Isobest 20mg/10mg Tablet Glenmark uses the active ingredient Isotretinoin . Isotretinoin pills are famous for their significant effects in treating severe nodular cystic Acne, especially in situations where conventional treatments such as the use of benzoyl peroxide, have failed. Nodular cyst acne is a condition in young individuals going through puberty. At the onset of adolescence, many changes occur in the body, with an increase of hormones being the most significant that contribute to the development of acne . According to a poll in 2013, acne affects as many as 660 million people in the world making it the eighth most common disease in the world. In addition, as many as an average of 80% of adolescents in western countries suffer from acne. The condition is characterized by a greasy skin and inflammations, usually black, white, or reddish. Isobest is manufactured and distributed as capsules with an equivalent dosage of 20 mg ISO content. Contraindications include usage of the drug by pregnant women, breastfeeding women, and women who are about to get pregnant, patients with known severe kidney and liver diseases and patients with a known record of hypersensitivity to Isotretinoin .
About Glenmark Pharmaceuticals ltd.
Glenmark, an Indian drug manufacturer, was founded in 1977 by the founder Emeritus Late Mr. Gracias Saldanha. The company specializes in the research and development of novel molecules and high qualities generics and specialty products.
The company has an approximate workforce of about 12000 employees spread out across its 17 manufacturing facilities in five countries including the USA, Argentina, India, and the Czech Republic. The company’s formulations and API manufacturing plants all over the globe have been approved by such bodies as the US FDA in the US, the TPD in Canada, the MHRA in the UK, ANVISA in Brazil, and the MCC in South Africa .
Scientific Research on Isotretinoin
For years now, Isotretinoin has been at the heart of a controversy that links its usage to depression, and suicidal ideation. Alan Byrne et al. appraises this alleged relationship in the journal article “Isotretinoin Therapy and Depression – Evidence for an Association” , where their prime objective and method involved analyzing evidence that suggests that the use of Isotretinoin leads to the development of depression. In their study, the researchers picked three case histories of individuals who had developed depression while undergoing Isotretinoin treatment. The authors observed that all three individuals showed signs of irritability, agitation, and aggression during the treatment. AS a result, the study done revealed that there is an association between Isotretinoin use and the above stated Psychiatric effects. According to Alan Byrne et al., this could be because of Isotretinoin stimulation action on hypovitaminosis A which subsequently leads to the development of the depressive illness.
Isotretinoin was first introduced in 1982 under the name Accutane and it has ever grown to prove how potent it is in treating a variety of acne conditions as well as preventing their occurrence. According to Doshi, who published the study “The Cost of Clear Skin: Balancing the Social and Safety Costs of IPledge with the Efficacy of Accutane (Isotretinoin”)” Isotretinoin effectiveness resulted in as many as 5 million prescriptions from 1982 – 2000. However, as it has been shown in many papers and studies, use of Isotretinoin carries a serious risk to an unborn baby .
Isotretinoin can lead to congenital effects such as deformation of the ears and heart, cleft palate, and learning disabilities. In the journal article, “Skin in the Game: Comparing the Private and Public Regulation of Isotretinoin, Raymond J. March  compares the effectiveness of the public regulation of Isotretinoin to private regulation. The private regulation system comprises of only one body that holds a government approved monopoly for the production and administration of Isotretinoin, the Hoffman-Laroche recommendations that make up the pregnancy prevention program. The public regulation system, on the other hand, involves regulatory guidelines specified and administered by the FDA through the iPLEDGE body. The author found that whereas public regulation is more strict than private, it has led to higher incidences of Isotretinoin patients who are pregnant. This the author argues that it is primarily because of the nature of the regulations in the public system. The FDA’s regulation policies have led to limited access of Isotretinoin and thus resulting to some patients obtaining the drug illegally. To such patients, there is no proper consultation on the possible effects of Isotretinoin to their unborn babies, and thus adding the statistic of pregnancies to Isotretinoin affected children. The author further expresses fear that most pregnancies by women under illegally obtained Isotretinoin go unreported.
Isotretinoin Action and Description of its Mechanism
All studies done on Isotretinoin only reveal a superficial view of the mechanism of action of Isotretinoin. The actual “skins cells deep” pharmacodynamics of the drug remains uncertain. Studies suggest that the main actions of Isotretinoin that lead to resolving acne include, suppression of sebum production, halting comedogenesis, and optimizing keratinization. Through sebaceous gland apoptosis, Isotretinoin can reduce the size of sebaceous glands, and thus reducing the amount of sebum produced. As a result, Isotretinoin creates an environment unconducive for the inhabitation of P.acnes. Furthermore, Isotretinoin anti-inflammatory properties also help in the prevention of any emergence of new blemishes.
Isobest Effects for Acne and Wrinkles
Before treatment, black, white, and reddish heads that glimmer due to the greasy skin usually characterize the skin’s condition. In situations where this condition persists for a long period without being treated, it leads to scarring. During treatment, Isotretinoin pills engage a mechanism that leads to a reduction of sebum secretion and suppresses comedones from forming. Without the prime ingredients for the skin inflammations, patients can expect a general decline in their acne scores that would be characterized by the disappearance of blemishes on the skin. Besides treating Acne, Isotretinoin replenishing effects also lead to the elimination of stretch marks as well as smoothening of the skin by reducing incidences and topography of wrinkles.
Recommended Doses and Duration of Therapy
Isotretinoin treatment is administered through two conventional courses. One course stresses more on the duration of medication while the other lays more emphasis on the cumulative dosage of the product in respect to the acne severity of a patient. Isobest belongs in the first course, which includes administration of Isotretinoin pills that contain low dosages of Isotretinoin, usually 10mg, and 20mg. the second course is inclusive of higher dosages of Isotretinoin, which are 0.5mg/kg/day – 1.0mg/per kg/per day. Furthermore, the second course has a recommended cumulative dosage of about 150mg/per kg for the best results. However, the latter course is synonymous with a higher chance of occurrence of side effects when compared to the lower dosage. In addition, the higher dosage is dependent on a patient’s respective weight as well as his/her acne severity. The period of treatment lasts for about 16-30 weeks.
Side effects and Warnings
Side effects include seizure, stroke, red eyes, and blisters, peeling skin, severe stomachaches, chest, and bowel pains, heartburn, Joint pains, headache, nausea, and vomiting . The FDA has issued strict regulations that require the additional contraceptive administration to women who are likely to engage in sexual activity. Isotretinoin should also not be taken by pregnant and breastfeeding women. The regulatory agency has also issued guidelines that stipulate patients under Isotretinoin treatment should not operate critical and heavy machinery during times and in places where light intensity is low. This is due to the reason that Isotretinoin has been reported to cause transient partial or full loss of vision in one or both eyes. Also, there has dermatologists are recommended to check with a patient’s psychiatric record since Isotretinoin has been reported to cause depression, suicidal ideation, and suicide in a few cases. These claims have not yet been proved true but conversely, they have not been proved as false.
Out of the 92 known drugs that interact with Isotretinoin, 26 are known to have the highest clinical significance while the rest 66 are regarded to moderately interact with Isotretinoin. Drugs such as Dienestrol, Dienogest reduces the efficacy of Isotretinoin. Alcohol has the same effect on Isotretinoin while tetracycline leads to more severe side effects when administered with Isotretinoin. Other drugs that have the same side effects as Isotretinoin should not be coadministered with ISO since this will increase intoxication and subsequently lead to more occurring more adverse side effects.
Customer reviews can serve as an essential contribution to a potential user’s confidence in a drug. The presence of reviews not only point out the drugs’ strengths and weaknesses but also variations in the treatment of people with different severity of acne. However, in some cases, a drug may be new or its popularity too poor and this fact will not allow finding a review. Isobest is one such drug with low popularity which renders the process of finding a review hard. Given the high affinity for acne products, I, however, don’t feel enthusiastic about the efficacy of Isobest.
Price, Available Forms, and Dosage
Ndrugs online health store retails Isobest 10mg x 10 for a price of 1.50 dollars which is equivalent to 0.15 USD per pill; an unusually low price. 20 mg x 10 capsules retail at 2.43 USD equivalent to an approximate 0.25 US dollars per pill. The drug is exclusively sold locally in India through online websites as well as health stores; however, bulk shipments can be made to international markets such as the USA, Australia, and Canada. The shipping charges are, however, not listed on the website, and thus unavailable.
Conclusion and Rating
Isobest seems to lack international popularity given that only Indian health stores sell it. Its lack of presence in major markets does influence the popularity of the drug in a positive way. It raises the question if the drug is good at treating one of the world’s most common disease and why it is not in demand in some of the world’s largest markets? However, this is not one major peculiarity when we take into consideration the regulations of Isotretinoin pills.
Glenmark is one of the best pharmaceutical companies in India, which means that Isobest could be an effective drug in acne treatment but we lack a proof that supports nor disapproves this fact. I would recommend the use of other drugs with confirmed reputation. I rate Isobest at 2/5.
Isobest Wiki Facts
- Brand: Isobest
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Glenmark Pharmaceuticals Ltd.
- Country of Manufacture: India
- Availability: EU, US, UK, India, Canada, South Africa
- Drug – Isobest (20 mg) 20mg (10 Capsules) (Isotretinoin) Price List [Internet]. Medindia.net. 2016. Accessible at: http://www.medindia.net/drug-price/isotretinoin/Isobest-20-mg.htm
- 6. Acne Treatments, Skin Care – Dr. Weil [Internet]. DrWeil.com. 2016. Accessible at: http://www.drweil.com/health-wellness/body-mind-spirit/skin/acne/
- Isotretinoin Drug Information – Indications, Dosage, Side Effects, and Precautions | Medindia [Internet]. Medindia. 2016. Accessible at: http://www.medindia.net/doctors/drug_information/isotretinoin.htm#Contraindications
- API Quality and Compliance | Glenmark [Internet]. Glenmarkpharma.com. 2016. Accessible at: http://www.glenmarkpharma.com/api/api-quality-and-compliance
- Byrne A, Costello M, Greene E, Zibin T. Isotretinoin therapy and depression – evidence for an association. Irish Journal of Psychological Medicine [Internet]. 1998 ;15(02):58-60. Accessible at: http://doi.org/10.1017/S0790966700003530
- Doshi A. The Cost of Clear Skin: Balancing the Social and Safety Costs of IPledge with the Efficacy of Accutane (Isotretinoin). Seton hall Law Review. 2007;37(2):625-660. Accessible at: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwi0yZrN2p3RAhWCahoKHVPBCaQQFggbMAA&url=http%3A%2F%2Fscholarship.shu.edu%2Fcgi%2Fviewcontent.cgi%3Farticle%3D1158%26context%3Dshlr&usg=AFQjCNGfLOisr7CdzR-isJlxVL3qXSj6DQ&sig2=EQ3c3h0HBDBU16F6BX36EQ
- MARCH R. Skin in the game: comparing the private and public regulation of Isotretinoin. Journal of Institutional Economics [Internet]. 2016 ;:1-24. Accessible at: http://10.1017/S1744137416000382
- Isotretinoin Drug Information – Indications, Dosage, Side Effects, and Precautions | Medindia [Internet]. Medindia. 2016. Accessible at: http://www.medindia.net/doctors/drug_information/isotretinoin.htm#sideeffects