What is the appropriate dosing of Accutane (isotretinoin) for a young male with cystic acne?

From the Guidelines

The appropriate dosing of Accutane (isotretinoin) for a young male with cystic acne is typically started at 0.5mg/kg/day and uptitrated to 1mg/kg/day as tolerated.

Key Considerations

• The goal of treatment is to achieve a cumulative dose of >220mg/kg to decrease the rate of relapse, as seen in a prospective study of 180 patients with severe acne, where the relapse rate at 1 year was 26.6% among those who received >220mg/kg cumulative dose compared to 43.8% among those treated with lower doses 1.
• Low-dose isotretinoin (e.g. 0.2 to 0.4mg/kg/day) has been demonstrated to have similar effectiveness and reduced side-effects when compared to higher dose regimens, although these studies have been in patients with mild to moderate acne with limited follow-up 1.
• Daily dosing is conditionally recommended over intermittent dosing of isotretinoin based on low certainty evidence from 3 RCTs, with greater reductions in global acne grading system score, inflammatory lesion counts, and non-inflammatory lesion counts seen in daily dosing 1.
• Standard isotretinoin or lidose-isotretinoin can be used, with standard isotretinoin having better bioavailability when taken with a high fat meal, and lidose-isotretinoin showing non-inferiority in reducing facial and truncal nodular lesions and in the proportion of patients achieving 90% reduction of total lesions at 20 weeks 1.

Important Notes

• Younger age at initial treatment and male gender are associated with an increased risk of relapse, with those under 16 years of age having approximately a 25% increased rate of relapse 1.
• Clinicians should monitor for depression, anxiety, suicidal ideation/suicidality, and other neuropsychiatric adverse effects and individualize therapeutic decisions based on individual differences in response to isotretinoin 1.

From the FDA Drug Label

The recommended dosage range for isotretinoin capsules is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated. Table 4 Isotretinoin Capsules Dosing by Body Weight (Based on Administration With Food) Body Weight Total mg/day kilograms pounds 0.5 mg/kg 1 mg/kg 2 mg/kg*

The appropriate dosing of Accutane (isotretinoin) for a young male with cystic acne is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. The dose may be adjusted according to response of the disease and/or the appearance of clinical side effects. For severe cases, the dose may be increased up to 2 mg/kg/day. It is essential to take isotretinoin with food to ensure adequate absorption. 2

From the Research

Dosing of Accutane (Isotretinoin) for Cystic Acne

The appropriate dosing of Accutane (isotretinoin) for a young male with cystic acne can vary depending on the severity of the condition and the patient's response to treatment.

• The usual oral dosage of isotretinoin for patients with cystic acne is 1-2 mg/kg/day in two divided doses, with treatment continuing for 15-20 weeks 3.
• A study found that isotretinoin prescribed at 1.5 mg/kg/day or greater for 5-6 months, with a cumulative total dose of 290 mg/kg, is safe and effective compared to current standard dosing practices 4.
• Another study suggested that a lower dose of 0.5 to 1.0 mg/kg/day may be effective, with 90% of participants showing very good results after 3 months of treatment with 20 mg/day (approximately 0.3-0.4 mg/kg/day) 5.
• Guidelines for optimal use of isotretinoin in acne recommend a dose of 0.5 to 1.0 mg/kg/day, with a higher dose of 1 mg/kg/day reducing the relapse rate, especially in young patients and men with truncal acne and more severe disease 6.
• The dose of isotretinoin used in infantile cystic acne cases ranged from 0.2 mg/kg/day to 1.5 mg/kg/day, with treatment duration varying from 5 to 14 months 7.

Considerations for Treatment

When treating a young male with cystic acne, it is essential to consider the potential side effects of isotretinoin, such as cheilitis, xerosis, and elevated serum lipid levels, and to monitor the patient closely for any adverse effects.

• Careful monthly monitoring is recommended due to the many side effects reported with isotretinoin 7.
• The treatment should be individualized based on the patient's response and the severity of the condition.
• Repeat courses of isotretinoin can also be given if necessary, and the use of isotretinoin should be limited to patients with severe conditions that do not respond to older therapies due to its cost and potential serious adverse effects 3, 6.