AISOSKIN ® Isotretinoin

AISOSKIN ® 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

Indications AISOSKIN ® Isotretinoin

AISOSKIN ® is indicated in the treatment of severe acne resistant to common topical treatments and characterized by cystic nodule spread also to the trunk.

Mechanism of action AISOSKIN ® Isotretinoin

Isotretinoin, active ingredient of AISOSKIN ®, is a retinoid derived from trans-retinal acid characterized by important biological effects that usually require reprogramming of gene expression.

Taken orally Isotretinoin is absorbed at the gastrointestinal level and distributed in a circle mainly bound to albumin, through which it reaches the skin environment where it mainly performs its therapeutic action.

Although not entirely characterized, the hypothesized mechanism of action for Isotretinoin, provides a particular reprogramming of the gene expression that results in:

reduction of the inflammatory stimulus, probably through the control of the synthesis of anti-inflammatory mediators;
reduction of keratinocyte proliferation, with normalization of the stratum corneum;
sebostatic activity, useful for the reduction of sebum production, ideal growth medium for comedogenic bacterial strains such as Proprionibacetrium acnes;
reduction in the volume of the sebaceous glands.

All the aforementioned activities guarantee a rapid regression of acne lesions, even of the most inflamed ones, with a restoration of the physiological skin balance.

After its activity, and following a hepatic metabolism, Isotretinoin is eliminated in equal parts through feces and urine.

Studies carried out and clinical efficacy

SKIN BARRIER AND THERAPY WITH ORAL ISOTRETINOIN

J Drugs Dermatol. 2013 Jun 1; 12 (6): 626-31.

Interesting work that shows how important it is to adequately preserve the skin epidermal barrier before starting oral therapy with Isotretinoin, given the ability of the latter to determine, especially in the initial stages of therapy, an aggravation of the clinical picture, thus facilitating the onset of skin lesions and potential bacterial colonization.

PREDICTIVE FACTORS THE EFFECTIVENESS OF THERAPY WITH ISOTRETINOIN

Eur J Dermatol. 2013 Jun 24. [Epub ahead of print]

Study describing the presence of positive predictive factors for the efficacy of oral Isotretinoin therapy for acne such as: low body weight, hypoglycemic diets, absence of smoking, early-stage reeds without neck involvement.

ISOTRETINOIN AND INTESTINAL INFLAMMATORY DISEASES

J Am Acad Dermatol. 2013 May 14.

Very interesting study that associates in about 2200 cases the appearance or the acute of inflammatory intestinal pathologies following the oral intake of Isotretinoin, thus underlining the importance of a correct pharmacovigilance protocol.

Method of use and dosage

AISOSKIN ®

Isotretinoin 10-20 mg soft capsules.

The therapeutic scheme with systemic retinoids useful in the course of acne, should be defined by a doctor experienced in such treatments, taking into account the needs of the patient, his clinical picture and the potential side effects that such therapy entails.

In principle, the duration of a therapeutic cycle should be between 16 and 24 weeks, while the overall dosage chosen by the doctor should be divided into two different doses to be taken together with the two main meals.

Warnings AISOSKIN ® Isotretinoin

The oral intake of Isotretinoin necessarily requires the supervision of a doctor experienced in the treatment of retinoids, given the many side effects of the therapy and the high risks for the patient's health.

Among the most important precautions, which must be reiterated from time to time by the doctor in charge of the treatment, it is necessary to remember:

to continuously monitor the absence of pregnancy in women of childbearing age, before, during and at least 5 weeks after the end of treatment, given the overt teratogenic effects of retinoids;
to avoid direct exposure to ultraviolet rays, given the photosensitising power of the drug;
to avoid invasive dermatological procedures even after stopping treatment, given the potential side effects to the skin:
to periodically monitor liver and kidney function;
to monitor the parameters of lipid metabolism in patients suffering from metabolic disorders.

Continuous medical supervision is therefore essential to maintain the effectiveness of the therapy and to safeguard the health of the patient.

AISOSKIN ® contains among its excipients sorbitol and soy oils, therefore it is contraindicated in patients suffering from fructose intolerance and soy allergic.

PREGNANCY AND BREASTFEEDING

Given the clear teratogenic effects of retinoids which include abnormalities of the central nervous system, facial dimorphisms, cleft lip and palate, cardiovascular and other abnormalities, pregnancy is an absolute contraindication to AISOSKIN ® intake.

The contraindication to the use of AISOSKIN ® should also be extended to breastfeeding given the ability of isotretinoin to pass through the breast filter concentrating in breast milk.

Interactions

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

Contraindications AISOSKIN ® Isotretinoin

The use of AISOSKIN ® is contraindicated in patients who are hypersensitive to the active ingredient or to one of its excipients, during pregnancy and lactation, in women of childbearing 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

Treatment with AISOSKIN ® is characterized by numerous side effects, which fortunately are dose-dependent and promptly regress once therapy is stopped.

Among the most frequent side effects it is possible to find: anemia, increased ESR, thrombocytopenia, neutropenia, thrombocytosis, headache, epistaxis, nasal dryness, increased transaminases, dermatitis, pruritus, skin exfoliation, increased triglycerides, arthralgias, myalgia and asthenia.

Psychiatric disorders, severe kidney disorders and gastro-enteric disorders are fortunately rarer