▶ Adult: 5–10 mg 3–4 times a day
MHRA/CHM ADVICE (MARCH 2008 AND FEBRUARY 2009) OVERTHE-COUNTER COUGH AND COLD MEDICINES FOR CHILDREN
Children under 6 years should not be given over-thecounter cough and cold medicines containing
pholcodine (cough suppressant).
Over-the-counter cough and cold medicines can be
considered for children aged 6–12 years after basic
principles of best care have been tried, but treatment
should be restricted to 5 days or less. Children should
not be given more than 1 cough or cold preparation at a
time because different brands may contain the same
active ingredient; care should be taken to give the
l CONTRA-INDICATIONS Bronchiectasis . bronchiolitis (in
children). chronic bronchitis . chronic obstructive
pulmonary disease (in adults). patients at risk of
l CAUTIONS Asthma . chronic cough . persistent cough . productive cough
l INTERACTIONS → Appendix 1: pholcodine
l PREGNANCY Manufacturer advises avoid unless potential
l BREAST FEEDING Manufacturer advises avoid unless
potential benefit outweighs risk—no information
l HEPATIC IMPAIRMENT Manufacturer advises caution; avoid
l RENAL IMPAIRMENT Use with caution in renal impairment.
Avoid in severe renal impairment.
l PRESCRIBING AND DISPENSING INFORMATION Pholcodine
is not generally recommended for children.
Flavours of oral liquid formulations may include orange.
When prepared extemporaneously, the BP states
Pholcodine Linctus, BP consists of pholcodine 5 mg/5 mL
in a suitable flavoured vehicle, containing citric acid
monohydrate 1% and Pholcodine Linctus, Strong, BP
consists of pholcodine 10 mg/5 mL in a suitable flavoured
vehicle, containing citric acid monohydrate 2%
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Pholcodine (Non-proprietary)
Pholcodine 1 mg per 1 ml Pholcodine 5mg/5ml linctus | 200 ml p
£1.23–£1.32 DT = £1.32m Pholcodine 5mg/5ml linctus sugar free sugar-free | 200 ml p £1.34
DT = £1.34msugar-free | 2000 ml p £13.40m
Pholcodine 2 mg per 1 ml Pholcodine 10mg/5ml linctus strong sugar
£1.67m ▶ Covonia Dry Cough (Thornton & Ross Ltd)
Pholcodine 1 mg per 1 ml Covonia Dry Cough Sugar Free Formula
5mg/5ml oral solution sugar-free | 150 ml p £3.30m ▶ Galenphol (Thornton & Ross Ltd)
Pholcodine 1 mg per 1 ml Galenphol 5mg/5ml linctus sugar-free | 2000 ml p £8.50m
Pholcodine 2 mg per 1 ml Galenphol Strong 10mg/5ml linctus sugarfree | 2000 ml p £9.88 DT = £9.88m
COUGH AND COLD PREPARATIONS › OTHER
(Formulated as Simple Linctus)
▶ Adult: 5 mL 3–4 times a day, this dose is for Simple
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include anise.
When prepared extemporaneously, the BP states Simple
Linctus, BP consists of citric acid monohydrate 2.5%, in a
suitable vehicle with an anise flavour.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Citric acid (Non-proprietary)
Citric acid monohydrate 25 mg per 1 ml Simple linctus sugar free
sugar-free | 200 ml G £1.25 DT = £0.92 sugar-free | 2000 ml G £9.20
Simple linctus | 200 ml G £0.93–£0.96 DT = £0.93
Aromatic inhalation for relief of nasal congestion
▶ Adult: Add one teaspoonful to a pint of hot, not
boiling, water and inhale the vapour
l PRESCRIBING AND DISPENSING INFORMATION When
prepared extemporaneously, the BP states Menthol and
Eucalyptus Inhalation, BP 1980 consists of racementhol or
levomenthol 2 g, eucalyptus oil 10 mL, light magnesium
carbonate 7 g, water to 100 mL.
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
Menthol and Eucalyptus Inhalation BP, 1980 may be
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Eucalyptus with menthol (Non-proprietary)
Menthol 20 mg per 1 ml, Magnesium carbonate light 70 mg per
1 ml, Eucalyptus oil 100 microlitre per 1 ml Menthol and
Eucalyptus inhalation | 100 ml G £1.39 DT = £1.39
Aromatic inhalation for relief of nasal congestion
▶ Child: Add 5 mL to a pint of hot, not boiling, water and
inhale the vapour; repeat after 4 hours if necessary
▶ Adult: Add 5 mL to a pint of hot, not boiling, water and
inhale the vapour; repeat after 4 hours if necessary
l SIDE-EFFECTS Skin sensitisation
l PRESCRIBING AND DISPENSING INFORMATION Not
recommended (applied as a rub or to pillows) for infants
BNF 78 Cough and congestion 297
When prepared extemporaneously, the BP states
Benzoin Tincture, Compound, BP consists of balsamic
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 15
▶ Benzoin tincture, compound (Non-proprietary)
Benzoin sumatra 100 mg per 1 ml, Storax prepared 100 mg per
1 ml Benzoin compound tincture | 500 ml £12.11 DT = £12.11
Friars’ Balsam | 50 ml G £2.11
Other drugs used for Idiopathic pulmonary fibrosis
l DRUG ACTION The exact mechanism of action of
pirfenidone is not yet understood, but it is believed to slow
down the progression of idiopathic pulmonary fibrosis by
exerting both antifibrotic and anti-inflammatory
Treatment of mild to moderate idiopathic pulmonary
fibrosis (initiated under specialist supervision)
▶ Adult: Initially 267 mg 3 times a day for 7 days, then
increased to 534 mg 3 times a day for 7 days, then
increased to 801 mg 3 times a day
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Caution with concomitant use with ciprofloxacin—
reduce dose of pirfenidone to 534 mg three times daily
with high-dose ciprofloxacin (750 mg twice daily).
l CONTRA-INDICATIONS Cigarette smoking
▶ Photosensitivity Avoid exposure to direct sunlight—if
photosensitivity reaction or rash occurs, dose adjustment
or treatment interruption may be required (consult
▶ Treatment interruption If treatment is interrupted for
14 consecutive days or more, the initial 2 week titration
regimen should be repeated; if treatment is interrupted for
less than 14 consecutive days, the dose can be resumed at
the previous daily dose without titration.
l INTERACTIONS → Appendix 1: pirfenidone
▶ Rare or very rare Agranulocytosis
SIDE-EFFECTS, FURTHER INFORMATION Gastrointestinal
side-effects may require dose reduction or treatment
interruption—consult product literature.
l PREGNANCY Manufacturer advises avoid—no information
l BREAST FEEDING Manufacturer advises avoid—no
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment (risk of increased exposure);
avoid in severe impairment (no information available).
l RENAL IMPAIRMENT Avoid use if eGFR less than
▶ Test liver function before treatment, then at monthly
intervals for the next 6 months, and then every 3 months
thereafter; review if abnormal liver function tests—dose
reduction, treatment interruption or discontinuation may
be required (consult product literature).
Driving and skilled tasks Dizziness or malaise may affect
performance of skilled tasks (e.g. driving).
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Pirfenidone for treating idiopathic pulmonary fibrosis
Pirfenidone (Esbriet ®) is recommended as an option for
treating idiopathic pulmonary fibrosis in adults only if:
. the patient has a forced vital capacity (FVC) between
. the manufacturer provides pirfenidone with the discount
agreed in the patient access scheme, and
. treatment is stopped if there is evidence of disease
progression (an absolute decline of 10% or more in
predicted FVC within any 12-month period).
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
www.nice.org.uk/guidance/ta504
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (August
2013) that pirfenidone (Esbriet ®) is accepted for restricted
use within NHS Scotland for the treatment of mild to
moderate idiopathic pulmonary fibrosis. Pirfenidone is
restricted for use in patients with a predicted forced vital
capacity less than or equal to 80%, and only whilst
pirfenidone is available at the price agreed in the patient
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Esbriet (Roche Products Ltd)
Pirfenidone 267 mg Esbriet 267mg tablets | 63 tablet P £501.92 | 252 tablet P £2,007.70
Pirfenidone 801 mg Esbriet 801mg tablets | 84 tablet P £2,007.70
CAUTIONARY AND ADVISORY LABELS 21, 25, 11
▶ Esbriet (Roche Products Ltd)
298 Idiopathic pulmonary fibrosis BNF 78
Respiratory stimulants (analeptic drugs) have a limited place
in the treatment of ventilatory failure in patients with
chronic obstructive pulmonary disease. They are effective
only when given by intravenous injection or infusion and
have a short duration of action. Their use has largely been
replaced by ventilatory support including nasal intermittent
positive pressure ventilation. However, occasionally when
ventilatory support is contra-indicated and in patients with
hypercapnic respiratory failure who are becoming drowsy or
comatose, respiratory stimulants in the short term may
arouse patients sufficiently to co-operate and clear their
Respiratory stimulants can also be harmful in respiratory
failure since they stimulate non-respiratory as well as
respiratory muscles. They should only be given under expert
supervision in hospital and must be combined with active
physiotherapy. There is at present no oral respiratory
stimulant available for long-term use in chronic respiratory
Doxapram hydrochloride 28-Jun-2018
Postoperative respiratory depression
▶ INITIALLY BY INTRAVENOUS INJECTION
▶ Adult: Initially 1–1.5 mg/kg, to be administered over at
least 30 seconds, repeated if necessary after intervals of
one hour, alternatively (by intravenous infusion)
2–3 mg/minute, adjusted according to response
▶ Adult: 1.5–4 mg/minute, adjusted according to
response, to be given concurrently with oxygen and
whenever possible monitor with frequent
measurement of blood gas tensions
l CONTRA-INDICATIONS Cerebral oedema . cerebrovascular
accident. coronary artery disease . epilepsy and other
convulsive disorders . hyperthyroidism . physical
obstruction of respiratory tract. severe hypertension . status asthmaticus
or severely decreased lung compliance (because of
increased work load of breathing). hypertension . impaired
cardiac reserve . phaeochromocytoma
l INTERACTIONS → Appendix 1: doxapram
disorders . nausea . neuromuscular dysfunction . oral
l PREGNANCY No evidence of harm, but manufacturer
advises avoid unless benefit outweighs risk.
l HEPATIC IMPAIRMENT Manufacturer advises use with
l MONITORING REQUIREMENTS Frequent arterial blood gas
and pH measurements are necessary during treatment to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Doxapram hydrochloride (Non-proprietary)
Doxapram hydrochloride 20 mg per 1 ml Doxapram 100mg/5ml
solution for injection ampoules | 5 ampoule P £126.50
▶ Doxapram hydrochloride (Non-proprietary)
Doxapram hydrochloride 2 mg per 1 ml Doxapram 1g/500ml
BNF 78 Respiratory depression, respiratory distress syndrome and apnoea 299
2 Epilepsy and other seizure disorders 305
3.2 Attention deficit hyperactivity disorder 346
3.3 Bipolar disorder and mania 353
3.5 Inappropriate sexual behaviour 380
3.6 Psychoses and schizophrenia 381
4.1 Dystonias and other involuntary movements 405
5 Nausea and labyrinth disorders page 428
Dementia is a progressive clinical syndrome characterised by
a range of cognitive and behavioural symptoms that can
include memory loss, problems with reasoning and
communication, a change in personality, and a reduced
ability to carry out daily activities such as washing or
dressing. Alzheimer’s disease is the most common type of
dementia; other common types of dementia include vascular
dementia (due to cerebrovascular disease), dementia with
Lewy bodies, mixed dementia, and frontotemporal dementia.
The aim of treatment is to promote independence, maintain
function, and manage symptoms of dementia.
g Patients with all types of mild-to-moderate dementia
presenting with cognitive symptoms should be given the
opportunity to participate in a structured group cognitive
stimulation programme. Group reminiscence therapy (use of
life stories to improve psychological well-being), and
cognitive rehabilitation or occupational therapy to support
daily functional ability, should also be considered. h
Management of cognitive symptoms
g Some commonly prescribed drugs are associated with
increased antimuscarinic (anticholinergic) burden, and
therefore cognitive impairment; their use should be
minimised. hDrugs with antimuscarinic effects include
some antidepressants (e.g. amitriptyline hydrochloride
p. 372, paroxetine p. 366), antihistamines (e.g.
chlorphenamine maleate p. 283, promethazine
hydrochloride p. 286), antipsychotics (e.g. olanzapine p. 398,
quetiapine p. 401), and urinary antispasmodics (e.g.
solifenacin succinate p. 779, tolterodine tartrate p. 780).
g In newly diagnosed patients, drug treatment should
only be initiated under the advice of a specialist clinician
experienced in the management of Alzheimer’s disease.
In patients with mild-to-moderate Alzheimer’s disease,
monotherapy with donepezil hydrochloride p. 301,
galantamine p. 302, or rivastigmine p. 303
(acetylcholinesterase inhibitors) are first-line treatment
options. If acetylcholinesterase inhibitors are not tolerated
or contra-indicated, memantine hydrochloride p. 304 is a
suitable alternative in patients with moderate Alzheimer’s
disease. Memantine hydrochloride is the drug of choice in
patients with severe Alzheimer’s disease.
In patients already receiving an acetylcholinesterase
inhibitor to treat Alzheimer’s disease, the addition of
memantine hydrochloride should be considered if they
develop moderate or severe disease; in this case, memantine
hydrochloride can be initiated in primary care without advice
from a specialist clinician. h
In patients with moderate Alzheimer’s disease,
discontinuing acetylcholinesterase inhibitor treatment can
cause a substantial worsening in cognitive function;g
treatment discontinuation should not be based on disease
g Donepezil hydrochloride [unlicensed indication] or
rivastigmine [unlicensed indication] should be given to
patients with mild-to-moderate dementia with Lewy bodies;
galantamine [unlicensed indication] can be considered only
if treatment with both donepezil hydrochloride or
rivastigmine is not tolerated. Donepezil hydrochloride
[unlicensed indication] or rivastigmine [unlicensed
indication] can also be considered in patients with severe
dementia with Lewy bodies. Memantine hydrochloride
[unlicensed indication] can be considered as an alternative in
patients with dementia with Lewy bodies in whom
acetylcholinesterase inhibitors are contra-indicated or not
Acetylcholinesterase inhibitors [unlicensed indication] or
memantine hydrochloride [unlicensed indication] should
only be considered in patients with vascular dementia if they
have suspected co-morbid Alzheimer’s disease, Parkinson’s
disease dementia, or dementia with Lewy bodies. h
g Acetylcholinesterase inhibitors and memantine
hydrochloride are not recommended in patients with
frontotemporal dementia or cognitive impairment caused by
For management of Parkinson’s disease dementia see
Management of non-cognitive symptoms
Agitation, aggression, distress and psychosis
g Patients with dementia should be offered psychosocial
and environmental interventions such as counselling and
management of pain and delirium to reduce distress.
Antipsychotic drugs should only be offered to patients
with dementia if they are either at risk of harming
themselves or others, or experiencing agitation,
hallucinations or delusions that are causing them severe
distress. hThe CHM/MHRA has reported (2009) an
increased risk of stroke and a small increased risk of death
when antipsychotic drugs are used in elderly patients with
dementia. The balance of risks and benefits should be
carefully assessed, including any previous history of stroke
or transient ischaemic attack and any risk factors for
cerebrovascular disease such as hypertension, diabetes,
smoking, and atrial fibrillation.
g Antipsychotic drugs should be used at the lowest
effective dose and for the shortest time possible, with a
regular review at least every 6 weeks. h
In patients who have dementia with Lewy bodies or
Parkinson’s disease dementia, antipsychotic drugs can
worsen the motor features of the condition, and in some
cases cause severe antipsychotic sensitivity reactions. See
also management of psychotic symptoms in Parkinson’s
g Psychological treatments (e.g. cognitive behavioural
therapy (CBT), multisensory stimulation, relaxation, or
animal-assisted therapies) should be considered for patients
with mild-to-moderate dementia who have mild to moderate
depression or anxiety; antidepressants should be reserved
for pre-existing severe mental health problems. h
g Patients should be offered non-drug treatment
approaches to manage sleep problems and insomnia,
including sleep hygiene education, exposure to daylight, and
increasing exercise and activity. h
Dementia: assessment, management and support for people
living with dementia and their carers. National Institute for
Health and Care Excellence. NICE guideline 97. June 2018.
Other drugs used for Dementia Risperidone, p. 402
ANTICHOLINESTERASES › CENTRALLY ACTING
Donepezil hydrochloride 25-Jul-2018
l DRUG ACTION Donepezil is a reversible inhibitor of
Mild to moderate dementia in Alzheimer’s disease
▶ Adult: Initially 5 mg once daily for one month, then
increased if necessary up to 10 mg daily, doses to be
l CAUTIONS Asthma . chronic obstructive pulmonary
disease . sick sinus syndrome . supraventricular conduction
abnormalities . susceptibility to peptic ulcers
l INTERACTIONS → Appendix 1: anticholinesterases,
▶ Common or very common Aggression . agitation . appetite
▶ Uncommon Bradycardia . gastrointestinal haemorrhage . hypersalivation . seizure
malignant syndrome .rhabdomyolysis
SIDE-EFFECTS, FURTHER INFORMATION Dose should be
started low and increased if tolerated and necessary.
l HEPATIC IMPAIRMENT Manufacturer advises caution (risk
of increased exposure in mild to moderate impairment; no
information available in severe impairment).
Dose adjustments Manufacturer advises dose escalation
should be performed according to individual tolerability in
l DIRECTIONS FOR ADMINISTRATION Donepezil
orodispersible tablet should be placed on the tongue,
allowed to disperse, and swallowed.
l PATIENT AND CARER ADVICE Patient or carers should be
given advice on how to administer donepezil
hydrochloride orodispersible tablets.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Donepezil, galantamine, rivastigmine, and memantine for the
treatment of Alzheimer’s disease (updated June 2018)
The three acetylcholinesterase (AChE) inhibitors
donepezil, galantamine, and rivastigmine as
monotherapies are recommended as options for managing
mild to moderate Alzheimer’s disease under all of the
conditions specified below and in recommendation 1.5.5 of
the NICE guideline on dementia.
If prescribing an AChE inhibitor (donepezil,
galantamine, or rivastigmine), treatment should normally
be started with the drug with the lowest acquisition cost
(taking into account required daily dose and the price per
dose once shared care has started). However, an
alternative AChE inhibitor could be prescribed if it is
considered appropriate when taking into account adverse
event profile, expectations about adherence, medical
comorbidity, possibility of drug interactions and dosing
Healthcare professionals should not rely solely on
assessment scales to determine the severity of Alzheimer’s
disease when the patient has learning or other disabilities,
or other communication difficulties.
www.nice.org.uk/guidance/ta217
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
▶ Donepezil hydrochloride (Non-proprietary)
Donepezil hydrochloride 1 mg per 1 ml Donepezil 1mg/ml oral
solution sugar free sugar-free | 150 ml P £51.00 DT = £50.98
▶ Donepezil hydrochloride (Non-proprietary)
Donepezil hydrochloride 5 mg Donepezil 5mg orodispersible tablets
sugar free sugar-free | 28 tablet P £7.29–£50.87 DT = £7.36
Donepezil hydrochloride 10 mg Donepezil 10mg orodispersible
tablets sugar free sugar-free | 28 tablet P £7.95–£71.31 DT =
Donepezil hydrochloride 5 mg Aricept Evess 5mg orodispersible
tablets sugar-free | 28 tablet P £59.85 DT = £7.36
Donepezil hydrochloride 10 mg Aricept Evess 10mg orodispersible
tablets sugar-free | 28 tablet P £83.89 DT = £8.26
▶ Donepezil hydrochloride (Non-proprietary)
Donepezil hydrochloride 5 mg Donepezil 5mg tablets | 28 tablet P £59.85 DT = £0.83
Donepezil hydrochloride 10 mg Donepezil 10mg tablets | 28 tablet P £83.89 DT = £0.97
Donepezil hydrochloride 5 mg Aricept 5mg tablets |
Donepezil hydrochloride 10 mg Aricept 10mg tablets | 28 tablet P £83.89 DT = £0.97
l DRUG ACTION Galantamine is a reversible inhibitor of
acetylcholinesterase and it also has nicotinic receptor
Mild to moderately severe dementia in Alzheimer’s
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 4 mg twice daily for 4 weeks, increased
to 8 mg twice daily for at least 4 weeks; maintenance
▶ BY MOUTH USING MODIFIED-RELEASE CAPSULES
▶ Adult: Initially 8 mg once daily for 4 weeks, increased
to 16 mg once daily for at least 4 weeks; maintenance
l CAUTIONS Avoid in gastro-intestinal obstruction . avoid in
urinary outflow obstruction . avoid whilst recovering from
pulmonary disease . congestive heart failure . electrolyte
to peptic ulcers . unstable angina
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