ROACCUTAN ® Isotretinoin

ROACCUTAN® is a drug based on Isotretinoin

THERAPEUTIC GROUP: Retinoids for the treatment of acne

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions ROACCUTAN ® Isotretinoin

ROACCUTAN® is indicated in the treatment of severe acne and resistant to classic topical therapy.

Mechanism of action ROACCUTAN ® Isotretinoin

ROACCUTAN®, a medicinal product used in the treatment of severe acne characterized by nodular and conglobated 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 process of reprogramming of gene expression through specific retinoid-sensitive nuclear receptors, allows the expression of inflammatory mediators to be controlled, reducing the inflammatory extent of the lesion, controlling the proliferation of keratinocytes, normalizing cellular turnover and thus avoiding the typical hyperkeratinization present during acne and reducing the production of sebum, responsible for filling the ducts of the sebaceous glands and the consequent proliferation of comdegone bacterial strains.

The excellent therapeutic activities are however balanced by potentially serious side effects, so as to require continuous medical supervision and the application of prevention and monitoring programs.

After its activity, following a sustained hepatic metabolism, Isotretinoin is eliminated both by hepatic and renal route.

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]

Case report reporting a strange complication associated with ROACCUTAN® therapy such as vaginal bleeding. These work reaffirm the importance of medical supervision during Isotretinoin treatment.

PHARMACOGENOMICS AND CLINICAL EFFICACY OF ISOTRETINOIN

Int J Clin Pharmacol Ther. 2013 Aug; 51 (8): 631-40. doi: 10.5414 / CP201874.

An interesting genomic drug study that demonstrates how polymorphisms of the gene encoding retinoic acid receptors can alter the functionality of isotretinoin, altering its therapeutic efficacy in patients suffering from acne.

ISTRETIONINE AND QUALITY OF LIFE

Acta Derm Venereol. 2013 May 27. doi: 10.2340 / 00015555-1638. [Epub ahead of print]

Study that shows that despite Isotretinoin can determine the occurrence of numerous side effects, some of which are also psychiatric, it is however able to improve the quality of life of acne patients in 84% of cases.

Method of use and dosage

ROACCUTAN®

Isotretinoin 20 mg soft capsules.

The definition of the therapeutic dosage is up to the doctor experienced in the treatment with retinoids, considering the state of health of the affected patient, the possible presence of hepatic and renal pathologies and the therapeutic purposes.

The total 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, note its high teratogenicity, it is essential that the patient receiving ROACCUTAN® follow 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 the treatment, avoid direct exposure to ultraviolet rays, note the photosensitizing power of the drug, avoid invasive dermatological procedures even after the suspension of treatment, periodic monitoring of liver and kidney function and parameters of lipid metabolism in patients suffering from metabolic disorders 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 soy allergy.

PREGNANCY AND BREASTFEEDING

Pregnancy represents an absolute contraindication to treatment with ROACCUTAN®, given the very high teratogenic power of isotretinoin.

The contraindications to the use of ROACCUTAN® should also be extended to the subsequent breastfeeding period, given the ability of the active ingredient to concentrate in breast milk in pharmacologically active concentrations.

Interactions

The patient receiving ROACCUTAN® should avoid taking tetracycline and vitamin A due to the potential side effects to health.

Contraindications ROACCUTAN ® Isotretinoin

The use of ROACCUTAN® is contraindicated in patients who are hypersensitive to the active substance or to one of its excipients, during pregnancy and lactation, in women of child-bearing age who do not follow the Prevention of Pregnancy protocol, in patients with severe liver diseases and kidney and in patients on tetracycline therapy.

Undesirable effects - Side effects

Oral Isotretinoin therapy is generally characterized by numerous side effects that fortunately regress with the suspension of therapy.

Anemia, increased ESR, thrombocytopenia, neutropenia, thrombocytosis, headache, epistaxis, nasal dryness, increased transaminases, dermatitis, pruritus, skin exfoliation, increased triglycerides, arthralgias, myalgia and asthenia represent the most frequent adverse reactions generally while sphere disorders psychiatric, severe renal diseases and gastro-enteric disorders are generally rarer