Beloretin Isotretinoin 10mg 30 capsules

Composition
active ingredient: isotretinoin;
1 capsule contains 10 mg of isotretinoin;
excipients:
capsule content: refined soybean oil, all-rac-ɑ-tocopherol (E 307), disodium edetate (dihydrate), butylhydroxyanisole (E 320), partially hydrogenated soybean oil, hydrogenated vegetable oil, yellow wax (E 901);
capsule shell for 10 mg: gelatin; glycerin (E 422); sorbitol solution, non-crystallizing (E 420); purified water; titanium dioxide (E 171); ponceau 4 R (E 124); black iron oxide (E 172).

Indications for use

Severe forms of acne (including nodular and conglobatic acne, acne with a tendency to permanent scarring), which are not amenable to standard treatment methods (systemic antibacterial therapy, topical treatment).

Method of administration
Standard dosage regimen.

Treatment with isotretinoin should only be prescribed and administered 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 monitoring the patient’s condition.

Capsules should be taken with meals 1-2 times a day.

Adults (including adolescents and the elderly). Treatment should be initiated at a dose of 0.5 mg/kg/day. The therapeutic response to isotretinoin and some adverse reactions are dose-dependent and vary from patient to patient. Therefore, individual dose adjustment is necessary during treatment. In most patients, the dose ranges from 0.5 to 1 mg/kg/day.

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

In most patients, acne disappears completely after a single course of treatment. In case of severe relapse, a second course of treatment with Beloretin should be carried out in the same daily and course dose as the first. Since the condition may improve within

8 weeks after the end of treatment, a second course should be prescribed no earlier than the end of this period.