lCONTRA-INDICATIONSHistory of severe or unstable and
uncontrolled cardiovascular disease
lCAUTIONSCerebrovascular disease.depression.heart
failure.history of angina.hypertension.loss of effect may
occur over time.Raynaud’s syndrome.recent myocardial
infarction.reduction in vision in end-stage glaucoma
(suspend treatment).severe coronary insufficiency.
thromboangiitis obliterans.vasovagal attack
lINTERACTIONS→Appendix 1 : apraclonidine
lSIDE-EFFECTS
▶Common or very commonEye disorders
▶UncommonBradycardia.conjunctival haemorrhage.
diarrhoea.dry eye.eye discomfort.eye inflammation.
gastrointestinal discomfort.irritability.libido decreased.
nasal dryness.palpitations.postural hypotension.
sensation abnormal.sleep disorders.syncope.vision
disorders.vomiting
▶Rare or very rareChest pain.dry mouth.fatigue.
headache.hyperhidrosis.pain in extremity.pruritus.
taste altered.temperature sensation altered
SIDE-EFFECTS, FURTHER INFORMATIONSince systemic
absorption may follow topical application, see clonidine
hydrochloride p. 102.
Ocular intoleranceManufacturer advises withdrawal if
eye pruritus, ocular hyperaemia, increased lacrimation, or
oedema of the eyelids and conjunctiva occur.
lPREGNANCYManufacturer advises avoid—no information
available.
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lHEPATIC IMPAIRMENTManufacturer advises caution.
lRENAL IMPAIRMENTUse with caution in chronic renal
failure.
lMONITORING REQUIREMENTS
▶Monitor intra-ocular pressure and visualfields.
▶Monitor for excessive reduction in intra-ocular pressure
following peri-operative use.
lPATIENT AND CARER ADVICE
Driving and skilled tasksDrowsiness may affect
performance of skilled tasks (e.g. driving).
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Eye drops
EXCIPIENTS:May contain Benzalkonium chloride
▶Iopidine(Novartis Pharmaceuticals UK Ltd)
Apraclonidine (as Apraclonidine hydrochloride) 5 mg per
1mlIopidine 5 mg/ml eye drops| 5 mlP£ 10. 88 DT = £ 10. 88
Apraclonidine (as Apraclonidine hydrochloride) 10 mg per
1mlIopidine 1 % eye drops 0. 25 ml unit dose| 24 unit doseP
£ 77. 85 DT = £ 77. 85
6 Retinal disorders
6.1 Optic neuropathy
DRUGS FOR METABOLIC DISORDERS›
ANTIOXIDANTSIdebenone 31-May-2017
lDRUG ACTIONIdebenone is a nootropic and antioxidant
that is thought to act by restoring cellular ATP generation,
thereby reactivating retinal ganglion cells.lINDICATIONS AND DOSE
Leber’s Hereditary Optic Neuropathy (initiated by a
specialist)
▶BY MOUTH
▶Child 12–17 years: 300 mg 3 times a daylSIDE-EFFECTS
▶Common or very commonCough.diarrhoea.increased risk
of infection.pain
▶Frequency not knownAgranulocytosis.anaemia.anxiety.
appetite decreased.azotaemia.delirium.dizziness.
dyspepsia.hallucination.headache.hepatitis.leucopenia
.malaise.movement disorders.nausea.neutropenia.
poriomania.seizure.skin reactions.stupor.
thrombocytopenia.urine discolouration.vomiting
SIDE-EFFECTS, FURTHER INFORMATIONThe metabolites of
idebenone may cause red-brown discolouration of the
urine. This effect is harmless, but the manufacturer
advises caution as this may mask colour changes due to
other causes (e.g. renal or blood disorders).
lPREGNANCYManufacturer advises avoid unless potential
benefit outweighs risk—no information available.
lBREAST FEEDINGManufacturer advises avoid—present in
milk inanimalstudies.
lHEPATIC IMPAIRMENTManufacturer advises use with
caution—no information available.
lRENAL IMPAIRMENTManufacturer advises use with
caution—no information available.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (May 2017 )
that idebenone (Raxone®) is accepted for restricted use
within NHS Scotland for the treatment of visual
impairment in patients with Leber’s Hereditary Optic
Neuropathy (LHON) who are not yet blind i.e. they do not
meet the UK criteria to be registered as severely sight
impaired. 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.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: tablet
Tablet
CAUTIONARY AND ADVISORY LABELS14, 21
▶Raxone(Santhera (UK) Ltd)A
Idebenone 150 mgRaxone 150 mg tablets| 180 tabletP
£ 6 , 364. 00BNFC 2018 – 2019 Optic neuropathy 687
Eye11