementias - Specialist use only. See shared care and EMC for more information Memantine (excluding starter pack) Amber Amber Amber Amber Amber Amber Amber Licensed Treatment of patients with moderate to severe Alzheimer's disease Use for Behavioural and Psychological Symptoms in persons with Dementia (BPSD) See shared care and EMC for more information Rivastigmine oral & topical patches Amber Amber Amber Amber Amber Amber Amber Licensed May vary depending on preparation (see below). Symptomatic treatment of mild to moderately severe Alzheimer's dementia Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease. The Patches are not licensed in dementia with 35 P a g e

36 Parkinson s disease. See shared care and EMC for more information Drugs used to treat ADHD General Prescribing Information Drugs and Driving Prescribers and other healthcare professionals should advise patients if treatment is likely to affect their ability to perform skilled tasks (e.g. driving). This applies especially to drugs with sedative effects; patients should be warned that these effects are increased by alcohol. General information about a patient's fitness to drive is available from the Driver and Vehicle Licensing Agency at For information on 2015 legislation regarding driving whilst taking certain controlled drugs, including amphetamines, see Drugs and driving under Guidance on prescribing. Methylphenidate Amber Amber Amber Amber Amber Amber Amber Licensed Attention deficit hyperactivity disorder (initiated under specialist supervision) use in children under 6 years use in narcolepsy Methylphenidate XL preparations aren t all the same so please prescribe and advise GP to prescribe by brand name. Different brands differ significantly in price. Monitor for psychiatric disorders. Pulse, blood pressure, psychiatric symptoms, appetite, weight and height should be recorded at initiation of therapy, following each dose adjustment, and at least every 6 months thereafter. NICE TA98 Methylphenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) (March 2006) In children: Methylphenidate is recommended, within its licensed indications, as an option for the management of ADHD in children and adolescents P a g e

37 Dexamfetamine Amber Amber Amber Amber Amber Amber Amber Licensed Refractory attention deficit hyperactivity disorder (initiated under specialist supervision) Narcolepsy use in adults for refractory attention deficit hyperactivity disorder. Discontinue use if tics occur Monitor height and weight as growth restriction may occur during prolonged therapy (drug-free periods may allow catch-up in growth but withdraw slowly to avoid inducing depression or renewed hyperactivity). Monitor for aggressive behaviour or hostility during initial treatment. Pulse, blood pressure, psychiatric symptoms, appetite, weight and height should be recorded at initiation of therapy, following each dose adjustment, and at least every 6 months thereafter NICE TA98 Methylphenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) (March 2006) In children: Dexamfetamine is recommended, within its licensed indications, as an option for the management of ADHD in children and adolescents. Atomoxetine Amber Amber Amber Amber Amber Amber Amber Licensed Attention deficit hyperactivity disorder (initiated under specialist supervision) Doses above 100mg in children Doses above 120mg in adults Atomoxetine doses in BNF may differ from those in product literature Following reports of suicidal thoughts and behaviour, patients and their carers should be informed about the risk and told to report clinical worsening, suicidal 37 P a g e

38 thoughts or behaviour, irritability, agitation, or depression. Monitor for appearance or worsening of anxiety, depression or tics. Pulse, blood pressure, psychiatric symptoms, appetite, weight and height should be recorded at initiation of therapy, following each dose adjustment, and at least every 6 months thereafter NICE TA98 Methylphenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) (March 2006) Atomoxetine is recommended, within its licensed indications, as an option for the management of ADHD in children and adolescents. Lisdexamfetamine Amber Amber Amber Amber Amber Amber Amber Licensed Attention deficit hyperactivity disorder refractory to methylphenidate (initiated by a specialist) use in adults for attention deficit hyperactivity disorder. Discontinue use if tics occur Monitor height and weight as growth restriction may occur during prolonged therapy (drug-free periods may allow catch-up in growth but withdraw slowly to avoid inducing depression or renewed hyperactivity). Monitor for aggressive behaviour or hostility during initial treatment. Pulse, blood pressure, psychiatric symptoms, appetite, weight and height should be recorded at initiation of therapy, following each dose adjustment, and at least every 6 months thereafter 38 P a g e

39 Guafacine Red Not yet Red Red Red Red Not yet assessed assessed Licensed Attention deficit hyperactivity disorder in children for whom stimulants are not suitable, not tolerated or ineffective (initiated under specialist supervision) Fourth line use only Manufacturer advises to conduct a baseline evaluation to identify patients at risk of somnolence, sedation, hypotension, bradycardia, QTprolongation, and arrhythmia; this should include assessment of cardiovascular status. Monitor for signs of these adverse effects weekly during dose titration and then every 3 months during the first year of treatment, and every 6 months thereafter. Monitor BMI prior to treatment and then every 3 months for the first year of treatment, and every 6 months thereafter. More frequent monitoring is advised following dose adjustments. Monitor blood pressure and pulse during dose downward titration and following discontinuation of treatment. 39 P a g e

40 Drugs used in substance misuse and alcohol use disorder Opioid replacement therapy General Prescribing Information Buprenorphine Licensed Substitution treatment for opioid drug dependence, within a recovery framework of medical, social and psychological treatment. Refer to TAG guidelines for primary care prescribers with competence in the treatment of opioid dependence e_guidelines.pdf guidelinesmanaging withdrawal symptoms for inpatients Suboxone (Buprenorphine/Naloxone) Licensed Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction. 40 P a g e

41 Lofexidine Licensed To relieve symptoms in patients undergoing opiate detoxification The dosage of lofexidine should be titrated according to the patient's response. Initial dosage should be 0.8mg per day in divided doses. The dosage may be increased by increments of 0.4 to 0.8mg per day up to a maximum of 2.4mg daily Lofexidine is a hypotensive agent and should not be discontinued abruptly (2-4 days should suffice) BP and pulse should be monitored frequently (normally pulse is taken before each dose) Methadone Mixture 1mg/mL Licensed Maintenance therapy in the management of opioid dependence NICE Guidance January 2007 (TA 114): methadone (oral formulations), using flexible dosing regimens, are recommended as options for maintenance therapy in the management of opiod dependence. Methadone should be admininstered daily,under supervision, for at least the first 3 months, as part of a programme of supportive care. Orange guidelines Managing withdrawal symptoms for inpatients Naloxone Injection 400micrograms/mL I/M Licensed Naloxone is indicated for the treatment of respiratory depression induced by natural and synthetic opioids. It may also be used for the diagnosis of suspected acute opioid overdosage. Also recommended for use before administering naltrexone orally (emc for naltrexone) Naloxone test -Intramuscular: Administer 400mcg naloxone. Monitor the patient for one hour for signs of withdrawals. If negative then oral naltrexone can be initiated 41 P a g e

42 Naltrexone for management of opioid dependence Red Red Red Red Red Licensed Naltrexone is indicated as an adjunctive prophylactic therapy in the maintenance of detoxified, formerly opioid-dependent patients. NICE TA115 Naltrexone for the management of opioid dependence Administration of naltrexone must not be started before a naloxone challenge test is performed and a negative result obtained Alcohol use disorder Vitamin B Compound Strong is not recommended for use in patients with a history of excess alcohol intake and is not mentioned in NICE guidance on management of alcohol use disorder (CG 100 & CG 115) Acamprosate Licensed Therapy to assist in maintenance of abstinence in alcohol-dependent patients between ages of It should be combined with psychotherapeutic interventions Non abstinence. Treatment of alcohol withdrawal (short term) Usually continue treatment for up to 6 months or longer for those benefitting from the drug who want to continue with it. Almost all eveidence for the effectiveness of acamprosate has included a psychosocial component No formal monitoring is required Acamprosate should be stopped if drinking persists 4 6 weeks after starting the drug. Psychosocial interventions should also be provided Caution in hepatic and renal impairment (refer to emc) 42 P a g e