Isotretinoin is harmful to the fetus and therefore should not be used during pregnancy. Women of childbearing age must have two negative pregnancy test results before therapy is started, and a pregnancy test must be conducted during each month of therapy. Isotretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly. Each soft capsule contains 10 mg of isotretinoin. Excipients with known effect: Contains soya bean oil (refined, hydrogenated and partially hydrogenated) and sorbitol. Special Prescribing Requirements. Because of Accutane (isotretinoin) 's teratogenicity and to minimize fetal exposure, Accutane (isotretinoin) is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. Accutane (isotretinoin) is a powerful medication that is approved for people with severe acne that is non-responsive to other treatments. It is the most effective medication on the market for acne, but also comes with a worrying list of side effects, some of which can be lifelong. Isotretinoin, also known as 13-cis-retinoic acid (and colloquially referred to by its former brand name Accutane or Roaccutane), is a medication primarily used to treat severe acne. Each soft capsule contains isotretinoin 10 mg. Excipient(s) with known effect. Soya Oil: 104.2 mg/capsule. For the full list of excipients, see section 6.1. User Reviews for Isotretinoin. Also known as: Absorica, Amnesteem, Claravis, Myorisan, Sotret, Zenatane. The following information is NOT intended to endorse drugs or recommend therapy. ACNE OVERVIEW. Acne is a skin condition that causes pimples to develop. Acne is the most common skin disorder in North America, affecting an estimated 85 percent of adolescents. UKPAR Isotretinoin 40mg Soft Capsules PL 04569/0723 6 DRUG PRODUCT Other ingredients Other ingredients consist of pharmaceutical excipients, namely soya bean oil, beeswax.