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Roaccutane is a vitamin-A derivative. The liver naturally makes small quantities of isotretinoin from vitamin-A, but the drug we prescribe is made synthetically. It was developed in the 1950s, but only started being used in the mid 1970s. The original brand names were Accutane® and Roaccutane®, but there are now many generic versions on the market, of varying potency.
Isotretinoin is a very effective medication for the treatment of acne. Originally licensed for use in severe disease, it is increasingly prescribed for all grades of acne. Low dose Roaccutane is used by Dr Treacy for the following conditions.
It is also prescribed for many other skin diseases. Examples include:
Roaccutane must not be taken in pregnancy, or if there is a significant risk of pregnancy. Blood donation by males and females on isotretinoin is not allowed in case the blood is used for a pregnant woman.
Isotretinoin should be used with caution during breastfeeding.
Commercial pilots may be subject to flying restrictions if they take isotretinoin.
High dose isotretinoin in very young children has been associated with premature epiphyseal closure, leading to shorter stature (not seen in low dose for the treatment of acne).
What is the usual dose of isotretinoin?
The range of doses used each day for acne is less than 0.1 to over 1 mg/kg body weight. A course of treatment may be completed in a few months or continue for several years. For acne, some prescribers have targeted a total cumulative dose of 120–140 mg/kg, in the hope of reducing relapse, but the evidence for this remains controversial.
Reduces sebum production * Shrinks the sebaceous glands * Reduces follicular occlusion Inhibits growth of bacteria * Has anti-inflammatory properties
Most patients should be treated until their skin condition clears and then for a further few months. However, courses have often been restricted to 16–30 weeks (4–7 months) to minimise risk of teratogenicity (risk of congenital abnormalities), and to comply with local regulatory authorities. Isotretinoin may be prescribed for years, usually in low dose or intermittently.
The side effects of Roaccutane are dose dependent; at 1 mg/kg/day, nearly all patients will have some side effects, whereas at 0.1 mg/kg/day, most patients will not. The range and severity of the side effects also depends on personal factors and the disease being treated. Patients with significant liver or kidney disease, high blood fats, diabetes and depression may be advised not to take isotretinoin or to be on a lower dose than usual and to have regular follow-up visits.
Roaccutane must not be taken in pregnancy because of a very high risk of serious congenital abnormalities in the baby. Caution needs to be used during breast-feeding as it enters the breast milk and might affect the baby. All females who could biologically have a child should take the following precautions during treatment with isotretinoin and for four weeks after the medication has been discontinued.
No contraceptive precautions are necessary for men
Isotretinoin has no effect on sperm or male fertility and has not been shown to cause birth defects in children fathered by men taking it.
Although isotretinoin is usually very effective for acne, occasionally it responds unexpectedly slowly and incompletely.
As many as ninety per cent of patients with acne have a long lasting response after a single adequate course of isotretinoin. In others, acne may recur a few months to a few years after the medication has been discontinued. Relapse is more common in females than in males, and in patients >25 years of age.
Author: Hon A/Prof Amanda Oakley, Dermatologist, Hamilton, New Zealand, 1999. Updated by Dr Amanda Oakley; Hon A/Prof Marius