The composition and the form of:
Roaccutane capsules of 30 or 100 pieces. in the package.
1 capsule contains Roaccutane isotretinoin (13-cis-retinoic acid) 10 or 20 mg.

Properties / Action:
Isotretinoin – an active ingredient Roaccutane – stereoisomer of all-trans retinoic acid (tretinoin).
The exact mechanism of action Roaccutane not yet been elucidated, but found that the improvement of the clinical picture of severe acne is associated with dose-dependent suppression of activity of sebaceous glands and histologically confirmed by a decrease in their size. Moreover, it is proved anti-inflammatory effect Roaccutane (isotretinoin) on the skin.

Pharmacokinetics:
The dynamics Roaccutane concentrations in the blood can be predicted on the basis of a linear pharmacokinetics model.
In healthy volunteers and patients with cystic acne the maximum plasma concentrations (Cmax) after administration of 80-100 mg of isotretinoin was approximately 250 ng / ml were achieved within 1-4 hours.
Receiving Roaccutane with food increases the bioavailability of 2 times compared with the reception on an empty stomach, probably as a result of improved absorption of this compound, which has high lipophilicity. Moreover, reception Roaccutane during the meal is accompanied, in general, a decrease in vibration systemic bioavailability.
Isotretinoin is highly bound to plasma proteins (99.9%), so that a wide range of therapeutic concentrations of free (pharmacologically active) fraction of the drug is less than 0.1% of its total. The main binding protein is apparently albumin.
The volume of distribution of isotretinoin in humans is not known, since the dosage form for intravenous use do not exist.
Isotretinoin crosses the placental barrier in quantities that cause congenital malformations of the fetus. Lipophilicity isotretinoin causes high probability that he gets into breast milk.
The main metabolite of isotretinoin is 4-oxo-isotretinoin, which is rapidly formed after oral administration. Furthermore, in vivo, and isotretinoin is metabolized by an alternative path to the formation of tretinoin (all-trans retinoic acid). No conclusive data on glyukuronizatsii metabolites in man is not, however, it is a high probability suggest animal studies. Studies in humans and in dogs indicate enterohepatic circulation of isotretinoin, which may play a role in individual differences in plasma concentrations of the drug.
Apparently, isotretinoin is derived almost exclusively by hepatic metabolism and biliary excretion. In healthy volunteers and patients with cystic form of acne during the half-life of unmodified form of the drug after oral administration is, on average, 20 hours (7 – 39 hours).
The average half-life of 4-oksoizotretinoina in patients with cystic acne somewhat longer – an average of 25 hours (from 17 to 50 hours).
Since Roaccutane (isotretinoin) is contraindicated in abnormal liver function or renal data on the pharmacokinetics Roaccutane this group of patients is not available.

Indications:
Roaccutane used to treat severe nodulocystica acne, acne that can not be carried out before therapy, in particular, cystic acne, especially on the trunk.

Dosage and administration:
The initial dose Roaccutane – 0.5 mg / kg per day. Often in the beginning of treatment is observed transient exacerbation of acne. Efficacy and side effects Roaccutane vary in different patients, so after about 4 weeks of therapy necessary to adjust the individual maintenance dose Roaccutane in the range of 0.1 to 1.0 mg / kg per day. The highest daily dose Roaccutane (1 mg / kg) should be prescribed only for a limited time. The treatment usually lasts 16 weeks Roaccutane. In evaluating the results, it should be remembered that often the improvement continues even after the abolition Roaccutane. Therefore, before re-appointment rate Roaccutane should make a break of at least 8 weeks. A second course of treatment Roaccutane carried out in accordance with the above recommendations.
Capsules Roaccutane taken with food, small doses, once a day, higher doses – one or more devices per day.
Simultaneous external treatment.
The simultaneous appointment of other drugs for the treatment of acne with keratolytic or exfoliative action, as well as UV-therapy, not shown. Patients should avoid insolation. You can assign external protivougrevye preparations mild.

Overdose:
In case of overdose Roaccutane may appear signs of hypervitaminosis A. In the first few hours after the overdose may need a gastric lavage.

Contraindications:
Pregnancy
hepatic and renal failure;
hypervitaminosis A;
marked hyperlipidemia;
Hypersensitivity to Roaccutane (isotretinoin).