Isotretinoin, Acutane

Brand name

  • Accutane

Drug Class

  • Accutane (isotretinoin) is an oral drug used for the treatment and prevention of severe acne.


  1. Soft gelatin capsules, 10 mg, 20 mg and 40 mg


  • Treatment of Acne


  • The recommended dosage range for Accutane (isotretinoin) is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks.
  • In studies comparing 0.1, 0.5, and 1.0 mg/kg/day,8 it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages.
  • During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related
  • Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated.
  • Failure to take Accutane (isotretinoin) with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
  • The safety of once daily dosing with Accutane (isotretinoin) has not been established. Once daily dosing is not recommended.
  • If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued.
  • After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated.

Adverse Effects

  • Allergic reaction:
    1. hives
    2. difficulty breathing
    3. swelling of face, lips, tongue, or throat
  • Depressed mood
  • Trouble concentrating
  • Sleep problems
  • Crying spells
  • Aggression or agitation
  • Changes in behavior
  • Hallucinations
  • Thoughts of suicide
  • Sudden numbness or weakness
  • Dry skin
  • Itching
  • Dry nose
  • Nosebleeds (epistaxis)
  • Cracks in the corners of the mouth (chilitis)
  • Dry mouth
  • Conjunctivities


  • Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders (including depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone…


  1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J Med 300:329-333, 1979.
  2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991.
  3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980.
  4. Jones H, Blanc D, Cunliffe WJ. 13-cisretinoic acid and acne. Lancet 2:1048-1049, 1980.
  5. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.
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