Roaccutane Isotretinoin 10-20mg 30 capsules

Composition
active substance: isotretinoin;

1 capsule contains 20 mg of isotretinoin;

auxiliary substances: yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, refined soybean oil;

capsule shell: gelatin, glycerin (85%), dry substance Karion 83 (sorbitol (E 420), mannitol (E 421), hydrolyzed hydrogenated starch), titanium dioxide (E 171), iron oxide red (E 172), printing ink.

Pharmacotherapeutic group
Means for systemic treatment of acne. ATX code D10B A01.

Indication
Severe forms of acne (in particular, nodular and conglobat acne, acne with a tendency to permanent scarring) that do not respond to standard treatment methods (systemic antibacterial therapy, local treatment).

Method of application and dosage
Standard dosing regimen.

Treatment with isotretinoin should be prescribed and administered only by a physician experienced in the use of systemic retinoids for the treatment of severe acne and fully aware of the risks of retinoid therapy and the requirements for patient monitoring.

Capsules are taken with meals 1-2 times a day.

Adults (including teenagers and the elderly). Treatment should be started with a dose of 0.5 mg/kg per day. The therapeutic response to isotretinoin and some adverse reactions are dose-dependent and vary between patients. In this regard, individual correction of the dose during treatment is necessary. In most patients, the dose ranges from 0.5 to 1 mg/kg of body weight per day.

Long-term remission and relapse rates are more related to the total dose administered than to the duration of treatment or the daily dose. It has been proven that no additional benefit should be expected when using a course dose higher than 120–150 mg/kg. The duration of therapy depends on the daily dose. A course of treatment of 16–24 weeks is usually enough to achieve remission.

In most patients, acne disappears completely after a single course of treatment. In case of a pronounced relapse, a repeated course of treatment with Roaccutane® should be carried out in the same daily and course dose as the first. Since the condition can improve within 8 weeks after the end of treatment, a repeat course should be prescribed no earlier than the end of this period.

Dosage in special cases.

Patients with renal failure. In patients with severe renal insufficiency, treatment should be started with a lower dose (for example, 10 mg/day), and then increased to 1 mg/kg/day or to the maximum tolerated dose (see the section “Particulars of use”).

Patients with intolerance. For patients who develop severe intolerance to the recommended dose, treatment can be continued at a lower dose. In this case, the duration of therapy will be longer, and the risk of relapse will be higher. In order to achieve the maximum possible effectiveness, the highest tolerated dose should be used.