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Isotretinoin

Isotretinoin is a generic medication used for the treatment of severe acne and most commonly known under the brands Accutane and Roaccutane. It is a retinoid, meaning it is derived from vitamin A and is found naturally in the body, produced by the liver in small quantities. more...

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History

Prior to the development of isotretinoin, the mainstay treatment of severe acne was oral antibiotics such as the tetracyclines and erythromycin. While these drugs have proven efficacy, they worked against only one contributing factor of acne, Propionibacterium acnes bacteria. The antibiotics gradually became less effective over time as more resistant strains of the bacterium became prominent.

An early, effective treatment of acne was high doses of the fat soluble vitamin A. At these dose levels (sometimes 500,000 IU per day) effects such as reduced production of sebum and dry hair could be noticed. However the vitamin also had many other prominent side effects which inhibited its widespread use.

The development of the derivative of retinoic acid, isotretinoin (13-cis-retinoic acid), and its release in 1982 by Hoffmann-La Roche was a great step forward in the treatment of acne. The synthetic compound provided better therapeutic benefit than vitamin A, while also producing fewer side effects. In February 2002 Roche's patents for isotretinoin expired, there are now many other companies selling cheaper generic versions of the drug.

Today isotretinoin is usually prescribed after other acne treatments have failed to produce results. The treatment of acne usually begins with topicals, moves onto oral antibiotics (or a combination) and finally isotretinoin therapy. This is because other treatments, while less effective than isotretinoin, produce far fewer side effects.

Brand names

Isotretinoin is produced under many brand names by many manufacturers. It is available typically as 5 mg, 10 mg, 20 mg and (in the USA) 40 mg capsules.

Some brands of isotretinoin include:

  • Accure® by Alphapharm
  • Accutane® and Roaccutane® by Roche
  • Aknenormin® by Hermal
  • Amnesteem® by Mylan
  • Ciscutan® by Pelpharma
  • Claravis® by Barr
  • Isohexal® by Hexal Australia
  • Isotroin® by Cipla
  • Oratane® by Douglas Pharmaceuticals
  • Sotret® by Ranbaxy

Indications

Isotretinoin is indicated for treatment for a number of dermatological conditions, most commonly acne. It is generally not used as a first-line treatment due to the potential side effects. Antibiotics (such as the tetracyclines) are usually prescribed before isotretinoin.

Severe forms of acne (conglobata, fulminans and nodulocystic) as well as acne that scars can be successfully treated with isotretinoin.

Acne that has not responded to other treatment will usually respond to isotretinoin. Dysmorphophobic patients may also be prescribed isotretinoin.

Read more at Wikipedia.org


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FDA approves iPLEDGE for isotretinoin
From Journal of Drugs in Dermatology, 11/1/05

The FDA recently approved iPLEDGE, the new risk management program developed to decrease pregnancy and subsequent fetal exposure in women taking isotretinoin for recalcitrant nodular acne. This new program will replace current risk management programs by December 31, 2005. In order for patients to receive isotretinoin, prescribing physicians, pharmacies, and patients must be registered through the iPLEDGE system. Furthermore, monthly pregnancy tests will be tracked through a computerized system. Only if all criteria are met will the system provide a registered pharmacy with an authorization number to dispense an isotretinoin prescription. The goal of this new enhanced program is to prevent the distribution of isotretinoin to pregnant women and to prevent pregnancy in women taking isotretinoin.

COPYRIGHT 2005 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2005 Gale Group

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