BNF for Children 2011-2012

BNFC 2011–2012 13.6.2 Oral preparations for acne 579dermatologist. It is given for at least 16 weeks; repeatcourses are not normally required.Side-effects of isotretinoin include severe dryness of theskin and mucous membranes, nose bleeds, and jointpains. The drug is teratogenic and must not be given tofemales of child-bearing age unless they practise effectivecontraception (oral progestogen-only contraceptivesnot considered effective) and then only afterdetailed assessment and explanation by the physician.They must also be registered with a pregnancy preventionprogramme (see under Cautions below).Although a causal link between isotretinoin use andpsychiatric changes (including suicidal ideation) hasnot been established, the possibility should be consideredbefore initiating treatment; if psychiatric changesoccur during treatment, isotretinoin should be stopped,the prescriber informed, and specialist psychiatricadvice should be sought.ISOTRETINOINNote Isotretinoin is an isomer of tretinoinCautions see notes above; also avoid blood donationduring treatment and for at least 1 month after treatment;history of depression; monitor all patients fordepression; measure hepatic function and serumlipids before treatment, 1 month after starting andthen every 3 months (reduce dose or discontinue iftransaminase or serum lipids persistently raised);discontinue if uncontrolled hypertriglyceridaemia orpancreatitis; diabetes; dry eye syndrome (associatedwith risk of keratitis); avoid keratolytics; interactions:Appendix 1 (retinoids)Pregnancy prevention In women of child-bearing potential,exclude pregnancy up to 3 days before treatment (starttreatment on day 2 or 3 of menstrual cycle), every monthduring treatment (unless there are compelling reasons toindicate that there is no risk of pregnancy), and 5 weeks afterstopping treatment—perform pregnancy test in the first 3days of the menstrual cycle. Women must practise effectivecontraception for at least 1 month before starting treatment,during treatment, and for at least 1 month after stoppingtreatment. Women should be advised to use at least 1method of contraception, but ideally they should use 2methods of contraception. Oral progestogen-only contraceptivesare not considered effective. Barrier methodsshould not be used alone, but can be used in conjunctionwith other contraceptive methods. Each prescription forisotretinoin should be limited to a supply of up to 30 days’treatment and dispensed within 7 days of the date stated onthe prescription. Women should be advised to discontinuetreatment and to seek prompt medical attention if theybecome pregnant during treatment or within 1 month ofstopping treatment.Counselling Warn patient to avoid wax epilation (risk ofepidermal stripping), dermabrasion, and laser skin treatments(risk of scarring) during treatment and for at least 6months after stopping; patient should avoid exposure to UVlight (including sunlight) and use sunscreen and emolient(including lip balm) preparations from the start of treatmentContra-indications hypervitaminosis A, hyperlipidaemiaHepatic impairment avoid—further impairment mayoccurRenal impairment in severe impairment, reduceinitial dose and increase gradually, if necessary, up to1 mg/kg daily as toleratedPregnancy avoid—teratogenic; effective contraceptionmust be used—see Pregnancy PreventionaboveBreast-feeding avoidSide-effects dryness of skin (with dermatitis, scaling,thinning, erythema, pruritus), epidermal fragility(trauma may cause blistering), dryness of lips (sometimescheilitis), dryness of eyes (with blepharitis andconjunctivitis), dryness of pharyngeal mucosa (withhoarseness), dryness of nasal mucosa (with epistaxis),headache, myalgia and arthralgia, raised plasma-triglycerideconcentration (risk of pancreatitis if triglyceridesabove 9 mmol/litre), raised serum-cholesterolconcentration (with reduced high-densitylipoprotein concentration), raised blood-glucose concentration,raised serum-transaminase concentration,haematuria and proteinuria, thrombocytopenia,thrombocytosis, neutropenia and anaemia; rarelymood changes (depression, aggressive behaviour,anxiety, and very rarely psychosis and suicidal ideation)—expertreferral required, skin reactions(including reports of Stevens-Johnson syndrome andtoxic epidermal necrolysis), alopecia; very rarelynausea, hepatitis, inflammatory bowel disease, gastrointestinalhaemorrhage, haemorrhagic diarrhoea(discontinue treatment), benign intracranial hypertension(avoid concomitant tetracyclines), convulsions,malaise, drowsiness, dizziness, diabetesmellitus, lymphadenopathy, hyperuricaemia, glomerulonephritis,tendinitis, arthritis, raised serum-creatinekinase concentration, bone changes (includingreduced bone density, early epiphyseal closure, andskeletal hyperstosis) and calcification of tendons andligaments following long-term administration, visualdisturbances (papilloedema, corneal opacities, cataracts,decreased night vision, photophobia, blurredvision, colour blindness)—expert referral requiredand consider withdrawal, decreased tolerance tocontact lenses, keratitis, impaired hearing, Grampositiveinfections of skin and mucous membranes,exacerbation of acne, acne fulminans, allergic vasculitisand granulomatous lesions, paronychia, hirsutism,nail dystrophy, skin hyperpigmentation, photosensitivity,increased sweatingLicensed use not licensed for use in infantile acneIndication and doseAcne vulgaris under supervision of consultant dermatologist,see notes above. By mouthChild 12–18 years 500 micrograms/kg daily (in1–2 divided doses), increased if necessary to1 mg/kg daily, for 16–24 weeks (repeat treatmentcourse after a period of at least 8 weeks if failure orrelapse after first course); max. cumulative dose150 mg/kg per courseSevere infantile acne under supervision of a consultantdermatologist, see p. 574. By mouthChild 1 month–2 years 200 micrograms/kg daily(in 1–2 divided doses), increased if necessary to1 mg/kg daily, for 16–24 weeks; max. cumulativedose 150 mg/kg per courseIsotretinoin (Non-proprietary) ACapsules, isotretinoin 5 mg, net price 56-cap pack =£14.99; 20 mg, 56-cap pack = £39.99. Label: 10,patient information leaflet, 11, 21Roaccutane c (Roche) ACapsules, isotretinoin 10 mg (brown-red), net price30-cap pack = £14.54; 20 mg (brown-red/white), 30-13 Skin