Isoderm 20mg/10mg Cream Isotretinoin is a medication used in the treatment of moderate to severe nodular cyst acne , the eighth most common disease in the world as of 2013. Nodular cyst acne is a type of severe acne that is characterized by black and white inflammation marks on the skin, especially in areas that have the highest concentration of sebaceous glands. Isoderm patients mostly include a cohort of young people who are undergoing puberty. This is usually instigated by a surge in the patient’s hormones, which leads to an increase in the amount of sebum produced as well as the growth of extra hair. The resultant inflammation is the result of growing hair follicles getting clogged with dead cells and sebum . Isoderm is available in encapsulated pills of 10 and 20mg doses of Isotretinoin, the world’s top active ingredient in the bigger percentage of Acne Medication drugs. The use of Isotretinoin pills by pregnant women or women willing to undergo Isotretinoin treatment is highly contradicted. Women, who are about to undergo Isotretinoin treatment, are actually required to sign an extra consent form to this effect. Other contraindications include the use of the Isoderm by patients with severe liver and kidney conditions as well as patients with known volatile psychiatric tendencies.
Sun Farm is the largest pharmaceutical company which was started by Dilip Shangvi in 1983. By now, it has grown to be India’s biggest pharmaceutical company, India’s biggest company in the US and the fifth largest pharmaceutical company in the world . Most of its products are US FDA approved given that the United States form a huge section of their market share.
One of its manufacturing plant in Halol, however, has been warned by the US FDA. Currently, the company is a world leader in psychiatry, neurology, cardiology, orthopedics, ophthalmology, gastroenterology, and nephrology. The Mumbai-based company has been ranked second in the list of India’s most reputable brands and has employed a workforce of 52700 people who aid the company in achieving a turnover of 580 million USD annually .
Scientific Studies on Isotretinoin
The association between depression, suicidal ideation, and suicide has been one of the highly controversial areas in modern day pharmacy. This concern has been fueled by different scientific studies that have concluded in different results with some suggesting that an association between Isotretinoin use and depressive illness does not exist. Other Scientific studies, however, have led to the suggestion that depressive illness is a resultant condition from the subsequent deterioration of confidence and self-esteem that results primarily from acne itself and not its medication. Either way, due to the lack of concrete evidence to refute or support the claim, the FDA has issued guidelines and recommendations of contraindicating Isotretinoin to patients with known depressive tendencies. Chee Hong ng et al. aims at appraising if this association is, in fact, true in the journal article “The Association Between Depression and Isotretinoin Use in Acne.”, the authors do this by critically examining literature pertaining to depression in patients who were treated with Isotretinoin. Their study expectedly reveals inconclusive results with the authors affirming that the above causal relationship needs further studies. Furthermore, as a guideline, the authors suggest the use of a low threshold evaluation when assessing the development of possible depressive conditions in Isotretinoin taking patients.
In yet another scientific study according to Dr. Chao Chen et al. in the journal “ Negligible Systemic Absorption of Topical Isotretinoin Cream: Implications for Teratogenicity”, comparison between the least systemic availability of ISO cream to the allowed US threshold for vitamin A supplements provides substantial evidence that shows lack of potential teratogenic risk. Their study included 18 women with photodamaged skin that were treated with 10g topical application of Isotretinoin cream for a period of 42 days. The patients were required not to take high vitamin A containing foods or concomitant medications during this period. Before commencement of the study, the authors measured the plasma levels and used the scores as the baseline for comparison to plasma levels after the end of treatment. The results showed a general increase in the plasma levels with a higher increase being registered for patients treated with 4-oxo-Isotretinoin.
Description and Mechanism of Action of Isotretinoin
Isotretinoin acts through suppressing sebum suppression, anti–Inflammatory effects, inhibiting comedogenesis as well as the inhibiting habitation of p.acne. The main contributing factor towards healing being suppression of sebum levels through apoptosis of sebaceous glands. As a result, the sebaceous glands are significantly reduced in size and thus producing lower volumes of sebum. The resultant low sebum levels result into an environment that is unfavorable for the habitation of P.acne, which is a prime component to the inflammation of skin cells. The exact mechanism behind these superficial actions is however not yet scientifically approved.
Isoderm 20mg/10mg Benefits for Acne and Scars
Isoderm, Isotretinoin pills scientific benefits effects result in a general reduction in Acne. Each of Isotretinoin fourfold action cleanses a respective physical expression instigated by an acne contributing condition that the respective action clears. In a more clear way, Part of Isotretinoin fourfold action is through suppressing the secretion of sebum, this has the physical expression of a dryer skin as opposed to a greasy skin that characterizes Acne. Isoderm also has some other desirable far-reaching effects that cover other several aspects of skin blemishes conditions. This happens through keratinization optimization, which enables the clearing of blotches such as scars/ wrinkles, and stretch marks
Recommended Doses and Duration of Therapy
Emerging studies have shown that lower dosages of Isotretinoin pills are as equally effective in the treatment of acne with an added advantage of lesser incidences of Side effects. These lower dosages include a range equivalent of 5mg and 10mg/ day of ISO. The current recommended low dosage of the drug stands at 20mg/day and 40 mg/ day. While the higher dosage course of the two takes an optimal period, of 6 months the lower dosage course will take a longer period and several follow-up session to assess and prevent relapse. The highest dosage of Isotretinoin Pills ranges averages at 1.0mg/kg/day. This dosage is more reliant on the patient’s weight and acne severity that the other two. This course lasts for a period of 16 – 30 weeks with a cumulative dosage of 150 mg/kg. The last course is however plagued with a higher incidence of more adverse effects and such a prescription should only be taken under a qualified dermatologist’s directions
Side effects and Warnings
As a case study, in the United States for instance, Isotretinoin sale is highly regulated and one can only acquire a prescription from an iPLEDGe satisfied dermatologist. This is due to the drug’s potency which has been proven to have significant congenital effects on prenatal and breastfeeding children. In fact, as a procedure, the regulatory body requires prospective patients to be put under Isotretinoin medication to sign patients consent form. The FDA has also issued warnings about possible transient hearing and vision loss either partially or fully. AS a result, all Isotretinoin users are required to refrain from driving during or in places with low light intensities. Furthermore, the use of Isotretinoin has been shown to result in violence in men and carries an association with psychiatric symptoms such as depression. Common side effects as issued by drug manufacturers include a headache, nausea, vomiting, seizures, stroke, red, or inflamed eyes, blisters, peeling skin, severe stomach aches, chest, or bowel pain, heartburn, diarrhea, rectal bleeding, dark urine, back pain, and joint pains . The most common reported side effects, results from mucocutaneous toxicity and are characterized by dry skin especially the lips.
Isotretinoin belongs to a class of drugs referred to as retinoid, which serves the purpose of regulating epithelial growth . Use of Isotretinoin with any of other drugs in this group will ultimately lead to intoxication and accelerated severity in side effects. Such is the reaction when Isotretinoin is taken with a tetracycline such as a doxycycline. In addition, alcohol has been scientifically shown to interact with Isotretinoin in that it reduces the drug’s efficacy. Isotretinoin interacts with some birth control pills, Dilantin, and corticosteroid with the latter two leading to weaker bones when coadministered with Isotretinoin.
Any drug brand’ strength is best recommended by its current and previous users. However, in Isoderm case, such an evaluation is rendered impossible due to the absence of reviews. This can be a fair depiction of a new product but considering the huge market capacity for acne products, I believe it is not a positive sign. Customer reviews indicate how efficacious a drug can work for an average patient. They do not only show the strengths of the product on a general scale but also divulge helpful patient-specific information especially in situations where the reviewer had the same condition. The good news is that are plenty of brands out there that have received positive feedback by patients and as a result, I would highly recommend the use of one of them.
Price, Available Forms, and Dosage
As a baseline for the price and shipping costs for the drug, I used the ViagraOnline online health store. They sell the drugs in the capsules form, the available form (as described in the “Isoderm section”). The health store prices also show a distinctive pattern in the pricing, which reveals that the prices of the tablets vary according to their respective dosages. The lowest dosage of 5mg * 60 retails at a price of 52.44 USD, which is an equivalent of 0.87 USD per pill. Consecutive dosage prices for 10mg, 20mg, 30mg, 40mg are 1.48 USD per pill, 4.71 USD per pill 5.8 USD per pill, and 6.5 USD per pill respectively.
The health store’s shipping charges are as shown in the above image. The store states that it offers two shipping options that are Airmail, which may take 2-3 weeks, and Express Mail Service (EMS), which takes a duration of 3-8 days. Shipping through airmail is charged at 14.95 USD while EMS shipping charges stand at 24.95 USD. Furthermore, the store offers free shipping through both Airmail and EMS For orders over 200USD and 300USD respectively to the USA, Australia, Canada, and elsewhere.
Conclusion and Rating
Having done a fair number of different acne medications reviews, the usual pattern I find is that most Isotretinoin drugs can be rarely found in online health stores, yet somehow they get patient reviews. In the case of Isoderm, it’s the unexpected contrary of that since the drug can be easily found online but still lacks customer reviews. The lack of reviews is not as damaging as poor reviews but nevertheless, it is not such a great sign. On the other hand, Sun farm, the manufacturing company received the award for being the second best brand in India, and I logically believe it was a metric done based on the general company’s portfolio. As a result, I give the drug a rating of 3/5 with the recommendation that patients should first look for acne drugs that have so far been positively reviewed before opting for Isoderm.
Isoderm Wiki Facts
- Brand: Isoderm
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Dermapharm, Sun-Farm
- Country of Manufacture:
- Availability: USA, EU, UK, Germany, Poland
- Isoderm (isotretinoin) drug & pharmaceuticals. Isoderm available forms, doses, prices [Internet]. Medicatione.com. Available from: http://www.medicatione.com/?c=drug&s=isoderm&ingredient=isotretinoin
- Acne [Internet]. WebMD. Available from: http://www.webmd.com/skin-problems-and-treatments/acne/
- Milestones | Sun Pharmaceutical Industries Ltd. [Internet]. Sunpharma.com. Available from: http://www.sunpharma.com/about-us/milestones
- Sun Pharmaceutical [Internet]. En.wikipedia.org. Available from: https://en.wikipedia.org/wiki/Sun_Pharmaceutical
- Hong Ng CSchweitzer I. The association between depression and isotretinoin use in acne. Australian and New Zealand Journal of Psychiatry [Internet]. 2003 ;37(1):78-84. Available from: http://10.1046/j.1440-1614.2003.01111.x
- Chen C, Jensen B, Mistry G, Wyss R, Zultak M, Patel I et al. Negligible Systemic Absorption of Topical Isotretinoin Cream: Implications for Teratogenicity. The Journal of Clinical Pharmacology [Internet]. 1997;37(4):279-284. Available from: http://10.1002/j.1552-4604.1997.tb04303.x
- Isoderm Drug Information, Indications & Other Medicaments on Catalog.md [Internet]. Catalog.md. Available from: http://www.catalog.md/drugs/isoderm.html
- Retinoid Treatment for Skin Problems [Internet]. WebMD. Available from: http://www.webmd.com/beauty/retinoid-gel-and-cream-treatments#1