Roaccutane 20 mg

Manufacturer: Roche
Substance: Isotretinoin 
Packing: 30 caps. (20 mg/cap)

About Roaccutane:

An early treatment of acne first used during the 1930s was high doses of the fat-soluble vitamin A (retinoic acid).At these dosage levels (sometimes 500,000 IU per day), sebum production is notably reduced, thwarting acne, but overly dry hair is a negative side-effect, and such high doses can lead to vitamin A toxicity. Use of animal-based vitamin A at nutritive levels (where the upper limit dosage is 10,000 IU daily), taken over the course of a year, has also been shown to reduce acne.

Building on the discovery that vitamin A can inhibit sebum production at toxic dosages, the retinoic acid derivative isotretinoin (13-cis-retinoic acid) was developed in 1982 by Hoffmann-La Roche. Dr. Gary Peck is credited with discovering its use for the treatment of cystic acne as well as disorders of keratinization such as lamellar ichthyosis, Darier's disease, and pityriasis rubra pilaris. In addition, he demonstrated its chemopreventive properties in patients with Basal Cell Nevus Syndrome, also known as nevoid basal cell carcinoma syndrome and Gorlin's syndrome. In fact, within one year of attaining the U.S. patent for discovering the use of isotretinoin in the treatment of acne, he received the Inventor's Award from the US Department of Commerce and a Meritorious Service Medal from the US Public Health Services in 1983. In 2003, he was honored with The Discovery Award by the Dermatology Foundation in "recognition of extraordinary scientific accomplishments that have had a profound influence on the specialty of dermatology and have gained the respect and admiration of the world scientific community".

Dosage requirements of isotretinoin have been disputed. After a 1984 study funded by Roche, relatively high dosages of isotretinoin became mainstream in treatment in the United States. Lower dosages were found to be effective in treatment by independent research (see dosage section of this article).

From the time of its introduction, the drug was known to have teratogenic potential, and pregnancies with the drug were strongly discouraged. When they occurred, they were found to have approximately 30% rates of congenital malformation, versus a 3–5% baseline risk.Beginning in 1998, prescriptions of the drug came under scrutiny, as fewer than half of prescribers were testing for pregnancy, usually relying on less sensitive urine tests. On the grounds that pregnancies by women taking the drug had been underreported by the manufacturer between 1982 and 2000, and that, once generic manufacturers entered the market risk management was no longer centralized, the FDA instituted restrictions on prescribing and dispensing the drug, first with the "System to Manage Accutane Related Teratogenicity" (SMART) in 2000, and subsequently the ipledge program in 2006. A retrospective cohort study recently found that pregnancy rates were quite high during the period (1 per 30 women per year), and 84% of pregnancies were ended by induced abortion.

In February 2002, Roche's patents for isotretinoin expired, and there are now many other companies selling cheaper generic versions of the drug. On June 29, 2009, Roche Pharmaceuticals, the original creator and distributor of isotretinoin, officially discontinued both the manufacture and distribution of their Accutane brand in the united states due to what the company described as business reasons related to low market share (below 5%) coupled with the high cost of defending personal-injury lawsuits brought by some patients prescribed the drug. Generic isotretinoin will remain available in the United States through various manufacturers. Roche USA continues to defend Accutane and claims to have treated over 13 million patients since its introduction in 1982. F. Hoffmann-La Roche Ltd. apparently will continue to manufacture and distribute Roaccutane outside of America.

Isotretinoin is available over the internet from countries where it can be dispensed without a prescription. This presents a dilemma for acne sufferers residing in countries with highly regulated medical and pharmaceutical industries (FD&C Act), as private importation might violate existing statutes.

Side effects:

The following adverse effects have been reported to persist, even after discontinuing therapy: alopecia (hair loss), arthralgias, decreased night vision inflammatory bowel disease, degenerative disc disease, keloids, bone disease, dry eyes,"dry skin". High dosages of isotretinoin have been reported to cause rosacea (a disease of severe facial skin redness and irritation). It is not known how these side effects can be permanent but several studies have shown that Isotretinoin induces apoptosis (cell death) in various cells. A recent study about how pharmaceuticals have epigenetic effects (for example DNA methylation) mentions Isotretinoin.

Effective dose:

The dose of isotretinoin a patient receives is dependent on their weight and the severity of the condition. High-dose treatments are administered between 0.5 mg/kg/day to 2 mg/kg/day (usually at 0.5 to 1 mg/kg/day, divided into two doses), for a total treatment of 4–6 months. In some rare cases where the patient's acne is severe or unresponsive the initial course may last up to 9 months. A second course may be used at least 8 weeks following the cessation of the initial course if severe acne recurs. Efficacy appears to be related to the cumulative dose of isotretinoin taken, with a total cumulative dose over each course of 120–150  mg/kg used as a guideline. Shorter, higher dose treatments or uninterrupted double courses should be used only as a last resort, due to adverse side-effects.

Nearly all patients achieve initial clearing of acne during high-dose isotretinoin therapy. Furthermore, about 40% observe complete and long-term remission of the disease following one course of isotretinoin, while another 40% eventually develop less severe recurrent acne, which is treatable with less invasive medications. The remaining 20% relapse significantly enough to warrant an additional course of isotretinoin. Each additional course, however, has a higher probability of cure.

Lower-dosage treatments, such as 10–20 mg/day (approximately half the high dosage treatments above), are also highly effective, with greatly diminished side-effects. However, such lower dosage courses may be associated with higher relapse rates requiring additional courses of isotretinoin, especially if not taken for sufficient time.

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