Roaccutane 20 mg 30 capsules

Trade name:

Roaccutane

Compound:

Each capsule contains:

Isotretinoin 20 mg

Auxiliary components:

Soybean oil, yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil.

Properties:

Retinoid for systemic treatment of acne.

Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin).

The exact mechanism of action of Roaccutane has not yet been elucidated, however, it has been established that the improvement in the clinical picture of severe forms of acne is associated with the suppression of the activity of the sebaceous glands and a histologically confirmed decrease in their size. In addition, the anti-inflammatory effect of isotretinoin on the skin has been proven.

Hyperkeratosis of the cells of the epithelium of the hair follicle and the sebaceous gland leads to desquamation of corneocytes into the duct of the gland and to blockage of the latter with keratin and excess sebaceous secretion. This is followed by the formation of a comedone and, in some cases, the addition of an inflammatory process. Roaccutane inhibits the proliferation of sebocytes and acts on acne by restoring the normal process of cell differentiation. Sebum is the main substrate for the growth of Propionibacterium acnes, so reducing sebum production inhibits bacterial colonization of the duct.

Indications:

– severe forms of acne (nodular cystic, conglobate acne or acne with a risk of scarring);

– acne, not amenable to other types of therapy.

Dosage and administration:

Inside, during meals once or twice a day.

The therapeutic efficacy of Roaccutane and its side effects are dose dependent and vary from patient to patient. This dictates the need for individual dose selection during treatment.

Treatment with Roaccutane should begin with a dose of 0.5 mg/kg body weight/day. In most patients, the dose ranges from 0.5 to 1.0 mg / kg of body weight per day. Patients with very severe forms of the disease or with acne of the trunk may require higher daily doses – up to 2.0 mg / kg / day.

Complete remission of acne is often achieved within 16-24 weeks of treatment.

Contraindications:

-liver failure;

– hypervitaminosis A;

– severe hyperlipidemia;

– concomitant therapy with tetracyclines;

-pregnancy;

– period of breastfeeding;

– children’s age up to 12 years;

hypersensitivity to the drug or its components.

Precautionary measures:

Pregnancy is an absolute contraindication for Roaccutane therapy. If pregnancy occurs, despite warnings, during treatment or within a month after the end of therapy, there is a very high risk of having a child with severe malformations.

Isotretinoin is a drug with a strong teratogenic effect.

Roaccutane is contraindicated in women of childbearing age.

Roaccutane should only be prescribed by physicians, preferably dermatologists, experienced in the use of systemic retinoids and aware of the risk of teratogenicity of the drug. Both female and male patients should be given a copy of the patient information leaflet.

In order to avoid accidental exposure of the drug to the body of other people, patients who receive or shortly before (1 month) received Roaccutane should not take donated blood.

Side effects:

Symptoms of vitamin A hypervitaminosis: dry skin, mucous membranes.

On the part of the skin and its appendages: very often – cheilitis, dermatitis, dry skin, localized peeling, itching, erythematous rash, increased.

At the beginning of treatment, an exacerbation of acne is possible, which persists for several weeks.

From the musculoskeletal system: very often – arthralgia, back pain, myalgia with or without an increase in the level of CPK in the blood serum.

From the side of the central nervous system and mental sphere: often – headache.

From the senses: very often – blepharitis, conjunctivitis, dryness of the mucous membrane of the eye, eye irritation.

On the part of the respiratory system: often – epistaxis, dryness of the nasal mucosa, nasopharyngitis.

On the part of the blood system: very often – anemia, an increase in ESR, an increase or decrease in the number of platelets; often – neutropenia.

Laboratory indicators: very often – hypertriglyceridemia, a decrease in HDL levels; often – hypercholesterolemia, hyperglycemia, hematuria, proteinuria.

Storage method:

Store at a temperature not exceeding 30 degrees.

Package:

Cardboard box contains 30 capsules, paper instructions.