Dermavax

Isotretinoin

Severe forms of acne (eg, nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy w/ systemic antibacterials & topical therapy.

Adult including adolescent & elderly Initially 0.5 mg/kg daily. Individually adjust dose during therapy. Dose ranges from 0.5 to 1 mg/kg daily. Patient w/ severe renal insufficiency Start at a lower dose (eg, 10 mg/day), then increase up to 1 mg/kg/day or until max tolerated dose. Patient w/ severe intolerance to recommended dose May continue at a lower dose w/ consequences of longer therapy duration & higher risk of relapse.

Should be taken with food.

Hypersensitivity to isotretinoin, peanut or soya. Concomitant treatment w/ tetracyclines. Patients w/ excessively elevated blood lipid values; hypervitaminosis A; hepatic insufficiency. Women of childbearing potential (unless all conditions of the Pregnancy Prevention Programme are met). Pregnancy & lactation.

Interrupt therapy & carefully monitor in case of severe allergic reactions. Acute exacerbation of acne during initial period (subsides w/ continued treatment, usually w/in 7-10 days). Risk of dry skin & lips; dry eyes, corneal opacities, decreased night vision & keratitis; intolerance to contact lenses. Avoid exposure to intense sunlight or UV rays. Avoid aggressive chemical dermabrasion & cutaneous laser treatment for 5-6 mth after treatment, & wax depilation for at least 6 mth after treatment. Avoid co-administration w/ topical keratolytic or exfoliative anti-acne agents. Reports of depression, aggravated depression, anxiety, aggressive tendencies, mood alterations, psychotic symptoms; severe skin reactions (eg, erythema multiforme, SJS & TEN); myalgia, arthralgia & increased serum creatine phosphokinase values; sacroiliitis; benign intracranial HTN. Associated w/ increased plasma triglyceride levels. Discontinue treatment if hypertriglyceridaemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur. Associated w/ inflammatory bowel disease (including regional ileitis) in patients w/o prior history of intestinal disorders. Patients experiencing severe (haemorrhagic) diarrhoea should discontinue treatment immediately. Check liver enzymes & serum lipids before treatment, 1 mth after start of treatment, & subsequently at 3 mthly intervals unless more frequent monitoring is clinically indicated. More frequent checks of serum values for lipids &/or blood glucose may be necessary during treatment in patients w/ diabetes, obesity, alcoholism or lipid metabolism disorder. Do not donate blood during therapy & for 1 mth following treatment discontinuation. Potential influence on ability to drive & use machines. Teratogenic. Women of childbearing potential should use effective contraception for at least 1 mth before treatment initiation, during treatment, & for at least 1 mth after treatment cessation. Women of childbearing potential should undergo pregnancy testing before starting treatment, ideally mthly during treatment, & 1 mth after stopping treatment. Risk of severe & serious foetal malformations if pregnancy occurs during treatment or w/in 1 mth following end of treatment. Not recommended in childn <12 yr. Do not use for treatment of prepubertal acne.

Thrombocytopenia, anaemia, thrombocytosis, increased RBC sedimentation rate; blepharitis, conjunctivitis, dry eye, eye irritation; increased transaminases; pruritus, rash erythematous, dermatitis, cheilitis, dry skin, localised exfoliation, skin fragility; arthralgia, myalgia, back pain (particularly in childn & adolescents); increased blood triglycerides, decreased HDL. Neutropenia; headache; nasopharyngitis, epistaxis, nasal dryness; increased blood cholesterol/glucose, haematuria, proteinuria.

Risk of developing hypervitaminosis A w/ concurrent use of vit A. Reports of benign intracranial HTN (pseudotumor cerebri) w/ concomitant use of tetracyclines. Local irritation may increase w/ co-administration of topical keratolytic or exfoliative anti-acne agents.

Acne Treatment Preparations

D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.

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