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Isotretinoin

Amnesteem, Claravis, Sotret, (Formerly Sold as Accutane)

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Updated April 19, 2014

Isotretinoin, commonly referred to by the brand name Accutane, is a powerful systemic drug used to treat severe inflammatory acne. Isotretinoin is classified as a retinoid, made from a synthetic form of vitamin A. It is taken orally, in pill form, once or twice daily.

Isotretinoin has become one of the most effective treatments available for patients with severe or cystic acne. It is even successful in clearing acne that has not responded to other treatments. According to a study published in the Journal of the American Academy of Dermatology (2001, vol. 45, pgs. 187–195) 69 percent to 75 percent of those who completed a course of isotretinoin have a significant decrease breakout production or a complete remission of acne.

The decision to begin taking isotretinoin is something you must discuss with your dermatologist. Because of its potency and possible side effects, isotretinoin is reserved only for those with severe inflammatory or cystic acne that has failed to respond to other treatment options. All patients taking isotretinoin are kept under careful monitoring by their doctors.

Isotretinoin is sold under the brand names Amnesteem, Claravis, and Sotret. Prior to June 2009 it was also sold as Accutane. It has been available as a generic drug since 2002.

How it Works

Isotretinoin works by shrinking the sebaceous glands within the dermis, reducing the amount of oil produced. The exact mechanism of this is still unknown. The reduction of oil within the follicle means less clogging of the pores, leading to a reduction of overall breakouts.

Common Course of Treatment

The most common treatment process consists of a 16- to 20-week course followed by a period of rest. More courses are then prescribed if sufficient clearing is not achieved. For the majority of patients, one course is all that is needed. Approximately 20 percent of patients require a second course. To avoid a relapse, patients must finish the prescribed course, even if the skin becomes clear before all the pills have been taken.

During treatment, patients are closely monitored by their doctors. Patients are required to schedule regular follow-up appointments and submit to blood testing to check for possible side effects, such as liver damage and an increase in triglycerides in the blood.

Possible Side Effects

While isotretinoin is a valuable treatment for those with severe acne it is not without side effects. Probably the most serious side effects of this drug are miscarriage and severe birth defects in babies whose mothers took the medication while pregnant.

The U.S. Food and Drug Administration requires women not be pregnant or become pregnant during isotretinoin use. All women who are of childbearing age are required to take two pregnancy tests prior to beginning isotretinoin treatments.

The FDA also requires women to use two forms of birth control for one month prior to treatment, during treatment, and for one month after treatment ends. Women may not breastfeed during this time. Patients who wish to become pregnant after therapy ends should talk to their doctor to determine if it is safe to do so.

The most common side effects of isotretinoin use are:

  • drying of the skin and mucus membranes
  • peeling of the skin
  • nosebleeds
  • thinning hair
  • sensitivity to the sun
  • decreased night vision
  • fatigue
Patients are warned to contact their doctors if they develop any side effects. Other severe side effects may include:
  • nausea and vomiting
  • headaches
  • bone and joint pain
  • diarrhea or rectal bleeding
  • severe chest or abdominal pain
  • difficult or painful swallowing

Another possible side effect of isotretinoin therapy is serious changes of mood. The Center for Drug Evaluation and Research division of the FDA warns isotretinoin may cause depression, psychosis, and suicide or thoughts of suicide. Any changes in mood should be reported to your doctor.

Isotretinoin has proven to be a successful acne treatment. For those who suffer from severe inflammatory or cystic acne, it may be a viable treatment option, especially if acne has not responded well to other medications. Ultimately, you and your dermatologist must decide if isotretinoin therapy is right for you.

Questions and Answers About Isotretinoin

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  6. Isotretinoin (Accutane)
  7. Isotretinoin - Treating Acne with Isotretinoin

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