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NORTH ESSEX PARTNERSHIP NHS FOUNDATION TRUST GUIDELINES AND INFORMATION FOR ALL NORTH ESSEX PRESCRIBERS AND Date of implementation July 2006 Date of review July 2008

Introduction Contraindications for Dosulepin 2. /suicidal thoughts This guidance follows the NICE Clinical As above, and in manic phase. 3. / Guideline 23 (December 2004) and the 4. Increased dose-related , amended licence for Venlafaxine (May 26th Cautions for Venlafaxine common at higher doses. Reduce dose or 2006). The new licence for Venlafaxine ♦Suicide/suicidal thoughts. Monitor closely until discontinue if sustained. supersedes the NICE 23 guidance, so it no remission. Patients and caregivers must be 5. Aggression, especially on starting or stopping longer requires a shared care protocol for advised of the increased risk in the first few weeks 6. Psychomotor restlessness (akathisia) doses below 300mg, but there are specific of treatment, alerted to monitor for the emergence 7. Cardiotoxicity requirements for its use. The NICE guidelines of suicidal thoughts and to seek medical advice 8. Significant ECG changes (rarely) recommend that Dosulepin should be initiated immediately if these symptoms occur. 9. Seizures, especially in overdose by a specialist. It is the most toxic in overdose, ♦Heart disease (e.g. recent myocardial infarction, 10. Increased heartrate and cardiotoxic, and is not recommended for cardiac failure, coronary artery disease, ECG 11. Postural hypotension, esp. in elderly. use in North Essex except for existing patients abnormalities including pre-existing QT interval 12. Hyponatraemia, esp. in elderly for whom it is a successful treatment, and who prolongation) 13. Increase in serum cholesterol are at low risk from cardiac side effects or ♦ Existing high blood pressure controlled by other attempted suicide. (see NEPFT “traffic lights” For Dosulepin for the prescribing of psychotrophics in North ♦ Electrolyte disturbance As above, and blurred vision, difficulty in Essex). ♦ History of epilepsy or mania micturition, rashes, confusion/delirium, , ♦ Hepatic or renal impairment blood sugar changes, endocrine changes,, Indications for use of Venlafaxine white blood cell changes, abnormal LFTs. ♦ Major depressive disorder, which has not been ♦ Concomitant use of drugs that increase risk of treated successfully with an SSRI or other Interactions bleeding, or history of bleeding disorders 1.Increased risk of bleeding with NSAIDS, aspirin, Moderate to severe generalised anxiety ♦ Hyponatraemia or abnormal ADH secretion warfarin, disorder which has not been treated ♦ Concomitant drug abuse. 2. Enhanced CNS effects and toxicity with MAOIs successfully with at least two SSRIs at For Dosulepin and Moclobamide. adequate dosage for at least 12 weeks each, As above, and thyroid disease, 3. Avoid with antimalarials (artemether and at doses up to 75mg daily. phaeochromocytoma, psychoses, urinary lumefantrine) retention, concurrent ECT, anaesthesia, porphyria. 4. Clozapine and haloperidol plasma Contraindications for Venlafaxine concentrations are increased. Risk of serious cardiac ventricular arrhythmia, **********Avoid abrupt withdrawal********** 5. Hypertension/CNS excitation risk increased uncontrolled high blood pressure, severe with entacapone. hepatic or renal impairment, , Side effects of Venlafaxine 6. Avoid starting within I week of breastfeeding, known hypersensitivity to 1. , , dry mouth, , stopping Venlafaxine. Increased seratonergic Venlafaxine or product components, children , constipation, sweating, nervousness, effects with Duloxetine are possible. under 18 years. asthenia, abnormal ejaculation/orgasm, usually 7. CNS toxicity with . Avoid decreasing over time. concomitant use.

NEPFT Venlafaxine and Dosulepin Guidelines July 2006 1 6. If the dose of Venlafaxine is 300mg or more 8. Risk of Neuroleptic malignant syndrome with the prescriber must refer the patient to a mental Crosstaper Crosstaper neuroleptics. health specialist. cautiously cautiously 9. Ketoconazole, Erythromycin and other 6. If the continuation of treatment is Duloxetine Crosstaper Withdraw.Start potent CYP3A4 inhibitors must only be used contraindicated following the ECG and blood cautiously, at 60mg alt with Venlafaxine if absolutely necessary – risk pressure monitoring the GP must discuss start at 60mg die. Increase for patients with “poor metaboliser” genotype. alternative therapies and withdrawal with the alt die slowly. patient, and refer to specialist care if necessary. Increase Possible effects of withdrawal Treatment must not be discontinued suddenly. slowly. Avoid sudden withdrawal. Venlafaxine Crosstaper Short term effects include: Nightmares and Switching cautiously, insomnia, Dizziness, sensory disturbance Monitor carefully when switching, check at each starting with V Agitation, anxiety, Nausea, vomiting, tremor, stage, and be prepared to go more slowly in 37.5mg OM sweating headache, diarrhoea, palpitations, response to patient need. Moclobamide Withdraw. Withdraw. emotional instability, return of depressive New From From Venlafaxine Wait at least Wait at least illness. antidep Dosulepin 1/52 1/52 Usually resolved in 2 weeks but may occur for MAOI Withdraw.Wait Withdraw.Wait up to 3 months. Withdrawal Reduce by Reduce by 75mg Specialist at least 2/52 at least 2/52 75mg each 2/52 then supervision Existing patients each 2/52, 37.5mg,then recomm. 1 Advise the patient of the revised side-effect then 25mg 37.5mg EOD profile of the medication they are taking, and 2/52 New Patients discuss the risks/benefits of continuing the 1.Venlafaxine may be considered when at least treatment. SSRI Halve dose Crosstaper VERY one other antidepressant has been ineffective or 2. If the treatment is to be withdrawn, it should (, and add cautiously. Start not tolerated after a reasonable dose and trial be very gradual, over 1 week to 1 year , SSRI, then with Cit 10mg OM, period. depending on the patient and the length of , slow Fluox 20mg alt die, 2. The patient should have normal or adequately treatment. ) withdrawal. Par 10mgOM, Sert controlled blood pressure, and the GP should 3. If another antidepressant is to be started, 25mgOD. Monitor check that there is no existing heart disease (see most (except MAOIs) can be weekly C/I and cautions). An ECG within the last year cross tapered cautiously (see overleaf) would be helpful. 4. If the treatment is to continue, the patient Halve Crosstaper 2.Patients MUST be carefully evaluated for should have a blood pressure measurement, if dose, add cautiously evidence or worsening of suicide-related they have not had one within the last 3 Traz then behaviour months.The GP should check for heart disease slow wdl 3. A maximum of 2 weeks supply must be (see C/I and cautions). An ECG within the prescribed at initiation, during dose adjustments, previous year would be helpful. Mirtazepine Crosstaper Crosstaper and until improvement occurs, to reduce risk of 5. If they are not now contraindicated and the cautiously cautiously overdose. treatment is of benefit to the patient, the GP or 4.Doses of 300mg or more may only be initiated other prescriber may continue to prescribe Crosstaper C’taper cautiously, by specialist care and continued under shared Venlafaxine or Dosulepin, with monitoring. The cautiously, with very low dose care arrangements. changes in licensed use must be discussed of TCA 5. Dosulepin must not be initiated by primary or with the patient.

NEPFT Venlafaxine and Dosulepin Guidelines July 2006 2 specialist care. Advice and useful information The GP must be advised of any change in Continuing care and monitoring by GP treatment. Venlafaxine should be taken with food. If Venlafaxine or Dosulepin are to be continued The local CMHT team must be involved where the prescriber must ensure that the blood necessary. Summary of product characteristics for pressure measurement is repeated monthly for Venlafaxine (Efexor and Efexor XL) and 3 months after initiation or dose increase, and Shared care for Venlafaxine 300mg or above Dosulepin (Prothiaden and various brands) 6-monthly after that. See separate shared care guideline www.emc.medicines.org.uk or ABPI medicines Serum cholesterol levels after 3 months then compendium annually. Preparations available Patient information leaflets for Venlafaxine The minimum effective dose should be Venlafaxine 37.5mg tablet £23.41/56 (revised June 06) www.medicines.org.uk prescribed, the dose reviewed regularly, and Venlafaxine 50mg and 75mg tablets not BNF March 2006 www.bnf.org.uk reduced where possible. recommended to avoid errors and confusion www.ukmi.nhs.uk For venlafaxine, treatment for depression may Venlafaxine XL 75mg capsule £23.41/28 UKPPG Helpline Maudsley 020 7919 2999 be 12 months, and for GAD 6 months, but this Venlafaxine XL 150mg capsule £39.03/28 Maudsley Guidelines 8th edition will vary depending on the response of the (14-tablet packs to be available soon) Royal College of Psychiatry www.rcpsych.ac.uk individual patient. Dosulepin 25mg capsule 93p/20 Dosulepin 75mg tablet £1.50/28 Harlow PAH MI 01279 82 7054 Referral Colchester General MI 01206 74 2161 1.Referral will usually be by the GP or by Chelmsford Bmf’d Hospital MI 01245 514822 another secondary care consultant, to a NOTE consultant psychiatrist or a GP with a special The patient information leaflets in the current Authors interest in mental health packs of Venlafaxine may not include the Judith Woolley (lead pharmacist, NEPFT) North 2. On referral the specialist must be provided necessary warnings yet. Please discuss the Essex Partnership NHS Foundation Trust with a brief patient history, a recent ECG, changes with your patient, and if possible provide Medicines Management Committee blood pressure, and cholesterol level. an amended Patient Information Leaflet from the In consultation with the PCOs and acute Trusts in 3. Patients who are prescribed Venlafaxine website www.medicines.org.uk North Essex 300mg or more must be referred to specialist care.

Specialist care The patient must be assessed for continuing treatment and care. Changes in treatment should usually be prescribed by the specialist until the planned long term treatment is in place. If a very prolonged withdrawal or cross tapering is planned the specialist must liaise with the GP and arrange a treatment plan for the GP and the community mental health team to carry out.

NEPFT Venlafaxine and Dosulepin Guidelines July 2006 3

NEPFT Venlafaxine and Dosulepin Guidelines July 2006 4