lCONCEPTION AND CONTRACEPTIONFemales of child-
bearing age must use effective contraception (oral
progestogen-only contraceptives not considered
effective).
lPREGNANCYAvoid.
lBREAST FEEDINGAmount of drug in milk probably too
small to be harmful; ensure infant does not come in
contact with treated areas.
lPATIENT AND CARER ADVICEIf sun exposure is
unavoidable, an appropriate sunscreen or protective
clothing should be used.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Cream
CAUTIONARY AND ADVISORY LABELS 11
EXCIPIENTS:May contain Disodium edetate, hydroxybenzoates
(parabens)
▶Adapalene (Non-proprietary)
Adapalene 1 mg per 1 gramAdapalene 0. 1 % cream|
45 gramP£ 16. 43 DT = £ 16. 43
▶Differin(Galderma (UK) Ltd)
Adapalene 1 mg per 1 gramDifferin 0. 1 % cream| 45 gramP
£ 16. 43 DT = £ 16. 43
Gel
CAUTIONARY AND ADVISORY LABELS 11
EXCIPIENTS:May contain Disodium edetate, hydroxybenzoates
(parabens), propylene glycol
▶Adapalene (Non-proprietary)
Adapalene 1 mg per 1 gramAdapalene 0. 1 % gel| 45 gramP
£ 16. 43 DT = £ 16. 43
▶Differin(Galderma (UK) Ltd)
Adapalene 1 mg per 1 gramDifferin 0. 1 % gel| 45 gramP
£ 16. 43 DT = £ 16. 43
Adapalene with benzoyl peroxide
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, adapalene p. 756 , benzoyl peroxide p. 756.
lINDICATIONS AND DOSE
Acne vulgaris
▶TO THE SKIN
▶Child 9–17 years:Apply once daily, to be applied thinly
in the eveninglINTERACTIONS→Appendix 1 : retinoids
lCONCEPTION AND CONTRACEPTIONFemales of child-
bearing age must use effective contraception (oral
progestogen-only contraceptives not considered
effective).
lPATIENT AND CARER ADVICEGel may bleach clothing and
hair.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (March
2014 ) thatEpiduo®should be restricted for use in mild to
moderate facial acne when monotherapy with benzoyl
peroxide or adapalene is inappropriate.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Gel
CAUTIONARY AND ADVISORY LABELS 11
EXCIPIENTS:May contain Disodium edetate, polysorbates, propylene
glycol
▶Epiduo(Galderma (UK) Ltd)
Adapalene 1 mg per 1 gram, Benzoyl peroxide 25 mg per
1 gramEpiduo 0. 1 %/ 2. 5 % gel| 45 gramP£ 19. 53 DT = £ 19. 53
Isotretinoin 03-Nov-2017
lINDICATIONS AND DOSE
Topical treatment of mild to moderate acne
▶TO THE SKIN
▶Child:Apply 1 – 2 times a day, to be applied thinly
Severe acne (under expert supervision)|Acne which is
associated with psychological problems (under expert
supervision)|Acne which has not responded to an
adequate course of a systemic antibacterial (under
expert supervision)|Acne with scarring (under expert
supervision)|Systemic treatment of nodulo-cystic and
conglobate acne (under expert supervision)
▶BY MOUTH
▶Child 12–17 years:Initially 500 micrograms/kg daily in
1 – 2 divided doses, increased if necessary to 1 mg/kg
daily for 16 – 24 weeks, repeat treatment course after a
period of at least 8 weeks if relapse afterfirst course;
maximum 150 mg/kg per course
Severe infantile acne (under expert supervision)
▶BY MOUTH
▶Child 1 month–1 year:Initially 200 micrograms/kg daily
in 1 – 2 divided doses, increased if necessary to 1 mg/kg
daily for 16 – 24 weeks; maximum 150 mg/kg per courselUNLICENSED USENot licensed for use in infantile acne.IMPORTANT SAFETY INFORMATION
MHRA/CHM ADVICE: ISOTRETINOIN (ROACCUTANE®): RARE
REPORTS OF ERECTILE DYSFUNCTION AND DECREASED LIBIDO
(OCTOBER 2017)
An EU-wide review has concluded that on rare occasions,
oral isotretinoin, indicated for severe acne, may cause
sexual side-effects, including erectile dysfunction and
decreased libido.lCONTRA-INDICATIONS
▶With oral useHyperlipidaemia.hypervitaminosis A
▶With topical usePerioral dermatitis.rosacea
lCAUTIONS
▶With oral useAvoid blood donation during treatment and
for at least 1 month after treatment.diabetes.dry eye
syndrome (associated with risk of keratitis).history of
depression.monitor for depression
▶With topical useAllow peeling (resulting from other irritant
treatments) to subside before using a topical retinoid.
alternating a preparation that causes peeling with a topical
retinoid may give rise to contact dermatitis (reduce
frequency of retinoid application).avoid accumulation in
angles of the nose.avoid contact with eyes, nostrils,
mouth and mucous membranes, eczematous, broken or
sunburned skin.avoid exposure to UV light (including
sunlight, solariums).avoid in severe acne involving large
areas.avoid use of topical retinoids with abrasive cleaners,
comedogenic or astringent cosmetics.caution in sensitive
areas such as the neck.personal or familial history of skin
cancer
lINTERACTIONS→Appendix 1 : retinoids
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonSkin reactions
▶Rare or very rarePhotosensitivity reaction
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With oral useAlopecia.anaemia.arthralgia.back pain.
cheilitis.dry eye.eye discomfort.eye inflammation.
haemorrhage.headache.increased risk of infection.
myalgia.nasal dryness.neutropenia.proteinuria.skin
fragility (trauma may cause blistering).thrombocytopenia
.thrombocytosisBNFC 2018 – 2019 Acne 757
Skin13