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 solution
CAUTIONARY AND ADVISORY LABELS 2
▶ Aripiprazole (Non-proprietary)
Aripiprazole 5 mg Aripiprazole 5mg tablets | 28 tablet P £96.04
Aripiprazole 10 mg Aripiprazole 10mg tablets | 28 tablet P £96.04 DT = £1.51
Aripiprazole 15 mg Aripiprazole 15mg tablets | 28 tablet P £96.04 DT = £1.63
Aripiprazole 30 mg Aripiprazole 30mg tablets | 28 tablet P £192.08 DT = £12.25
▶ Arpoya (Torrent Pharma (UK) Ltd)
Aripiprazole 5 mg Arpoya 5mg tablets | 28 tablet P s DT =
Aripiprazole 10 mg Arpoya 10mg tablets | 28 tablet P s DT =
Aripiprazole 15 mg Arpoya 15mg tablets | 28 tablet P s DT =
Aripiprazole 30 mg Arpoya 30mg tablets | 28 tablet P s DT =
▶ Abilify (Otsuka Pharmaceuticals (U.K.) Ltd)
Aripiprazole 7.5 mg per 1 ml Abilify 9.75mg/1.3ml solution for
injection vials | 1 vial P £3.43
CAUTIONARY AND ADVISORY LABELS 2
▶ Aripiprazole (Non-proprietary)
Aripiprazole 1 mg per 1 ml Aripiprazole 1mg/ml oral solution | 150 ml P £102.90 DT = £101.05
▶ Abilify (Otsuka Pharmaceuticals (U.K.) Ltd)
Aripiprazole 1 mg per 1 ml Abilify 1mg/ml oral solution | 150 ml P £102.90 DT = £101.05
Powder and solvent for suspension for injection
▶ Abilify Maintena (Otsuka Pharmaceuticals (U.K.) Ltd)
Aripiprazole 400 mg Abilify Maintena 400mg powder and solvent
Abilify Maintena 400mg powder and solvent for prolonged-release
suspension for injection vials | 1 vial P £220.41 DT = £220.41
CAUTIONARY AND ADVISORY LABELS 2
EXCIPIENTS: May contain Aspartame
▶ Aripiprazole (Non-proprietary)
Aripiprazole 10 mg Aripiprazole 10mg orodispersible tablets sugar
free sugar-free | 28 tablet P £96.04 DT = £79.22
Aripiprazole 15 mg Aripiprazole 15mg orodispersible tablets sugar
free sugar-free | 28 tablet P £96.04 DT = £79.22
▶ Adult: 1.5 mg once daily, increased in steps of 1.5 mg if
required; maximum 6 mg per day
l INTERACTIONS → Appendix 1: cariprazine
▶ Rare or very rare Cataract. dysphagia . hypothyroidism . memory loss .rhabdomyolysis
▶ Frequency not known Hepatitis toxic
l CONCEPTION AND CONTRACEPTION Manufacturer advises
highly effective contraception in women of childbearing
potential during treatment and for at least 10 weeks after
the last dose; addition of barrier method recommended in
women using systemically-acting hormonal
l PREGNANCY Manufacturer advises avoid—toxicity in
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
severe impairment (no information available).
l RENAL IMPAIRMENT Manufacturer advises avoid in severe
impairment (no information available).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Reagila (Recordati Pharmaceuticals Ltd) A
Cariprazine (as Cariprazine hydrochloride) 1.5 mg Reagila 1.5mg
capsules | 28 capsule P £80.36
Cariprazine (as Cariprazine hydrochloride) 3 mg Reagila 3mg
capsules | 28 capsule P £80.36
Cariprazine (as Cariprazine hydrochloride) 4.5 mg Reagila 4.5mg
capsules | 28 capsule P £80.36
Cariprazine (as Cariprazine hydrochloride) 6 mg Reagila 6mg
capsules | 28 capsule P £80.36
l DRUG ACTION Clozapine is a dopamine D1, dopamine D2,
5-HT2A, alpha1-adrenoceptor, and muscarinic-receptor
Schizophrenia in patients unresponsive to, or intolerant
of, conventional antipsychotic drugs
▶ Adult 18–59 years: 12.5 mg 1–2 times a day for day 1,
then 25–50 mg for day 2, then increased, if tolerated,
in steps of 25–50 mg daily, dose to be increased
gradually over 14–21 days, increased to up to 300 mg
daily in divided doses, larger dose to be taken at night,
up to 200 mg daily may be taken as a single dose at
bedtime; increased in steps of 50–100 mg 1–2 times a
week if required, it is preferable to increase once a
week; usual dose 200–450 mg daily, max. 900 mg per
day, if restarting after interval of more than 48 hours,
12.5 mg once or twice on first day (but may be feasible
to increase more quickly than on initiation)—extreme
caution if previous respiratory or cardiac arrest with
▶ Adult 60 years and over: 12.5 mg once daily for day 1,
then increased to 25–37.5 mg for day 2, then increased,
if tolerated, in steps of up to 25 mg daily, dose to be
increased gradually over 14–21 days, increased to up to
300 mg daily in divided doses, larger dose at to be taken
night, up to 200 mg daily may be taken as a single dose
at bedtime; increased in steps of 50–100 mg 1–2 times
a week if required, it is preferable to increase once a
week; usual dose 200–450 mg daily, max. 900 mg per
day, if restarting after interval of more than 48 hours,
12.5 mg once or twice on first day (but may be feasible
to increase more quickly than on initiation)—extreme
caution if previous respiratory or cardiac arrest with
Psychosis in Parkinson’s disease
▶ Adult: 12.5 mg once daily, dose to be taken at bedtime,
then increased in steps of 12.5 mg up to twice weekly,
adjusted according to response; usual dose 25–37.5 mg
396 Mental health disorders BNF 78
once daily, dose to be taken at bedtime; increased in
steps of 12.5 mg once weekly, this applies only in
exceptional cases, increased if necessary up to 100 mg
daily in 1–2 divided doses; Usual maximum
MHRA/CHM ADVICE: CLOZAPINE: REMINDER OF POTENTIALLY
FATAL RISK OF INTESTINAL OBSTRUCTION, FAECAL IMPACTION,
AND PARALYTIC ILEUS (OCTOBER 2017)
Clozapine has been associated with varying degrees of
impairment of intestinal peristalsis—see Cautions and
Contra-indications for further information. Patients and
their carers should be advised to seek immediate medical
advice before taking the next dose of clozapine if
of agranulocytosis . history of circulatory collapse . history
of neutropenia . paralytic ileus . severe cardiac disorders
(e.g. myocarditis). severe CNS depression . uncontrolled
antipsychotics before starting
▶ Agranulocytosis Neutropenia and potentially fatal
agranulocytosis reported. Leucocyte and differential blood
counts must be normal before starting; monitor counts
every week for 18 weeks then at least every 2 weeks and if
clozapine continued and blood count stable after 1 year at
least every 4 weeks (and 4 weeks after discontinuation); if
leucocyte count below 3000 /mm3 or if absolute neutrophil
count below 1500 /mm3 discontinue permanently and refer
to haematologist. Patients who have a low white blood cell
count because of benign ethnic neutropenia may be
started on clozapine with the agreement of a
haematologist. Avoid drugs which depress leucopoiesis;
patients should report immediately symptoms of infection,
especially influenza-like illness.
▶ Myocarditis and cardiomyopathy Fatal myocarditis (most
commonly in first 2 months) and cardiomyopathy
. Perform physical examination and take full medical
. Specialist examination required if cardiac abnormalities
or history of heart disease found—clozapine initiated
only in absence of severe heart disease and if benefit
. Persistent tachycardia especially in first 2 months
should prompt observation for other indicators for
. If myocarditis or cardiomyopathy suspected clozapine
should be stopped and patient evaluated urgently by
. Discontinue permanently in clozapine-induced
▶ Intestinal obstruction Impairment of intestinal peristalsis,
including constipation, intestinal obstruction, faecal
impaction, and paralytic ileus, (including fatal cases)
reported. Clozapine should be used with caution in
patients receiving drugs that may cause constipation (e.g.
antimuscarinic drugs) or in those with a history of colonic
disease or lower abdominal surgery. It is essential that
constipation is recognised and actively treated.
l INTERACTIONS → Appendix 1: clozapine
hypotension (dose-related). speech impairment. sweating
abnormal . syncope .temperature regulation disorders . urinary disorders . vision blurred
▶ Rare or very rare Anaemia . cardiac arrest. cardiac
impaired . hepatic disorders . hyperglycaemia . increased
risk of infection . intestinal obstruction (including fatal
effusion .respiratory disorders .restlessness . sexual
dysfunction . skin reactions .thrombocytopenia . thrombocytosis
▶ Frequency not known Angina pectoris . angioedema . chest
pain . cholinergic syndrome . diarrhoea . gastrointestinal
SIDE-EFFECTS, FURTHER INFORMATION Hypersalivation
associated with clozapine therapy can be treated with
hyoscine hydrobromide [unlicensed indication], provided
that the patient is not at particular risk from the additive
antimuscarinic side-effects of hyoscine and clozapine.
l HEPATIC IMPAIRMENT Manufacturer advises caution—
monitor liver function (discontinue if liver enzymes are
greater than 3 times the upper limit of normal or jaundice
occurs); avoid in symptomatic or progressive impairment
l RENAL IMPAIRMENT Avoid in severe impairment.
▶ Monitor leucocyte and differential blood counts. Clozapine
requires differential white blood cell monitoring weekly for
18 weeks, then fortnightly for up to one year, and then
monthly as part of the clozapine patient monitoring
▶ Close medical supervision during initiation (risk of
collapse because of hypotension and convulsions).
▶ Blood lipids and weight should be measured at baseline, at
3 months (weight should be measured at frequent intervals
during the first 3 months), and then yearly with
antipsychotics. Patients taking clozapine require more
frequent monitoring of these parameters: every 3 months
for the first year, then yearly.
▶ Fasting blood glucose should be measured at baseline, at
4–6 months, and then yearly. Patients taking clozapine
should have fasting blood glucose tested at baseline, after
one months’ treatment, then every 4–6 months.
▶ Patient, prescriber, and supplying pharmacist must be
registered with the appropriate Patient Monitoring
Service—it takes several days to do this.
l TREATMENT CESSATION On planned withdrawal reduce
dose over 1–2 weeks to avoid risk of rebound psychosis. If
abrupt withdrawal necessary observe patient carefully.
l DIRECTIONS FOR ADMINISTRATION Shake oral suspension
well for 90 seconds when dispensing or if visibly settled
and stand for 24 hours before use; otherwise shake well for
10 seconds before use. May be diluted with water.
l PRESCRIBING AND DISPENSING INFORMATION Clozapine
has been used for psychosis in Parkinson’s disease in
children aged 16 years and over.
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer clozapine oral
BNF 78 Psychoses and schizophrenia 397
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
CAUTIONARY AND ADVISORY LABELS 2, 10
▶ Denzapine (Britannia Pharmaceuticals Ltd)
Clozapine 50 mg per 1 ml Denzapine 50mg/ml oral suspension
CAUTIONARY AND ADVISORY LABELS 2, 10
Clozapine 25 mg Clozaril 25mg tablets | 28 tablet P £3.02
(Hospital only) | 84 tablet P £8.40 (Hospital only) | 100 tablet P £10.00 (Hospital only)
Clozapine 100 mg Clozaril 100mg tablets | 28 tablet P £12.07
(Hospital only) | 84 tablet P £33.60 (Hospital only) | 100 tablet P £39.00 (Hospital only)
▶ Denzapine (Britannia Pharmaceuticals Ltd)
Clozapine 25 mg Denzapine 25mg tablets | 84 tablet P £16.64
Clozapine 50 mg Denzapine 50mg tablets | 100 tablet P £39.60
Clozapine 100 mg Denzapine 100mg tablets | 84 tablet P £66.53 | 100 tablet P £79.20
Clozapine 200 mg Denzapine 200mg tablets | 100 tablet P £158.40
Clozapine 25 mg Zaponex 25mg tablets | 84 tablet P £8.28 | 500 tablet P £48.39
Clozapine 100 mg Zaponex 100mg tablets | 84 tablet P £33.88
Lurasidone hydrochloride 03-Aug-2018
l DRUG ACTION Lurasidone is a dopamine D2, 5-HT2A, 5-HT7,
alpha2A- and alpha2C- adrenoceptor antagonist, and is a
partial agonist at 5-HT1a receptors.
▶ Adult: Initially 37 mg once daily, increased if necessary
Schizophrenia when given with concomitant moderate
CYP3A4 inhibitors (e.g. diltiazem, erythromycin,
▶ Adult: Initially 18.5 mg once daily (max. per dose 74 mg
l CAUTIONS High doses in elderly . susceptibility to QTinterval prolongation
l INTERACTIONS → Appendix 1: lurasidone
disorders . pain . psychiatric disorders . sleep disorders
▶ Uncommon Appetite decreased . dysarthria . dysuria . gait
▶ Rare or very rare Eosinophilia .rhabdomyolysis
failure . Stevens-Johnson syndrome . suicidal behaviour. vertigo
l PREGNANCY Use only if potential benefit outweighs risk—
limited information available.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate to severe impairment (risk of increased
Dose adjustments Manufacturer advises initially 18.5 mg
once daily in moderate to severe impairment, increased if
necessary up to 74 mg once daily in moderate impairment,
or up to max. 37 mg once daily in severe impairment.
l RENAL IMPAIRMENT Manufacturer advises use only if
potential benefit outweighs risk if eGFR less than
Dose adjustments Initially 18.5 mg once daily, up to max.
74 mg once daily if eGFR less than 50 mL/minute/1.73 m2
l DIRECTIONS FOR ADMINISTRATION Patients on doses
higher than 111 mg once daily whose treatment is
interrupted for longer than 3 days should restart on
111 mg once daily and titrate to usual dose; for all other
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2, 21, 25
▶ Latuda (Sunovion Pharmaceuticals Europe Ltd) A
Lurasidone (as Lurasidone hydrochloride) 18.5 mg Latuda 18.5mg
tablets | 28 tablet P £90.72 DT = £90.72
Lurasidone (as Lurasidone hydrochloride) 37 mg Latuda 37mg
tablets | 28 tablet P £90.72 DT = £90.72
Lurasidone (as Lurasidone hydrochloride) 74 mg Latuda 74mg
tablets | 28 tablet P £90.72 DT = £90.72
l DRUG ACTION Olanzapine is a dopamine D1, D2, D4, 5-HT2,
histamine- 1-, and muscarinic-receptor antagonist.
Schizophrenia | Combination therapy for mania
▶ Adult: 10 mg daily, adjusted according to response,
usual dose 5–20 mg daily, doses greater than 10 mg
daily only after reassessment, when one or more
factors present that might result in slower metabolism
(e.g. female gender, elderly, non-smoker) consider
lower initial dose and more gradual dose increase;
Preventing recurrence in bipolar disorder
▶ Adult: 10 mg daily, adjusted according to response,
usual dose 5–20 mg daily, doses greater than 10 mg
daily only after reassessment, when one or more
factors present that might result in slower metabolism
(e.g. female gender, elderly, non-smoker) consider
lower initial dose and more gradual dose increase;
▶ Adult: 15 mg daily, adjusted according to response,
usual dose 5–20 mg daily, doses greater than 15 mg
daily only after reassessment, when one or more
factors present that might result in slower metabolism
(e.g. female gender, elderly, non-smoker) consider
lower initial dose and more gradual dose increase;
Control of agitation and disturbed behaviour in
▶ Adult: Initially 5–10 mg for 1 dose; usual dose 10 mg
for 1 dose, followed by 5–10 mg after 2 hours if
required, maximum 3 injections daily for 3 days;
maximum daily combined oral and parenteral dose
20 mg, when one or more factors present that might
result in slower metabolism (e.g. female gender,
elderly, non-smoker) consider lower initial dose and
398 Mental health disorders BNF 78
▶ Elderly: Initially 2.5–5 mg, followed by 2.5–5 mg after
2 hours if required, maximum 3 injections daily for
3 days; maximum daily combined oral and parenteral
dose 20 mg, when one or more factors present that
might result in slower metabolism (e.g. female gender,
elderly, non-smoker) consider lower initial dose and
l CAUTIONS Bone-marrow depression . hypereosinophilic
disorders . low leucocyte count. low neutrophil count. myeloproliferative disease . paralytic ileus
▶ CNS and respiratory depression
▶ With intramuscular use Blood pressure, pulse and respiratory
rate should be monitored for at least 4 hours after
intramuscular injection, particularly in those also
receiving a benzodiazepine or another antipsychotic (leave
at least one hour between administration of olanzapine
intramuscular injection and parenteral benzodiazepines).
l INTERACTIONS → Appendix 1: olanzapine
▶ Common or very common Appetite increased . arthralgia . oedema
▶ Uncommon Alopecia . epistaxis . memory loss
▶ Rare or very rare Hepatic disorders . pancreatitis . rhabdomyolysis
▶ With intramuscular use Dyslipidaemia . malaise
▶ With oral use Hypothermia .thrombocytopenia
▶ With intramuscular use Hypoventilation
l PREGNANCY Use only if potential benefit outweighs risk;
neonatal lethargy, tremor, and hypertonia reported when
l BREAST FEEDING Avoid—present in milk.
l HEPATIC IMPAIRMENT Manufacturer advises caution.
Dose adjustments Manufacturer advises consider initial
dose of 5 mg daily and cautious titration.
Dose adjustments Consider initial dose of 5 mg daily.
▶ Blood lipids and weight should be measured at baseline, at
3 months (weight should be measured at frequent intervals
during the first 3 months), and then yearly with
antipsychotic drugs. Patients taking olanzapine require
more frequent monitoring of these parameters: every
3 months for the first year, then yearly.
▶ Fasting blood glucose should be measured at baseline, at
4–6 months, and then yearly. Patients taking olanzapine
should have fasting blood glucose tested at baseline, after
one months’ treatment, then every 4–6 months.
l DIRECTIONS FOR ADMINISTRATION Olanzapine
orodispersible tablet may be placed on the tongue and
allowed to dissolve, or dispersed in water, orange juice,
l PRESCRIBING AND DISPENSING INFORMATION
▶ With intramuscular use When prescribing, dispensing, or
administering, check that this injection is the correct
preparation—this preparation is usually used in hospital
for the rapid control of an acute episode and should not be
confused with depot preparations which are usually used
in the community or clinics for maintenance treatment.
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer orodispersible tablets.
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
CAUTIONARY AND ADVISORY LABELS 2
▶ Olanzapine (Non-proprietary)
Olanzapine 2.5 mg Olanzapine 2.5mg tablets | 28 tablet P £21.85 DT = £1.09
Olanzapine 5 mg Olanzapine 5mg tablets | 28 tablet P £43.70
Olanzapine 10 mg Olanzapine 10mg tablets | 28 tablet P £87.40
Olanzapine 15 mg Olanzapine 15mg tablets | 28 tablet P £119.18 DT = £1.69
Olanzapine 20 mg Olanzapine 20mg tablets | 28 tablet P £158.90 DT = £2.11
▶ Zalasta (Consilient Health Ltd)
Olanzapine 2.5 mg Zalasta 2.5mg tablets | 28 tablet P £18.57
Olanzapine 5 mg Zalasta 5mg tablets | 28 tablet P £37.14 DT =
Olanzapine 7.5 mg Zalasta 7.5mg tablets | 56 tablet P £111.43
Olanzapine 10 mg Zalasta 10mg tablets | 28 tablet P £74.29 DT
Olanzapine 15 mg Zalasta 15mg tablets | 28 tablet P £101.30
Olanzapine 20 mg Zalasta 20mg tablets | 28 tablet P £135.06
▶ Zyprexa (Eli Lilly and Company Ltd)
Olanzapine 2.5 mg Zyprexa 2.5mg tablets | 28 tablet P £21.85
Olanzapine 5 mg Zyprexa 5mg tablets | 28 tablet P £43.70 DT =
Olanzapine 7.5 mg Zyprexa 7.5mg tablets | 56 tablet P £131.10
Olanzapine 10 mg Zyprexa 10mg tablets | 28 tablet P £87.40 DT
Olanzapine 15 mg Zyprexa 15mg tablets | 28 tablet P £119.18
Olanzapine 20 mg Zyprexa 20mg tablets | 28 tablet P £158.90
▶ Zyprexa (Eli Lilly and Company Ltd)
Olanzapine 5 mg Zyprexa 5mg Velotabs sugar-free | 28 tablet P £48.07 DT = £48.07
Olanzapine 10 mg Zyprexa 10mg Velotabs sugar-free | 28 tablet P £87.40 DT = £87.40
Olanzapine 15 mg Zyprexa 15mg Velotabs sugar-free | 28 tablet P £131.10 DT = £131.10
Olanzapine 20 mg Zyprexa 20mg Velotabs sugar-free | 28 tablet P £174.79 DT = £174.79
CAUTIONARY AND ADVISORY LABELS 2
EXCIPIENTS: May contain Aspartame
▶ Olanzapine (Non-proprietary)
Olanzapine 2.5 mg Olanzapine 2.5mg orodispersible tablets sugar
free sugar-free | 28 tablet P s
Olanzapine 5 mg Olanzapine 5mg orodispersible tablets sugar free
sugar-free | 28 tablet P £20.18 DT = £4.71
Olanzapine 5mg orodispersible tablets | 28 tablet P £30.00 DT =
Olanzapine 7.5 mg Olanzapine 7.5mg orodispersible tablets sugar
free sugar-free | 28 tablet P s
Olanzapine 10 mg Olanzapine 10mg orodispersible tablets | 28 tablet P £50.00 DT = £44.62
Olanzapine 10mg orodispersible tablets sugar free sugar-free | 28 tablet P £49.74 DT = £6.46
BNF 78 Psychoses and schizophrenia 399
Olanzapine 15 mg Olanzapine 15mg orodispersible tablets sugar free
sugar-free | 28 tablet P £66.76 DT = £6.97
Olanzapine 15mg orodispersible tablets | 28 tablet P £50.00 DT =
Olanzapine 20 mg Olanzapine 20mg orodispersible tablets sugar
free sugar-free | 28 tablet P £96.14 DT = £8.84
Olanzapine 20mg orodispersible tablets | 28 tablet P £80.00 DT =
▶ Zalasta (Consilient Health Ltd)
Olanzapine 5 mg Zalasta 5mg orodispersible tablets sugar-free | 28 tablet P £40.85 DT = £4.71
Olanzapine 10 mg Zalasta 10mg orodispersible tablets sugar-free |
Olanzapine 15 mg Zalasta 15mg orodispersible tablets sugar-free | 28 tablet P £111.43 DT = £6.97
Olanzapine 20 mg Zalasta 20mg orodispersible tablets sugar-free | 28 tablet P £148.57 DT = £8.84
l DRUG ACTION Paliperidone is a metabolite of risperidone.
Schizophrenia | Psychotic or manic symptoms of
▶ Adult: 6 mg once daily, dose to be taken in the
morning, then adjusted in steps of 3 mg if required,
dose to be adjusted over at least 5 days; usual dose
TREVICTA ® PRE-FILLED SYRINGES
Maintenance of schizophrenia in patients who are
clinically stable on once-monthly intramuscular
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: Initially 175–525 mg every 3 months, adjusted
according to response, to be administered into the
deltoid or gluteal muscle, dose is based on previous
once-monthly intramuscular paliperidone and should
be initiated in place of the next scheduled dose—
Maintenance in schizophrenia in patients previously
responsive to paliperidone or risperidone
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: 150 mg for 1 dose on day 1, then 100 mg for
1 dose on day 8, to be injected into the deltoid muscle,
dose subsequently adjusted at monthly intervals
according to response; maintenance 75 mg once a
month, alternatively maintenance 25–150 mg once a
month, following the second dose, monthly
maintenance doses can be administered into either the
GENERAL CAUTIONS Cataract surgery (risk of
intraoperative floppy iris syndrome). dementia with Lewy
bodies . elderly patients with dementia . elderly patients
▶ With intramuscular use when transferring from oral to depot
therapy, the dose by mouth should be reduced gradually
l INTERACTIONS → Appendix 1: paliperidone
of infection . joint disorders . laryngeal pain . mood altered
. nasal congestion . nausea . oral disorders . pain . skin
▶ Rare or very rare Angioedema . cerebrovascular
▶ With oral use Weight decreased
▶ With oral use Concentration impaired . confusion . diabetes
▶ With intramuscular use Injection site necrosis
l PREGNANCY Use only if potential benefit outweighs risk—
toxicity in animal studies; if discontinuation during
pregnancy is necessary, withdraw gradually.
TREVICTA ® PRE-FILLED SYRINGES Manufacturer advises to
consider long-acting nature of formulation—paliperidone
detected in plasma up to 18 months after single dose.
l BREAST FEEDING Manufacturer advises avoid—present in
TREVICTA ® PRE-FILLED SYRINGES Manufacturer advises to
consider long-acting nature of formulation—paliperidone
detected in plasma up to 18 months after single dose.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment (no information available).
▶ With oral use Manufacturer advises avoid if creatinine
clearance less than 10 mL/minute.
▶ With intramuscular use Manufacturer advises avoid if
creatinine clearance less than 50 mL/minute.
Dose adjustments ▶ With oral use Manufacturer advises
reduce initial dose to 3 mg once daily if creatinine
clearance 50–80 mL/minute (max. 6 mg once daily).
Manufacturer advises reduce initial dose to 1.5 mg once
daily if creatinine clearance 10–50 mL/minute (max. 3 mg
TREVICTA ® PRE-FILLED SYRINGES DOSE
ADJUSTMENTS Manufacturer advises dose should be
adjusted and stabilised using once-monthly injectable
paliperidone before switching to three-monthly injectable
paliperidone, if creatinine clearance 50–80 mL/minute.
XEPLION ® PRE-FILLED SYRINGES DOSE
ADJUSTMENTS Manufacturer advises initial dose 100 mg
on day 1 and then 75 mg on day 8 if creatinine clearance
50–80 mL/minute; recommended maintenance dose 50 mg
(range 25–100 mg) monthly if creatinine clearance
▶ With intramuscular use Treatment requires careful
monitoring for optimum effect.
l DIRECTIONS FOR ADMINISTRATION
▶ With intramuscular use Correct injection technique
(including the use of z-track technique) and rotation of
injection sites are essential.
400 Mental health disorders BNF 78
▶ With oral use Always take with breakfast or always take on
l PRESCRIBING AND DISPENSING INFORMATION
XEPLION ® PRE-FILLED SYRINGES Xeplion ® 25 mg prefilled syringes may be difficult to obtain.
▶ With oral use Patients or carers should be given advice on
how to administer paliperidone tablets.
Missed doses ▶ With intramuscular use For missed doses see
l NATIONAL FUNDING/ACCESS DECISIONS
TREVICTA ® PRE-FILLED SYRINGES
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (September
2016) that paliperidone palmitate (Trevicta ®) is accepted
for use within NHS Scotland for the maintenance
treatment of schizophrenia in patients who are clinically
stable on one-monthly paliperidone palmitate injectable
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Prolonged-release suspension for injection
▶ Trevicta (Janssen-Cilag Ltd)
Paliperidone (as Paliperidone palmitate) 200 mg per
1 ml Trevicta 175mg/0.875ml prolonged-release suspension for
injection pre-filled syringes | 1 pre-filled disposable injection P £551.76 DT = £551.76
Trevicta 263mg/1.315ml prolonged-release suspension for injection
pre-filled syringes | 1 pre-filled disposable injection P £734.70 DT
Trevicta 350mg/1.75ml prolonged-release suspension for injection
pre-filled syringes | 1 pre-filled disposable injection P £942.21 DT
Trevicta 525mg/2.625ml prolonged-release suspension for injection
pre-filled syringes | 1 pre-filled disposable injection P £1,177.77
CAUTIONARY AND ADVISORY LABELS 2, 25
Paliperidone 3 mg Invega 3mg modified-release tablets |
28 tablet P £97.28 DT = £97.28
Paliperidone 6 mg Invega 6mg modified-release tablets | 28 tablet P £97.28 DT = £97.28
Paliperidone 9 mg Invega 9mg modified-release tablets | 28 tablet P £145.92 DT = £145.92
Paliperidone (as Paliperidone palmitate) 100 mg per 1 ml Xeplion
150mg/1.5ml suspension for injection pre-filled syringes | 1 pre-filled
disposable injection P £392.59 DT = £392.59
l DRUG ACTION Quetiapine is a dopamine D1, dopamine D2,
5-HT2, alpha1-adrenoceptor, and histamine-1 receptor
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: 25 mg twice daily for day 1, then 50 mg twice
daily for day 2, then 100 mg twice daily for day 3, then
150 mg twice daily for day 4, then, adjusted according
to response, usual dose 300–450 mg daily in 2 divided
doses, the rate of dose titration may need to be slower
and the daily dose lower in elderly patients; maximum
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Adult: 300 mg once daily for day 1, then 600 mg once
daily for day 2, then, adjusted according to response,
usual dose 600 mg once daily, maximum dose under
specialist supervision; maximum 800 mg per day
▶ Elderly: Initially 50 mg once daily, adjusted according
to response. adjusted in steps of 50 mg daily
Treatment of mania in bipolar disorder
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: 50 mg twice daily for day 1, then 100 mg twice
daily for day 2, then 150 mg twice daily for day 3, then
200 mg twice daily for day 4, then adjusted in steps of
up to 200 mg daily, adjusted according to response,
usual dose 400–800 mg daily in 2 divided doses, the
rate of dose titration may need to be slower and the
daily dose lower in elderly patients; maximum 800 mg
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Adult: 300 mg once daily for day 1, then 600 mg once
daily for day 2, then, adjusted according to response,
usual dose 400–800 mg once daily
▶ Elderly: Initially 50 mg once daily, adjusted according
to response. adjusted in steps of 50 mg daily
Treatment of depression in bipolar disorder
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: 50 mg once daily for day 1, dose to be taken at
bedtime, then 100 mg once daily for day 2, then 200 mg
once daily for day 3, then 300 mg once daily for day 4,
then, adjusted according to response; usual dose
300 mg once daily, the rate of dose titration may need
to be slower and the daily dose lower in elderly
patients; maximum 600 mg per day
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Adult: 50 mg once daily for day 1, dose to be taken at
bedtime, then 100 mg once daily for day 2, then 200 mg
once daily for day 3, then 300 mg once daily for day 4,
then, adjusted according to response; usual dose
300 mg once daily; maximum 600 mg per day
Prevention of mania and depression in bipolar disorder
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Continue at the dose effective for treatment of
bipolar disorder and adjust to lowest effective dose;
usual dose 300–800 mg daily in 2 divided doses
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Adult: Continue at the dose effective for treatment of
bipolar disorder and adjust to lowest effective dose;
usual dose 300–800 mg once daily
Adjunctive treatment of major depression
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Adult: 50 mg once daily for 2 days, dose to be taken at
bedtime, then 150 mg once daily for 2 days, then,
adjusted according to response, usual dose
▶ Elderly: Initially 50 mg once daily for 3 days, then
increased if necessary to 100 mg once daily for 4 days,
then adjusted in steps of 50 mg, adjusted according to
response, usual dose 50–300 mg once daily, dose of
300 mg should not be reached before day 22 of
DOSE EQUIVALENCE AND CONVERSION
▶ Patients can be switched from immediate-release to
modified-release tablets at the equivalent daily dose;
to maintain clinical response, dose titration may be
l CAUTIONS Cerebrovascular disease . elderly . patients at
risk of aspiration pneumonia .treatment of depression in
patients under 25 years (increased risk of suicide)
l INTERACTIONS → Appendix 1: quetiapine
BNF 78 Psychoses and schizophrenia 401
oedema .rhinitis . sleep disorders . suicidal behaviour
(particularly on initiation). suicidal ideation (particularly
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