Indications for Accutane® (Isotretinoin)

Approved Indications

FDA approved in 1982. Approved for severe, recalcitrant nodular cystic acne unresponsive to other first line therapies.

Physician Initiated (Off-Label) Use

• Other Acne Use:
  • Moderate acne
  • Unresponsive Mild inflammatory acne scarring
  • Acne resulting insignificant emotional sequelae
  • Patients unwilling to use long term medication for the control of their acne
• Acne keloidalis nuchae
• Dissecting cellulitis of the scalp
• Hidradenitis suppurativa
• Pyoderma faciale
• Rosacea
• Grovers disease
• Follicular mucinosis

Severe non-cystic acne

• Severe unresponsive acne without cysts.
• Scars often present

Moderate acne

• Inflammatory acne causing scars or psychological harm.
• In some the degree of acne may be mild.

Occasional or few cysts

• Adult onset acne characterized by occasional large painful cysts that are often unresponsive to other therapy.

Excoriated acne

• Those with compulsive disorders resulting in picking of their acne lesions producing significant scars.

Failure of, or unwilling to take long term therapy

• Many patients do not want to continue with long term oral antibiotics which may be required for control.. Acne tends to relapse after stopping antibiotics.

Use of Isotretinoin in Rosacea

• Unresponsive to typical rosacea therapy
• Rosacea fulminans
• Granulomatous rosacea
• Localised rosacea lymphoedema

Dosage

• 0.2 to 1mg /kg/day or 10 to 60 mg a day.
• Duration of therapy ranging from 6 weeks to 6 months
• Higher total doses trend to better long term results
• Start with low dose for first month makes patients tolerate the drug better.
• 120mg/kg total dose is minimum for all patient
• Multiple treatment acceptable
• Long term low dose regimen is favoured by some clinicians
• Good results in some to mini dose of 10mg daily
• Some respond well in 2 weeks when acne like doses used
• Reports of long term responses seen

Rosacea Variants:

• • Pyoderma Faciale
    • Severe sudden onset of pustules and abscesses.
    • Isotretinoin 1 mg /kg/day usually required for 4-5 months. Early short course of systemic steroids desirable starting at around 30mg and reducing by 5-10mg per week.This can be combined with oral anti-inflammatory antibiotics.

[Euro J Dermatol 1996;6:94-6.]

• Lymphodema
  • Rosacea may on rare occasion present with a localized fixed plaque of erythematous swelling particularly on the forehead or cheek.
  • Low dose 0.1-0.2mg/kg/day for 2-4 months may be adequate. The dose can be increased if a poor response is achieved.