CAUTIONARY AND ADVISORY LABELS 2, 21

▶ Zaditen (CD Pharma Srl)

Ketotifen (as Ketotifen fumarate) 1 mg Zaditen 1mg tablets | 60 tablet P £7.53 DT = £7.53

Promethazine hydrochloride

l INDICATIONS AND DOSE

Symptomatic relief of allergy such as hay fever and

urticaria | Insomnia associated with urticaria and

pruritus

▶ BY MOUTH

▶ Child 2–4 years: 5 mg twice daily, alternatively 5–15 mg

once daily, dose to be taken at night

▶ Child 5–9 years: 5–10 mg twice daily, alternatively

10–25 mg once daily, dose to be taken at night

▶ Child 10–17 years: 10–20 mg 2–3 times a day,

alternatively 25 mg once daily, dose to be taken at

night, increased if necessary to 25 mg twice daily

▶ Adult: 10–20 mg 2–3 times a day

▶ BY DEEP INTRAMUSCULAR INJECTION

▶ Adult: 25–50 mg (max. per dose 100 mg)

Emergency treatment of anaphylactic reactions

▶ BY SLOW INTRAVENOUS INJECTION

▶ Adult: 25–50 mg, to be administered as a solution

containing 2.5 mg/mL in water for injections;

maximum 100 mg per course

Sedation (short-term use)

▶ BY MOUTH

▶ Child 2–4 years: 15–20 mg

▶ Child 5–9 years: 20–25 mg

▶ Child 10–17 years: 25–50 mg

▶ Adult: 25–50 mg

▶ BY DEEP INTRAMUSCULAR INJECTION

▶ Adult: 25–50 mg

Nausea | Vomiting | Vertigo | Labyrinthine disorders |

Motion sickness

▶ BY MOUTH

▶ Child 2–4 years: 5 mg, to be taken at bedtime on night

before travel, repeat following morning if necessary

▶ Child 5–9 years: 10 mg, to be taken at bedtime on night

before travel, repeat following morning if necessary

286 Allergic conditions BNF 78

Respiratory system

3

▶ Child 10–17 years: 20–25 mg, to be taken at bedtime on

night before travel, repeat following morning if

necessary

▶ Adult: 20–25 mg, to be taken at bedtime on night

before travel, repeat following morning if necessary

IMPORTANT SAFETY INFORMATION

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

promethazine.

l CONTRA-INDICATIONS Should not be given to children

under 2 years, except on specialist advice, because the

safety of such use has not been established

l CAUTIONS

GENERAL CAUTIONS Epilepsy . prostatic hypertrophy (in

adults). pyloroduodenal obstruction . severe coronary

artery disease . susceptibility to angle-closure glaucoma . urinary retention

SPECIFIC CAUTIONS

▶ With intravenous use Avoid extravasation with intravenous

injection

l INTERACTIONS → Appendix 1: antihistamines, sedating

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS Arrhythmia . blood disorder. confusion . dizziness . drowsiness . dry mouth . headache . hypotension . jaundice . movement disorders . palpitations . photosensitivity reaction . urinary retention . vision

blurred

SPECIFIC SIDE-EFFECTS

▶ With oral use Agranulocytosis . angle closure glaucoma . anticholinergic syndrome . anxiety . insomnia . leucopenia . nasal congestion . nausea .rash . seizure . thrombocytopenia .tinnitus .tremor. vomiting

▶ With parenteral use Appetite decreased . epigastric

discomfort.fatigue . haemolytic anaemia . hypersensitivity . muscle spasms . nightmare .restlessness . skin reactions

SIDE-EFFECTS, FURTHER INFORMATION Elderly patients are

more susceptible to anticholinergic side-effects.

l PREGNANCY Most manufacturers of antihistamines advise

avoiding their use during pregnancy; however, there is no

evidence of teratogenicity. Use 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.

l RENAL IMPAIRMENT Use with caution.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect the

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

sedating effects enhanced by alcohol.

l PROFESSION SPECIFIC INFORMATION

Dental practitioners’ formulary

Promethazine Hydrochloride Tablets 10 mg or 25 mg may

be prescribed.

Promethazine Hydrochloride Oral Solution (elixir)

5 mg/5 mL may be prescribed.

l LESS SUITABLE FOR PRESCRIBING Promethazine is less

suitable for prescribing for sedation.

l EXCEPTIONS TO LEGAL CATEGORY Prescription only

medicine restriction does not apply to promethazine

hydrochloride injection where administration is for saving

life in emergency.

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

Solution for injection

EXCIPIENTS: May contain Sulfites

▶ Phenergan (Sanofi)

Promethazine hydrochloride 25 mg per 1 ml Phenergan 25mg/1ml

solution for injection ampoules | 10 ampoule P £6.74

Oral solution

CAUTIONARY AND ADVISORY LABELS 2

EXCIPIENTS: May contain Sulfites

ELECTROLYTES: May contain Sodium

▶ Phenergan (Sanofi)

Promethazine hydrochloride 1 mg per 1 ml Phenergan 5mg/5ml

elixir sugar-free | 100 ml p £2.85 DT = £2.85

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Promethazine hydrochloride (Non-proprietary)

Promethazine hydrochloride 10 mg Promethazine hydrochloride

10mg tablets | 56 tablet P £3.56 DT = £3.41

Promethazine hydrochloride 25 mg Promethazine hydrochloride

25mg tablets | 56 tablet p £4.65 DT = £4.65

▶ Phenergan (Sanofi)

Promethazine hydrochloride 25 mg Phenergan 25mg tablets | 56 tablet p £4.65 DT = £4.65

▶ Sominex (Teva UK Ltd)

Promethazine hydrochloride 20 mg Sominex 20mg tablets | 8 tablet p £1.89 | 16 tablet p £2.69

VACCINES › ALLERGEN-TYPE VACCINES

Bee venom extract 25-Apr-2019

l INDICATIONS AND DOSE

Hypersensitivity to bee venom

▶ BY SUBCUTANEOUS INJECTION

▶ Adult: (consult product literature)

IMPORTANT SAFETY INFORMATION

DESENSITISING VACCINES

In view of concerns about the safety of desensitising

vaccines, it is recommended that they are used by

specialists and only for the following indications:

. seasonal allergic hay fever (caused by pollen) that has

not responded to anti-allergic drugs;

. hypersensitivity to wasp and bee venoms.

Desensitising vaccines should generally be avoided or

used with particular care in patients with asthma.

l CONTRA-INDICATIONS Consult product literature

l CAUTIONS Consult product literature

l INTERACTIONS → Appendix 1: bee venom extract

l SIDE-EFFECTS

SIDE-EFFECTS, FURTHER INFORMATION Life-threatening

hypersensitivity reactions can occur. Cardiopulmonary

resuscitation must be immediately available. Manufacturer

advises monitoring for at least 1 hour after injection.

l PREGNANCY Avoid.

l PRESCRIBING AND DISPENSING INFORMATION Each set of

allergen extracts usually contains vials for the

administration of graded amounts of allergen to patients

undergoing hyposensitisation. Maintenance sets

containing vials at the highest strength are also available.

Product literature must be consulted for details of

allergens, vial strengths, and administration.

BNF 78 Allergic conditions 287

Respiratory system

3

l NATIONAL FUNDING/ACCESS DECISIONS

NICE decisions

▶ Pharmalgen® for the treatment of bee and wasp venom

allergy (February 2012) NICE TA246

Pharmalgen ® is an option for the treatment of IgEmediated bee and wasp venom allergy in those who have

had:

. a severe systemic reaction to bee or wasp venom, or

. a moderate systemic reaction to bee or wasp venom and

who have a raised baseline serum-tryptase

concentration, a high risk of future stings, or anxiety

about future stings.

Treatment with Pharmalgen ® should be initiated and

monitored in a specialist centre experienced in venom

immunotherapy.

www.nice.org.uk/guidance/ta246

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder and solvent for solution for injection

▶ Pharmalgen Bee Venom (ALK-Abello Ltd)

Bee venom 120 nanogram Pharmalgen Bee Venom 120nanogram

powder and solvent for solution for injection vials | 1 vial P s

Bee venom 1.2 microgram Pharmalgen Bee Venom 1.2microgram

powder and solvent for solution for injection vials | 1 vial P s

Bee venom 12 microgram Pharmalgen Bee Venom 12microgram

powder and solvent for solution for injection vials | 1 vial P s

Bee venom 120 microgram Pharmalgen Bee Venom maintenance

set 120microgram powder and solvent for solution for injection vials | 4 vial P £150.00

Grass pollen extract

l INDICATIONS AND DOSE

Treatment of seasonal allergic hay fever due to grass

pollen in patients who have failed to respond to antiallergy drugs

▶ BY SUBCUTANEOUS INJECTION

▶ Adult: (consult product literature)

Treatment of seasonal allergic hay fever due to grass

pollen in patients who have failed to respond to antiallergy drugs (initiated under specialist supervision)

▶ BY MOUTH

▶ Adult: 1 tablet daily, treatment to be started at least

4 months before start of pollen season and continue for

up to 3 years

IMPORTANT SAFETY INFORMATION

DESENSITISING VACCINES

In view of concerns about the safety of desensitising

vaccines, it is recommended that they are used by

specialists and only for the following indications:

. seasonal allergic hay fever (caused by pollen) that has

not responded to anti-allergic drugs;

. hypersensitivity to wasp and bee venoms.

Desensitising vaccines should generally be avoided or

used with particular care in patients with asthma.

l CONTRA-INDICATIONS Consult product literature

l CAUTIONS Consult product literature

l INTERACTIONS → Appendix 1: grass pollen extract

l SIDE-EFFECTS

SIDE-EFFECTS, FURTHER INFORMATION Hypersensitivity

reactions to immunotherapy can be life-threatening;

bronchospasm usually develops within 1 hour and

anaphylaxis within 30 minutes of injection. Therefore,

cardiopulmonary resuscitation must be immediately

available and patients need to be monitored for at least

1 hour after injection. If symptoms or signs of

hypersensitivity develop (e.g. rash, urticaria,

bronchospasm, faintness), even when mild, the patient

should be observed until these have resolved completely.

l PREGNANCY Should be avoided in pregnant women—

consult product literature.

l MONITORING REQUIREMENTS The first dose of grass pollen

extract (Grazax ®) should be taken under medical

supervision and the patient should be monitored for

20–30 minutes.

l DIRECTIONS FOR ADMINISTRATION Oral lyophylisates

should be placed under the tongue and allowed to

disperse. Advise patient not to swallow for 1 minute, or eat

or drink for 5 minutes after taking the tablet. The first

should be taken under medical supervision and the patient

should be monitored for 20–30 minutes.

l PRESCRIBING AND DISPENSING INFORMATION Each set of

allergen extracts usually contains vials for the

administration of graded amounts of allergen to patients

undergoing hyposensitisation. Maintenance sets

containing vials at the highest strength are also available.

Product literature must be consulted for details of

allergens, vial strengths, and administration.

l PATIENT AND CARER ADVICE

▶ With oral use Patients or carers should be given advice on

how to administer oral lyophilisates.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Suspension for injection

▶ Pollinex Grasses + Rye (Allergy Therapeutics (UK) Ltd)

Pollinex Grasses + Rye suspension for injection treatment and

extension course vials | 4 vial P £450.00

Oral lyophilisate

▶ Grazax (ALK-Abello Ltd)

Phleum pratense 75000 SQ-T Grazax 75,000 SQ-T oral lyophilisates

sugar-free | 30 tablet P £80.12 DT = £80.12

Tree pollen extract

l INDICATIONS AND DOSE

Treatment of seasonal allergic hay fever due to tree pollen

in patients who have failed to respond to anti-allergy

drugs

▶ BY SUBCUTANEOUS INJECTION

▶ Adult: (consult product literature)

IMPORTANT SAFETY INFORMATION

DESENSITISING VACCINES

In view of concerns about the safety of desensitising

vaccines, it is recommended that they are used by

specialists and only for the following indications:

. seasonal allergic hay fever (caused by pollen) that has

not responded to anti-allergic drugs;

. hypersensitivity to wasp and bee venoms.

Desensitising vaccines should generally be avoided or

used with particular care in patients with asthma.

l CONTRA-INDICATIONS Consult product literature

l CAUTIONS Consult product literature

l INTERACTIONS → Appendix 1: tree pollen extract

l SIDE-EFFECTS

SIDE-EFFECTS, FURTHER INFORMATION Hypersensitivity

reactions to immunotherapy can be life-threatening.

Cardiopulmonary resuscitation must be immediately

available and patients need to be monitored for at least

1 hour after injection. If symptoms or signs of

hypersensitivity develop (e.g. rash, urticaria,

bronchospasm, faintness), even when mild, the patient

should be observed until these have resolved completely.

l PREGNANCY Should be avoided in pregnant women—

consult product literature.

288 Allergic conditions BNF 78

Respiratory system

3

 

l SIDE-EFFECTS Aggression . agranulocytosis . anxiety . appetite abnormal . arrhythmias . bronchial secretion

viscosity increased . chest tightness . chills . confusion . constipation . coordination abnormal . diarrhoea . dizziness . drowsiness . dry mouth . dry throat. epigastric

distress . epistaxis .fatigue . haemolytic anaemia . hallucination . headache . hepatic disorders . hyperhidrosis . hypotension . insomnia . labyrinthitis . leucopenia . menstruation irregular. mood altered . nasal complaints . nausea . neuritis . oedema . palpitations . paraesthesia . photosensitivity reaction . seizure . skin reactions . thrombocytopenia .tinnitus .tremor. urinary disorders . vertigo . vision disorders . vomiting . weight increased . wheezing

l PREGNANCY Most manufacturers of antihistamines advise

avoiding their use during pregnancy; however, there is no

evidence of teratogenicity. Use 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 PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. 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, oral

solution

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Periactin (Teva UK Ltd)

Cyproheptadine hydrochloride 4 mg Periactin 4mg tablets | 30 tablet p £5.99 DT = £5.99

Hydroxyzine hydrochloride 30-Mar-2017

l DRUG ACTION Hydroxyzine is a sedating antihistamine

which exerts its actions by antagonising the effects of

histamine.

l INDICATIONS AND DOSE

Pruritus

▶ BY MOUTH

▶ Child 6 months–5 years: 5–15 mg daily in divided doses,

dose adjusted according to weight; maximum 2 mg/kg

per day

▶ Child 6–17 years (body-weight up to 40 kg): Initially

15–25 mg daily in divided doses, dose increased as

necessary, adjusted according to weight; maximum

2 mg/kg per day

▶ Child 6–17 years (body-weight 40 kg and above): Initially

15–25 mg daily in divided doses, increased if necessary

to 50–100 mg daily in divided doses, dose adjusted

according to weight

▶ Adult: Initially 25 mg daily, dose to be taken at night;

increased if necessary to 25 mg 3–4 times a day

▶ Elderly: Initially 25 mg daily, dose to be taken at night;

increased if necessary to 25 mg twice daily

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: RISK OF QT-INTERVAL PROLONGATION AND

TORSADE DE POINTES (APRIL 2015)

Following concerns of heart rhythm abnormalities, the

safety and efficacy of hydroxyzine has been reviewed by

the European Medicines Agency. The review concludes

that hydroxyzine is associated with a small risk of QTinterval prolongation and torsade de pointes; these

events are most likely to occur in patients who have risk

factors for QT prolongation, e.g. concomitant use of

drugs that prolong the QT-interval, cardiovascular

disease, family history of sudden cardiac death,

significant electrolyte imbalance (low plasma-potassium

or plasma-magnesium concentrations), or significant

bradycardia. To minimise the risk of such adverse effects,

the following dose restrictions have been made and new

cautions and contra-indications added:

. Hydroxyzine is contra-indicated in patients with

prolonged QT-interval or who have risk factors for QTinterval prolongation;

. Avoid use in the elderly due to increased susceptibility

to the side-effects of hydroxyzine;

. Consider the risks of QT-interval prolongation and

torsade de pointes before prescribing to patients

taking drugs that lower heart rate or plasmapotassium concentration;

. In children with body-weight up to 40 kg, the

maximum daily dose is 2 mg/kg;

. In adults, the maximum daily dose is 100 mg;

. In the elderly, the maximum daily dose is 50 mg (if use

of hydroxyzine cannot be avoided);

. The lowest effective dose for the shortest period of

time should be prescribed.

l CONTRA-INDICATIONS Acquired or congenital QT interval

prolongation . predisposition to QT interval prolongation

CONTRA-INDICATIONS, FURTHER INFORMATION

▶ QT interval prolongation Risk factors for QT interval

prolongation include significant electrolyte imbalance,

bradycardia, cardiovascular disease, and family history of

sudden cardiac death.

l CAUTIONS Bladder outflow obstruction . breathing

problems . cardiovascular disease . children . decreased

gastrointestinal motility . dementia . elderly . epilepsy . hypertension . hyperthyroidism . myasthenia gravis . prostatic hypertrophy (in adults). pyloroduodenal

obstruction . stenosing peptic ulcer. susceptibility to

angle-closure glaucoma . urinary retention

CAUTIONS, FURTHER INFORMATION

▶ Elderly Elderly patients are particularly susceptible to sideeffects; manufacturers advise avoid or reduce dose.

▶ Children Children have an increased susceptibility to sideeffects, particularly CNS effects.

l INTERACTIONS → Appendix 1: antihistamines, sedating

l SIDE-EFFECTS

▶ Rare or very rare Severe cutaneous adverse reactions

(SCARs). skin reactions

▶ Frequency not known Agranulocytosis . alopecia . anticholinergic syndrome . anxiety . appetite decreased . arrhythmias . asthenia . blood disorder. bronchial

secretion viscosity increased . chest tightness . chills . coma . concentration impaired . confusion . constipation . depression . diarrhoea . dizziness . drowsiness . dry mouth . dry throat. dyskinesia (on discontinuation). epigastric

pain . fever. flushing . gastrointestinal disorders . haemolytic anaemia . hallucination . headache . hepatic

function abnormal . hyperhidrosis . hypotension . irritability . labyrinthitis . leucopenia . malaise . menstruation irregular. movement disorders . myalgia . nasal congestion . nausea . palpitations . paraesthesia . QT

interval prolongation .respiratory disorders .respiratory

tract dryness . seizure (with high doses). sexual

dysfunction . sleep disorders . speech slurred .taste bitter. thrombocytopenia .tinnitus .tremor (with high doses). urinary disorders . vertigo . vision disorders . vomiting

SIDE-EFFECTS, FURTHER INFORMATION Paradoxical

stimulation may occur rarely, especially with high doses or

in the elderly. Drowsiness may diminish after a few days of

treatment.

BNF 78 Allergic conditions 285

Respiratory system

3

l ALLERGY AND CROSS-SENSITIVITY Manufacturer advises

hydroxyzine should be avoided in patients with previous

hypersensitivity to cetirizine or other piperazine

derivatives, and aminophylline.

l PREGNANCY Manufacturers advise avoid—toxicity in

animal studies with higher doses. Use in the latter part of

the third trimester may cause irritability, paradoxical

excitability, and tremor in the neonate.

l BREAST FEEDING Manufacturer advises avoid—expected

to be present in milk but effect unknown.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

mild to moderate impairment (increased risk of

accumulation); avoid in severe impairment.

Dose adjustments Manufacturer advises dose reduction of

33% in mild to moderate impairment.

l RENAL IMPAIRMENT

Dose adjustments Manufacturers advise reduce daily dose

by half in moderate to severe renal impairment.

l EFFECT ON LABORATORY TESTS May interfere with

methacholine test—manufacturer advises stop treatment

96 hours prior to test. May interfere with skin testing for

allergy—manufacturer advises stop treatment one week

prior to test.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. cycling or 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, oral

solution

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Hydroxyzine hydrochloride (Non-proprietary)

Hydroxyzine hydrochloride 10 mg Hydroxyzine 10mg tablets | 84 tablet P £1.20–£1.65 DT = £1.65

Hydroxyzine hydrochloride 25 mg Hydroxyzine 25mg tablets | 28 tablet P £0.62–£0.85 DT = £0.85

▶ Atarax (Alliance Pharmaceuticals Ltd)

Hydroxyzine hydrochloride 10 mg Atarax 10mg tablets |

84 tablet P £1.20 DT = £1.65

Hydroxyzine hydrochloride 25 mg Atarax 25mg tablets | 28 tablet P £0.62 DT = £0.85

Ketotifen

l INDICATIONS AND DOSE

Allergic rhinitis

▶ BY MOUTH

▶ Child 3–17 years: 1 mg twice daily

▶ Adult: 1 mg twice daily, increased if necessary to 2 mg

twice daily, to be taken with food

Allergic rhinitis in readily sedated patients

▶ BY MOUTH

▶ Adult: Initially 0.5–1 mg once daily, dose to be taken at

night

l CONTRA-INDICATIONS Avoid in Acute porphyrias p. 1058

l CAUTIONS Epilepsy . prostatic hypertrophy (in adults). pyloroduodenal obstruction . susceptibility to angleclosure glaucoma . urinary retention

l INTERACTIONS → Appendix 1: antihistamines, sedating

l SIDE-EFFECTS

▶ Common or very common Anxiety . insomnia . irritability

▶ Uncommon Cystitis . dizziness . dry mouth . skin reactions

▶ Rare or very rare Hepatitis . sedation . seizure . StevensJohnson syndrome . weight increased

SIDE-EFFECTS, FURTHER INFORMATION Drowsiness is a

significant side-effect with most of the older

antihistamines although paradoxical stimulation may

occur rarely, especially with high doses or in children and

the elderly. Drowsiness may diminish after a few days of

treatment and is considerably less of a problem with the

newer antihistamines.

l PREGNANCY Most manufacturers of antihistamines advise

avoiding their use during pregnancy; however, there is no

evidence of teratogenicity. Use 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 PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

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

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 solution

Oral solution

CAUTIONARY AND ADVISORY LABELS 2, 21

▶ Zaditen (CD Pharma Srl)

Ketotifen (as Ketotifen fumarate) 200 microgram per

1 ml Zaditen 1mg/5ml elixir sugar-free | 300 ml P £8.91 DT =

£8.91

Tablet

 

l INDICATIONS AND DOSE

Symptomatic relief of allergic rhinitis and urticaria

▶ BY MOUTH USING TABLETS

▶ Child 12–17 years: 10 mg once daily

▶ Adult: 10 mg once daily

l CAUTIONS Elderly—limited information available . history

of QT-interval prolongation . predisposition to arrhythmia . uncorrected hypokalaemia

l INTERACTIONS → Appendix 1: antihistamines, nonsedating

l SIDE-EFFECTS

▶ Common or very common Asthenia . dizziness . drowsiness . dry mouth . headache

▶ Uncommon Appetite increased . arthralgia . back pain . concentration impaired . constipation . cough . diarrhoea . dry throat. eosinophilia (in children). epistaxis . fever. gastrointestinal discomfort. increased risk of infection . irritability . malaise . myalgia . nasal dryness . nausea . neutropenia (in children). night sweats (in children). oropharyngeal pain . skin reactions .thirst. vomiting . weight increased

▶ Rare or very rare Palpitations .tachycardia

SIDE-EFFECTS, FURTHER INFORMATION Non-sedating

antihistamines such as rupatadine cause less sedation and

psychomotor impairment than the older antihistamines,

but can still occur; sedation is generally minimal. This is

because non-sedating antihistamines penetrate the blood

brain barrier to a much lesser extent.

l PREGNANCY Most manufacturers of antihistamines advise

avoiding their use during pregnancy; however, there is no

evidence of teratogenicity.

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 avoid (no

information available).

l RENAL IMPAIRMENT Manufacturer advises avoid—no

information available.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Rupatadine (Non-proprietary)

Rupatadine (as Rupatadine fumarate) 10 mg Rupatadine 10mg

tablets | 30 tablet P £30.00 DT = £30.00

ANTIHISTAMINES › SEDATING ANTIHISTAMINES

Alimemazine tartrate 11-Sep-2018

(Trimeprazine tartrate)

l INDICATIONS AND DOSE

Urticaria | Pruritus

▶ BY MOUTH

▶ Child 2–4 years: 2.5 mg 3–4 times a day

282 Allergic conditions BNF 78

Respiratory system

3

▶ Child 5–11 years: 5 mg 3–4 times a day

▶ Child 12–17 years: 10 mg 2–3 times a day, in severe cases

up to maximum daily dose has been used; maximum

100 mg per day

▶ Adult: 10 mg 2–3 times a day, in severe cases up to

maximum daily dose has been used; maximum 100 mg

per day

▶ Elderly: 10 mg 1–2 times a day

l CONTRA-INDICATIONS Children under 2 years except on

specialist advice (safety of such use has not been

established). epilepsy . hepatic dysfunction . history of

narrow angle glaucoma . hypothyroidism . myasthenia

gravis . Parkinson’s disease . phaeochromocytoma . prostatic hypertrophy (in adults).renal dysfunction

l CAUTIONS Cardiovascular diseases (due to tachycardiainducing and hypotensive effects of phenothiazines). elderly . exposure to sunlight should be avoided during

treatment with high doses . pyloroduodenal obstruction . urinary retention . volume depleted patients who are more

susceptible to orthostatic hypotension

l INTERACTIONS → Appendix 1: antihistamines, sedating

l SIDE-EFFECTS Agitation . agranulocytosis . amenorrhoea . atrioventricular block . autonomic dysfunction . bile

thrombus . consciousness impaired . drug fever. dry mouth . eosinophilia . erectile dysfunction . eye disorder. galactorrhoea . gynaecomastia . hepatic disorders . hyperprolactinaemia . hyperthermia . hypotension . insomnia . leucopenia (on prolonged high dose). movement disorders . muscle rigidity . nasal congestion . neuroleptic malignant syndrome . pallor. parkinsonism . photosensitivity reaction . postural hypotension (more

common in the elderly or in volume depletion). QT

interval prolongation .respiratory depression . seizure . skin reactions .tardive dyskinesia (more common after

long term high doses).tremor. ventricular fibrillation

(increased risk with hypokalamia and cardiac disease). ventricular tachycardia (increased risk with hypokalamia

and cardiac disease)

SIDE-EFFECTS, FURTHER INFORMATION Drowsiness may

diminish after a few days.

Patients on high dosage may develop photosensitivity

and should avoid exposure to direct sunlight.

Children and elderly patients are more susceptible to

side-effects.

l PREGNANCY Most manufacturers of antihistamines advise

avoiding their use during pregnancy; however, there is no

evidence of teratogenicity. Use 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 avoid—no

information available.

l RENAL IMPAIRMENT Avoid.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. cycling or 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 solution

Oral solution

CAUTIONARY AND ADVISORY LABELS 2

▶ Alimemazine tartrate (Non-proprietary)

Alimemazine tartrate 1.5 mg per 1 ml Alimemazine 7.5mg/5ml oral

solution | 100 ml P £179.55 DT = £179.55

Alimemazine tartrate 6 mg per 1 ml Alimemazine 30mg/5ml oral

solution | 100 ml P £243.51 DT = £243.51

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Alimemazine tartrate (Non-proprietary)

Alimemazine tartrate 10 mg Alimemazine 10mg tablets | 28 tablet P £112.85 DT = £112.85

Chlorphenamine maleate 09-Jul-2018

(Chlorpheniramine maleate)

l INDICATIONS AND DOSE

Symptomatic relief of allergy such as hay fever, urticaria,

food allergy, drug reactions | Relief of itch associated

with chickenpox

▶ BY MOUTH

▶ Child 1–23 months: 1 mg twice daily

▶ Child 2–5 years: 1 mg every 4–6 hours; maximum 6 mg

per day

▶ Child 6–11 years: 2 mg every 4–6 hours; maximum

12 mg per day

▶ Child 12–17 years: 4 mg every 4–6 hours; maximum

24 mg per day

▶ Adult: 4 mg every 4–6 hours; maximum 24 mg per day

▶ Elderly: 4 mg every 4–6 hours; maximum 12 mg per day

▶ BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS

INJECTION

▶ Child 1–5 months: 250 micrograms/kg (max. per dose

2.5 mg), repeated if necessary; maximum 4 doses per

day

▶ Child 6 months–5 years: 2.5 mg, repeated if necessary;

maximum 4 doses per day

▶ Child 6–11 years: 5 mg, repeated if necessary; maximum

4 doses per day

▶ Child 12–17 years: 10 mg, repeated if necessary;

maximum 4 doses per day

▶ Adult: 10 mg, repeated if necessary; maximum 4 doses

per day

Emergency treatment of anaphylactic reactions

▶ BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS

INJECTION

▶ Child 1–5 months: 250 micrograms/kg (max. per dose

2.5 mg), repeated if necessary; maximum 4 doses per

day

▶ Child 6 months–5 years: 2.5 mg, repeated if necessary;

maximum 4 doses per day

▶ Child 6–11 years: 5 mg, repeated if necessary; maximum

4 doses per day

▶ Child 12–17 years: 10 mg, repeated if necessary;

maximum 4 doses per day

▶ Adult: 10 mg, repeated if necessary; maximum 4 doses

per day

l UNLICENSED USE Tablets not licensed for use in children

under 6 years. Syrup not licensed for use in children under

1 year.

IMPORTANT SAFETY INFORMATION

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

chlorphenamine.

l CAUTIONS Epilepsy . prostatic hypertrophy (in adults). pyloroduodenal obstruction . susceptibility to angleclosure glaucoma . urinary retention

l INTERACTIONS → Appendix 1: antihistamines, sedating

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Common or very common Concentration impaired . coordination abnormal . dizziness . dry mouth . fatigue . headache . nausea . vision blurred

BNF 78 Allergic conditions 283

Respiratory system

3

▶ Frequency not known Agitation . appetite decreased . blood

disorder. bronchial secretion viscosity increased . depression . diarrhoea . haemolytic anaemia . hypotension . irritability . muscle twitching . muscle weakness . nightmare . palpitations . photosensitivity reaction . skin

reactions .tinnitus . urinary retention . vomiting

SPECIFIC SIDE-EFFECTS

▶ Common or very common

▶ With oral use Drowsiness

▶ Frequency not known

▶ With oral use Angioedema . arrhythmias . chest tightness . confusion . gastrointestinal discomfort. hepatic disorders

▶ With parenteral use Central nervous system stimulation . confusional psychosis (in adults). dyspepsia . gastrointestinal disorder. hepatitis . sedation

SIDE-EFFECTS, FURTHER INFORMATION Children and

elderly patients are more susceptible to side-effects.

l PREGNANCY Most manufacturers of antihistamines advise

avoiding their use during pregnancy; however, there is no

evidence of teratogenicity. Use 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.

l DIRECTIONS FOR ADMINISTRATION For intravenous

injection, give over 1 minute; if small dose required, dilute

with Sodium Chloride 0.9%.

l PATIENT AND CARER ADVICE

Medicines for Children leaflet: Chlorphenamine maleate for allergy

symptoms www.medicinesforchildren.org.uk/chlorphenaminemaleate-allergy-symptoms-0

Driving and skilled tasks Drowsiness may affect

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

sedating effects enhanced by alcohol.

l PROFESSION SPECIFIC INFORMATION

Dental practitioners’ formulary

▶ With oral use Chlorphenamine tablets may be prescribed.

Chlorphenamine oral solution may be prescribed.

l EXCEPTIONS TO LEGAL CATEGORY

▶ With intramuscular use or intravenous use Prescription only

medicine restriction does not apply to chlorphenamine

injection where administration is for saving life in

emergency.

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

▶ Chlorphenamine maleate (Non-proprietary)

Chlorphenamine maleate 10 mg per 1 ml Chlorphenamine

10mg/1ml solution for injection ampoules | 5 ampoule P £22.48–

£22.50 DT = £22.50

Oral solution

CAUTIONARY AND ADVISORY LABELS 2

▶ Chlorphenamine maleate (Non-proprietary)

Chlorphenamine maleate 400 microgram per

1 ml Chlorphenamine 2mg/5ml oral solution sugar free sugar-free |

150 ml p £2.78 DT = £2.21

▶ Allerief (Crescent Pharma Ltd)

Chlorphenamine maleate 400 microgram per 1 ml Allerief

2mg/5ml oral solution sugar-free | 150 ml p £2.21 DT = £2.21

▶ Piriton (GlaxoSmithKline Consumer Healthcare)

Chlorphenamine maleate 400 microgram per 1 ml Piriton

2mg/5ml syrup | 150 ml p £2.78 DT = £2.78

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Chlorphenamine maleate (Non-proprietary)

Chlorphenamine maleate 4 mg Chlorphenamine 4mg tablets | 28 tablet p £1.00 DT = £0.76

▶ Allerief (Crescent Pharma Ltd)

Chlorphenamine maleate 4 mg Allerief 4mg tablets | 28 tablet p

£1.74 DT = £0.76

▶ Hayleve (Genesis Pharmaceuticals Ltd)

Chlorphenamine maleate 4 mg Hayleve 4mg tablets | 28 tablet p

£0.76 DT = £0.76

▶ Piriton (GlaxoSmithKline Consumer Healthcare)

Chlorphenamine maleate 4 mg Piriton 4mg tablets | 500 tablet p

£6.96

Piriton Allergy 4mg tablets | 30 tablet p £2.06 | 60 tablet p £3.73

▶ Pollenase (chlorphenamine) (E M Pharma)

Chlorphenamine maleate 4 mg Pollenase Antihistamine 4mg

tablets | 30 tablet p £1.00

Clemastine 09-Jul-2018

l INDICATIONS AND DOSE

Symptomatic relief of allergy such as hay fever, urticaria

▶ BY MOUTH

▶ Adult: 1 mg twice daily, increased if necessary up to

6 mg daily

l CONTRA-INDICATIONS Avoid in Acute porphyrias p. 1058

l CAUTIONS Elderly . epilepsy . prostatic hypertrophy . pyloroduodenal obstruction . stenosing peptic ulcer. susceptibility to angle-closure glaucoma . urinary

retention

l INTERACTIONS → Appendix 1: antihistamines, sedating

l SIDE-EFFECTS

▶ Common or very common Asthenia . sedation

▶ Uncommon Dizziness

▶ Rare or very rare Abdominal pain . agitation . constipation . dry mouth . dyspnoea . headache . nausea . palpitations . rash .tachycardia

l PREGNANCY Most manufacturers of antihistamines advise

avoiding their use during pregnancy; however, there is no

evidence of teratogenicity. Use 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 PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. driving); sedating effects

enhanced by alcohol.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 2

▶ Tavegil (GlaxoSmithKline Consumer Healthcare)

Clemastine (as Clemastine hydrogen fumarate) 1 mg Tavegil 1mg

tablets | 60 tablet p £6.66 DT = £6.66

Cyproheptadine hydrochloride 30-Jun-2018

l INDICATIONS AND DOSE

Symptomatic relief of allergy such as hay fever, urticaria |

Pruritus

▶ BY MOUTH

▶ Adult: 4 mg 3 times a day, usual dose 4–20 mg daily;

maximum 32 mg per day

l CONTRA-INDICATIONS Avoid in Acute porphyrias p. 1058

l CAUTIONS Epilepsy . prostatic hypertrophy . pyloroduodenal obstruction . susceptibility to angleclosure glaucoma . urinary retention

l INTERACTIONS → Appendix 1: antihistamines, sedating

284 Allergic conditions BNF 78

Respiratory system

3