Roaccutan (isotretinoin) capsules 20 mg. №30

Description

Roaccutan (isotretinoin) capsules 20 mg. №30

Composition

active substance: isotretinoin;

1 capsule contains 10 mg or 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 .

Medicinal form

Capsules.

The main physical and chemical properties:

• capsules 10 mg: oval opaque capsules of brownish-red color, on the surface of the capsule there is a clear imprint “ROA 10”, the length of the capsules is 8.3–10.7 mm, the diameter of the capsules is 5.3–7.7 mm; the contents of the capsule are a homogeneous suspension of dark yellow color;
• capsules 20 mg: oval opaque capsules, one half is brown-red, the other half is white, on the surface of the capsule there is a clear imprint “ROA 20”, the length of the capsules is 12.4–14.2 mm, the diameter of the capsules is 7.3–9 ,1 mm; the contents of the capsule are a homogeneous suspension of dark yellow color.

Pharmacotherapeutic group

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

Pharmacological properties

Isotretinoin is a stereoisomer of all-trans-retinoic acid (tretinoin). The exact mechanism of action of isotretinoin has not yet been determined in detail, but it has been established that the improvement of the clinical picture of severe forms of acne is associated with a decrease in 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 is proven.

Indications

Topical anti-inflammatory drug Roaccutan capsules capable of suppressing the activity of the sebaceous glands. It is used in the treatment of severe forms of acne (acne), including conglobat and cystic forms, also prone to scarring.
Stimulates regeneration, has a special antiseborrheic effect. Proved to be a highly effective remedy for acne that has not responded to other treatments.

Contraindications

Do not prescribe in hepatic insufficiency, hypervitaminosis with vitamin A. It is also not used in concomitant therapy with tetracycline antibiotics. Contraindicated in allergic hypersensitivity to isotretinoins.
Caution should be exercised in patients with type 1 and type 2 diabetes, as well as in obesity (lipid imbalance), alcohol dependence, depression or predisposition to them.

Use during pregnancy and breastfeeding

Categorically contraindicated in pregnancy due to the powerful teratogenicity of the drug. Reliable contraception should be used for one month after the end of therapy.

Method of application and dose

Appointed exclusively by a specialist in dermatology with experience in the use of systemic retinoids.
Roaccutan take orally, once a day, preferably at the same time of day, at the rate of 0.5 milligrams per 1 kilogram of patient weight. At the initial stage of the treatment process there may be a short-term exacerbation of the disease, increased rash. In the case of severe forms of acne or acne of the torso, the daily dose of the drug can reach 0.2 grams (2.0 milligrams) per 1 kilogram of patient weight.

Overdose

Cases of overdose are extremely rare. At excessive reception symptomatology of a hypervitaminosis with vitamin A is shown. For removal of intoxication it is necessary to wash out a stomach and to accept sorbents, to apply symptomatic treatment.

Side effects

Taking Roaccutan capsules can cause some side effects that are dose-dependent. In the first stages of treatment may be an exacerbation of the disease, increased rash, accompanied by photosensitization, itching, sweating.
People with bronchial asthma may experience bronchospasm. A musculoskeletal reaction in the form of hyperostosis and tendinitis is possible. Dyspeptic disorders, leukocytosis, erythrocytosis, manifestations of thrombocypenia or thrombocytosis, increased ESR are likely.
Most likely the development of hypervitaminosis of vitamin A (the appearance of dry skin and mucous membranes, nosebleeds, conjunctivitis).