▶Rare or very rare
▶With oral useAnxiety.arthritis.behaviour abnormal.bone
disorders.bronchospasm.cataract.corneal opacity.
depression.diabetes mellitus.dizziness.drowsiness.dry
throat.gastrointestinal disorders.glomerulonephritis.
hair changes.hearing impairment.hepatitis.hoarseness.
hyperhidrosis.hyperuricaemia.idiopathic intracranial
hypertension.inflammatory bowel disease.
lymphadenopathy.malaise.mood altered.nail dystrophy
.nausea.pancreatitis.psychotic disorder.pyogenic
granuloma.seizure.suicidal tendencies.tendinitis.
vasculitis.vision disorders
▶Frequency not known
▶With oral useRhabdomyolysis.severe cutaneous adverse
reactions (SCARs)
SIDE-EFFECTS, FURTHER INFORMATIONRisk of pancreatitis
if triglycerides above 9 mmol/litre—discontinue if
uncontrolled hypertriglyceridaemia or pancreatitis.
Discontinue treatment if skin peeling severe or
haemorrhagic diarrhoea develops.
Visual disturbances require expert referral and possible
withdrawal.
Psychiatric side-effects could require expert referral.
lCONCEPTION AND CONTRACEPTION
Pregnancy prevention
▶With oral useEffective contraception must be used. In
women of child-bearing potential, exclude pregnancy up
to 3 days before treatment (start treatment on day 2 or 3 of
menstrual cycle), every month during treatment (unless
there are compelling reasons to indicate that there is no
risk of pregnancy), and 5 weeks after stopping treatment—
perform pregnancy test in thefirst 3 days of the menstrual
cycle. Women must practise effective contraception for at
least 1 month before starting treatment, during treatment,
and for at least 1 month after stopping treatment. Women
should be advised to use at least 1 method of
contraception, but ideally they should use 2 methods of
contraception. Oral progestogen-only contraceptives are
not considered effective. Barrier methods should not be
used alone, but can be used in conjunction with other
contraceptive methods. Each prescription for isotretinoin
should be limited to a supply of up to 30 days’treatment
and dispensed within 7 days of the date stated on the
prescription; repeat prescriptions or faxed prescriptions
are not acceptable. Women should be advised to
discontinue treatment and to seek prompt medical
attention if they become pregnant during treatment or
within 1 month of stopping treatment.
▶With topical useFemales of child-bearing age must use
effective contraception (oral progestogen-only
contraceptives not considered effective).
lPREGNANCYContra-indicated in pregnancy (teratogenic).
lBREAST FEEDINGAvoid.
lHEPATIC IMPAIRMENT
▶With oral useAvoid—further impairment may occur.
lRENAL IMPAIRMENT
Dose adjustments▶With oral useIn severe impairment,
reduce initial dose and increase gradually, if necessary, up
to 1 mg/kg daily as tolerated.
lMONITORING REQUIREMENTS
▶With oral useMeasure hepatic function and serum lipids
before treatment, 1 month after starting and then every
3 months (reduce dose or discontinue if transaminase or
serum lipids persistently raised).
lPRESCRIBING AND DISPENSING INFORMATIONIsotretinoin
is an isomer of tretinoin.
lPATIENT AND CARER ADVICE
▶With oral useWarn patient to avoid wax epilation (risk of
epidermal stripping), dermabrasion, and laser skin
treatments (risk of scarring) during treatment and for at
least 6 months after stopping; patient should avoidexposure to UV light (including sunlight) and use
sunscreen and emollient (including lip balm) preparations
from the start of treatment.
Patients and carers should be told how to recognise
signs and symptoms of psychiatric disorders such as
depression, anxiety, and rarely suicidal thoughts.
▶With topical usePatients should be warned that some
redness and skin peeling can occur initially but settles with
time. If undue irritation occurs, the frequency of
application should be reduced or treatment suspended
until the reaction subsides; if irritation persists,
discontinue treatment. Several months of treatment may
be needed to achieve an optimal response and the
treatment should be continued until no new lesions
develop. If 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.
Capsule
CAUTIONARY AND ADVISORY LABELS10, 11, 21
▶Isotretinoin (Non-proprietary)
Isotretinoin 5 mgIsotretinoin 5 mg capsules| 30 capsuleP
£ 10. 10 – £ 10. 15 | 56 capsuleP£ 14. 78 DT = £ 14. 78
Isotretinoin 10 mgIsotretinoin 10 mg capsules| 30 capsuleP
£ 14. 54 DT = £ 14. 54
Isotretinoin 20 mgIsotretinoin 20 mg capsules| 30 capsuleP
£ 20. 00 DT = £ 16. 66 | 56 capsuleP£ 31. 01 – £ 37. 85
Isotretinoin 40 mgIsotretinoin 40 mg capsules| 30 capsuleP
£ 38. 98 DT = £ 38. 98
▶Roaccutane(Roche Products Ltd)
Isotretinoin 10 mgRoaccutane 10 mg capsules| 30 capsuleP
£ 14. 54 DT = £ 14. 54
Isotretinoin 20 mgRoaccutane 20 mg capsules| 30 capsuleP
£ 20. 02 DT = £ 16. 66Isotretinoin with erythromycin
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, isotretinoin p. 757 , erythromycin p. 331.lINDICATIONS AND DOSE
Topical treatment of mild to moderate acne
▶TO THE SKIN
▶Child:(consult product literature)lINTERACTIONS→Appendix 1 : macrolides.retinoids
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 Butylated hydroxytoluene
▶Isotrexin(Stiefel Laboratories (UK) Ltd)
Isotretinoin 500 microgram per 1 gram, Erythromycin 20 mg per
1 gramIsotrexin gel| 30 gramP£ 7. 47 DT = £ 7. 47Tretinoin with clindamycin
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, tretinoin p. 554 , clindamycin p. 327.lINDICATIONS AND DOSE
Facial acne
▶TO THE SKIN
▶Child 12–17 years:Apply daily, (to be applied thinly at
bedtime)lCONTRA-INDICATIONSPerioral dermatitis.personal or
familial history of skin cancer.rosacea758 Rosacea and acne BNFC 2018 – 2019
Skin13