ROACCUTAN® is an Isotretinoin-based drug
THERAPEUTIC GROUP: Retinoids for the treatment of acne
Indications ROACCUTAN ® Isotretinoin
ROACCUTAN® is indicated in the treatment of severe and resistant acne to classic topical therapy.
Mechanism of action ROACCUTAN ® Isotretinoin
ROACCUTAN®, a medicinal product used in the treatment of severe acne characterized by nodular and conglobate inflammatory lesions, owes its therapeutic efficacy to the active ingredient Isotretinoin, a synthetic retinoid obtained from trans-retinal acid.
Its mechanism of action, particularly complex and associated with the reprogramming process of gene expression through specific nuclear receptors sensitive to retinoids, allows to control the expression of inflammatory mediators, reducing the inflammatory entity of the lesion, controlling the proliferation of keratinocytes, normalizing cell turnover and thus avoiding the typical hyperkeratinization present in acne and reducing the production of sebum, responsible for the obstruction of the sebaceous gland ducts and the consequent proliferation of comdegoneic bacterial strains.
The excellent therapeutic activities are however balanced by potentially serious side effects, so much so as to require continuous medical supervision and the application of prevention and monitoring programs.
At the end of its activity, following a sustained hepatic metabolism, Isotretinoin is eliminated both by the liver and by the kidneys.
Studies carried out and clinical efficacy
SKIN BARRIER AND THERAPY WITH ORAL ISOTRETINOIN
J Sex Med. 2013 Jul 11. doi: 10.1111 / jsm.12259. [Epub ahead of print]
Dyspareunia and Vaginal Bleeding Associated with Isotretinoin: A Rare Complication.
Oguz Topal I.
Case report reporting a strange complication associated with ROACCUTAN® therapy such as vaginal bleeding. These works reaffirm the importance of medical supervision during treatment with isotretinoin.
PHARMACOGENOMICS AND CLINICAL EFFECTIVENESS OF ISOTRETINOIN
Int J Clin Pharmacol Ther. 2013 Aug; 51: 631-40. doi: 10.5414 / CP201874.
The effect of genetic polymorphisms of RARA gene on the adverse effects profile of isotretinoin-treated acne patients.
Alzoubi KH, Khabour OF, Hassan RE, Qarqaz F, Al-Azzam S, Mhaidat N.
Interesting genomic drug study that demonstrates how polyformisms of the gene coding for retinoic acid receptors can alter the functionality of isotretinoin, altering its therapeutic efficacy in acne patients.
ISTRETHIONINE AND QUALITY OF LIFE
Acta Derm Venereol. 2013 May 27. doi: 10.2340 / 00015555-1638. [Epub ahead of print]
Anxiety, Depression, Quality of Life and Patient Satisfaction in Acne Patients Treated with Oral Isotretinoin.
Marron SE, Tomas-Aragones L, Boira S.
This study demonstrates how despite Isotretinoin can cause numerous side effects, some of which are psychiatric, it is still able to improve the quality of life of acne patients in 84% of cases.
Method of use and dosage
ROACCUTAN®
Soft capsules of 20 mg of Isotretinoin.
The definition of the therapeutic dosage is up to the physician experienced in the treatment with retinoids, considering the state of health of the affected patient, the possible presence of liver and kidney diseases and the therapeutic purposes.
The overall dosage should be divided into two different doses to be taken preferably at lunch and dinner, while the duration of treatment should be extended from 16 to 24 weeks.
Warnings ROACCUTAN ® Isotretinoin
Given the numerous side effects of Isotretinoin taken orally, its high teratogenicity is noted, it is essential that the patient receiving ROACCUTAN® follows the appropriate rules to limit the numerous adverse reactions.
Continuous monitoring of the absence of pregnancy in women of childbearing age, before, during and at least 5 weeks after the end of treatment, avoid direct exposure to ultraviolet rays, known the photosensitizing power of the drug, avoid invasive dermatological procedures even after discontinuation of the treatment, the periodic monitoring of hepatic and renal function and of the parameters of the lipid metabolism in patients suffering from metabolic diseases represent only some of the precautions to be used during treatment with ROACCUTAN®.
ROACCUTAN® contains among its excipients sorbitol and soy oils, therefore its use is contraindicated in patients suffering from fructose intolerance and allergy to soy.
PREGNANCY AND BREASTFEEDING
Pregnancy represents an absolute contraindication to treatment with ROACCUTAN®, given the very high teratogenic power of isotretinoin.
Contraindications to the use of ROACCUTAN® must also be extended to the subsequent period of breastfeeding, given the ability of the active principle to concentrate in breast milk in pharmacologically active concentrations.
Interactions
Patients on ROACCUTAN® therapy should avoid taking tetracyclines and vitamin A due to the potential health side effects.
Contraindications ROACCUTAN ® Isotretinoin
The use of ROACCUTAN® is contraindicated in patients hypersensitive to the active substance or to one of its excipients, during pregnancy and lactation, in women of childbearing age who do not follow the Pregnancy Prevention protocol, in patients with severe liver disease and kidney and in patients receiving tetracyclines.
Undesirable Effects - Side Effects
Oral Isotretinoin therapy is generally characterized by numerous side effects which fortunately regress with the suspension of therapy.
Anemia, increased ESR, thrombocytopenia, neutropenia, thrombocytosis, headache, epistaxis, dry nose, increased transaminases, dermatitis, pruritus, skin exfoliation, increased triglycerides, arthralgia, myalgia and asthenia are generally the most frequent adverse reactions while disorders of the sphere psychiatric, severe renal diseases and gastrointestinal disorders are generally rarer
Note
ROACCUTAN® is a prescription drug.
The information on ROACCUTAN ® Isotretinoin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
