Acnegen 10mg/20mg Tablet Isotretinoin is an oral capsule medication that is used in the treatment of severe nodular acne. Acne Vulgaris or acne is commonly known as a condition that results from clogging of hair follicles with dead skin cells and sebum. This condition is the eighth most common disease in the world having affected an estimated 660 million people globally as per a report in 2003 . Acnegen contains the active ingredient Isotretinoin which is FDA approved for the treatment of Acne. Isotretinoin is proven to be quite potent and hence used only in cases where the severity of acne ranges from moderate to severe. The use of Acnegen in pregnant women or women who may become pregnant is highly contraindicated; this is because Isotretinoin causes neurocognitive impairment in prenatal children. Other contraindications include patients known to be suffering from diabetes and liver problems .
Biogen is one of the world’s biggest drug manufacturers. The company was co-founded in 1978 in Geneva, Turkey by four prominent scientists, two of whom received Nobel prizes. Phillip Allen Sharp of the Massachusetts institute of technology was awarded a Nobel Prize for his work in discovering split genes. Walter Gilbert also earned a Nobel Prize in Chemistry for his impressive work in understanding DNA sequencing.
The other two distinguished scientists were Kenneth Murray of the University of Edinburgh and Charles Weissman of the University of Zurich. In 2003, the company merged with Sandiego based IDEC pharmaceuticals and adopted the name BIOGEN IDEC but was later shortened back to Biogen. The company was listed as the first on the news week list of Top green companies in the world and named as the biotechnology industry leader on the Dow jones index in 2014 and 2015. The company specializes in the research and manufacture of medical solutions as well as innovative therapeutical treatments in neurodegenerative, hematologic, and autoimmune diseases .
Scientific Studies on Isotretinoin
Ayse Akman et al. in their journal article titled “Treatment of Acne with Intermittent and Conventional Isotretinoin: a Randomized, Controlled Multicenter Study” , seeks to appraise how two different intuitive courses of Isotretinoin application courses are compared to the conventional treatment. 66 patients, suffering from moderate to severe acne, were picked to participate in this randomized, multicenter, and controlled study. The patients were divided into three groups and placed in disparate courses. Patients in Group 1 were administered with a dosage of 0.5mg/kg/day of Isotretinoin for the first ten days of each month throughout a period of six months. Group 2 received the same dosage every day in the first month and then during the first 10 days of each month throughout a period of five months. The third group was treated with the same dosage but daily for six months. The general result showed a decrease in acne scores in each group. However, when the patients were evaluated based on the severity of their acne, there were no significant differences in the changes of acne scores of moderately affected acne patients across the respective groups. In addition, there was a significant difference in the response of group 1 and 2 when compared to group 3 for patients who had severe acne. Patients in groups 1 and 2 also experienced lower incidences of side effects than their counterparts in group 3. Based on these results, the authors suggested that intermittent Isotretinoin could be an efficacious treatment for moderate acne with a resultant low frequency of side effects.
From its inception, Isotretinoin has been over prescribed for treating severe acne due to its impressive results when compared to conventional treatments. However, this has been amid reports that it leads to depression and suicidal ideation in patients who are treated using the drug. Diane K. Wysowski et al. studied this phenomenon and tried to establish if there is a link in their journal article “An Analysis of Reports of Depression and Suicide in Patients Treated with Isotretinoin” . The authors analyzed reports of suicidal ideation and depression made to the FDA and the manufacturer between the periods 1982 to May 2000. In this period, the researchers found that there had been 37 United States patients who had committed suicide while undergoing acne treatment by use of Isotretinoin. Furthermore, there were 110 cases of Isotretinoin taking patients who were hospitalized for depression, suicidal ideation, and suicide attempts. A further 284 non-hospitalized patients were recorded to suffer from depression. The authors concluded that the analysis was inconclusive and recommended additional studies to determine if such a correlation exist as well as create systems that can detect patients likely to suffer from such symptoms. As a preventive measure, the authors argued that it would be deserving if patients who were waiting to undergo Isotretinoin treatment were apprised of such possible effects. As an additional measure, guardians and parents of patients should also be advised to report any signs that may be associated with depression such as sadness, crying, and inability to concentrate.
Description and Mechanism of Action of Isotretinoin
Isotretinoin mechanism of action is still not yet confirmed. However, recent studies show Isotretinoin mechanism of action works in four ways, namely, through decreased comedogenesis, sebum suppression, inflammation reduction, and suppression of P.acnes proliferation. The production of sebum has been known to be a contributing factor in the development of acne, and thus Isotretinoin suppression of sebum production has been documented to improve the disease. This is attributed to Isotretinoin direct impact on cell survival and apoptosis. In one study, sebum secretion decreased by 90% in a period of 6 weeks under a dosage of o.5 to 1.0 mg/kg/day .
Acnegen 10mg/20mg Effects for Acne and Scars
Isotretinoin shrinks sebaceous glands and reduces the amount of sebum produced. It also serves to optimize keratinization and prevents comedones from forming. As a result, patients get a noticeable reduction in acne as well as an increase in unclogged pores due to the lower sebum levels. Acnegen also leads to a reduction in inflammation and acne scars. Isotretinoin has an overall effect of eradicating scars, wrinkles, and stretch marks. As a result, a patient regains a blemishless smooth healthy skin and a subsequent rejuvenation in one’s confidence and self-esteem after the course of treatment.
Recommended Doses and Duration of Therapy
Acnegen is packed in dosages of 10 to 20 mg per day, which is a low dosage when compared to the other course of treating Acne. In higher doses, the drug administered is dependent on the patient’s weight as well as their acne severity. These dosages are often in the range of 0.5mg/kg/day to 1 mg/kg/day in the latter dose, the course of treatment lasts for a period of about 8-1o months with a total cumulative dose of 150 mg/kg. Lower dosages, such as of those of Acnegen, are also very effective and are associated with low incidences of side effects. Treatment with lower doses also last for an average of 8 months with several follow up session and, in several cases, additional treatment courses .
Side effects and Warnings
The side effects of Isotretinoin-based drugs during pregnancy are highly dangerous to the unborn baby. In fact, FDA recommendation to pregnant women who are undergoing treatment is to abort. As of mood changes and depression especially among the adolescent, studies by the FDA show little or no increase in such psychiatric conditions. However, this has remained an area plagued with contradictory reports, and thus the recommendations still include observing and reporting psychiatric changes in patients being treated with Isotretinoin. The FDA has also added guidelines on a possible increase in aggression especially in males undergoing treatment. In addition, Acnegen may lead to mucocutaneous side effects, which are dependent on the amount of the dosage. However, this side effect can be controlled by use of moisturizers and lip balms.
Isotretinoin is known to interact with 92 drugs . 26 of these drugs have major interactions with Isotretinoin, which means that the interaction carries the greatest clinical significance while the remaining 66 interact with Isotretinoin moderately. Moderate interactions can be defined as interactions of moderate clinical significance I.e. exceptions can be done under special circumstances and under directions of a validated medical practitioner. Examples of such drugs include Desogestrel, Dienestrol, Dienogest, all of which therapeutically efficacy is reduced when coadministered with Isotretinoin. Other drugs like Doxycycline and Ethinyl Ethanol lead to more severe adverse effects once these drugs are taken with Isotretinoin .
Acnegen and other Isotretinoin-based drugs are best used under a prescription of a qualified doctor. This is because the drug’s active ingredient potency has been known to cause some severe side effects, especially when used in high doses. Zeynep, in the review below, seems to be one such patient experiencing the unwanted side of the drug, besides the fact that he is on a low dosage of 20mg/day.
Irena, another client of the Acnegen brand, lauds the product by a brief precise explicit statement that addresses the basic fundamentality of what a drug’s review is all about, is it effective? The client claims that Acnegen was an efficient medication and goes further to give the medication a perfect rating of 5/5. It’s a drug you definitely do not want to acquire through an “ over the counter” scheme.
Price, Available Forms, and Dosage
As stated in above sections, Acnegen is prescribed in doses of 10- 20 mg/day. The medication is taken orally, and thus packaged in oral capsules form. The medication retails at 19.29 tls, which is an approximate equivalence of 5.53 US dollars. Acnegen sales face several restrictions by governing bodies, and thus they are hardly sold in online stores. As a result, the shipping costs of the drug to major markets such as the USA, Australia, and Canada could be determined.
Conclusion and Rating
Acnegen offers a low dosage that may instigate a lower incidence of side effects when compared to other treatment courses that use higher doses. The active ingredient has been subject to several scientific studies and while its mechanism of action is still not quite known, all studies agree on the fact that Isotretinoin is an efficacious treatment of moderate/severe acne especially in patients where other treatments have not been effective. However, FDA recommendations on psychiatric evaluations of susceptible patients should always be adhered to until there is concrete evidence that does not link the use of Isotretinoin to depression and suicidal ideation. In conclusion, Acnegen helps many adolescents, as well as other people, deals with nodular acne and enables patients to live a more confident and fulfilling life. I give Acnegen 10mg/20mg a rating of 3 out 5 due to its adverse side effects.
Acnegen Wiki Facts
- Brand: Acnegen
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Biogen
- Country of Manufacture: Turkey
- Availability: Turkey, USA, EU, UK
- Acne vulgaris [Internet]. En.wikipedia.org. 2016. Available from: https://en.wikipedia.org/wiki/Acne_vulgaris
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- About Us [Internet]. Biogen.com. 2016. Available from: https://www.biogen.com/en_us/about-biogen.html
- Akman A, Durusoy C, Senturk M, Koc C, Soyturk D, Alpsoy E. Treatment of acne with intermittent and conventional Isotretinoin: a randomized, controlled multicenter study. Archives of Dermatological Research [Internet]. 2007;299(10):467-473. Available from: http://link.springer.com/article/10.1007/s00403-007-0777-2
- Wysowski D, Pitts M, Beitz J. An analysis of reports of depression and suicide in patients treated with Isotretinoin [Internet]. Journal of the American Academy of Dermatology. 2016. Available from: http://www.jaad.org/article/S0190-9622(01)28089-X/abstract
- Global Academy for Medical Education: Isotretinoin: Mechanism of Action and Patient Selection [Internet]. Globalacademycme.com. 2016. Available from: http://www.globalacademycme.com/Isotretinoin-mechanism-of-action-and-patient-selection.html
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