l UNLICENSED USE g Metoclopramide is used for the

treatment of acute migraine, hbut is not licensed for

this indication.

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE—METOCLOPRAMIDE: RISK OF NEUROLOGICAL

ADVERSE EFFECTS—RESTRICTED DOSE AND DURATION OF USE

(AUGUST 2013)

The benefits and risks of metoclopramide have been

reviewed by the European Medicines Agency’s

Committee on Medicinal Products for Human Use, which

concluded that the risk of neurological effects such as

extrapyramidal disorders and tardive dyskinesia

outweigh the benefits in long-term or high-dose

treatment. To help minimise the risk of potentially

serious neurological adverse effects, the following

restrictions to indications, dose, and duration of use

have been made:

. In adults over 18 years, metoclopramide should only

be used for prevention of postoperative nausea and

vomiting, radiotherapy-induced nausea and vomiting,

delayed (but not acute) chemotherapy-induced nausea

and vomiting, and symptomatic treatment of nausea

and vomiting, including that associated with acute

migraine (where it may also be used to improve

absorption of oral analgesics);

. Metoclopramide should only be prescribed for shortterm use (up to 5 days);

. Usual dose is 10 mg, repeated up to 3 times daily; max.

daily dose is 500 micrograms/kg;

. Intravenous doses should be administered as a slow

bolus over at least 3 minutes;

. Oral liquid formulations should be given via an

appropriately designed, graduated oral syringe to

ensure dose accuracy.

This advice does not apply to unlicensed uses of

metoclopramide (e.g. palliative care).

l CONTRA-INDICATIONS 3–4 days after gastrointestinal

surgery . gastro-intestinal haemorrhage . gastro-intestinal

obstruction . gastro-intestinal perforation . phaeochromocytoma

l CAUTIONS Asthma . atopic allergy . bradycardia . cardiac

conduction disturbances . children . elderly . epilepsy . may

mask underlying disorders such as cerebral irritation . Parkinson’s disease . uncorrected electrolyte imbalance . young adults (15–19 years old)

l INTERACTIONS → Appendix 1: metoclopramide

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Common or very common Asthenia . depression . diarrhoea . drowsiness . hypotension . menstrual cycle irregularities . movement disorders . parkinsonism

▶ Uncommon Arrhythmias . hallucination . hyperprolactinaemia . level of consciousness decreased

▶ Rare or very rare Confusion . galactorrhoea . seizure

▶ Frequency not known Atrioventricular block . blood

disorders . cardiac arrest. gynaecomastia . hypertension . neuroleptic malignant syndrome . QT interval

prolongation . shock . syncope .tremor

SPECIFIC SIDE-EFFECTS

▶ With parenteral use Anxiety . dizziness . dyspnoea . oedema . skin reactions . visual impairment

SIDE-EFFECTS, FURTHER INFORMATION Metoclopramide

can induce acute dystonic reactions involving facial and

skeletal muscle spasms and oculogyric crises. These

dystonic effects are more common in the young (especially

girls and young women) and the very old; they usually

occur shortly after starting treatment with

metoclopramide and subside within 24 hours of stopping

it. Injection of an antiparkinsonian drug such as

procyclidine will abort dystonic attacks.

l PREGNANCY Not known to be harmful.

l BREAST FEEDING Small amount present in milk; avoid.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

severe impairment (risk of accumulation).

Dose adjustments Manufacturer advises dose reduction of

50% in severe impairment.

l RENAL IMPAIRMENT

Dose adjustments Avoid or use small dose in severe

impairment; increased risk of extrapyramidal reactions.

l DIRECTIONS FOR ADMINISTRATION Oral liquid preparation

to be given via a graduated oral dosing syringe.

l PRESCRIBING AND DISPENSING INFORMATION

Palliative care For further information on the use of

metoclopramide hydrochloride in palliative care, see

www.medicinescomplete.com/#/content/palliative/

metoclopramide.

l PATIENT AND CARER ADVICE Counselling on use of pipette

advised with oral solution.

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

Solution for injection

▶ Metoclopramide hydrochloride (Non-proprietary)

Metoclopramide hydrochloride 5 mg per 1 ml Metoclopramide

10mg/2ml solution for injection ampoules | 5 ampoule P £1.31–

£15.00 | 10 ampoule P £25.00 DT = £2.65

▶ Maxolon (Advanz Pharma)

Metoclopramide hydrochloride 5 mg per 1 ml Maxolon 10mg/2ml

solution for injection ampoules | 12 ampoule P £3.21

Maxolon High Dose 100mg/20ml solution for injection ampoules | 10 ampoule P £26.68

Oral solution

▶ Metoclopramide hydrochloride (Non-proprietary)

Metoclopramide hydrochloride 1 mg per 1 ml Metoclopramide

5mg/5ml oral solution sugar free sugar-free | 150 ml P £19.77 DT

= £19.77

Tablet

▶ Metoclopramide hydrochloride (Non-proprietary)

Metoclopramide hydrochloride 10 mg Metoclopramide 10mg

tablets | 28 tablet P £1.40 DT = £0.61

▶ Maxolon (Advanz Pharma)

Metoclopramide hydrochloride 10 mg Maxolon 10mg tablets | 84 tablet P £5.24

Combinations available: Paracetamol with metoclopramide,

p. 476

ANTIEMETICS AND ANTINAUSEANTS ›

NEUROKININ RECEPTOR ANTAGONISTS

Aprepitant 11-Sep-2018

l INDICATIONS AND DOSE

Adjunct treatment to prevent nausea and vomiting

associated with moderately and highly emetogenic

chemotherapy

▶ BY MOUTH

▶ Adult: Initially 125 mg, dose to be taken 1 hour before

chemotherapy, then 80 mg once daily for 2 days,

consult product literature for dose of concomitant

dexamethasone and 5HT3-antagonist

l CONTRA-INDICATIONS Acute porphyrias p. 1058

l INTERACTIONS → Appendix 1: aprepitant

l SIDE-EFFECTS

▶ Common or very common Appetite decreased . asthenia . constipation . gastrointestinal discomfort. headache . hiccups

▶ Uncommon Anaemia . anxiety . burping . dizziness . drowsiness . dry mouth .febrile neutropenia .

BNF 78 Nausea and labyrinth disorders 433

Nervous system

4

gastrointestinal disorders . hot flush . malaise . nausea . palpitations . skin reactions . urinary disorders . vomiting

▶ Rare or very rare Bradycardia . cardiovascular disorder. chest discomfort. cognitive disorder. conjunctivitis . cough . disorientation . euphoric mood . gait abnormal . hyperhidrosis . increased risk of infection . muscle spasms . muscle weakness . oedema . oropharyngeal pain . photosensitivity reaction . polydipsia . seborrhoea . severe

cutaneous adverse reactions (SCARs). sneezing . stomatitis .taste altered .throat irritation .tinnitus . weight decreased

▶ Frequency not known Dysarthria . dyspnoea . insomnia . miosis . sensation abnormal . visual acuity decreased . wheezing

l CONCEPTION AND CONTRACEPTION Manufacturer advises

effectiveness of hormonal contraceptives may be

reduced—alternative non-hormonal methods of

contraception necessary during treatment and for

2 months after stopping aprepitant.

l PREGNANCY Manufacturer advises avoid unless clearly

necessary—no information available.

l BREAST FEEDING Manufacturer advises avoid—present in

milk in animal studies.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

moderate to severe impairment—limited information

available.

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

Capsule

▶ Emend (Merck Sharp & Dohme Ltd)

Aprepitant 80 mg Emend 80mg capsules | 2 capsule P £31.61

Aprepitant 125 mg Emend 125mg capsules | 5 capsule P £79.03

Fosaprepitant 29-Aug-2018

l DRUG ACTION Fosaprepitant is a prodrug of aprepitant.

l INDICATIONS AND DOSE

Adjunct to dexamethasone and a 5HT3-receptor

antagonist in preventing nausea and vomiting associated

with moderately and highly emetogenic chemotherapy

▶ BY INTRAVENOUS INFUSION

▶ Adult: 150 mg, dose to be administered over

20–30 minutes and given 30 minutes before

chemotherapy on day 1 of cycle only, consult product

literature for dose of concomitant corticosteroid and

5HT3-receptor antagonist

l CONTRA-INDICATIONS Acute porphyrias p. 1058

l INTERACTIONS → Appendix 1: fosaprepitant

l SIDE-EFFECTS

▶ Common or very common Appetite decreased . asthenia . constipation . gastrointestinal discomfort. headache . hiccups

▶ Uncommon Anaemia . anxiety . burping . dizziness . drowsiness . dry mouth . febrile neutropenia . flushing . gastrointestinal disorders . malaise . nausea . palpitations . skin reactions .thrombophlebitis . urinary disorders . vomiting

▶ Rare or very rare Bradycardia . cardiovascular disorder. chest discomfort. cognitive disorder. conjunctivitis . cough . disorientation . euphoric mood . gait abnormal . hyperhidrosis . increased risk of infection . muscle spasms . muscle weakness . oedema . oropharyngeal pain . photosensitivity reaction . polydipsia . seborrhoea . severe

cutaneous adverse reactions (SCARs). sneezing . stomatitis .taste altered .throat irritation .tinnitus . weight decreased

▶ Frequency not known Dysarthria . dyspnoea . insomnia . miosis . sensation abnormal . visual acuity decreased . wheezing

l CONCEPTION AND CONTRACEPTION Effectiveness of

hormonal contraceptives reduced—effective nonhormonal methods of contraception necessary during

treatment and for 2 months after stopping fosaprepitant.

l PREGNANCY Avoid unless potential benefit outweighs

risk—no information available.

l BREAST FEEDING Avoid—present in milk in animal studies.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

moderate to severe impairment—limited information

available.

l DIRECTIONS FOR ADMINISTRATION For intravenous infusion

(Ivemend ®), manufacturer advises give intermittently in

Sodium chloride 0.9%; reconstitute each 150 mg vial with

5 mL sodium chloride 0.9% gently without shaking to avoid

foaming, then dilute in 145 mL infusion fluid; give over

20–30 minutes.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 678/11

The Scottish Medicines Consortium has advised (March

2011) that fosaprepitant (Ivemend ®) is accepted for

restricted use within NHS Scotland for the prevention of

acute and delayed nausea and vomiting associated with

highly emetogenic cisplatin-based chemotherapy in

adults.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder for solution for infusion

▶ Ivemend (Merck Sharp & Dohme Ltd)

Fosaprepitant (as Fosaprepitant dimeglumine) 150 mg Ivemend

150mg powder for solution for infusion vials | 1 vial P £47.42

Rolapitant 26-Oct-2017

l INDICATIONS AND DOSE

Adjunct to dexamethasone and a 5HT3-receptor

antagonist in preventing delayed nausea and vomiting

associated with moderately and highly emetogenic

chemotherapy

▶ BY MOUTH

▶ Adult: 180 mg as a single dose, dose should be

administered up to 2 hours before chemotherapy.

Interval between repeated doses must be at least

2 weeks, consult product literature for dose of

concomitant corticosteroid and 5HT3-antagonist

l INTERACTIONS → Appendix 1: rolapitant

l SIDE-EFFECTS

▶ Common or very common Asthenia . constipation . headache

▶ Uncommon Appetite decreased . concentration impaired . diarrhoea . dizziness . drowsiness . gastrointestinal

discomfort. hiccups . increased risk of infection . insomnia . myalgia . nausea . neutropenia . stomatitis .taste altered

▶ Rare or very rare Alopecia . angioedema . anxiety . arthralgia . back pain . dehydration . dry mouth . dyspnoea . gait abnormal . gastrointestinal disorders . hearing

impairment. hypertension . hypomagnesaemia . leucopenia . movement disorders . muscle weakness . rhabdomyolysis . skin reactions . syncope .teeth grinding . thrombocytopenia .tinnitus . vision blurred . vomiting

l PREGNANCY Manufacturer advises avoid unless potential

benefit outweighs risk—limited information available.

l BREAST FEEDING Manufacturer advises avoid—present in

milk in animal studies.

434 Nausea and labyrinth disorders BNF 78

Nervous system

4

l HEPATIC IMPAIRMENT Manufacturer advises caution in

severe impairment (no information available).

l RENAL IMPAIRMENT Manufacturer advises use with

caution in severe impairment—limited information

available.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 1266/17

The Scottish Medicines Consortium has advised (September

2017) that rolapitant (Varuby ®) is accepted for restricted

use within NHS Scotland as a first-line option for the

prevention of delayed nausea and vomiting in adults

undergoing highly emetogenic chemotherapy. This advice

is contingent upon the continuing availability of the

patient access scheme in NHS Scotland or a list price that

is equivalent or lower.

All Wales Medicines Strategy Group (AWMSG) decisions

AWMSG No. 1303

The All Wales Medicines Strategy Group has advised (March

2018) that rolapitant (Varuby ®) is not recommended for

use within NHS Wales for the prevention of delayed

nausea and vomiting associated with highly and

moderately emetogenic cancer chemotherapy in adults.

The case for cost-effectiveness has not been proven.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 3

EXCIPIENTS: May contain Polysorbates

▶ Varuby (Tesaro UK Ltd) A

Rolapitant (as Rolapitant hydrochloride monohydrate)

90 mg Varuby 90mg tablets | 2 tablet P £47.42

ANTIEMETICS AND ANTINAUSEANTS ›

SEROTONIN (5HT3) RECEPTOR ANTAGONISTS

Granisetron 14-Jul-2018

l DRUG ACTION Granisetron is a specific 5HT3-receptor

antagonist which blocks 5HT3 receptors in the gastrointestinal tract and in the CNS.

l INDICATIONS AND DOSE

Nausea and vomiting induced by cytotoxic chemotherapy

for planned duration of 3–5 days where oral antiemetics

cannot be used

▶ BY TRANSDERMAL APPLICATION USING PATCHES

▶ Adult: Apply 3.1 mg/24 hours, apply patch to clean,

dry, non-irritated, non-hairy skin on upper arm (or

abdomen if upper arm cannot be used) 24–48 hours

before treatment, patch may be worn for up to 7 days;

remove at least 24 hours after completing

chemotherapy

Prevention of postoperative nausea and vomiting

▶ BY INTRAVENOUS INJECTION

▶ Adult: 1 mg, to be administered before induction of

anaesthesia, dose to be diluted to 5 mL and given over

30 seconds

Treatment of postoperative nausea and vomiting

▶ BY INTRAVENOUS INJECTION

▶ Adult: 1 mg, dose to be diluted to 5 mL and given over

30 seconds; maximum 3 mg per day

Management of nausea and vomiting induced by cytotoxic

chemotherapy or radiotherapy

▶ BY MOUTH

▶ Adult: 1–2 mg, to be taken within 1 hour before start of

treatment, then 2 mg daily in 1–2 divided doses for up

to 1 week following treatment, when intravenous route

also used, maximum combined total dose 9 mg in

24 hours

▶ BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION

▶ Adult: 10–40 micrograms/kg (max. per dose 3 mg), to

be given 5 minutes before start of treatment, dose may

be repeated if necessary, further maintenance doses

must not be given less than 10 minutes apart, for

intravenous injection, each 1 mg granisetron diluted to

5 mL and given over not less than 30 seconds, for

intravenous infusion, to be given over 5 minutes;

maximum 9 mg per day

l CAUTIONS Subacute intestinal obstruction . susceptibility

to QT-interval prolongation (including electrolyte

disturbances)

l INTERACTIONS → Appendix 1: granisetron

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Common or very common Constipation . headache

SPECIFIC SIDE-EFFECTS

▶ Common or very common

▶ With intravenous use or oral use Diarrhoea . insomnia

▶ Uncommon

▶ With intravenous use or oral use Extrapyramidal symptoms . QT interval prolongation . serotonin syndrome

▶ With transdermal use Appetite decreased . arthralgia . dry

mouth . flushing . generalised oedema . vertigo

▶ Rare or very rare

▶ With transdermal use Dystonia

l PREGNANCY Manufacturer advises avoid.

l BREAST FEEDING Avoid—no information available.

l HEPATIC IMPAIRMENT Manufacturer advises caution.

l DIRECTIONS FOR ADMINISTRATION

▶ With intravenous use For intravenous infusion, give

intermittently in Glucose 5% or Sodium Chloride 0.9%;

dilute up to 3 mL in 20–50 mL infusion fluid; give over

5 minutes.

l PATIENT AND CARER ADVICE

▶ With transdermal use Patients should be advised not to

expose the site of the patch to sunlight during use and for

10 days after removal.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

▶ Granisetron (Non-proprietary)

Granisetron (as Granisetron hydrochloride) 1 mg per

1 ml Granisetron 3mg/3ml concentrate for solution for injection

ampoules | 5 ampoule P £24.00–£30.00 | 10 ampoule P £48.00

Granisetron 1mg/1ml concentrate for solution for injection ampoules

| 5 ampoule P £8.00–£10.00 | 10 ampoule P £16.00

Tablet

▶ Granisetron (Non-proprietary)

Granisetron (as Granisetron hydrochloride) 1 mg Granisetron 1mg

tablets | 10 tablet P £51.20 DT = £40.79

Granisetron (as Granisetron hydrochloride) 2 mg Granisetron 2mg

tablets | 5 tablet P s DT = £52.39

▶ Kytril (Atnahs Pharma UK Ltd)

Granisetron (as Granisetron hydrochloride) 1 mg Kytril 1mg

tablets | 10 tablet P £52.39 DT = £40.79

Granisetron (as Granisetron hydrochloride) 2 mg Kytril 2mg

tablets | 5 tablet P £52.39 DT = £52.39

Transdermal patch

▶ Sancuso (Kyowa Kirin Ltd)

Granisetron 3.1 mg per 24 hour Sancuso 3.1mg/24hours

transdermal patches | 1 patch P £56.00 DT = £56.00

BNF 78 Nausea and labyrinth disorders 435

Nervous system

4

Ondansetron

l DRUG ACTION Ondansetron is a specific 5HT3-receptor

antagonist which blocks 5HT3 receptors in the gastrointestinal tract and in the CNS.

l INDICATIONS AND DOSE

Moderately emetogenic chemotherapy or radiotherapy

▶ BY MOUTH

▶ Adult: Initially 8 mg, dose to be taken 1–2 hours before

treatment, then 8 mg every 12 hours for up to 5 days

▶ BY RECTUM

▶ Adult: Initially 16 mg, dose to be taken 1–2 hours

before treatment, then 16 mg daily for up to 5 days

▶ INITIALLY BY INTRAMUSCULAR INJECTION, OR BY SLOW

INTRAVENOUS INJECTION

▶ Adult: Initially 8 mg, dose to be administered

immediately before treatment, then (by mouth) 8 mg

every 12 hours for up to 5 days, alternatively (by

rectum) 16 mg daily for up to 5 days

▶ INITIALLY BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS

INFUSION

▶ Elderly: Initially 8 mg, dose to be administered

immediately before treatment, intravenous infusion to

be given over at least 15 minutes, then (by mouth) 8 mg

every 12 hours for up to 5 days, alternatively (by

rectum) 16 mg daily for up to 5 days

Severely emetogenic chemotherapy (consult product

literature for dose of concomitant corticosteroid)

▶ BY MOUTH

▶ Adult: 24 mg, dose to be taken 1–2 hours before

treatment, then 8 mg every 12 hours for up to 5 days

▶ BY RECTUM

▶ Adult: 16 mg, dose to be administered 1–2 hours before

treatment, then 16 mg daily for up to 5 days

▶ INITIALLY BY INTRAMUSCULAR INJECTION, OR BY SLOW

INTRAVENOUS INJECTION

▶ Adult: Initially 8 mg, dose to be administered

immediately before treatment, followed by (by

intramuscular injection or by slow intravenous

injection) 8 mg every 4 hours if required for 2 doses,

alternatively, followed by (by continuous intravenous

infusion) 1 mg/hour for up to 24 hours, then (by

mouth) 8 mg every 12 hours for up to 5 days,

alternatively (by rectum) 16 mg daily for up to 5 days

▶ INITIALLY BY INTRAMUSCULAR INJECTION

▶ Adult 65–74 years: Initially 8 mg, to be given

immediately before treatment, followed by (by

intramuscular injection) 8 mg every 4 hours if required

for 2 doses, alternatively, followed by (by continuous

intravenous infusion) 1 mg/hour for up to 24 hours,

then (by mouth) 8 mg every 12 hours for up to 5 days,

alternatively (by rectum) 16 mg daily for up to 5 days

▶ INITIALLY BY INTRAVENOUS INFUSION

▶ Adult: Initially 16 mg, immediately before treatment

(over at least 15 minutes), followed by (by

intramuscular injection or by slow intravenous

injection) 8 mg every 4 hours if required for 2 doses,

then (by mouth) 8 mg every 12 hours for up to 5 days,

alternatively (by rectum) 16 mg daily for up to 5 days

▶ Adult 65–74 years: Initially 8–16 mg, immediately

before treatment (over at least 15 minutes), followed

by (by intramuscular injection or by intravenous

infusion) 8 mg every 4 hours if required for 2 doses,

then (by mouth) 8 mg every 12 hours for up to 5 days,

alternatively (by rectum) 16 mg daily for up to 5 days

▶ Adult 75 years and over: Initially 8 mg, immediately

before treatment (over at least 15 minutes), followed

by (by intravenous infusion) 8 mg every 4 hours if

required for 2 doses, then (by mouth) 8 mg every

12 hours for up to 5 days, alternatively (by rectum)

16 mg daily for up to 5 days

Prevention of postoperative nausea and vomiting

▶ INITIALLY BY MOUTH

▶ Adult: 16 mg, dose to be taken 1 hour before

anaesthesia, alternatively (by intramuscular injection

or by slow intravenous injection) 4 mg, dose to be

administered at induction of anaesthesia

Treatment of postoperative nausea and vomiting

▶ BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS

INJECTION

▶ Adult: 4 mg for 1 dose

l CONTRA-INDICATIONS Congenital long QT syndrome

l CAUTIONS Adenotonsillar surgery . subacute intestinal

obstruction . susceptibility to QT-interval prolongation

(including electrolyte disturbances)

l INTERACTIONS → Appendix 1: ondansetron

l SIDE-EFFECTS

▶ Common or very common Constipation . feeling hot. headache . sensation abnormal

▶ Uncommon Arrhythmias . chest pain . hiccups . hypotension . movement disorders . oculogyric crisis . seizure

▶ Rare or very rare Dizziness . QT interval prolongation . vision disorders

l PREGNANCY No information available; avoid unless

potential benefit outweighs risk.

l BREAST FEEDING Present in milk in animal studies—avoid.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

moderate to severe impairment (decreased clearance).

Dose adjustments Manufacturer advises maximum 8 mg

daily in moderate to severe impairment.

l DIRECTIONS FOR ADMINISTRATION

▶ With intravenous use For intravenous infusion (Zofran ®), give

continuously or intermittently in Glucose 5% or Glucose

5% with Potassium chloride 0.3% or Sodium chloride 0.9%

or Sodium chloride 0.9% with Potassium chloride 0.3% or

Mannitol 10% or Ringers solution; for intermittent

infusion, dilute the required dose in 50–100 mL of infusion

fluid and give over at least 15 minutes.

▶ With oral use Orodispersible films and lyophylisates should

be placed on the tongue, allowed to disperse and

swallowed.

l PRESCRIBING AND DISPENSING INFORMATION Flavours of

oral liquid formulations may include strawberry.

l PATIENT AND CARER ADVICE Patients or carers should be

given advice on how to administer orodispersible films and

lyophilisates.

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

▶ Ondansetron (Non-proprietary)

Ondansetron (as Ondansetron hydrochloride) 4 mg Ondansetron

4mg tablets | 10 tablet P £0.81–£25.46 DT = £9.94 | 30 tablet P £3.15–£76.38

Ondansetron (as Ondansetron hydrochloride) 8 mg Ondansetron

8mg tablets | 10 tablet P £47.99 DT = £10.31

▶ Ondemet (Alliance Pharmaceuticals Ltd)

Ondansetron (as Ondansetron hydrochloride) 8 mg Ondemet 8mg

tablets | 10 tablet P £54.36 DT = £10.31 (Hospital only)

▶ Zofran (Novartis Pharmaceuticals UK Ltd)

Ondansetron (as Ondansetron hydrochloride) 4 mg Zofran 4mg

tablets | 30 tablet P £107.91

Ondansetron (as Ondansetron hydrochloride) 8 mg Zofran 8mg

tablets | 10 tablet P £71.94 DT = £10.31

Suppository

▶ Zofran (Novartis Pharmaceuticals UK Ltd)

Ondansetron 16 mg Zofran 16mg suppositories | 1 suppository P £14.39

436 Nausea and labyrinth disorders BNF 78

Nervous system

4

Solution for injection

▶ Ondansetron (Non-proprietary)

Ondansetron (as Ondansetron hydrochloride) 2 mg per

1 ml Ondansetron 8mg/4ml solution for injection ampoules | 5 ampoule P £11.80–£58.45 DT = £59.95

Ondansetron 4mg/2ml solution for injection ampoules | 5 ampoule P £5.00–£29.97 DT = £29.97 | 10 ampoule P £15.00 DT = £15.00

▶ Zofran Flexi-amp (Novartis Pharmaceuticals UK Ltd)

Ondansetron (as Ondansetron hydrochloride) 2 mg per

1 ml Zofran Flexi-amp 8mg/4ml solution for injection | 5 ampoule P £59.95 DT = £59.95

Zofran Flexi-amp 4mg/2ml solution for injection | 5 ampoule P £29.97 DT = £29.97

Oral solution

▶ Ondansetron (Non-proprietary)

Ondansetron (as Ondansetron hydrochloride) 800 microgram

per 1 ml Ondansetron 4mg/5ml oral solution sugar free sugar-free | 50 ml P £38.11 DT = £38.10

▶ Zofran (Novartis Pharmaceuticals UK Ltd)

Ondansetron (as Ondansetron hydrochloride) 800 microgram

per 1 ml Zofran 4mg/5ml syrup sugar-free | 50 ml P £35.97 DT =

£38.10

Orodispersible film

▶ Setofilm (Norgine Pharmaceuticals Ltd)

Ondansetron 4 mg Setofilm 4mg orodispersible films sugar-free | 10 film P £28.50 DT = £28.50

Ondansetron 8 mg Setofilm 8mg orodispersible films sugar-free |

10 film P £57.00 DT = £57.00

Oral lyophilisate

EXCIPIENTS: May contain Aspartame

▶ Zofran Melt (Novartis Pharmaceuticals UK Ltd)

Ondansetron 4 mg Zofran Melt 4mg oral lyophilisates sugar-free |

10 tablet P £35.97 DT = £35.97

Ondansetron 8 mg Zofran Melt 8mg oral lyophilisates sugar-free | 10 tablet P £71.94 DT = £71.94

Orodispersible tablet

▶ Ondansetron (Non-proprietary)

Ondansetron 4 mg Ondansetron 4mg orodispersible tablets |

10 tablet P £43.46 DT = £43.46

Ondansetron 8 mg Ondansetron 8mg orodispersible tablets | 10 tablet P £85.43 DT = £85.43

Palonosetron

l DRUG ACTION Palonosetron is a specific 5HT3-receptor

antagonist which blocks 5HT3 receptors in the gastrointestinal tract and in the CNS.

l INDICATIONS AND DOSE

Moderately emetogenic chemotherapy

▶ INITIALLY BY MOUTH

▶ Adult: 500 micrograms, dose to be taken 1 hour before

treatment, alternatively (by intravenous injection)

250 micrograms for 1 dose, dose to be administered

over 30 seconds, 30 minutes before treatment

Severely emetogenic chemotherapy

▶ BY INTRAVENOUS INJECTION

▶ Adult: 250 micrograms for 1 dose, dose to be

administered over 30 seconds, 30 minutes before

treatment

l CAUTIONS History of constipation . intestinal obstruction . susceptibility to QT-interval prolongation (including

electrolyte disturbances)

l INTERACTIONS → Appendix 1: palonosetron

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Common or very common Constipation . headache

SPECIFIC SIDE-EFFECTS

▶ Common or very common

▶ With intravenous use Diarrhoea . dizziness . electrolyte

imbalance . metabolic disorder

▶ Uncommon

▶ With intravenous use Amblyopia . anxiety . appetite

decreased . arrhythmias . arthralgia . asthenia . drowsiness . dry mouth . dyspepsia . euphoric mood . eye irritation . feeling hot.fever. flatulence . glycosuria . hiccups . hyperbilirubinaemia . hyperglycaemia . hypertension . hypotension . influenza like illness . motion sickness . myocardial ischaemia . paraesthesia . peripheral

neuropathy . QT interval prolongation . skin reactions . sleep disorders .tinnitus . urinary retention . vasodilation . vein discolouration

▶ With oral use Atrioventricular block . dyspnoea . eye

swelling . insomnia . myalgia

▶ Rare or very rare

▶ With intravenous use Shock

l PREGNANCY Avoid—no information available.

l BREAST FEEDING Avoid—no information available.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Dizziness or drowsiness may affect

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

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

▶ Palonosetron (Non-proprietary)

Palonosetron (as Palonosetron hydrochloride) 50 microgram per

1 ml Palonosetron 250micrograms/5ml solution for injection vials | 1 vial P £53.10–£55.89 | 10 vial P £616.10

▶ Aloxi (Chugai Pharma UK Ltd)

Palonosetron (as Palonosetron hydrochloride) 50 microgram per

1 ml Aloxi 250micrograms/5ml solution for injection vials | 1 vial P £55.89

Capsule

▶ Aloxi (Chugai Pharma UK Ltd)

Palonosetron (as Palonosetron hydrochloride)

500 microgram Aloxi 500microgram capsules | 1 capsule P £55.89

Palonosetron with netupitant 20-Jun-2016

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, palonosetron above.

l INDICATIONS AND DOSE

Moderately emetogenic chemotherapy | Highly emetogenic

cisplatin-based chemotherapy

▶ BY MOUTH

▶ Adult: 1 capsule, to be taken approximately 1 hour

before the start of each chemotherapy cycle

l CAUTIONS Patients over 75 years

l INTERACTIONS → Appendix 1: netupitant. palonosetron

l SIDE-EFFECTS

▶ Common or very common Asthenia . constipation . headache

▶ Uncommon Alopecia . cardiac conduction disorders . cardiomyopathy . diarrhoea . dizziness . flatulence . gastrointestinal discomfort. hiccups . hypertension . increased leucocytes . neutropenia . QT interval

prolongation . sleep disorders . urticaria . vertigo

▶ Rare or very rare Acute psychosis . arrhythmias . conjunctivitis . cystitis . dysphagia . feeling hot. hypokalaemia . hypotension . leucopenia . mitral valve

incompetence . mood altered . myocardial ischaemia . numbness . pain .tongue coated . vision blurred

l CONCEPTION AND CONTRACEPTION Manufacturer

recommends exclude pregnancy before treatment in

females of childbearing age; ensure effective

contraception during treatment and for one month after

treatment.

BNF 78 Nausea and labyrinth disorders 437

Nervous system

4

l PREGNANCY Manufacturer advises avoid—toxicity in

animal studies.

l BREAST FEEDING Manufacturer advises avoid during

treatment and for 1 month after last dose—no information

available.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

severe impairment (risk of increased exposure, limited

information available).

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

The Scottish Medicines Consortium (December 2015) has

advised that palonosetron in combination with netupitant

(Akynzeo ®) is accepted for restricted use within NHS

Scotland for the prevention of acute and delayed nausea

and vomiting associated with highly emetogenic cisplatinbased cancer chemotherapy.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Capsule

CAUTIONARY AND ADVISORY LABELS 25

▶ Akynzeo (Chugai Pharma UK Ltd) A

Palonosetron (as Palonosetron hydrochloride) 500 microgram,

Netupitant 300 mg Akynzeo 300mg/0.5mg capsules | 1 capsule P £69.00 (Hospital only)

ANTIHISTAMINES › SEDATING ANTIHISTAMINES

Cinnarizine 09-Jul-2018

l INDICATIONS AND DOSE

Relief of symptoms of vestibular disorders, such as

vertigo, tinnitus, nausea, and vomiting in Ménière’s

disease

▶ BY MOUTH

▶ Child 5–11 years: 15 mg 3 times a day

▶ Child 12–17 years: 30 mg 3 times a day

▶ Adult: 30 mg 3 times a day

Motion sickness

▶ BY MOUTH

▶ Child 5–11 years: Initially 15 mg, dose to be taken

2 hours before travel, then 7.5 mg every 8 hours if

required, dose to be taken during journey

▶ Child 12–17 years: Initially 30 mg, dose to be taken

2 hours before travel, then 15 mg every 8 hours if

required, dose to be taken during journey

▶ Adult: Initially 30 mg, dose to be taken 2 hours before

travel, then 15 mg every 8 hours if required, dose to be

taken during journey

l CONTRA-INDICATIONS Avoid in Acute porphyrias p. 1058

l CAUTIONS Epilepsy . glaucoma (in children). Parkinson’s

disease (in adults). prostatic hypertrophy (in adults). pyloroduodenal obstruction . susceptibility to angleclosure glaucoma (in adults). urinary retention

l INTERACTIONS → Appendix 1: antihistamines, sedating

l SIDE-EFFECTS

▶ Common or very common Drowsiness . gastrointestinal

discomfort. nausea . weight increased

▶ Uncommon Fatigue . hyperhidrosis . vomiting

▶ Frequency not known Dry mouth . gastrointestinal disorder . headache . jaundice cholestatic . movement disorders . muscle rigidity . parkinsonism . skin reactions . subacute

cutaneous lupus erythematosus .tremor

l PREGNANCY Manufacturer advises avoid; however, there

is no evidence of teratogenicity. The use of sedating

antihistamines in the latter part of the third trimester may

cause adverse effects in neonates such as irritability,

paradoxical excitability, and tremor.

l BREAST FEEDING Most antihistamines are present in

breast milk in varying amounts; although not known to be

harmful, most manufacturers advise avoiding their use in

mothers who are breast-feeding.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

hepatic insufficiency—no information available.

l RENAL IMPAIRMENT Use with caution—no information

available.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. cycling, driving);

sedating effects enhanced by alcohol.

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

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Cinnarizine (Non-proprietary)

Cinnarizine 15 mg Cinnarizine 15mg tablets | 84 tablet p £15.40

DT = £5.05

▶ Stugeron (Johnson & Johnson Ltd, Janssen-Cilag Ltd)

Cinnarizine 15 mg Stugeron 15mg tablets | 15 tablet p £2.21 |

100 tablet p £4.18

Cinnarizine with dimenhydrinate

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, cinnarizine above.

l INDICATIONS AND DOSE

Vertigo

▶ BY MOUTH

▶ Adult: 1 tablet 3 times a day

l INTERACTIONS → Appendix 1: antihistamines, sedating . dimenhydrinate

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 2, 21

▶ Arlevert (Hennig Arzneimittel GmbH & Co. KG)

Cinnarizine 20 mg, Dimenhydrinate 40 mg Arlevert tablets | 100 tablet P £24.00 DT = £24.00

Promethazine teoclate

l INDICATIONS AND DOSE

Nausea | Vomiting | Labyrinthine disorders

▶ BY MOUTH

▶ Child 5–9 years: 12.5–37.5 mg daily

▶ Child 10–17 years: 25–75 mg daily; maximum 100 mg

per day

▶ Adult: 25–75 mg daily; maximum 100 mg per day

Motion sickness prevention (acts longer than

promethazine hydrochloride)

▶ BY MOUTH

▶ Child 5–9 years: 12.5 mg once daily, dose to be taken at

bedtime on night before travel or 1–2 hours before

travel

▶ Child 10–17 years: 25 mg once daily, dose to be taken at

bedtime on night before travel or 1–2 hours before

travel

▶ Adult: 25 mg once daily, dose to be taken at bedtime on

night before travel or 1–2 hours before travel

Motion sickness treatment (acts longer than

promethazine hydrochloride)

▶ BY MOUTH

▶ Child 5–9 years: 12.5 mg, dose to be taken at onset of

motion sickness, then 12.5 mg daily for 2 days, dose to

be taken at bedtime

438 Nausea and labyrinth disorders BNF 78

Nervous system

4

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