Piplex 20mg/10mg Mediderm is a medication for treating recalcitrant nodular Acne. The drug uses the active ingredient, Isotretinoin, which is a derivative of vitamin A. Acne, is most common in people who are undergoing puberty. The surge in hormonal changes in the body leads to an increase in the amount of sebum and thus leading to skin pores clogging. As a result, one gets inflammation marks on the skin characterized by lesions which may grow to a diameter of 5mm or greater. Most drugs inclusive of Piplex that incorporate Isotretinoin are oral and they are commonly available in capsules form. Piplex specifically is available in oral capsules of dosages 5mg, 10mg, 20mg, 30mg . Isotretinoin is quite potent and has been associated with several side effects especially when not administered wisely. As a result, countries like the USA and European nations require that all Isotretinoin pills prescriptions be done by an iPLEDE-certified dermatologist. Pregnant and breastfeeding women are warned not to take Isotretinoin due to the congenital effects that may occur to the children. Contraindications include the use of Isotretinoin in patients with severe liver and kidney disease, coadministration with tetracyclines, hypervitaminosis and in patients with known allergic reactions to Isotretinoin .
About Mediderm, Recalcine Laboratorios
The CFR pharmaceuticals company founded in 1922 and whose headquarters are in Santiago Chile is one of the biggest pharmaceuticals company in Latin America comprising of 15 countries namely, Bolivia, Argentina, Chile, Costa Rica, Colombia, Venezuela, Ecuador, Peru, Paraguay and Vietnam in Asia.
The company, founded by Nicholas Weinstein Rudoy, is divided into eight prime divisions: Recalcine, Gynophram, Mediderm, complex therapeutics, drug tech, K2 health, & wellness, Neumobiotics, and Cardiopharm. The Recalcine and Mediderm division carry the most significance in the manufacture of Piplex . These two divisions offer therapeutic solutions to areas such as general medicine: infectious diseases, gastroenterology, pediatrics, traumatology, ENT, otorhinolaryngology, obesity, and nutrition for the treatment of symptoms (acute and acute-chronic). According to a financial report in 2012, The Company makes a gross revenue of 570.8 million Us dollars and a net revenue of 79.6 million Usd. The company has 4559 employees and only mentions two manufacturing plants, one of which was constructed in 2003 and the other began construction in 2006.
Scientific Studies on Isotretinoin
Pregnancy during Isotretinoin treatment has always been a major concern. Hannah Browne et al. comprehensively addresses issues that may arise when Isotretinoin is administered to an expectant mother in the journal article” Retinoids and Pregnancy: an Update”. The literature is based on the fact that Isotretinoin is known to teratogenic and while all patients are required to take up the pregnancy prevention program, some still end up pregnant. In such situations, these women are left with a dilemma of whether to either terminate or proceed with the pregnancy. At times such a dilemma is even made worse by a doctor’s indecisiveness in their council to patients due to lack of a concrete literature that would guide the medical practitioners on the optimal advice to give to their patients. According to this paper , exposure to Isotretinoin or any other teratogenic drug in the 17 day period after conception may lead to the death of the unborn child, while during the embryonic days it will lead to permanent malformations. This, the author argue is because teratogenic drugs will damage the differentiated cells which are irreplaceable and thus leading to the permanent malformations. The deformities that an embryo may be exposed to includes craniofacial defects such as ear defects, Central Nervous System defects such as facial nerve phalsy, cardiovascular defects such as septal defects and thymic abnormalities such as aplasia and ectopic. Prevention of such cases boils down to the therapy management system itself. Patients should be provided with educational materials that easily and fully outline the negative effects that may arise; this should also be coupled with medically supervised pregnancy tests before treatment and 5 weeks after treatment. A combination of oral and barrier contraceptives could also go a long way in preventing pregnancy while under Isotretinoin treatment.
According to C.C. Zouboulis et al. in his paper “Management of Severe Acne”, Acne affects up to 95 % of adolescents and thus rendering it as one of the most common diseases in the world. The author states that acne severity is usually dependent on a positive history of severe acne in first-degree relatives, especially the mother. Acne can be treated with oral antibiotics, hormonal antiandrogens in females and oral Isotretinoin. Oral Isotretinoin has been shown to affect all the etiological factors that cause Acne, however, due its potency and risk of wide side effects, it should only be used as a second-line of therapy in severe, conglobate and nodular acne.
Description and Mechanism of Action of Isotretinoin
Over thirty years into Acne treatment and Isotretinoin has continuously superseded any other therapeutical Acne treatment while producing long-term remission. However, the drug’s exact mechanism against the physiological factors of Acne remains uncertain. One undeniable fact that most scientists agree on is that the whole mechanism is mainly dependent on Isotretinoin influence on Cell-cycle progression, cellular differentiation, cell survival, and apoptosis. More specifically, through apoptosis of sebaceous glands, Isotretinoin is able to reduce their size and inadvertently reduces the amount of sebum secreted. Low sebum secretion provides an environment in which P.acnes, acne causative bacterium, rarely inhibit. The low sebum levels also make sure pores remain unclogged thus minimizing the occurrence of inflammations that arise from skin pores clogging. Isotretinoin also modifies monocyte chemotaxis and increases host defenses, two factors that make up its anti-inflammatory effects. Isotretinoin also leads to decreased hyperkeratinization, which leads to a significant reduction in comedogenesis.
Piplex Effects for Acne and Scars
Before treatment, a patient’s skin is usually characterized by inflammation marks that are usually black or white in color. The skin itself has a greasy texture due to the overproduction of Sebum. Furthermore, if the lesions on the skin are left untreated for quite some time they may lead to permanent scarring. This condition not only affects the patient’s skin condition but also a person’s social life. A patient is more prone to lose self-confidence and self-esteem due to the physical expression of the condition. After treatment, however, the patient can expect to lose blackheads and whiteheads that can be removed easily. The skin pores get unclogged and thus stop the formation of any new whiteheads and blackheads. Isotretinoin anti-inflammatory properties coupled with its effects in decreasing hyperkeratinization help eradicate most of the skin blemishes such as wrinkles, scars and stretch marks.
Recommended Doses and Duration of Therapy
The recommended dosage of Isotretinoin is 0.5-1.0 mg/kg/day. As you can tell, the dosage is dependent on the weight and severity of acne in a patient. This course of treatment lasts for an approximate period of 16 weeks after which a patient may be subjected to another session should there be the risk of a relapse . The cumulative dosage for this course of treatment stands at 150mg/kg. In an alternative course of treatment, Isotretinoin is administered for a period of about 6 months with dosages of either 5mg, 10,mg, 20mg, and 30mg. this course has the benefit that it is coupled with fewer incidences of side effects.
Side effects and Warnings
The FDA has issued regulations that require people working with machinery that could cause harm to others or themselves, not to work in places or periods with low light intensity. This is due to the causative relationship between Isotretinoin and transient hearing and vision loss either partially or fully. The FDA also require that medical practitioners look into a patient’s psychiatric record or evaluate the stability of the same before prescribing Isotretinoin pills. This is due to recent reports made to the FDA linking Isotretinoin use to depressive illnesses that have resulted in suicidal ideation and suicide in a few cases. Isotretinoin is also associated with anger but this has only been recorded mostly in males. Most importantly, the FDA through the iPledge has instituted strict regulations concerning the use of Isotretinoin in women inside the childbearing brackets. Isotretinoin has been shown to cause serious cardiovascular and skeletal deformities in unborn babies. The drug can also result in cognitive disabilities in both breastfeeding and unborn children. Common side effects of the drug include severe stomachaches, chest or bowel pain, heartburn, diarrhea, rectal bleeding, dark urine, back pain, and joint pains 
Isotretinoin has so far been scientifically shown interacts with 92 drugs. Among this drugs, tetracyclines such as doxycycline will result in more severe and manifesting side effects. Isotretinoin should also not be coadministered with any other drugs in the retinoids class or any other drug that have the same side effects since this will eventually lead to more severe side effects and intoxication. Patients taking alcohol are advised to stop while under Isotretinoin treatment since alcohol reduces the efficacy of Isotretinoin.
A 21-year-old Romania expresses dissatisfaction with Piplex partial efficacy in treating her Acne. However, the fact that a doctor prescribed this medication, says a lot about its credibility in the medicinal field. After a little more than 2 months of treatment Romania states that Piplex cleared her acne but seemingly did so in the areas that were most affected.
According to me, this could have just been another case of relapse but what bothers me on my hypothesis is that Romania’s doctor does not think the same way, he is actually puzzled by Romania’s condition. Unfortunately, Romania’s condition is one huge puzzle and one that does not really help evaluate the efficacy of Piplex in treating Acne.
Price, Available Forms, and Dosage
Piplex, just like many other potent Isotretinoin pills faces strict regulations surrounding its prescription and use. In America, the drug can only be assessed through an ipledge certified medical practitioner who has to register the patient in the ipledge database prior to giving him/her the medication. With that in mind, this is definitely a drug that you will hardly come across in online health stores. Unfortunately, due to this reason, I could not find pricing information on the drug as well as shipping cost to markets such as USA, Australia, Canada, and elsewhere in the world.
Conclusion and Rating
Isotretinoin is the most effective active ingredient in the treatment of moderate to severe acne. Its near transcendence efficacy in targeting all the aetiological factors that cause acne has enabled it to be used as a medication in situations where other conventional therapies such as the use of antibiotics have failed. It is sometimes subtle when one tries to understand how two drugs containing the same amount of Isotretinoin fail to have the same level of beneficial effects on a patient. Putting our review into consideration, it is still quite unclear on the efficacy of Piplex. However, one certain thing is that the reviewer affirms that for a short period of the treatment, his acne disappeared.However, later the acne reappeared in the areas that had been minimally affected. My take on this is that considering the low dosage of the drug, Piplex did its job in clearing the acne but the dosage was not enough for sustainable remission. Having said that, I believe what Romania required from the start, was a higher dosage of Piplex as well as some added Isotretinoin courses. Based on that I give Piplex a rating of 4/5.
Piplex Wiki Facts
- Brand: Piplex
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Mediderm, Recalcine Laboratorios
- Country of Manufacture: Chile, Peru
- Availability: USA, EU, UK, Chile, Peru, 14+
- Piplex drug & pharmaceuticals. Piplex available forms, doses, prices [Internet]. Medicatione.com. Available from: http://www.medicatione.com/?c=drug&s=Piplex
- Package Leaflet: Information for the User. (2014). Retrieved from https://www.medicines.org.uk/emc/PIL.15643.latest.pdf
- CFR Pharmaceuticals [Internet]. En.wikipedia.org . Available from: https://en.wikipedia.org/wiki/CFR_Pharmaceuticals
- Divisiones – CFR Recalcine [Internet]. CFR Recalcine. Available from: http://www.recalcine.cl/cfr-divisiones/
- Browne H, Mason G, Tang T. Retinoids and pregnancy: an update. The Obstetrician & Gynaecologist [Internet]. 2014 ;16(1):7-11. Available from: http://10.1111/tog.12075
- Zouboulis CBettoli V. Management of severe acne. British Journal of Dermatology [Internet]. 2015 ;172:27-36. Available from: http://onlinelibrary.wiley.com/doi/10.1111/bjd.13639/full
- Piplex Drug Information, Indications & Other Medicaments on Catalog.md [Internet]. Catalog.md. Available from: http://www.catalog.md/drugs/Piplex.html
- Accutane Side Effects: IBD, Ulcerative Colitis, Crohn’s & More [Internet]. DrugWatch. Available from: https://www.drugwatch.com/accutane/side-effects.php