Piriton Allergy 4 mg tablets| 30 tabletp£ 2. 06 | 60 tabletp£ 3. 73
▶Pollenase (chlorphenamine)(E M Pharma)
Chlorphenamine maleate 4 mgPollenase Antihistamine 4 mg
tablets| 30 tabletp£ 1. 00Hydroxyzine hydrochloride 22-Feb-2016
lDRUG ACTIONHydroxyzine is a sedating antihistamine
which exerts its actions by antagonising the effects of
histamine.
lINDICATIONS 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 weightIMPORTANT SAFETY INFORMATION
MHRA/CHM ADVICE: RISK OF QT-INTERVAL PROLONGATION AND
TORSADEDEPOINTES(APRIL2015)
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 QT-
interval 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 QT-
interval prolongation;
.Consider the risks of QT-interval prolongation and
torsade de pointes before prescribing to patients
taking drugs that lower heart rate or plasma-
potassium concentration;
.In children with body-weight up to 40 kg, the
maximum daily dose is 2 mg/kg;
.The lowest effective dose for the shortest period of
time should be prescribed.lCONTRA-INDICATIONSAcquired or congenital QT interval
prolongation.predisposition to QT interval prolongation
CONTRA-INDICATIONS, FURTHER INFORMATION
▶QT interval prolongationRisk factors for QT interval
prolongation include significant electrolyte imbalance,
bradycardia, cardiovascular disease, and family history of
sudden cardiac death.
lCAUTIONSBladder outflow obstruction.breathing
problems.cardiovascular disease.children.decreased
gastrointestinal motility.dementia.epilepsy.
hypertension.hyperthyroidism.myasthenia gravis.
pyloroduodenal obstruction.stenosing peptic ulcer.
susceptibility to angle-closure glaucoma.urinary
retention
CAUTIONS, FURTHER INFORMATIONChildren have an
increased susceptibility to side-effects, particularly CNS
effects.
lINTERACTIONS→Appendix 1 : antihistamines, sedating
lSIDE-EFFECTS
▶Rare or very rareSevere cutaneous adverse reactions
(SCARs).skin reactions
▶Frequency not knownAgranulocytosis.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 INFORMATIONParadoxical
stimulation may occur rarely, especially with high doses.
Drowsiness may diminish after a few days of treatment.
lALLERGY AND CROSS-SENSITIVITYManufacturer advises
hydroxyzine should be avoided in patients with previous
hypersensitivity to cetirizine or other piperazine
derivatives, and aminophylline.
lPREGNANCYManufacturers advise avoid—toxicity in
animalstudies with higher doses. Use in the latter part of
the third trimester may cause irritability, paradoxical
excitability, and tremor in the neonate.
lBREAST FEEDINGManufacturer advises avoid—expected
to be present in milk but effect unknown.
lHEPATIC IMPAIRMENTManufacturer advises avoid in
severe liver disease—increased risk of coma.
Dose adjustmentsManufacturer advises reduce daily dose
by one-third.
lRENAL IMPAIRMENT
Dose adjustmentsManufacturers advise reduce daily dose
by half in moderate to severe renal impairment.
lEFFECT ON LABORATORY TESTSMay 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.
lPATIENT AND CARER ADVICE
Driving and skilled tasksDrowsiness may affect
performance of skilled tasks (e.g. cycling or driving);
sedating effects enhanced by alcohol.lMEDICINAL 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 mgHydroxyzine 10 mg tablets|
84 tabletP£ 1. 20 – £ 1. 53 DT = £ 1. 37
Hydroxyzine hydrochloride 25 mgHydroxyzine 25 mg tablets|
28 tabletP£ 0. 62 – £ 0. 80 DT = £ 0. 71
▶Atarax(Alliance Pharmaceuticals Ltd)
Hydroxyzine hydrochloride 10 mgAtarax 10 mg tablets|
84 tabletP£ 1. 20 DT = £ 1. 37
Hydroxyzine hydrochloride 25 mgAtarax 25 mg tablets|
28 tabletP£ 0. 62 DT = £ 0. 71BNFC 2018 – 2019 Allergic conditions 179
Respiratory system3