Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Douglas Pharmaceuticals Ltd, PO Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660
Severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk.
ORATANE should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if ORATANE is used during pregnancy.
Patient response to isotretinoin is dose-related and varies from case to case. This necessitates adapting the dosage to individual needs according to severity of the clinical picture and side effects. With a dosage of between 0.1 and 1.0 mg/kg daily over 12-16 weeks, it is generally possible to achieve a considerable improvement or complete healing. The daily dose is taken with meals; low doses once daily and higher amounts as a single dose or in several doses spread over the day.
As a rule, therapy is started with 0.5 mg/kg daily and maintained for 2 to 4 weeks until the patient’s response is clear. Initially, the acne may be aggravated for a short period.
A cumulative dose of 120 mg/kg per treatment has been documented to increase remission rates and prevent relapse. The therapy duration in individual patients therefore varies as a function of the daily dose. Complete remission of the acne is often achieved by a therapy course of 16-24 weeks. In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequence of longer therapy duration.
In patients who respond well to isotretinoin, treatment should be continued with a dosage of 0.5 mg/kg daily. With patients who show signs of intolerance during the initial therapy, the daily dosage should be reduced to 0.1-0.2 mg/kg. Where response to the initial dosage is slight, and in particularly severe cases, the daily dosage may be increased to 1 mg/kg provided the medicine is well tolerated.
The maintenance dose is administered for a period of 12 weeks after which the first stage of therapy is generally terminated. After discontinuation of treatment, often a further improvement is observed which may last from a few weeks to several months. There should, therefore, be an interval of at least eight weeks before restarting treatment. In the event of recurrence of the acne, treatment should be resumed on the above lines, bearing in mind that recurrences may respond to a lower dosage.
As a rule, this is not indicated. It is advisable to discontinue antimicrobials before beginning treatment with isotretinoin (refer to section 4.8). Concomitant radiation (ultraviolet) therapy and exposure to sunlight should also be avoided. Concomitant topical therapy of a mild nature may, however, be carried out.
If appropriate, treatment should be started at a lower dose (e.g. 10 mg/day) and afterwards individually adjusted according to tolerability (refer to section 4.3).
Long term use in children under 13 years should be avoided because of a risk of premature epiphyseal closure (refer to section 4.4).
The daily dose is taken with meals.
Although the acute toxicity of overdosage is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Such symptoms are reversible. Nevertheless, evacuation of the stomach may be indicated in the first few hours after overdosage.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
ORATANE 5 mg, 10 mg, 20 mg, and 40 mg soft gelatin capsule: 36 months from date of manufacture.
ORATANE 30 mg soft gelatin capsule: 24 months from date of manufacture.
ORATANE 5 mg, 10 mg, 30 mg, and 40 mg soft gelatin capsule: Store at or below 25°C and protect from light.
ORATANE 20 mg soft gelatin capsule: Store at or below 30°C and protect from light.
ORATANE 5 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 60 capsules.
ORATANE 10 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 15 capsules as a starter pack, 60, 120 or 180 capsules.
ORATANE 20 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 15 capsules as a starter pack, 60, 90, 120 or 180 capsules.
ORATANE 30 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 60 or 120 capsules.
ORATANE 40 mg soft gelatin capsules: PVC/PVDC-Aluminium blister packs containing 30 capsules.
Not all strengths or pack sizes may be marketed.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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