lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Nasal drops
▶Ephedrine hydrochloride (Non-proprietary)
Ephedrine hydrochloride 5 mg per 1 mlEphedrine 0. 5 % nasal
drops| 10 mlp£ 1. 90 – £ 1. 94 DT = £ 1. 90
Ephedrine hydrochloride 10 mg per 1 mlEphedrine 1 % nasal drops
| 10 mlp£ 1. 94 – £ 2. 01 DT = £ 1. 94Pseudoephedrine hydrochloride
lINDICATIONS AND DOSE
Congestion of mucous membranes of upper respiratory
tract
▶BY MOUTH
▶Child 6–11 years: 30 mg 3 – 4 times a day
▶Child 12–17 years: 60 mg 3 – 4 times a dayIMPORTANT SAFETY INFORMATION
MHRA/CHM ADVICE (MARCH 2008 AND FEBRUARY 2009): OVER-
THE-COUNTER COUGH AND COLD MEDICINES FOR CHILDREN
Children under 6 years should not be given over-the-
counter cough and cold medicines containing
pseudoephedrine.lCAUTIONSDiabetes.heart disease.hypertension.
hyperthyroidism.raised intra-ocular pressure
lINTERACTIONS→Appendix 1 : sympathomimetics,
vasoconstrictor
lSIDE-EFFECTSAngle closure glaucoma.anxiety.
arrhythmias.circulation impaired.dry mouth.
hallucination.headache.hypertension.irritability.
nausea.palpitations.psychotic disorder.skin reactions.
sleep disorders.tremor.urinary retention.vomiting
lPREGNANCYDefective closure of the abdominal wall
(gastroschisis) reported very rarely in newborns afterfirst
trimester exposure.
lBREAST FEEDINGMay suppress lactation; avoid if lactation
not well established or if milk production insufficient.
lHEPATIC IMPAIRMENTManufacturer advises use with
caution in severe impairment.
lRENAL IMPAIRMENTUse with caution in mild to moderate
renal impairment. Manufacturer advises avoid in severe
renal impairment.
lLESS SUITABLE FOR PRESCRIBINGPseudoephedrine
hydrochloride is less suitable for prescribing.
lEXCEPTIONS TO LEGAL CATEGORYGalpseud®andSudafed®
can be sold to the public provided no more than 720 mg of
pseudoephedrine salts are supplied, and ephedrine base
(or salts) are not supplied at the same time; for details see
Medicines, Ethics and Practice, London, Pharmaceutical
Press (always consult latest edition).lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Oral solution
EXCIPIENTS:May contain Alcohol
▶Galpseud(Thornton & Ross Ltd)
Pseudoephedrine hydrochloride 6 mg per 1 mlGalpseud
30 mg/ 5 ml linctus sugar-free| 2000 mlP£ 14. 00
▶Sudafed Non-Drowsy Decongestant (pseudoephedrine)(McNeil
Products Ltd)
Pseudoephedrine hydrochloride 6 mg per 1 mlSudafed
Decongestant 30 mg/ 5 ml liquid| 100 mlp£ 2. 22
Tablet
▶Galpseud(Thornton & Ross Ltd)
Pseudoephedrine hydrochloride 60 mgGalpseud 60 mg tablets|
24 tabletP£ 2. 25 | 100 tabletP£ 5. 42 DT = £ 5. 42▶Sudafed Non-Drowsy Decongestant (pseudoephedrine)(McNeil
Products Ltd)
Pseudoephedrine hydrochloride 60 mgSudafed Decongestant
60 mg tablets| 12 tabletp£ 2. 43Xylometazoline hydrochloride
lDRUG ACTIONXylometazoline is a sympathomimetic.lINDICATIONS AND DOSE
Nasal congestion
▶BY INTRANASAL ADMINISTRATION USING NASAL DROPS
▶Child 6–11 years: 1 – 2 drops 1 – 2 times a day as required
for maximum duration of 5 days, 0. 05 % solution to be
administered into each nostril
▶Child 12–17 years: 2 – 3 drops 2 – 3 times a day as required
for maximum duration of 7 days, 0. 1 % solution to be
administered into each nostril
▶BY INTRANASAL ADMINISTRATION USING NASAL SPRAY
▶Child 12–17 years: 1 spray 1 – 3 times a day as required for
maximum duration of 7 days, to be administered into
each nostrilIMPORTANT SAFETY INFORMATION
The CHM/MHRA has stated that non-prescription cough
and cold medicines containing oxymetazoline or
xylometazoline can be considered for up to 5 days’
treatment in children aged 6 – 12 years after basic
principles of best care have been tried; these medicines
should not be used in children under 6 years of age.lCAUTIONSAngle-closure glaucoma.avoid excessive or
prolonged use.cardiovascular disease.diabetes mellitus.
hypertension.hyperthyroidism.rebound congestion
CAUTIONS, FURTHER INFORMATION
▶Rebound congestionSympathomimetic drugs are of limited
value in the treatment of nasal congestion because they
can, following prolonged use (more than 7 days), give rise
to a rebound congestion (rhinitis medicamentosa) on
withdrawal, due to a secondary vasodilatation with a
subsequent temporary increase in nasal congestion. This
in turn tempts the further use of the decongestant, leading
to a vicious cycle of events.
lINTERACTIONS→Appendix 1 : sympathomimetics,
vasoconstrictor
lSIDE-EFFECTSCardiovascular effects.headache.
hypersensitivity.nasal dryness.nausea.paraesthesia.
visual impairment
SIDE-EFFECTS, FURTHER INFORMATIONUse of
decongestants in infants and children under 6 years has
been associated with agitated psychosis, ataxia,
hallucinations, and even death—avoid.
lPREGNANCYManufacturer advises avoid.
lBREAST FEEDINGManufacturer advises caution—no
information available.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Spray
▶Otrivine(GlaxoSmithKline Consumer Healthcare)
Xylometazoline hydrochloride 1 mg per 1 mlOtrivine Congestion
Relief 0. 1 % nasal spray| 10 mlG£ 3. 05 DT = £ 2. 18
Otrivine Adult Measured Dose Sinusitis spray| 10 mlG£ 2. 62 DT =
£ 2. 18
Otrivine Allergy Relief 0. 1 % nasal spray| 10 mlG£ 2. 62 DT =
£ 2. 18
Otrivine Adult nasal spray| 10 mlG£ 2. 18 DT = £ 2. 18
Otrivine Adult Metered Dose 0. 1 % nasal spray| 10 mlG£ 2. 62 DT
=£ 2. 18696 Nasal congestion BNFC 2018 – 2019
Ear, nose and oropharynx12