Sotret 20mg/10mg gel contains Isotretinoin and are indicated for the treatment of severe acne in patients. Isotretinoin products are indicated for the treatment of severe cystic and nodular acne  and other acne cases unresponsive to the first-line treatments like benzoyl peroxide/clindamycin and tetracycline treatment or any antibiotic treatment .
The product Sotret 20mg/10mg is manufactured by Ranbaxy Pharmaceuticals, which is already acquired by the pharmaceutical giant, Sun Pharmaceutical Industries. The Indian company makes Sotret in oral form and it has two formulations for the product, the 10 mg, 20 mg, 30 mg, and 40 mg formulations. But aside from the oral capsules, Ranbaxy manufactures topical Sotret (gel) with 0.05% Isotretinoin and soap forms too.
Isotretinoin treatments are the ones used for severe acne, but though extremely effective, Isotretinoin treatment is not the first treatment considered for the management of acne in patients. It is always considered the last option, as its use is related to a large number of side effects in patients. Although the side effects are generally manageable, some patients experience more severe side effects related to the use of Isotretinoin medication in patients. There are systemic side effects caused by the use of Isotretinoin medication; the drug is known to cause alterations in the liver enzyme profiles, the lipid levels, ovarian reserves, and white blood cell counts in the body of the patients. Aside from these alterations, Isotretinoin is known to cause teratogenic effects in gravid female patients. Isotretinoin use is related to a number of terminated pregnancies over the years due to malformations of the fetus in the womb. The drug causes fetal malformations when taken during pregnancy, so it is imperative that patients are prevented from getting pregnant and educated regarding the harm Isotretinoin can cause while under treatment.
About Ranbaxy Pharmaceuticals
Ranbaxy is one of the companies which belong to Sun Pharma , as the company was acquired by Sun Pharma in 2014 . It is not the first time that the company was acquired since it was first bought by Daiichi-Sankyo in 2008 .
Ranbaxy started in 1937 but as a distributor for a certain Japanese company. But later on, the company developed into a pharmaceutical manufacturing company aside from being into distributorship . The company manufactures a number of pharmaceutical products which are used in the fields of dermatology, diabetes, analgesics, narcotics, and other medications . Ranbaxy is also concerned with the manufacture of a number of finished dose forms in the form of tablets, pills, creams, ointments, and more.
Ranbaxy operated on a large scale as it was able to distribute its products to about 125 countries . The company has 43 manufacturing facilities and is stationed in 8 countries . Ranbaxy has been recognized as the OTC Company of the year in 2011 and placed well in the 2012-2014 Brand Trust Reports .
Although the company is recognized by numerous award-giving bodies, it had not always been easy for Ranbaxy as there were a number of controversies where the company was involved in. The US FDA halted its reviews for the products of the company due to reports of the company falsifying the data for the products . The company’s products were also recalled a number of times due to the presence of impurities in the products. Aside from that, the company was also fined by the US due to its misinterpretation of clinical data for its generic drugs and due to impure drugs sold to the said country .
The company’s acquisition by Sun Pharma is actually a smart move to reinstate the company’s status. Sun Pharma, aside from being one of the world’s leading pharmaceutical companies and one of the largest in terms of production, is also well-accredited and is known for its high-quality products and manufacturing process. Ranbaxy’s acquisition by Sun Pharma, though hard to the employees, is actually beneficial for the company’s name.
Scientific Studies on Isotretinoin
One of the cultural studies for Isotretinoin’s effectiveness is the one done by Gan et al (“Isotretinoin is safe and efficacious in Asians with acne vulgaris”), which studied the effectiveness of Isotretinoin in Asian patients . This particular study involved the records of all the patients treated with Isotretinoin from January 2005 and December 2008 . There were 2,255 patient records found at the National Skin Centre in Singapore, and the researchers reviewed the patient records to determine the specifics of Isotretinoin treatment in the patients . According to the study, 93% of the patient population was able to achieve complete clearing/remission or significant improvement of the acne condition . Only a small percentage showed changes (elevation) in serum alanine (38 or 2.7%) and aspartate aminotransferase (24 or 2.2%) levels following treatment, 194 patients (12.1%) developed hyperlipidemia and 80 (4.8%) developed hypertriglyceridemia . Based on these results, Isotretinoin was received well by the patients and only 145/2255 or 6.4% discontinued the treatment due to adverse effects .
The study by Wessels et al, “The cost-effectiveness of isotretinoin in the treatment of acne. Part 1. A meta-analysis of effectiveness literature” in 1999 is also one study which analyzed the effectiveness of Isotretinoin treatment in the management of moderate to severe acne . According to this meta-analysis, the drug, Isotretinoin is consistent with its effectiveness in the management of moderate to severe acne vulgaris cases, as the study determined that the drug has a cure rate of 84.22-86.71% and the treatments usually lasted for 17.9 weeks to achieve the good results . Relapse rate is also low when patients are treated with Isotretinoin, as the relapse rate is only 21.45% . It was also determined that the optimal dose for acne remission using Isotretinoin is 1 mg per kg daily and 120 mg/kg cumulatively . Wessels et al concluded that Isotretinoin is still an effective treatment for moderate to severe acne cases and is relevant as it is not only a meta-analysis of the initial studies concerning Isotretinoin, but it is also a cultural study involving the use of Isotretinoin in patients in South Africa .
Isotretinoin has proven its effectiveness in the management of nodular and cystic acne, and also acne fulminians too. The study by Petiau et al, “Acne necrotica varioliformis, resolution with isotretinoin” also determined if Isotretinoin is also effective in the cure of Acne necrotica varioliformis , which is a rare form of severe acne in the scalp and is commonly caused by P.acnes and Staphylococcus Aureus, and is related to permanent hair loss and death of scalp tissue. This case study presented the effectiveness of oral Isotretinoin in a 24-year-old patient with the mentioned condition in a dose of 1 mg per kg/day . The patient tried other treatments before like antibiotic treatments, steroids, benzoyl peroxide, fungistatics, and Isotretinoin in topical form . The patient only responded well to the Isotretinoin treatment and after 5 weeks, the patient became lesion-free and maintained the clearing even after 6 months post therapy . This study indicates the possible application of Isotretinoin in other severe acne cases due to its effectiveness in treating Acne necrotica varioliformis in the 24-year-old patient .
Isotretinoin’s Mechanism of Action and Description
The active ingredient Isotretinoin belongs to the family of retinoids, which are derivatives of vitamin A. Retinoids are indicated in the treatment of dermatological conditions and the most famous ones are Tretinoin and Isotretinoin. Isotretinoin is more effective than Tretinoin in the treatment of acne cases (even the severe ones) as oral Isotretinoin deals directly with the source of the acne problem.
Isotretinoin acts on the sebaceous glands and induces apoptosis of the cells leading to the suppression of the hyperactive glands in patients with severe acne. This action of suppressing the excessive oil production corrects the sebum-rich skin environment which is easily colonized by acne-causing and acne-exacerbating bacteria, the corynebacterium P.acnes. Excessive oil production is the reason for the blockage of the follicles, the formation of pustules, and lesions and the presence of bacteria in the skin (since the bacteria tend to feed on sebum produced by the hyperactive glands).
Since Isotretinoin deals with the source of acne production (the sebum), the acne condition is corrected. Sebum production is limited so the formation of lesions and pustules are prevented. Inflammation of the skin due to the bacteria is also reduced as the bacteria population is eliminated.
Sotret Effects for Acne/Wrinkles
There are a number of benefits brought about by the use of Isotretinoin in patients. For acne, patients can expect complete remission as isotretinoin is highly effective in the elimination of acne lesions in the skin. Positive before and after results by Isotretinoin can be expected to show a few weeks while undergoing therapy and the full result may be observed in about 4 months (the typical duration of the treatment) .
Aside from its acne-clearing benefits, Isotretinoin is also observed to improve acne scars in patients treated with Isotretinoin, so the product is also used in a number of dermatological applications which are not related to acne. Wrinkles and stretch marks are also some examples of the conditions which Isotretinoin is being used in, as the drug is also discovered to have anti-aging properties due to its capability to induce cell growth for skin regeneration.
Recommended Doses and Sotret Duration of Therapy
Patients are initially treated with 0.5 mg/kg/day of Isotretinoin, but the dose tends to vary depending on the advice of the attending dermatologist. Treatments involving Isotretinoin products are always patient-centered, as the patient response is the critical marker for the appropriate treatment for the patients.
Some patients are prescribed with lower doses , while patients are prescribed with higher doses , depending on the nature of acne being treated. High doses are usually recommended for severe cases of acne, while the moderate cases call for lower Isotretinoin doses. If patients seem to experience side effects which are bothersome, their doctor may adjust their dose to lessen side effect incidence.
As for the duration, the common treatment duration is about 4 months, but some treatments just stop when visible results are achieved. Again, the length of treatment ultimately depends on the patient response to Isotretinoin treatment.
Side Effects and Warnings
Isotretinoin is known to cause skin drying, flaking, itchiness, redness, and other conditions which arise due to skin dryness. Dry lips are common to patients taking Isotretinoin  as well as the irritation of the eyes due to dryness. Nosebleeds are also common due to the change in mucosal integrity in the nasal area. Aside from these skin problems, hair loss and GI upset are also commonly reported by the patients under Isotretinoin treatment .
Side effects like depression and other mood changes are rare , as well as changes in the levels of liver enzymes and other markers in the bloodstream. Isotretinoin is also teratogenic, so patients who are pregnant may not take the medication. Women of childbearing age are advised to take extreme caution when taking the medication, as these patients cannot get pregnant in order to prevent the incidence of fetal malformations and other birth defects.
Patients are made aware by the drug interactions by their dermatologists upon consultation, and that is one of the reasons why Isotretinoin should only be taken as per prescription basis only. Consulting a specialist regarding Isotretinoin intake lessens the risk of drug interactions and prevents incidences of adverse drug events which are harmful to the patients.
Open communication between physician and patient is vital as the meds taken by the patients should be known by the doctors as there are a number of medications contraindicated with Isotretinoin like tetracyclines, vitamin-A-type drugs, anti-seizure medication, and corticosteroids .
It is wise for the patients to seek the advice of their physicians when planning to take any medication, even OTC meds and herbal supplements, as these meds can interact with Isotretinoin and hinder its effectiveness or cause harm to the patients.
Sotret 20mg/10mg is known to be one of the generic versions of Accutane (the medication famous for acne treatment) and it has earned a number of reviews from patients for its effectiveness. The photos below show reviews/user comments available for Sotret from a number of threads from Acne.org.
One user seemed to post his comment in response to a question regarding the Isotretinoin content of Sotret compared with the brand-name Isotretinoin medications. The user “Axsuul” mentioned that though Sotret contains the same Isotretinoin active ingredient, the product, as a whole differs from other medications as the inactive ingredients are not 100% the same. According to the user, the generic brands of Isotretinoin should give the same results but there are cases where the generic brands are ineffective and yield different outcomes in comparison to the brand-name Isotretinoin products. The user, however, attested to experience positive results with his Sotret treatment (currently his 2nd month at the time of his comment).
Based on these comments from users of Sotret, the patient response varies from one patient to another. The user “TennesseeGrl” mentioned that Sotret was effective in helping her clear her acne 100% and it only took 3 months for her skin to clear out. She was well-pleased with the results as well as the affordability of the medication.
However, the other user was not too pleased with Sotret’s action on his acne condition and preferred Accutaвne over the generic medication. According to the comment, the client’s preference of Accutane over Sotret is due to Sotret’s ineffectiveness when it comes to the management of his condition. He asked his doctor about the difference of the two meds, but his doctor mentioned that there is not much variation with the meds, although patients have different responses to each medication.
Due to good reports for the effectiveness of Sotret, the drug may be recommendable for patients prescribed with Isotretinoin and on a tight budget, although patients should be aware of their reaction to the medication as there are patients who react differently to the medication.
Price, Available Forms and Dosage
It is mentioned that Sotret 20mg/10mg’s sale is already discontinued in the US, although the product is still found in some online drugstores. Sotret is highly affordable and costs from $2.38-$4.60 for 10 capsules depending on the strength of the medication. This price is suitable for patients prescribed with Isotretinoin treatment but cannot afford the more expensive brand-name treatment for acne.
Sotret, though sold by a number of vendors online, is not available for sale outside India. The drug may have been restricted to ship to other countries due to several reasons and issues with the manufacturer. Ranbaxy’s products are generally restricted to ship to the US due to the controversies in drug impurities. It may be one of the reasons why there is no shipping available for countries like the USA, Australia, and Canada, plus other countries. Other Isotretinoin products are still available in several countries, so patients can still avail of Isotretinoin products in their own localities, but not Sotret, though, as it is available in India and several countries only.
Conclusion and Rating
Sotret 20mg/10mg gel had good reviews from some of its users but there were also others who did not find the drug effective. Also, the handful reviews are not enough to establish that the drug is highly effective in the treatment of acne in patients as the online reviews represent but a small fraction of the user population for the product.
Although Sotret’s manufacturer, Ranbaxy Pharmaceuticals is a large company with a number of recognitions, the company had been involved in a number of controversies regarding product contamination and data falsification in product testing. The US FDA halted the review for all its products pending for US FDA approval, so there is really not much assurance in the quality of the products produced by the company. But since the company has been recently acquired by Sun Pharma, Ranbaxy’s high-quality product status may be reinstated.
Since Sotret has been effective for some patients and since its price is affordable enough for patients to buy, the drug may be rated 3 out of 5. I recommend buying the product still, when available and when prescribed, but patients should be sensitive to their product reaction and gauge well the product’s effectiveness while on treatment. Although patients are actually better off with brand-name meds, the cost-effectiveness of generic drugs like Sotret plays a huge factor in the course of treatment, as not all patients can afford the high costs of the brand-name treatments.
Sotret Wiki Facts
- Brand: Sotret
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Ranbaxy Pharmaceuticals
- Country of Manufacture: India
- Availability: India, EU, UK +
- Webmd.com: Sotret. Available from: http://www.webmd.com/drugs/2/drug-74915/sotret-oral/details
- Rxlist.com: SOTRET PATIENT INFORMATION INCLUDING SIDE EFFECTS. Available from: http://www.rxlist.com/sotret-drug/patient-images-side-effects.htm
- Drugs.com: Ranbaxy Pharmaceuticals Inc. Available from: https://www.drugs.com/manufacturer/ranbaxy-pharmaceuticals-inc-120.html
- En.wikipedia.org: Ranbaxy Laboratories. Available from: https://en.wikipedia.org/wiki/Ranbaxy_Laboratories
- Empr.com: Ranbaxy Pharmaceuticals, Inc. Available from: http://www.empr.com/ranbaxy-pharmaceuticals-inc/manufacturer/317/
- Gan EY, Koh WP, Jin AZ, Tan AW, Tan HH, Tang MB. Isotretinoin is safe and efficacious in Asians with acne vulgaris. Journal of Dermatological Treatment. 2013 Oct 1;24(5):387-91. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~cJmm1f:16:@[email protected]@/cgi-bin/sis/search2/d?./temp/~JwIPtK:[email protected]
- Wessels F, Kropman K., Anderson AN. The cost-effectiveness of isotretinoin in the treatment of acne. Part 1. A meta-analysis of effectiveness literature. South African medical journal= Suid-Afrikaanse tydskrif vir geneeskunde. 1999 Jul;89(7 Pt 2):780-4. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~cJmm1f:21:@[email protected]@/cgi-bin/sis/search2/d?./temp/~JwIPtK:[email protected]
- Petiau P, Cribier B, Chartier C, Kalinkova L, Heid E, Grosshans E. Acne necrotica varioliformis, resolution with isotretinoin. EJD. European journal of dermatology. 1994;4(8):608-10. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~cJmm1f:29:@[email protected]@/cgi-bin/sis/search2/d?./temp/~JwIPtK:[email protected]