Isotretinoin-Mepha 10/20 solucaps is yet another Isotretinoin product indicated for severe forms of acne in patients. This particular product is manufactured by the company Mepha Pharma, which is situated in Switzerland (Basel) . Mepha manufactures Isotretinoin-Mepha only in oral soft capsule form and made several formulations available (10 mg, 20 mg, and 40 mg) .
Isotretinoin products are the ones being currently used in the treatment of acne cases which are otherwise very hard to treat. First-line treatment usually involves the use of topical agents like creams and gels which contain retinoids plus erythromycin or adapalene. These medications are OTC but the use of these products still needs the doctor’s advice for optimum effect. Oral Isotretinoin medications like Isotretinoin-Mepha are the last considered for acne treatment since the drug has many considerable side effects, especially its teratogenicity . Retinoids like Isotretinoin can cause Fetal Retinoid Syndrome which is characterized by visible abnormalities in the craniofacial region, cardiovascular system, central nervous system, and other deformities .
But even with the risks associated with the use of Isotretinoin in patients, dermatologists continuously recommend the use of the product due to its effectiveness. It is just imperative to adhere properly to treatment and undergo treatment only under the advice of a seasoned dermatologist for Isotretinoin use.
About Mepha Pharma
Mepha Pharma is a company with its headquarters in Switzerland and which specializes in the manufacture of generic medication . To date, the company has about 120 products which are indicated for a number of medical conditions . The company was established in 1949 and now employs some 150 people . Although the company is not too large, it holds the third place in terms of shares in the Swiss drug market .
The fields of specialty of Mepha Pharma include the manufacture of products for cardiovascular disorders, fat metabolism disorders, depression, infections, skin disorders, GI disease, diabetes, cancer, pain, and vitamins and supplements . The company manufactures high-quality generics for the said categories. As for accreditations and certifications, however, there is not much information provided by the company on its site. Mepha Pharma might have been a well-accredited company, but it did not indicate which agencies were able to certify its manufacturing process and its products’ quality.
Scientific Studies on Isotretinoin
Isotretinoin’s effectiveness is tried and tested when it comes to the management and eventual cure of almost all types of acne, even the more severe cases (“Systematically optimized biocompatible isotretinoin-loaded solid lipid nanoparticles (SLNs) for topical treatment of acne” by Raza et al) . However, the use of Isotretinoin either orally or topically gives patients several side effects which make patients suffer while taking the medication. There are studies like the one by Raza et al  which studied the optimization of the drug for ease of transport for the drug and the lessening of the side effects . The researchers found that Isotretinoin is also stable in the form of solid lipid nanoparticles and mentioned that the SLN form for the delivery of Isotretinoin has much promise when it comes to the drug’s delivery in the patient’s system .
There are also a number of other applications for Isotretinoin aside from being an anti-acne agent. Doctors are using Isotretinoin as an off-label treatment for other dermatologic conditions and some are using the drug for maintenance treatment after surgery for cancer. The drug is also being used for maintenance for glioblastoma, although the use of Isotretinoin for the condition has not yet been established. Chen et al, in his 2014 study, “Isotretinoin maintenance therapy for glioblastoma: A retrospective review” reviewed retrospectively the effectiveness of Isotretinoin when used for the prevention of tumor occurrence in cancer patients . Patients who were reviewed were the ones who underwent surgery plus radiation and temozolomide treatment and patients who had the same treatment but had Isotretinoin as maintenance medication post the mentioned treatments . According to the results of the study, Isotretinoin was indeed associated with the lessened progression of the glioblastomas, but there was no significant difference in the overall long-term survival of the patients . Also, the toxicity and adverse effects of Isotretinoin should be considered when choosing to use it for maintenance, as the negative effects of the drug are considerable enough .
Although the drug Isotretinoin is known to have a number of benefits for the patients (especially for severe acne patients), it also has been studied to see whether the drug has an effect on lipids and liver enzyme production in patients treated for acne (“Effects of oral isotretinoin on lipids and liver enzymes in acne patients” by Kızılyel et al in 2014) . Kızılyel et al mentioned that although the drug is effective in the treatment of various forms of acne, especially the recalcitrant ones, Isotretinoin affects lipid and liver enzymes . The study evaluated the significance in the changes observed in 322 acne patients’ TG (triglyceride), LDL (low-density lipoprotein), HDL (high-density lipoprotein), AST (aspartate aminotransferase), and ALT (alanine aminotransferase) levels . The research determined that LDL and TG level increase have statistical significance, HDL decrease is also statistically significant, although the ALT and AST level increase are not statistically significant too . According to the authors, Isotretinoin exerts its effects on lipid levels more than on liver enzymes . While the results show statistical significance on Isotretinoin’s effect, the use of the drug is still encouraged, but there is a recommendation by the authors for a more stringent follow-up of the acne patients .
Isotretinoin’s Description and its Mechanism of Action
Isotretinoin has been used by medical practitioners in the dermatologic field in the cure of severe acne as it is considered very effective . Papers say that the actual mechanism of action of Isotretinoin in patients is unknown, but the effects of the drug can be easily recognized.
The most remarkable effect of Isotretinoin in a patient’s skin is its effort in reducing the size of the sebaceous cells. Now sebaceous glands are unusually (very) active in patients with severe cases of acne, so the reduction in the glandular size of these sebum producers makes a significant change in the skin. Isotretinoin programs the cell death of sebaceous cells, therefore reducing their activity and inhibiting oil production. Now that the cellular activity for these oil producers is inhibited, the skin can start recovering from the effects of sebum overproduction.
The skin is rid of the formation of comedos as the pores are not blocked anymore and the skin gets less irritated. P.acnes, the bacteria which play a major role in the inflammation of the skin in acne patients inhabits sebaceous-rich environments, so patients with hyperactive sebaceous cells are prone to bacterial infestation. Since Isotretinoin targets sebum production, it also targets the bacteria as a consequence of its initial sebum-limiting effect. Since the bacterial population is limited, the skin can also improve, as the bacteria cause inflammation and the multiplication of the lesions in the skin. With the oil reduced and the bacteria gone due to Isotretinoin’s action, the skin can start to clear up and the lesions can now heal.
Isotretinoin-Mepha Effects for Acne/Stretch Marks
Isotretinoin, aside from having benefits for acne clearing, also has benefits on scars and the reversal of photo-aging. Isotretinoin is being used for stretch marks and wrinkles, as research determined that the drug is also effective in restoring skin fibers and therefore can improve skin integrity. Although the before and after results of Isotretinoin for stretch marks and wrinkles are considerable, the drug is reported to at times irritate the skin, so studies are underway in making the drug more skin-friendly for patients.
The side effects are also the consideration for the effectiveness of Isotretinoin for acne cases, but still, dermatologists and patients use the drug due to its effectiveness in clearing out acne, especially in the most severe of cases. Patients treated with Isotretinoin consider that its benefits weigh more than the side effects, as the side effects of the drug are just transient, while its benefits are almost permanent.
Recommended Doses and Duration of Therapy
There are various recommendations for the “proper” and “most effective” dose of Isotretinoin for acne treatment. The basic and acceptable dose for Isotretinoin use in patients is 0.5 to 1 mg per kg/day, but the starting dose does not usually exceed 0.5 mg/kg in a day. As for the other recommendations, there are studies on the high-dose of Isotretinoin for the more severe forms, while others advocate long-term, low-dose treatments, even for severe cases, like the study of Sbidian et al in 2016 (“A Randomized-Controlled Trial of Oral Low-Dose Isotretinoin for Difficult-To-Treat Papulopustular Rosacea”) . Although there are many variations for the dose of Isotretinoin for patients, it can be observed that nearly all of the variations in dosage are effective. It seems that treatment adherence is a large factor in the effectiveness of Isotretinoin treatment and not the dose itself.
As for the duration of therapy, there is somewhat an initial period of up to 4 weeks to see whether the patient will respond well to treatment. If no side effects are found, then the treatment can proceed and last for at least 4 months. Treatments are variable as some strictly follow 4 months while other treatments reach 6 months up to a year. Second rounds of treatment are spaced at least 8 months, though.
Side effects and Warnings
Isotretinoin, being systemic, has a number of identified side effects related to its use for acne treatment in patients. The most common of the side effects caused by Isotretinoin for acne treatment is dry skin, itching, rashes, drying of the nasal mucosa, epistaxis, cheilitis, dry mouth, conjunctivitis, dry eyes, joint pain, back pain, dizziness, drowsiness, and others .
There are more grave side effects caused by Isotretinoin in patients, so patients should contact their doctors immediately for systemic occurrences which are probably caused by Isotretinoin use. Isotretinoin use is also associated with fetal defects in pregnant mothers have used the drug during pregnancy, so the use of Isotretinoin should be contraindicated in patients who are pregnant or who can possibly get pregnant during therapy.
Drug interactions known for Isotretinoin are with Vitamin A medications, steroids, seizure medications, antibiotics like tetracyclines, and more. Using Isotretinoin with other Vitamin A medications can intensify the side effects of the drug . The mentioned drugs should also be avoided as these drugs can interact negatively with Isotretinoin and cause harmful side effects in patients.
Knowing that Isotretinoin interacts harmfully with a number of meds, patients should always disclose fully all their current medications before the start of their therapy. Patients should also take caution when dealing with OTC meds, as even harmless medications like supplements and herbal medication can also interact with Isotretinoin.
Customer feedback is essential for a drug’s evaluation, as it is good to know other patients’ experiences in their drug use. Unfortunately for Isotretinoin-Mepha, there were no user feedbacks available. There are a number of factors affecting the number of reviews of product present on the web. One of those factors is the availability of the product online. Isotretinoin-Mepha is not available in online pharmacies, so there is a low probability of the product getting reviews from patients online.
The product may only be sold locally in the manufacturing country or in the countries Isotretinoin-Mepha is exported to, and that also contributes to the product having no reviews. The patients may have felt no need to review the product, or it may also be that Isotretinoin-Mepha is not too popular to be given a review, given the number of Isotretinoin products available online.
Still, Isotretinoin-Mepha can probably be highly effective in the treatment of acne in patients since the product contains Isotretinoin which is very potent when it comes to dealing with acne in patients.
Price, Isotretinoin-Mepha Available Forms and Dosage
As mentioned, there is no vendor information for Isotretinoin-Mepha 10/20 solucaps on the web. The product may only be locally available and may still be prohibited to be sold in some territories, although there are a number of countries which are known to have the drug.
Cost and shipping dues for Isotretinoin-Mepha are unavailable and shipping to the USA, Canada, and Australia is unavailable. There are no posts on the product’s price from the clients’ end too, so there is not much information on its affordability. It is known to be available in Switzerland (and neighboring countries) and the USA, though, so patients in those locations can access the drug in their local drugstores.
Conclusion and Rating
Isotretinoin-Mepha 10/20 solucaps is one of the treatments containing Isotretinoin and is indicated for severe acne. The product is manufactured by Mepha Pharma and is available in several formulations (10, 20, and 40 mg). Unfortunately, there is not one review available for the product, so I can’t tell whether the product is found effective by the users.
As for the rating, I still think that the product deserves 3 out of 5, though, since it probably is highly effective too due to its Isotretinoin content. Isotretinoin in acne treatment proved to be very effective, as the active ingredient targets the overly active sebaceous cells in the skin.
Isotretinoin-Mepha can be bought locally in several countries like Switzerland, the USA, the UK, and some European countries. I don’t think I can give any recommendation regarding the product’s price, though, as there is no information on the product’s pricing anywhere on the web.
Isotretinoin-Mepha Wiki Facts
- Brand: Isotretinoin-Mepha
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Mepha Pharma
- Country of Manufacture: Switzerland
- Availability: USA, EU, UK, Switzerland
- De.wikipedia.org: Mepha. Available from: https://de.wikipedia.org/wiki/Mepha
- Compendium.ch: Isotretinoin-Mepha Solucaps ®. Available from: https://compendium.ch/mpro/mnr/9833/html/fr?Platform=Desktop
- Rarediseases.org: Fetal Retinoid Syndrome. Available from: https://rarediseases.org/rare-diseases/fetal-retinoid-syndrome/
- Mepha.ch: INDICATIONS. Available from: http://www.mepha.ch/de/Private/Produkte/Pages/Indikationsbereiche.aspx
- Mepha.ch: ORGANIZATION. Available from: http://www.mepha.ch/de/Fachpersonen/MephaPharma/Pages/Organisation.aspx
- Chen SE, Choi SS, Rogers JE, Lei X, De Groot JF. Isotretinoin maintenance therapy for glioblastoma: A retrospective review. Journal of Oncology Pharmacy Practice. 2014 Apr 1;20(2):112-9. Available from: https://www.ncbi.nlm.nih.gov/pubmed/23676507
- Kızılyel O, Metin MS, Elmas ÖF, Cayır Y, Aktaş A. Effects of oral isotretinoin on lipids and liver enzymes in acne patients. Cutis. 2014 Nov;94(5):234-8. Available from: https://www.ncbi.nlm.nih.gov/pubmed/25474452
- Sbidian E, Vicaut É, Chidiack H, Anselin E, Cribier B, Dréno B, Chosidow O. A Randomized-Controlled Trial of Oral Low-Dose Isotretinoin for Difficult-To-Treat Papulopustular Rosacea. Journal of Investigative Dermatology. 2016 Jun 30;136(6):1124-9. Available from: https://www.ncbi.nlm.nih.gov/pubmed/26854486
- Rxlist.com: Accutane Side Effects Center. Available from: http://www.rxlist.com/accutane-side-effects-drug-center.htm