Active Ingredient: Isotretinoin
Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring), resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy
For this indication, competent medicine agencies globally authorize below treatments:
Cutaneous
1 - 2 {spreads}
From 0.5 To 1 {spreads} 2 time(s) per day every day
Apply gel sparingly over the entire affected area once or twice daily, preferably after washing and drying the skin.
If undue irritation (redness, peeling, or discomfort) occurs, patients should reduce frequency of application or temporarily interrupt treatment. The normal frequency of application should be resumed once the irritation subsides. Treatment should be discontinued if the irritation persists.
Patients should be advised that 6-8 weeks of treatment may be required before the therapeutic effect is observed.
Patients should wash their hands after application of gel.
Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.
Oral
0.5 - 1 mg per kg of body weight
From 0.25 To 0.5 mg per kg of body weight 2 time(s) per day every day for 120 day(s)
0.5 mg per kg of body weight
Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are more closely related to the total dose administered than to either duration of treatment or daily dose. It has been shown that no substantial additional benefit is to be expected beyond a cumulative treatment dose of 120-150 mg/kg. The duration of treatment will depend on the individual daily dose. A treatment course of 16-24 weeks is normally sufficient to achieve remission.
In the majority of patients, complete clearing of the acne is obtained with a single treatment course. In the event of a definite relapse a further course of isotretinoin therapy may be considered using the same daily dose and cumulative treatment dose. As further improvement of the acne can be observed up to 8 weeks after discontinuation of treatment, a further course of treatment should not be considered until at least this period has elapsed.
Should be taken with food once or twice daily.
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