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Hull & East Riding Prescribing Committee Prescribing Framework for Phenelzine (MAOI) in the treatment of depressive illness Patients Name:…………………………………………………..… NHS Number: ……………… Patients Address:……………………………………………...……(Use addressograph sticker) GP’s Name:……………………………………………………….…….. Communication We agree to treat this patient within this Prescribing Framework. Specialist Prescriber’s Name ……………………………………………………………... Specialist Prescriber’s Signature……………………………………………………….Date:…………… Consultant’s Signature (if appropriate)…………………………………………………Date:…………… GP’s Signature:…………………………………………………………. Date:…………… The front page of this form should be completed by the specialist and the form sent to the patient’s general practitioner. The patient’s GP should sign and send back to specialist, to confirm agreement to enter into shared care arrangement. If the General Practitioner is unwilling to accept prescribing responsibility for the above patient the specialist should be informed within two weeks of receipt of this framework and specialist’s letter. Full copy of framework can also be found at : http://www.hey.nhs.uk/amber.htm Prescribing framework for Phenelzine Date approved by HERPC : Sep 13 Review date: Sep 2016 Page 1 of 7 1. Background Monoamine-oxidase inhibitors are used much less frequently than tricyclic and related antidepressants, or SSRIs and related antidepressants because of the dangers of dietary and drug interactions and the fact that it is easier to prescribe MAOIs when tricyclic antidepressants have been unsuccessful than vice versa. Phobic patients and depressed patients with atypical, hypochondriacal, or hysterical features are said to respond best to MAOIs. However, MAOIs may be tried in any patients who are refractory to treatment with other antidepressants as there is occasionally a dramatic response. Response to treatment may be delayed for 3 weeks or more and may take an additional 1 or 2 weeks to become maximal. MAOIs are associated with withdrawal symptoms on cessation of therapy. Symptoms include agitation, irritability, ataxia, movement disorders, insomnia, drowsiness, vivid dreams, cognitive impairment, and slowed speech. Withdrawal symptoms occasionally experienced when discontinuing MAOIs include hallucinations and paranoid delusions. If possible MAOIs should be withdrawn slowly. MAOIs inhibit monoamine oxidase, thereby causing an accumulation of amine neurotransmitters. The metabolism of some amine drugs such as indirect-acting sympathomimetics (present in many cough and decongestant preparations, section 3.10) is also inhibited and their pressor action may be potentiated; the pressor effect of tyramine (in some foods, such as mature cheese, pickled herring, broad bean pods, and Bovril®, Oxo®, Marmite® or any similar meat or yeast extract or fermented soya bean extract) may also be dangerously potentiated. These interactions may cause a dangerous rise in blood pressure. An early warning symptom may be a throbbing headache. Patients should be advised to eat only fresh foods and avoid food that is suspected of being stale or ‘going off’. This is especially important with meat, fish, poultry or offal; game should be avoided. The danger of interaction persists for up to 2 weeks after treatment with MAOIs is discontinued. Patients should also avoid alcoholic drinks or de-alcoholised (low alcohol) drinks. The guidelines should be read in conjunction with the general guidance on prescribing matters given in EL (91) 127 “Responsibility for prescribing between hospitals and GPs”. 2. Indication Depressive Illness. Phenelzine should be initiated in secondary care under specialist supervision. Once a patient’s mental state and medication have been stabilised they may be considered suitable for shared care between the specialist and GP. 3. Dose 15 mg 3 times daily, increased if necessary to 4 times daily after 2 weeks (hospital patients, max. 30 mg 3 times daily), then reduced gradually to lowest possible maintenance dose (15 mg on alternate days may be adequate). The last dose of the day should be taken before 3pm. The effectiveness of the drug may not become apparent in less than 4 weeks therapy. Child; not recommended. Elderly; same as adult dose but side effects may be more common 4. Duration of treatment NICE guidance states that people with depression who benefit from treatment with antidepressants are advised to continue with treatment for at least 6 months after remission, extending to at least 2 years for people at risk of relapse. 5. Contraindications Cerebrovascular disease, phaeochromocytoma, liver impairment, not indicated in manic phase 6. Cautions Diabetes mellitus, cardiovascular disease, epilepsy, blood disorders, concurrent electroconvulsive therapy; elderly (great caution); monitor blood pressure (risk of postural hypotension and hypertensive responses—discontinue if palpitations or frequent headaches); if possible avoid abrupt withdrawal; severe hypertensive reactions to certain drugs and foods (see interactions); avoid in agitated patients; acute porphyria Prescribing framework for Phenelzine Date approved by HERPC : Sep 13 Review date: Sep 2016 Page 2 of 7 Drowsiness:- may affect performance of skilled tasks (e.g. driving) 7. Adverse effects Commonly postural hypotension (especially in elderly) and dizziness; less common side-effects include drowsiness, insomnia, headache, weakness and fatigue, dry mouth, constipation and other gastrointestinal disturbances, oedema, myoclonic movement, hyperreflexia, elevated liver enzymes; agitation and tremors, nervousness, euphoria, arrhythmias, blurred vision, nystagmus, difficulty in micturition, sweating, convulsions, rashes, purpura, leucopenia, sexual disturbances, and weight gain with inappropriate appetite may also occur; psychotic episodes with hypomanic behaviour, confusion, and hallucinations may be induced in susceptible persons; suicidal behaviour; jaundice has been reported and, on rare occasions, fatal progressive hepatocellular necrosis; paraesthesia, peripheral neuritis, peripheral neuropathy may be due to pyridoxine deficiency; hyponatraemia 8. Interactions Information current to July 2013. Details of contraindications, cautions, drug interactions and adverse effects listed above are not exhaustive. For further information always check with BNF www.bnf.org.uk or SPC (www.medicines.org.uk). ACE Inhibitors Adrenergic Neurone Blockers Alcohol Alpha-blockers Angiotensin-II Receptor Antagonists Antidepressants, SSRI Antidepressants, Tricyclic Antidepressants, Tricyclic (related) Antidiabetics Antiepileptics Antihistamines Antimuscarinics Apraclonidine Atomoxetine MAOIs possibly enhance hypotensive effect of ACE inhibitors enhanced hypotensive effect when MAOIs given with adrenergic neurone blockers MAOIs interact with tyramine found in some beverages containing alcohol and some dealcoholised beverages (hypertensive crisis)—if no tyramine, enhanced hypotensive effect enhanced hypotensive effect when MAOIs given with alpha-blockers MAOIs possibly enhance hypotensive effect of angiotensin-II receptor antagonists MAOIs increase CNS effects of SSRIs (risk of serious toxicity) increased risk of hypertension and CNS excitation when MAOIs given with tricyclics, tricyclics should not be started until 2 weeks after stopping MAOIs (3 weeks if starting clomipramine or imipramine), also MAOIs should not be started for at least 1–2 weeks after stopping tricyclics (3 weeks in the case of clomipramine or imipramine) after stopping MAOIs do not start tricyclic-related antidepressants for 2 weeks, also MAOIs should not be started until at least 1–2 weeks after stopping tricyclic-related antidepressants MAOIs possibly enhance hypoglycaemic effect of antidiabetics MAOIs possibly antagonise anticonvulsant effect of antiepileptics (convulsive threshold lowered) increased antimuscarinic and sedative effects when MAOIs given with antihistamines Note: Sedative interactions apply to a lesser extent to the non-sedating antihistamines. Interactions do not generally apply to antihistamines used for topical action (including inhalation) increased risk of antimuscarinic side-effects when MAOIs given with antimuscarinics Note: Many drugs have antimuscarinic effects; concomitant use of two or more such drugs can increase side-effects such as dry mouth, urine retention, and constipation; concomitant use can also lead to confusion in the elderly. Interactions do not generally apply to antimuscarinics used by inhalation avoidance of MAOIs advised by manufacturer of apraclonidine after stopping MAOIs do not start atomoxetine for 2 weeks, also MAOIs should not be started until at least 2 weeks after stopping atomoxetine Prescribing framework for Phenelzine Date approved by HERPC : Sep 13 Review date: Sep 2016 Page 3 of 7 Beta-blockers Brimonidine Bupropion Buspirone Calcium-channel Blockers Carbamazepine Citalopram Clonidine Clozapine Diazoxide Diuretics Doxapram Duloxetine Entacapone Escitalopram Fluoxetine Fluvoxamine Histamine Hydralazine Indoramin Insulin Levodopa MAOIs Metformin Methyldopa Methylphenidate Minoxidil Mirtazapine Moclobemide Moxonidine Nefopam Nicorandil Nitrates Opioid Analgesics enhanced hypotensive effect when MAOIs given with beta-blockers Note: Since systemic absorption may follow topical application of beta-blockers to the eye the possibility of interactions, in particular, with drugs such as verapamil should be borne in mind avoidance of MAOIs advised by manufacturer of brimonidine avoidance of bupropion for 2 weeks after stopping MAOIs advised by manufacturer of bupropion avoidance of MAOIs advised by manufacturer of buspirone enhanced hypotensive effect when MAOIs given with calcium-channel blockers avoidance for 2 weeks after stopping MAOIs advised by manufacturer of carbamazepine, also antagonism of anticonvulsant effect after stopping MAOIs do not start citalopram for 2 weeks, also MAOIs should not be started until at least 1 week after stopping citalopram enhanced hypotensive effect when MAOIs given with clonidine CNS effects of MAOIs possibly increased by clozapine Note: Avoid concomitant use of clozapine with drugs that have a substantial potential for causing agranulocytosis enhanced hypotensive effect when MAOIs given with diazoxide enhanced hypotensive effect when MAOIs given with diuretics MAOIs enhance effects of doxapram after stopping MAOIs do not start duloxetine for 2 weeks, also MAOIs should not be started until at least 5 days after stopping duloxetine avoid concomitant use of non-selective MAOIs with entacapone after stopping MAOIs do not start escitalopram for 2 weeks, also MAOIs should not be started until at least 1 week after stopping escitalopram after stopping MAOIs do not start fluoxetine for 2 weeks, also MAOIs should not be started until at least 5 weeks after stopping fluoxetine after stopping MAOIs do not start fluvoxamine for 2 weeks, also MAOIs should not be started until at least 1 week after stopping fluvoxamine avoidance of MAOIs advised by manufacturer of histamine enhanced hypotensive effect when MAOIs given with hydralazine avoidance of MAOIs advised by manufacturer of indoramin MAOIs enhance hypoglycaemic effect of insulin risk of hypertensive crisis when MAOIs given with levodopa, avoid levodopa for at least 2 weeks after stopping MAOIs MAOIs can cause increased risk of hypertension and CNS excitation when given with other MAOIs (avoid for at least 2 weeks after stopping previous MAOIs and then start at a reduced dose) Note: For interactions of reversible MAO-A inhibitors (RIMAs) see Moclobemide, and for interactions of MAO-B inhibitors see Rasagiline and Selegiline; the antibacterial Linezolid is a reversible, non-selective MAO inhibitor MAOIs enhance hypoglycaemic effect of metformin avoidance of MAOIs advised by manufacturer of methyldopa risk of hypertensive crisis when MAOIs given with methylphenidate, some manufacturers advise avoid methylphenidate for at least 2 weeks after stopping MAOIs enhanced hypotensive effect when MAOIs given with minoxidil after stopping MAOIs do not start mirtazapine for 2 weeks, also MAOIs should not be started until at least 2 weeks after stopping mirtazapine after stopping MAOIs do not start moclobemide for at least 1 week enhanced hypotensive effect when MAOIs given with moxonidine avoidance of MAOIs advised by manufacturer of nefopam enhanced hypotensive effect when MAOIs given with nicorandil enhanced hypotensive effect when MAOIs given with nitrates possible CNS excitation or depression (hypertension or hypotension) when Prescribing framework for Phenelzine Date approved by HERPC : Sep 13 Review date: Sep 2016 Page 4 of 7 Paroxetine Pethidine Pholcodine Promethazine Rasagiline Reboxetine Rizatriptan Selegiline Sertraline Sodium Nitroprusside Sulfonylureas Sumatriptan Suxamethonium Sympathomimetics Tetrabenazine Tolcapone Tramadol Tryptophan Venlafaxine Zolmitriptan Artemether with Lumefantrine Atomoxetine Piperaquine with Artenimol MAOIs given with opioid analgesics—some manufacturers advise avoid concomitant use and for 2 weeks after stopping MAOIs after stopping MAOIs do not start paroxetine for 2 weeks, also MAOIs should not be started until at least 1 week after stopping paroxetine CNS excitation or depression (hypertension or hypotension) when MAOIs given with pethidine—avoid concomitant use and for 2 weeks after stopping MAOIs avoidance of pholcodine for 2 weeks after stopping MAOIs advised by manufacturer of pholcodine avoidance of promethazine for 2 weeks after stopping MAOIs advised by manufacturer of promethazine risk of hypertensive crisis when MAOIs given with rasagiline, avoid MAOIs for at least 2 weeks after stopping rasagiline Note: Rasagiline is a MAO-B inhibitor increased risk of hypertension and CNS excitation when MAOIs given with reboxetine (MAOIs should not be started until 1 week after stopping reboxetine, avoid reboxetine for 2 weeks after stopping MAOIs) risk of CNS toxicity when MAOIs given with rizatriptan (avoid rizatriptan for 2 weeks after MAOIs) enhanced hypotensive effect when MAOIs given with selegiline—manufacturer of selegiline advises avoid concomitant use Note: Selegiline is a MAO-B inhibitor after stopping MAOIs do not start sertraline for 2 weeks, also MAOIs should not be started until at least 1 week after stopping sertraline enhanced hypotensive effect when MAOIs given with sodium nitroprusside MAOIs enhance hypoglycaemic effect of sulfonylureas risk of CNS toxicity when MAOIs given with sumatriptan (avoid sumatriptan for 2 weeks after MAOIs) phenelzine enhances effects of suxamethonium risk of hypertensive crisis when MAOIs given with sympathomimetics risk of CNS toxicity when MAOIs given with tetrabenazine (avoid tetrabenazine for 2 weeks after MAOIs) avoid concomitant use of MAOIs with tolcapone possible increased serotonergic effects and increased risk of convulsions when MAOIs given with tramadol—some manufacturers advise avoid concomitant use and for 2 weeks after stopping MAOIs CNS excitation and confusion when MAOIs given with tryptophan (reduce dose of tryptophan) enhanced CNS effects and toxicity when MAOIs given with venlafaxine (venlafaxine should not be started until 2 weeks after stopping MAOIs, avoid MAOIs for 1 week after stopping venlafaxine) increased risk of CNS toxicity when MAOIs given with zolmitriptan avoidance of antidepressants advised by manufacturer of artemether with lumefantrine possible increased risk of convulsions when antidepressants given with atomoxetine avoidance of antidepressants advised by manufacturer of piperaquine with artenimol Note: Piperaquine has a long half-life; there is a potential for drug interactions to occur for up to 3 months after treatment has been stopped Other antidepressants should not be started for 2 weeks after treatment with MAOIs has been stopped (3 weeks with clomipramine or imipramine). Only experienced psychiatrists should use selected tricyclics in conjunction with MAOIs as this is potentially fatal. There is no evidence that the combination is more effective than when either constituent is used alone. The combination of tranylcypromine with clomipramine Prescribing framework for Phenelzine Date approved by HERPC : Sep 13 Review date: Sep 2016 Page 5 of 7 is particularly dangerous. Conversely, an MAOI should not be started until at least 7–14 days after a tricyclic or related antidepressant (3 weeks in the case of clomipramine or imipramine) has been stopped. In addition, an MAOI should not be started for at least 2 weeks after a previous MAOI has been stopped (then started at a reduced dose). 9. Monitoring Regular blood pressure measurement is recommended during initiation and routine checks should be made during maintenance. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. 10. Information to patient Verbal information along with the patient information leaflet from the Choice & Medication website will be provided. It is essential that the patient has a good understanding of the food restrictions and is able to adhere to these. Information on these food risks will be given to the patient prior to starting treatment. 11. Responsibilities of clinicians involved Stage of Treatment Initiation Hospital Specialist General Practitioner Provide details of any concurrent medication, coexisting health problems and compliance issues to the specialist Continued discussion of risks and benefits of medication with patients and carers as required. Prescribing once maintenance doses established. Switching or discontinuation should only be done through the specialist Continued monitoring blood pressure, as agreed with secondary care and referral back to secondary care if patient becomes noncompliant and/or if mental state deteriorates Respond to adverse reactions and advise on concomitant medication. Update specialist on any changes in medical condition or prescribed concomitant medication until discharged from specialist services Seek support from specialist when considering switching antidepressants Maintenance Switching Prescribing until maintenance regime established. Discussion of risks and benefits with patients and carers in particular the dietary restrictions and interactions with medication, including those available over the counter Provision of written information on the use, side effects and dietary restrictions Provide details of concurrent medication prescribed via secondary psychiatric care to GP. Provide details of ongoing monitoring requirements to GP. Provide details of patient follow up including care plan. Inform GP of any identified problems e.g. compliance with treatment. Provide details of mental health key worker if appropriate. Provide support to GP in response to queries about switching antidepressants Prescribing framework for Phenelzine Date approved by HERPC : Sep 13 Review date: Sep 2016 Page 6 of 7 Contact Details: During Office hours: HFT Pharmacy Department (01482) 301724 Out of hours: On Call Psychiatrist via Switchboard (01482) 223191 APPROVAL PROCESS Written by: Consultation process: Approved by: Ratified by: Review date: Jackie Stark, Principal Pharmacist HFT Wendy Tucker, Pharmacist Specialist Team, HFT Include MMIG (July 13), HFT DTC (July 13) HERPC Sep 2013 Sep 2016 Prescribing framework for Phenelzine Date approved by HERPC : Sep 13 Review date: Sep 2016 Page 7 of 7