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2/26/23

 Neuropathic pain | Migraine prophylaxis | Chronic tensiontype headache prophylaxis

▶ BY MOUTH

▶ Adult: Initially 10–25 mg daily, dose to be taken in the

evening, then increased, if tolerated, in steps of

10–25 mg every 3–7 days in 1–2 divided doses; usual

dose 25–75 mg daily, dose to be taken in the evening,

doses above 100 mg should be used with caution (doses

above 75 mg should be used with caution in the elderly

and in patients with cardiovascular disease); maximum

per dose 75 mg

l UNLICENSED USE Not licensed for use in abdominal pain

or discomfort in patients who have not responded to

laxatives, loperamide, or antispasmodics.

l CONTRA-INDICATIONS Arrhythmias . during manic phase

of bipolar disorder. heart block . immediate recovery

period after myocardial infarction

l CAUTIONS Cardiovascular disease . chronic constipation . diabetes . epilepsy . history of bipolar disorder. history of

psychosis . hyperthyroidism (risk of arrhythmias). increased intra-ocular pressure . patients with a significant

risk of suicide . phaeochromocytoma (risk of arrhythmias). prostatic hypertrophy . susceptibility to angle-closure

glaucoma . urinary retention

CAUTIONS, FURTHER INFORMATION Treatment should be

stopped if the patient enters a manic phase.

Elderly patients are particularly susceptible to many of

the side-effects of tricyclic antidepressants; low initial

doses should be used, with close monitoring, particularly

for psychiatric and cardiac side-effects.

l INTERACTIONS → Appendix 1: tricyclic antidepressants

l SIDE-EFFECTS

▶ Common or very common Anticholinergic syndrome . drowsiness . QT interval prolongation

▶ Frequency not known Agranulocytosis . alopecia . anxiety . appetite abnormal . arrhythmias . asthenia . bone marrow

depression . breast enlargement. cardiac conduction

disorders . coma . concentration impaired . confusion . constipation . delirium . delusions . diarrhoea . dizziness . dry mouth . dysarthria . eosinophilia . epigastric distress . face oedema . galactorrhoea . gynaecomastia . hallucination . headache . hepatic disorders . hyperhidrosis . hyperpyrexia . hypertension . hyponatraemia . hypotension . leucopenia . mood altered . movement

disorders . mydriasis . myocardial infarction . nausea . neuroleptic malignant syndrome . oral disorders . palpitations . paralytic ileus . peripheral neuropathy . photosensitivity reaction . seizure . sensation abnormal . sexual dysfunction . SIADH . skin reactions . sleep

disorders . stroke . sudden cardiac death . suicidal

tendencies . syncope .taste altered .testicular swelling . thrombocytopenia .tinnitus .tremor. urinary disorders . urinary tract dilation . vision disorders . vomiting . weight

changes . withdrawal syndrome

SIDE-EFFECTS, FURTHER INFORMATION The risk of sideeffects is reduced by titrating slowly to the minimum

effective dose (every 2–3 days). Consider using a lower

starting dose in elderly patients.

Overdose Overdosage with amitriptyline is associated with

a relatively high rate of fatality. Symptoms of overdosage

may include dry mouth, coma of varying degree,

hypotension, hypothermia, hyperreflexia, extensor plantar

responses, convulsions, respiratory failure, cardiac

conduction defects, and arrhythmias. Dilated pupils and

urinary retention also occur. For details on the

management of poisoning, see Tricyclic and related

antidepressants, under Emergency treatment of poisoning

p. 1359.

l PREGNANCY Use only if potential benefit outweighs risk.

l BREAST FEEDING The amount secreted into breast milk is

too small to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises use with

caution in mild-to-moderate impairment; avoid in severe

impairment.

l TREATMENT CESSATION Withdrawal effects may occur

within 5 days of stopping treatment with antidepressant

drugs; they are usually mild and self-limiting, but in some

cases may be severe. The risk of withdrawal symptoms is

increased if the antidepressant is stopped suddenly after

regular administration for 8 weeks or more. The dose

should preferably be reduced gradually over about 4 weeks,

or longer if withdrawal symptoms emerge (6 months in

patients who have been on long-term maintenance

treatment). If possible tricyclic and related antidepressants

should be withdrawn slowly.

l PRESCRIBING AND DISPENSING INFORMATION Limited

quantities of tricyclic antidepressants should be prescribed

at any one time because their cardiovascular and

epileptogenic effects are dangerous in overdosage.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect the

performance of skilled tasks (e.g. driving).

Effects of alcohol enhanced.

l LESS SUITABLE FOR PRESCRIBING Amitriptyline

hydrochloride is less suitable for prescribing, see Tricyclic

and related antidepressant drugs in Antidepressant drugs

p. 359.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral suspension, oral

solution

Oral solution

CAUTIONARY AND ADVISORY LABELS 2

▶ Amitriptyline hydrochloride (Non-proprietary)

Amitriptyline hydrochloride 2 mg per 1 ml Amitriptyline 10mg/5ml

oral solution sugar free sugar-free | 150 ml P £131.90 DT =

£131.90

Amitriptyline hydrochloride 5 mg per 1 ml Amitriptyline 25mg/5ml

oral solution sugar free sugar-free | 150 ml P £18.00 DT = £18.00

Amitriptyline hydrochloride 10 mg per 1 ml Amitriptyline

50mg/5ml oral solution sugar free sugar-free | 150 ml P £24.00

DT = £19.20

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Amitriptyline hydrochloride (Non-proprietary)

Amitriptyline hydrochloride 10 mg Amitriptyline 10mg tablets | 28 tablet P £1.50 DT = £0.87

Amitriptyline hydrochloride 25 mg Amitriptyline 25mg tablets |

28 tablet P £1.75 DT = £0.72

Amitriptyline hydrochloride 50 mg Amitriptyline 50mg tablets | 28 tablet P £5.99 DT = £2.04

Clomipramine hydrochloride 02-Jul-2018

l INDICATIONS AND DOSE

Depressive illness

▶ BY MOUTH

▶ Adult: Initially 10 mg daily, then increased if necessary

to 30–150 mg daily in divided doses, dose to be

increased gradually, alternatively increased if

necessary to 30–150 mg once daily, dose to be taken at

bedtime; maximum 250 mg per day

▶ Elderly: Initially 10 mg daily, then increased to

30–75 mg daily, dose to be increased carefully over

approximately 10 days

Phobic and obsessional states

▶ BY MOUTH

▶ Adult: Initially 25 mg daily, then increased to

100–150 mg daily, dose to be increased gradually over

2 weeks; maximum 250 mg per day continued→

BNF 78 Depression 373

Nervous system

4

▶ Elderly: Initially 10 mg daily, then increased to

100–150 mg daily, dose to be increased gradually over

2 weeks; maximum 250 mg per day

Adjunctive treatment of cataplexy associated with

narcolepsy

▶ BY MOUTH

▶ Adult: Initially 10 mg daily, dose to be gradually

increased until satisfactory response; increased if

necessary to 10–75 mg daily

l CONTRA-INDICATIONS Acute porphyrias p. 1058 . arrhythmias . during the manic phase of bipolar disorder. heart block . immediate recovery period after myocardial

infarction

l CAUTIONS Cardiovascular disease . chronic constipation . diabetes . epilepsy . history of bipolar disorder. history of

psychosis . hyperthyroidism (risk of arrhythmias). increased intra-ocular pressure . patients with a significant

risk of suicide . phaeochromocytoma (risk of arrhythmias). prostatic hypertrophy . susceptibility to angle-closure

glaucoma . urinary retention

CAUTIONS, FURTHER INFORMATION Treatment should be

stopped if the patient enters a manic phase.

Elderly patients are particularly susceptible to many of

the side-effects of tricyclic antidepressants; low initial

doses should be used, with close monitoring, particularly

for psychiatric and cardiac side-effects.

l INTERACTIONS → Appendix 1: tricyclic antidepressants

l SIDE-EFFECTS

▶ Common or very common Aggression . anxiety . arrhythmias . breast enlargement. concentration impaired . confusion . constipation . delirium . depersonalisation. depression exacerbated . diarrhoea . dizziness . drowsiness . dry mouth .fatigue . galactorrhoea . gastrointestinal

disorder. hallucination . headache . hot flush . hyperhidrosis . hypotension . memory loss . mood altered . movement disorders . muscle tone increased . muscle

weakness . mydriasis . nausea . palpitations . paraesthesia . photosensitivity reaction . sexual dysfunction . skin

reactions . sleep disorders . speech disorder.taste altered . tinnitus .tremor. urinary disorders . vision disorders . vomiting . weight increased . yawning

▶ Uncommon Psychosis . seizure

▶ Rare or very rare Agranulocytosis . alopecia . cardiac

conduction disorders . eosinophilia . glaucoma . hepatic

disorders . hyperpyrexia . leucopenia . neuroleptic

malignant syndrome . oedema . QT interval prolongation . respiratory disorders .thrombocytopenia . vaginal

haemorrhage

▶ Frequency not known Rhabdomyolysis . serotonin

syndrome . suicidal tendencies . withdrawal syndrome

SIDE-EFFECTS, FURTHER INFORMATION The patient should

be encouraged to persist with treatment as some tolerance

to these side-effects seems to develop.

The risk of side-effects is reduced by titrating slowly to

the minimum effective dose (every 2–3 days). Consider

using a lower starting dose in elderly patients.

Overdose Tricyclic and related antidepressants cause dry

mouth, coma of varying degree, hypotension,

hypothermia, hyperreflexia, extensor plantar responses,

convulsions, respiratory failure, cardiac conduction

defects, and arrhythmias. Dilated pupils and urinary

retention also occur. For details on the management of

poisoning see Tricyclic and related antidepressants under

Emergency treatment of poisoning p. 1359.

l PREGNANCY Neonatal withdrawal symptoms reported if

used during third trimester.

l BREAST FEEDING The amount secreted into breast milk is

too small to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution; avoid

in severe impairment (risk of hypertensive crisis).

l MONITORING REQUIREMENTS Manufacturer advises

monitor cardiac and hepatic function during long-term

use.

l TREATMENT CESSATION Withdrawal effects may occur

within 5 days of stopping treatment with antidepressant

drugs; they are usually mild and self-limiting, but in some

cases may be severe. The risk of withdrawal symptoms is

increased if the antidepressant is stopped suddenly after

regular administration for 8 weeks or more. The dose

should preferably be reduced gradually over about 4 weeks,

or longer if withdrawal symptoms emerge (6 months in

patients who have been on long-term maintenance

treatment). If possible tricyclic and related antidepressants

should be withdrawn slowly.

l PRESCRIBING AND DISPENSING INFORMATION Limited

quantities of tricyclic antidepressants should be prescribed

at any one time because their cardiovascular and

epileptogenic effects are dangerous in overdosage.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect the

performance of skilled tasks (e.g. driving).

Effects of alcohol enhanced.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: modified-release

tablet, oral suspension, oral solution

Capsule

CAUTIONARY AND ADVISORY LABELS 2

▶ Clomipramine hydrochloride (Non-proprietary)

Clomipramine hydrochloride 10 mg Clomipramine 10mg capsules

| 28 capsule P £6.72 DT = £1.47

Clomipramine hydrochloride 25 mg Clomipramine 25mg capsules

| 28 capsule P £9.36 DT = £1.62

Clomipramine hydrochloride 50 mg Clomipramine 50mg capsules

| 28 capsule P £11.76 DT = £3.66

Dosulepin hydrochloride

(Dothiepin hydrochloride)

l INDICATIONS AND DOSE

Depressive illness, particularly where sedation is required

(not recommended—increased risk of fatality in

overdose) (initiated by a specialist)

▶ BY MOUTH

▶ Adult: Initially 75 mg daily in divided doses,

alternatively initially 75 mg once daily, dose to be

taken at bedtime, increased if necessary to 150 mg

daily, doses to be increased gradually; up to 225 mg

daily in some circumstances (e.g. hospital use)

▶ Elderly: Initially 50–75 mg daily in divided doses,

alternatively initially 50–75 mg once daily, dose to be

taken at bedtime, increased if necessary to 75–150 mg

daily, doses to be increased gradually; up to 225 mg

daily in some circumstances (e.g. hospital use)

l CONTRA-INDICATIONS Acute porphyrias p. 1058 . arrhythmias . during the manic phase of bipolar disorder. heart block . immediate recovery period after myocardial

infarction

l CAUTIONS Cardiovascular disease . chronic constipation . diabetes . epilepsy . history of bipolar disorder. history of

psychosis . hyperthyroidism (risk of arrhythmias). increased intra-ocular pressure . patients with a significant

risk of suicide . phaeochromocytoma (risk of arrhythmias). prostatic hypertrophy . susceptibility to angle-closure

glaucoma . urinary retention

CAUTIONS, FURTHER INFORMATION Treatment should be

stopped if the patient enters a manic phase.

374 Mental health disorders BNF 78

Nervous system

4

Elderly patients are particularly susceptible to many of

the side-effects of tricyclic antidepressants; low initial

doses should be used, with close monitoring, particularly

for psychiatric and cardiac side-effects.

l INTERACTIONS → Appendix 1: tricyclic antidepressants

l SIDE-EFFECTS Accommodation disorder. agranulocytosis . alveolitis . anticholinergic syndrome . appetite abnormal . arrhythmias . asthenia . bone marrow depression . cardiac

conduction disorder. confusion . constipation . dizziness . drowsiness . dry mouth . endocrine disorder. eosinophilia . epigastric discomfort. galactorrhoea . gynaecomastia . hepatic disorders . hyperhidrosis . hypertension . hyponatraemia . hypotension . increased risk of fracture . leucopenia . mood altered . movement disorders . nausea . nervousness . paranoid delusions . photosensitivity

reaction . psychosis . seizures . sexual dysfunction . SIADH . skin reactions . speech disorder. suicidal tendencies . testicular hypertrophy .thrombocytopenia .tremor. urinary hesitation . vomiting . weight changes . withdrawal

syndrome

SIDE-EFFECTS, FURTHER INFORMATION The risk of sideeffects are reduced by titrating slowly to the minimum

effective dose (every 2–3 days). Consider using a lower

starting dose in elderly patients.

Overdose Overdosage with dosulepin is associated with a

relatively high rate of fatality.

Tricyclic and related antidepressants cause dry mouth,

coma of varying degree, hypotension, hypothermia,

hyperreflexia, extensor plantar responses, convulsions,

respiratory failure, cardiac conduction defects, and

arrhythmias. Dilated pupils and urinary retention also

occur. For details on the management of poisoning see

Tricyclic and related antidepressants under Emergency

treatment of poisoning.

l PREGNANCY Use only if potential benefit outweighs risk.

l BREAST FEEDING The amount secreted into breast milk is

too small to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

mild to moderate impairment; avoid in severe impairment.

l TREATMENT CESSATION Withdrawal effects may occur

within 5 days of stopping treatment with antidepressant

drugs; they are usually mild and self-limiting, but in some

cases may be severe. The risk of withdrawal symptoms is

increased if the antidepressant is stopped suddenly after

regular administration for 8 weeks or more. The dose

should preferably be reduced gradually over about 4 weeks,

or longer if withdrawal symptoms emerge. (6 months in

patients who have been on long-term maintenance

treatment). If possible tricyclic and related antidepressants

should be withdrawn slowly.

l PRESCRIBING AND DISPENSING INFORMATION Limited

quantities of tricyclic antidepressants should be prescribed

at any one time because their cardiovascular and

epileptogenic effects are dangerous in overdosage.

A maximum prescription equivalent to 2 weeks’ supply

of 75 mg daily should be considered in patients with

increased risk factors for suicide at initiation of treatment,

during any dose adjustment, and until improvement

occurs.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect the

performance of skilled tasks (e.g. driving).

Effects of alcohol enhanced.

l LESS SUITABLE FOR PRESCRIBING Dosulepin

hydrochloride is less suitable for prescribing, see Tricyclic

and related antidepressant drugs in Antidepressant drugs

p. 359.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral suspension, oral

solution

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Dosulepin hydrochloride (Non-proprietary)

Dosulepin hydrochloride 75 mg Dosulepin 75mg tablets | 28 tablet P £18.38 DT = £4.88

▶ Prothiaden (Teofarma)

Dosulepin hydrochloride 75 mg Prothiaden 75mg tablets | 28 tablet P £2.97 DT = £4.88

Capsule

CAUTIONARY AND ADVISORY LABELS 2

▶ Dosulepin hydrochloride (Non-proprietary)

Dosulepin hydrochloride 25 mg Dosulepin 25mg capsules | 28 capsule P £3.50 DT = £1.61

▶ Prothiaden (Teofarma)

Dosulepin hydrochloride 25 mg Prothiaden 25mg capsules | 28 capsule P £1.70 DT = £1.61

Doxepin

l INDICATIONS AND DOSE

Depressive illness (particularly where sedation is

required)

▶ BY MOUTH

▶ Adult: Initially 75 mg daily in divided doses,

alternatively 75 mg once daily, adjusted according to

response, dose to taken at bedtime; maintenance

25–300 mg daily, doses above 100 mg given in

3 divided doses

▶ Elderly: Start with lower doses and adjust according to

response

l CONTRA-INDICATIONS Acute porphyrias p. 1058 . arrhythmias . during manic phase of bipolar disorder. heart block . immediate recovery period after myocardial

infarction

l CAUTIONS Cardiovascular disease . chronic constipation . diabetes . epilepsy . history of bipolar disorder. history of

psychosis . hyperthyroidism (risk of arrhythmias). increased intra-ocular pressure . patients with significant

risk of suicide . phaeochromocytoma (risk of arrhythmias). prostatic hypertrophy . susceptibility to angle-closure

glaucoma . urinary retention

CAUTIONS, FURTHER INFORMATION Treatment should be

stopped if the patient enters a manic phase.

▶ Elderly Elderly patients are particularly susceptible to

many of the side-effects of tricyclic antidepressants; low

initial doses should be used, with close monitoring,

particularly for psychiatric and cardiac side-effects.

l INTERACTIONS → Appendix 1: tricyclic antidepressants

l SIDE-EFFECTS Agitation . agranulocytosis . alopecia . anticholinergic syndrome . appetite decreased . asthenia . asthma exacerbated . bone marrow depression . breast

enlargement. cardiovascular effects . chills . confusion . constipation . diarrhoea . dizziness . drowsiness . dry

mouth . dyspepsia . eosinophilia . face oedema . flushing . galactorrhoea . gynaecomastia . haemolytic anaemia . hallucination . headache . hyperhidrosis . hyperpyrexia . increased risk of fracture . jaundice . leucopenia . mania . movement disorders . nausea . oral ulceration . paranoid

delusions . photosensitivity reaction . postural

hypotension . psychosis . seizure . sensation abnormal . sexual dysfunction . SIADH . skin reactions . sleep

disorders . suicidal tendencies .tachycardia .taste altered . testicular swelling .thrombocytopenia .tinnitus .tremor. urinary retention . vision blurred . vomiting . weight

increased

SIDE-EFFECTS, FURTHER INFORMATION The risk of sideeffects is reduced by titrating slowly to the minimum

BNF 78 Depression 375

Nervous system

4

effective dose (every 2–3 days). Consider using a lower

starting dose in elderly patients.

Overdose Tricyclic and related antidepressants cause dry

mouth, coma of varying degree, hypotension,

hypothermia, hyperreflexia, extensor plantar responses,

convulsions, respiratory failure, cardiac conduction

defects, and arrhythmias. Dilated pupils and urinary

retention also occur. For details on the management of

poisoning see Tricyclic and related antidepressants under

Emergency treatment of poisoning p. 1359.

l PREGNANCY Use with caution—limited information

available.

l BREAST FEEDING The amount secreted into breast milk is

too small to be harmful. Accumulation of metabolite may

cause sedation and respiratory depression in neonate.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

mild to moderate impairment; avoid in severe impairment.

Dose adjustments Manufacturer advises consider dose

reduction in mild to moderate impairment.

l RENAL IMPAIRMENT Use with caution.

l TREATMENT CESSATION Withdrawal effects may occur

within 5 days of stopping treatment with antidepressant

drugs; they are usually mild and self-limiting, but in some

cases may be severe. The risk of withdrawal symptoms is

increased if the antidepressant is stopped suddenly after

regular administration for 8 weeks or more. The dose

should preferably be reduced gradually over about 4 weeks,

or longer if withdrawal symptoms emerge (6 months in

patients who have been on long-term maintenance

treatment). If possible tricyclic and related antidepressants

should be withdrawn slowly.

l PRESCRIBING AND DISPENSING INFORMATION Limited

quantities of tricyclic antidepressants should be prescribed

at any one time because their cardiovascular and

epileptogenic effects are dangerous in overdosage.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. driving). Effects of

alcohol enhanced.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: capsule, oral

suspension, oral solution

Capsule

CAUTIONARY AND ADVISORY LABELS 2

▶ Doxepin (Non-proprietary)

Doxepin (as Doxepin hydrochloride) 25 mg Doxepin 25mg capsules

| 28 capsule P £97.00 DT = £97.00

Doxepin (as Doxepin hydrochloride) 50 mg Doxepin 50mg capsules

| 28 capsule P £154.00 DT = £154.00

Imipramine hydrochloride 30-Mar-2017

l INDICATIONS AND DOSE

Depressive illness

▶ BY MOUTH

▶ Adult: Initially up to 75 mg daily in divided doses, then

increased to 150–200 mg daily, up to 150 mg may be

given as a single dose at bedtime, dose to be increased

gradually

▶ Elderly: Initially 10 mg daily, increased to 30–50 mg

daily, dose to be increased gradually

Depressive illness in hospital patients

▶ BY MOUTH

▶ Adult: Initially up to 75 mg daily in divided doses, dose

to be increased gradually, increased to up to 300 mg

daily in divided doses

Nocturnal enuresis

▶ BY MOUTH

▶ Child 6–7 years: 25 mg once daily, to be taken at

bedtime, initial period of treatment (including gradual

withdrawal) 3 months—full physical examination

before further course

▶ Child 8–10 years: 25–50 mg once daily, to be taken at

bedtime, initial period of treatment (including gradual

withdrawal) 3 months—full physical examination

before further course

▶ Child 11–17 years: 50–75 mg once daily, to be taken at

bedtime, initial period of treatment (including gradual

withdrawal) 3 months—full physical examination

before further course

l CONTRA-INDICATIONS Immediate recovery period after

myocardial infarction (in adults). Acute porphyrias

p. 1058 . arrhythmia . during the manic phase of bipolar

disorder. heart block

l CAUTIONS Cardiovascular disease . chronic constipation . diabetes . epilepsy . history of bipolar disorder. history of

psychosis . hyperthyroidism (risk of arrhythmias). increased intra-ocular pressure (in adults) . patients with a

significant risk of suicide . phaeochromocytoma (risk of

arrhythmias). prostatic hypertrophy (in adults). susceptibility to angle-closure glaucoma . urinary

retention

CAUTIONS, FURTHER INFORMATION Treatment should be

stopped if the patient enters a manic phase.

Elderly patients are particularly susceptible to many of

the side-effects of tricyclic antidepressants; low initial

doses should be used, with close monitoring, particularly

for psychiatric and cardiac side-effects.

l INTERACTIONS → Appendix 1: tricyclic antidepressants

l SIDE-EFFECTS

▶ Common or very common Anxiety . appetite decreased . arrhythmias . asthenia . cardiac conduction disorders . confusion . delirium . depression . dizziness . drowsiness . epilepsy . hallucination . headache . hepatic disorders . hypotension . mood altered . nausea . palpitations . paraesthesia . sexual dysfunction . skin reactions . sleep

disorder.tremor. vomiting . weight changes

▶ Uncommon Psychosis

▶ Rare or very rare Aggression . agranulocytosis . alopecia . bone marrow depression . enlarged mammary gland . eosinophilia .fever. galactorrhoea . gastrointestinal

disorders . glaucoma . heart failure . leucopenia . movement disorders . mydriasis . oedema . oral disorders . peripheral vasospastic reaction . photosensitivity reaction . respiratory disorders . SIADH . speech disorder. thrombocytopenia

▶ Frequency not known Anticholinergic syndrome . cardiovascular effects . drug fever. hyponatraemia . increased risk of fracture . neurological effects . paranoid

delusions exacerbated . psychiatric disorder. suicidal

tendencies .tinnitus . urinary disorder. withdrawal

syndrome

SIDE-EFFECTS, FURTHER INFORMATION The risk of sideeffects is reduced by titrating slowly to the minimum

effective dose (every 2–3 days). Consider using a lower

starting dose in elderly patients.

Overdose Tricyclic and related antidepressants cause dry

mouth, coma of varying degree, hypotension,

hypothermia, hyperreflexia, extensor plantar responses,

convulsions, respiratory failure, cardiac conduction

defects, and arrhythmias. Dilated pupils and urinary

retention also occur. For details on the management of

poisoning see Tricyclic and related antidepressants under

Emergency treatment of poisoning p. 1359.

l PREGNANCY Colic, tachycardia, dyspnoea, irritability,

muscle spasms, respiratory depression and withdrawal

376 Mental health disorders BNF 78

Nervous system

4

symptoms reported in neonates when used in the third

trimester.

l BREAST FEEDING The amount secreted into breast milk is

too small to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

mild to moderate impairment; avoid in severe impairment.

l RENAL IMPAIRMENT Use with caution in severe

impairment.

l TREATMENT CESSATION Withdrawal effects may occur

within 5 days of stopping treatment with antidepressant

drugs; they are usually mild and self-limiting, but in some

cases may be severe. The risk of withdrawal symptoms is

increased if the antidepressant is stopped suddenly after

regular administration for 8 weeks or more. The dose

should preferably be reduced gradually over about 4 weeks,

or longer if withdrawal symptoms emerge (6 months in

patients who have been on long-term maintenance

treatment). If possible tricyclic antidepressants should be

withdrawn slowly.

2/23/23


Venlafaxine (as Venlafaxine hydrochloride) 75 mg Majoven XL

75mg capsules | 28 capsule P £22.08 DT = £2.60

Venlafaxine (as Venlafaxine hydrochloride) 150 mg Majoven XL

150mg capsules | 28 capsule P £36.81 DT = £3.90

▶ Politid XL (Actavis UK Ltd)

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Politid XL 75mg

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Venlafaxine (as Venlafaxine hydrochloride) 150 mg Politid XL

150mg capsules | 28 capsule P £39.03 DT = £3.90

▶ Tonpular XL (Wockhardt UK Ltd)

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Tonpular XL

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Venlafaxine (as Venlafaxine hydrochloride) 150 mg Tonpular XL

150mg capsules | 28 capsule P £12.00 DT = £3.90

▶ Venaxx XL (Advanz Pharma)

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Venaxx XL

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Venlafaxine (as Venlafaxine hydrochloride) 150 mg Venaxx XL

150mg capsules | 28 capsule P £17.40 DT = £3.90

▶ Vencarm XL (Aspire Pharma Ltd)

Venlafaxine (as Venlafaxine hydrochloride) 37.5 mg Vencarm XL

37.5mg capsules | 28 capsule P £3.30 DT = £5.25

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Vencarm XL

75mg capsules | 28 capsule P £2.59 DT = £2.60

Venlafaxine (as Venlafaxine hydrochloride) 150 mg Vencarm XL

150mg capsules | 28 capsule P £3.89 DT = £3.90

Venlafaxine (as Venlafaxine hydrochloride) 225 mg Vencarm XL

225mg capsules | 28 capsule P £9.90 DT = £47.11

▶ Venlablue XL (Creo Pharma Ltd)

Venlafaxine (as Venlafaxine hydrochloride) 37.5 mg Venlablue XL

37.5mg capsules | 28 capsule P £5.25 DT = £5.25

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Venlablue XL

75mg capsules | 28 capsule P £6.95 DT = £2.60

Venlafaxine (as Venlafaxine hydrochloride) 150 mg Venlablue XL

150mg capsules | 28 capsule P £9.95 DT = £3.90

▶ Venlasov XL (Sovereign Medical Ltd)

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Venlasov XL

75mg capsules | 28 capsule P £2.45 DT = £2.60

Venlafaxine (as Venlafaxine hydrochloride) 150 mg Venlasov XL

150mg capsules | 28 capsule P £3.75 DT = £3.90

▶ Vensir XL (Morningside Healthcare Ltd)

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Vensir XL 75mg

capsules | 28 capsule P £2.60 DT = £2.60

Venlafaxine (as Venlafaxine hydrochloride) 150 mg Vensir XL

150mg capsules | 28 capsule P £3.90 DT = £3.90

Venlafaxine (as Venlafaxine hydrochloride) 225 mg Vensir XL

225mg capsules | 28 capsule P £21.90 DT = £47.11

▶ Venzip XL (Milpharm Ltd)

Venlafaxine (as Venlafaxine hydrochloride) 75 mg Venzip XL

75mg capsules | 28 capsule P £22.08 DT = £2.60

Venlafaxine (as Venlafaxine hydrochloride) 150 mg Venzip XL

150mg capsules | 28 capsule P £36.81 DT = £3.90

ANTIDEPRESSANTS › SEROTONIN UPTAKE

INHIBITORS

Trazodone hydrochloride

l INDICATIONS AND DOSE

Depressive illness (particularly where sedation is

required)

▶ BY MOUTH

▶ Adult: Initially 150 mg daily in divided doses, dose to

be taken after food, alternatively initially 150 mg once

daily, dose to be taken at bedtime, increased if

necessary to 300 mg daily; increased if necessary to

600 mg daily in divided doses, higher dose for use in

hospital patients only

▶ Elderly: Initially 100 mg daily in divided doses, dose to

be taken after food, alternatively initially 100 mg once

daily, dose to be taken at bedtime, increased if

necessary to 300 mg daily; increased if necessary to

600 mg daily in divided doses, higher dose for use in

hospital patients only

Anxiety

▶ BY MOUTH

▶ Adult: 75 mg daily, increased if necessary to 300 mg

daily

l CONTRA-INDICATIONS Arrhythmias . during the manic

phase of bipolar disorder. heart block . immediate recovery

period after myocardial infarction

l CAUTIONS Cardiovascular disease . chronic constipation . diabetes . epilepsy . history of bipolar disorder. history of

psychosis . hyperthyroidism (risk of arrhythmias). increased intra-ocular pressure . patients with a significant

risk of suicide . phaeochromocytoma (risk of arrhythmias). prostatic hypertrophy . susceptibility to angle-closure

glaucoma . urinary retention

CAUTIONS, FURTHER INFORMATION Treatment should be

stopped if the patient enters a manic phase.

Elderly patients are particularly susceptible to many of

the side-effects of tricyclic antidepressants; low initial

doses should be used, with close monitoring, particularly

for psychiatric and cardiac side-effects.

l INTERACTIONS → Appendix 1: trazodone

l SIDE-EFFECTS Aggression . agranulocytosis . alertness

decreased . anaemia . anxiety . aphasia . appetite abnormal . arrhythmias . arthralgia . asthenia . blood disorder. chest

pain . confusion . constipation . delirium . delusions . diarrhoea . dizziness . drowsiness . dry mouth . dyspnoea . eosinophilia .fever. gastroenteritis . gastrointestinal

discomfort. hallucination . headache . hepatic disorders . hyperhidrosis . hypersalivation. hypertension . hyponatraemia . influenza like illness . jaundice

(discontinue). leucopenia . libido decreased . mania . memory loss . movement disorders . myalgia . nasal

congestion . nausea . neuroleptic malignant syndrome . oedema . pain . palpitations . paraesthesia . paralytic ileus . postural hypotension . priapism (discontinue). QT interval

prolongation . seizure . serotonin syndrome . SIADH . skin

reactions . sleep disorders . suicidal tendencies . syncope . taste altered .thrombocytopenia .tremor. urinary disorder . vertigo . vision blurred . vomiting . weight decreased . withdrawal syndrome

SIDE-EFFECTS, FURTHER INFORMATION The risk of sideeffects is reduced by titrating slowly to the minimum

effective dose (every 2–3 days). Consider using a lower

starting dose in elderly patients.

Overdose The tricyclic-related antidepressant drugs may

be associated with a lower risk of cardiotoxicity in

overdosage.

Tricyclic and related antidepressants cause dry mouth,

coma of varying degree, hypotension, hypothermia,

hyperreflexia, extensor plantar responses, convulsions,

respiratory failure, cardiac conduction defects, and

arrhythmias. Dilated pupils and urinary retention also

occur. For details on the management of poisoning see

Tricyclic and related antidepressants under Emergency

treatment of poisoning p. 1359.

l PREGNANCY Avoid during first trimester—limited

information available. Monitor infant for signs of

withdrawal if used until delivery.

l BREAST FEEDING The amount secreted into breast milk is

too small to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution,

particularly in severe impairment (increased risk of sideeffects).

l RENAL IMPAIRMENT Use with caution in severe

impairment.

l TREATMENT CESSATION Withdrawal effects may occur

within 5 days of stopping treatment with antidepressant

drugs; they are usually mild and self-limiting, but in some

cases may be severe. The risk of withdrawal symptoms is

370 Mental health disorders BNF 78

Nervous system

4

increased if the antidepressant is stopped suddenly after

regular administration for 8 weeks or more. The dose

should preferably be reduced gradually over about 4 weeks,

or longer if withdrawal symptoms emerge (6 months in

patients who have been on long-term maintenance

treatment). If possible tricyclic and related antidepressants

should be withdrawn slowly.

l PRESCRIBING AND DISPENSING INFORMATION Limited

quantities of tricyclic antidepressants should be prescribed

at any one time because their cardiovascular and

epileptogenic effects are dangerous in overdosage.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect the

performance of skilled tasks (e.g. driving).

Effects of alcohol enhanced.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral suspension, oral

solution

Oral solution

CAUTIONARY AND ADVISORY LABELS 2, 21

▶ Trazodone hydrochloride (Non-proprietary)

Trazodone hydrochloride 10 mg per 1 ml Trazodone 50mg/5ml

oral solution sugar free sugar-free | 120 ml P £37.09–£180.00 DT

= £37.09

Trazodone hydrochloride 20 mg per 1 ml Trazodone 100mg/5ml

oral solution sugar free sugar-free | 120 ml P £155.00–£195.60

DT = £175.30

Tablet

CAUTIONARY AND ADVISORY LABELS 2, 21

▶ Trazodone hydrochloride (Non-proprietary)

Trazodone hydrochloride 150 mg Trazodone 150mg tablets | 28 tablet P £34.00 DT = £4.69

▶ Molipaxin (Zentiva)

Trazodone hydrochloride 150 mg Molipaxin 150mg tablets | 28 tablet P £16.08 DT = £4.69

Capsule

CAUTIONARY AND ADVISORY LABELS 2, 21

▶ Trazodone hydrochloride (Non-proprietary)

Trazodone hydrochloride 50 mg Trazodone 50mg capsules | 84 capsule P £35.00 DT = £5.22

Trazodone hydrochloride 100 mg Trazodone 100mg capsules | 56 capsule P £41.00 DT = £5.69

▶ Molipaxin (Zentiva)

Trazodone hydrochloride 50 mg Molipaxin 50mg capsules | 84 capsule P £23.92 DT = £5.22

Trazodone hydrochloride 100 mg Molipaxin 100mg capsules |

56 capsule P £28.14 DT = £5.69

ANTIDEPRESSANTS › TETRACYCLIC

ANTIDEPRESSANTS

Mianserin hydrochloride

l INDICATIONS AND DOSE

Depressive illness (particularly where sedation is

required)

▶ BY MOUTH

▶ Adult: Initially 30–40 mg daily in divided doses,

alternatively initially 30–40 mg once daily, dose to be

taken at bedtime, increase dose gradually as necessary;

usual dose 30–90 mg

▶ Elderly: Initially 30 mg daily in divided doses,

alternatively initially 30 mg once daily, dose to be

taken at bedtime, increase dose gradually as necessary;

usual dose 30–90 mg

l CONTRA-INDICATIONS Acute porphyrias p. 1058 . arrhythmias . during the manic phase of bipolar disorder. heart block . immediate recovery period after myocardial

infarction

l CAUTIONS Cardiovascular disease . chronic constipation . diabetes . epilepsy . history of bipolar disorder. history of

psychosis . hyperthyroidism (risk of arrhythmias). increased intra-ocular pressure . patients with a significant

risk of suicide . phaeochromocytoma (risk of arrhythmias). prostatic hypertrophy . susceptibility to angle-closure

glaucoma . urinary retention

CAUTIONS, FURTHER INFORMATION Treatment should be

stopped if the patient enters a manic phase.

Elderly patients are particularly susceptible to many of

the side-effects of tricyclic antidepressants; low initial

doses should be used, with close monitoring, particularly

for psychiatric and cardiac side-effects.

l INTERACTIONS → Appendix 1: mianserin

l SIDE-EFFECTS Agranulocytosis . arthritis . bone marrow

disorders . breast abnormalities . dizziness . granulocytopenia . gynaecomastia . hepatic disorders . hyperhidrosis . hyponatraemia . joint disorders . lactation

in absence of pregnancy . leucopenia . mood altered . neuromuscular irritability . oedema . paranoid delusions . postural hypotension . psychosis .rash . seizure . sexual

dysfunction . suicidal tendencies .tremor. withdrawal

syndrome

SIDE-EFFECTS, FURTHER INFORMATION The risk of sideeffects is reduced by titrating slowly to the minimum

effective dose (every 2–3 days). Consider using a lower

starting dose in elderly patients.

Overdose The tricyclic-related antidepressant drugs may

be associated with a lower risk of cardiotoxicity in

overdosage.

Tricyclic and related antidepressants cause dry mouth,

coma of varying degree, hypotension, hypothermia,

hyperreflexia, extensor plantar responses, convulsions,

respiratory failure, cardiac conduction defects, and

arrhythmias. Dilated pupils and urinary retention also

occur. For details on the management of poisoning see

Tricyclic and related antidepressants under Emergency

treatment of poisoning p. 1359.

l PREGNANCY Avoid.

l BREAST FEEDING The amount secreted into breast milk is

too small to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution; avoid

in severe impairment.

l RENAL IMPAIRMENT

Dose adjustments Caution in renal impairment.

l MONITORING REQUIREMENTS A full blood count is

recommended every 4 weeks during the first 3 months of

treatment; clinical monitoring should continue

subsequently and treatment should be stopped and a full

blood count obtained if fever, sore throat, stomatitis, or

other signs of infection develop.

l TREATMENT CESSATION Withdrawal effects may occur

within 5 days of stopping treatment with antidepressant

drugs; they are usually mild and self-limiting, but in some

cases may be severe. The risk of withdrawal symptoms is

increased if the antidepressant is stopped suddenly after

regular administration for 8 weeks or more. The dose

should preferably be reduced gradually over about 4 weeks,

or longer if withdrawal symptoms emerge (6 months in

patients who have been on long-term maintenance

treatment). If possible tricyclic and related antidepressants

should be withdrawn slowly.

l PRESCRIBING AND DISPENSING INFORMATION Limited

quantities of tricyclic antidepressants should be prescribed

at any one time because their cardiovascular and

epileptogenic effects are dangerous in overdosage.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect the

performance of skilled tasks (e.g. driving).

Effects of alcohol enhanced.

BNF 78 Depression 371

Nervous system

4

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral suspension, oral

solution

Tablet

CAUTIONARY AND ADVISORY LABELS 2, 25

▶ Mianserin hydrochloride (Non-proprietary)

Mianserin hydrochloride 10 mg Mianserin 10mg tablets | 28 tablet P £14.75 DT = £13.58

Mianserin hydrochloride 30 mg Mianserin 30mg tablets | 28 tablet P £33.45 DT = £30.82

Mirtazapine

l DRUG ACTION Mirtazapine is a presynaptic alpha2-

adrenoreceptor antagonist which increases central

noradrenergic and serotonergic neurotransmission.

l INDICATIONS AND DOSE

Major depression

▶ BY MOUTH

▶ Adult: Initially 15–30 mg daily for 2–4 weeks, dose to

be taken at bedtime, then adjusted according to

response to up to 45 mg once daily, alternatively up to

45 mg daily in 2 divided doses

l CAUTIONS Cardiac disorders . diabetes mellitus . elderly . history of bipolar depression . history of seizures . history

of urinary retention . hypotension . psychoses (may

aggravate psychotic symptoms). susceptibility to angleclosure glaucoma

l INTERACTIONS → Appendix 1: mirtazapine

l SIDE-EFFECTS

▶ Common or very common Anxiety . appetite increased . arthralgia . back pain . confusion . constipation . diarrhoea . dizziness . drowsiness . dry mouth . fatigue . headache (on

discontinuation). myalgia . nausea . oedema . postural

hypotension . sleep disorders .tremor. vomiting . weight

increased

▶ Uncommon Hallucination . mania . movement disorders . oral disorders . syncope

▶ Rare or very rare Aggression . pancreatitis

▶ Frequency not known Agranulocytosis . arrhythmias . bone

marrow disorders . dysarthria . eosinophilia . granulocytopenia . hyponatraemia . jaundice (discontinue) . QT interval prolongation .rhabdomyolysis . seizure . serotonin syndrome . severe cutaneous adverse reactions

(SCARs). SIADH . skin reactions . sudden death . suicidal

tendencies .thrombocytopenia . urinary retention . withdrawal syndrome

l PREGNANCY Use with caution—limited experience;

monitor neonate for withdrawal effects.

l BREAST FEEDING Present in milk; use only if potential

benefit outweighs risk.

l HEPATIC IMPAIRMENT Manufacturer advises caution (risk

of increased plasma concentration, no information

available in severe impairment).

l RENAL IMPAIRMENT Clearance reduced by 30% if eGFR

less than 40 mL/minute/1.73 m2

; clearance reduced by 50%

if eGFR less than 10 mL/minute/1.73 m2

.

l TREATMENT CESSATION Nausea, vomiting, dizziness,

agitation, anxiety, and headache are most common

features of withdrawal if treatment stopped abruptly or if

dose reduced markedly; dose should be reduced over

several weeks.

l DIRECTIONS FOR ADMINISTRATION Orodispersible tablet

(Zispin SolTab ®) should be placed on the tongue, allowed

to disperse and swallowed.

l PATIENT AND CARER ADVICE Counselling on

administration of orodispersible tablet advised.

Blood Disorders Patients should be advised to report any

fever, sore throat, stomatitis or other signs of infection

during treatment. Blood count should be performed and

the drug stopped immediately if blood dyscrasia suspected.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: capsule, oral

suspension, oral solution

Tablet

CAUTIONARY AND ADVISORY LABELS 2, 25

▶ Mirtazapine (Non-proprietary)

Mirtazapine 15 mg Mirtazapine 15mg tablets | 28 tablet P £4.60 DT = £1.23

Mirtazapine 30 mg Mirtazapine 30mg tablets | 28 tablet P £4.50 DT = £1.07

Mirtazapine 45 mg Mirtazapine 45mg tablets | 28 tablet P £4.95 DT = £1.36

Oral solution

CAUTIONARY AND ADVISORY LABELS 2

▶ Mirtazapine (Non-proprietary)

Mirtazapine 15 mg per 1 ml Mirtazapine 15mg/ml oral solution

sugar free sugar-free | 66 ml P £49.51 DT = £49.51

Orodispersible tablet

CAUTIONARY AND ADVISORY LABELS 2

EXCIPIENTS: May contain Aspartame

▶ Mirtazapine (Non-proprietary)

Mirtazapine 15 mg Mirtazapine 15mg orodispersible tablets | 30 tablet P £19.19 DT = £1.83

Mirtazapine 30 mg Mirtazapine 30mg orodispersible tablets | 30 tablet P £19.19 DT = £2.00

Mirtazapine 45 mg Mirtazapine 45mg orodispersible tablets |

30 tablet P £19.19 DT = £2.07

▶ Zispin SolTab (Merck Sharp & Dohme Ltd)

Mirtazapine 15 mg Zispin SolTab 15mg orodispersible tablets | 30 tablet P £15.06 DT = £1.83

Mirtazapine 30 mg Zispin SolTab 30mg orodispersible tablets | 30 tablet P £15.06 DT = £2.00

Mirtazapine 45 mg Zispin SolTab 45mg orodispersible tablets | 30 tablet P £15.06 DT = £2.07

ANTIDEPRESSANTS › TRICYCLIC

ANTIDEPRESSANTS

Amitriptyline hydrochloride 28-May-2018

l INDICATIONS AND DOSE

Abdominal pain or discomfort (in patients who have not

responded to laxatives, loperamide, or antispasmodics)

▶ BY MOUTH

▶ Adult: Initially 5–10 mg daily, to be taken at night;

increased in steps of 10 mg at least every 2 weeks as

required; maximum 30 mg per day

Major depressive disorder [not recommended—increased

risk of fatality in overdose]

▶ BY MOUTH

▶ Adult: Initially 50 mg daily in 2 divided doses, then

increased in steps of 25 mg once daily on alternate days

if required, maximum 150 mg daily in 2 divided doses

▶ Elderly: Initially 10–25 mg daily, increased if necessary

up to 100–150 mg daily in 2 divided doses, dose

increases dependent on individual patient response

and tolerability—doses above 100 mg should be used

with caution

Major depressive disorder in patients with cardiovascular

disease [not recommended—increased risk of fatality in

overdose]

▶ BY MOUTH

▶ Adult: Initially 10–25 mg daily, increased if necessary

up to 100–150 mg daily in 2 divided doses, dose

increases dependent on individual patient response

and tolerability—doses above 100 mg should be used

with caution

372 Mental health disorders BNF 78

Nervous system

4

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