Reducar (Accutane - Isotretinoin) 20mg 30softgels GAP S.A.

Everything you need to know about Accutane, including user reviews

What is Accutane?

Introduction to Accutane

Accutane (isotretinoin), or Roaccutane as it is known in parts of the world, was discovered in 1979 when it was first given to patients with severe acne, most of whom reacted with dramatic and permanent clearing of their acne symptoms. It is a vitamin A derivative (13-cis-retinoic acid) that is administered orally in pill form with a meal that contains an adequate amount of fat,1 normally for 15-20 weeks (3.5-4.5 months),2 although it is also sometimes prescribed at lower dosages for up to six months or longer. It was originally recommended for people with severe acne that did not respond to other treatments,3 but has gained in popularity in the past 25 years and is prescribed more and more frequently for less severe acne.4-6 This practice is controversial because Accutane is a serious medication that can cause severe birth defects as well as potentially long-lasting side effects to the user. Accutane need not be paired with other medications.7

How does Accutane work?

Exactly how Accutane works on a cellular level is unknown but we do know that it affects all four ways that acne develops.

• 1. It dramatically reduces the size of the skin's oil glands (35%-58%) and even more dramatically reduces the amount of oil these glands produce (around 80%).8-9
• 2. Acne bacteria (P. acnes) live in skin oil. Since oil is dramatically reduced, so is the amount of acne bacteria in the skin.9
• 3. It slows down how fast the skin produces skin cells inside the pore, which helps pores from becoming clogged in the first place.10
• 4. It has anti-inflammatory properties.10

Although acne may get worse within the first month of Accutane use for about 30% of patients, the ultimate results are usually dramatic.11 Accutane works to achieve partial or complete clearance of acne in about 95% of people who complete a cycle, regardless of whether they have inflammatory or non-inflammatory acne.12 The majority of people who take it see their acne effectively cured, experiencing long-term remission of acne symptoms. Studies show an average relapse rate of around 33%, and in these cases sometimes a second course is given.7,9,12-17 This relapse rate is dose-dependent.13 Patients who receive a cumulative dose of 100-120 mg/kg see the best results and lowest relapse rates. Patients who receive a lower dose relapse more frequently. Daily dosage depends on how much the patient weighs; 0.5 mg - 2 mg/kg is typical.15

Low and intermittent dosing: Researchers have published several studies attempting to gauge whether people with mild to moderate acne can achieve long-term remission of acne with lower dosages of Accutane. Initial data is showing that patients with mild to moderate acne may be able to achieve long-term remission with significantly lower dosages, and thus suffer less side effects,18-20 including lower incidence of scarring. For people with more severe acne, staying on a lower dose of Accutane for a longer period of time until the full 120mg/kg cumulative dose is achieved may be a way to produce long-term remission with significantly less side effects.21 Intermittent dosing (taking Accutane only 1 week of every month) appears to work less well, producing significantly poorer outcomes for more than half of the patients studied.19,22

Accutane side effects

Accutane is a systemic medication that affects the entire body. Side effects are numerous and widespread, and affect upwards of 80% of patients.1 Side effects are most often mild to moderate and reversible, but in some cases can be severe or long-term. When data exists, incidence information is listed.

Elevated liver enzymes

AKA Hepatotoxicity. Clinical research found this to occur in 15% of cases.3,28

Inflamed pancreas

AKA Pancreatitis. Clinical research found this to rarely occur.

Respiratory symptoms

Difficulty breathing (bronchospasms, respiratory infection, and voice alteration).8

Dry lips

Clinical research found this to occur in 92% of cases.3,8

Dry skin

AKA Xerosis. Clinical research found this to occur in 57% of cases.3,7-8

Take with a high fat meal

Because isotretinoin as a molecule dissolves best in fat, it is essential that you take it with a meal that contains an adequate amount of dietary fat. According to drug labeling information submitted to the U.S. National Library of Medicine by the makers of Accutane, "Both peak plasma concentration (Cmax) and the total exposure (AUC) of isotretinoin were more than doubled following a standardized high-fat meal when compared with Accutane given under fasted conditions. Therefore, Accutane capsules should always be taken with food. Failure to take Accutane with food will significantly decrease absorption."1 This failure to take Accutane with meals may account for some of the relapse that we see post-Accutane.

So what kind of meal should you eat when taking Accutane, and how much dietary fat should it contain? So far only 2 studies have been performed. The first asked participants to ingest approximately 20g of fat (2 poached eggs, toast with margarine, plus 8oz. of skimmed milk), and found that this was enough to approximately double the absorption of Accutane.2 The second asked participants to ingest 50g of fat (1 bagel, 2 tablespoons of peanut butter, 5 slices of bacon, 6 ounces of apple juice, and 1 donut), and found that this was also enough to approximately double the absorption rate.3 Further research is required to determine exactly how much fat one must optimally ingest to reach maximum isotretinoin levels in the blood, but suffice it to say that Accutane must be taken with a meal which contains dietary fat to deliver its full potential. Based on the research thus far, it is prudent to ingest at least 20 grams of fat when you take your Accutane pill.

One exception – Absorica™: In 2012, the FDA approved a new version of isotretinoin for sale in the U.S. that is marketed under the brand name Absorica. The package insert states that Absorica (1) is bioequivalent with Accutane when both are taken with a high fat meal; (2) has 83% greater absorption than Accutane under fasted conditions; (3) is not interchangeable with generic products of Accutane; and (4) can be dosed without regard to meals.4 While data does show that Absorica is absorbed significantly more than regular isotretinoin on an empty stomach, the claim that Absorica can be dosed without regard to meals may be skewed, since data shows that even with Absorica, the amount of isotretinoin in the blood remains significantly higher when taken with a high-fat meal. Thus, it may also be prudent to take Absorica with a meal which contains an adequate amount of dietary fat.

History of Accutane

Gerald Peck and co-workers from the NIH (National Institutes of Health) in Bethesda, Maryland first studied isotretinoin in patients with skin cell disorders. They accidentally found that it also worked on patients with severe acne. Isotretinoin was registered in 1979, released in the United States in 1982 as Accutane, and released in Europe in 1985 as Roaccutane.1

Roche's patent expired in 2002, and manufacturers began selling generic forms of the drug.

In June, 2009, shortly after a jury awarded $33 million in damages to people who claimed Accutane caused bowel disease, Roche decided to discontinue selling brand name Accutane. The company cited declining sales as their reason.

Topical isotretinoin

Topical isotretinoin exists but does not produce the results of oral isotretinoin. It is largely of historical significance in acne treatment.