Roaccutane Roaccutane Roaccutane Roaccutane Roaccutane

Roaccutane (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.
Roaccutane (Isotretinoin) is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
Roaccutane (Isotretinoin) may also be used for other purposes not listed in this medication guide.
Isotretinoin, a retinoid, is available as Roaccutane (Isotretinoin) in 10-mg and 20-mg soft gelatin capsules for oral administration. Each capsule contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20 mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol ( vitamin A).

DRUG INTERACTIONS
    - Vitamin A: Because of the relationship of Roaccutane (Isotretinoin) to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
    - Tetracyclines: Concomitant treatment with Roaccutane (Isotretinoin) and tetracyclines should be avoided because Roaccutane (Isotretinoin) use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
    -  Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations ("minipills" that do not contain an estrogen) may be an inadequate method of contraception during Roaccutane (Isotretinoin) therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from female patients who have used combined oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products. These reports are more frequent for female patients who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Roaccutane (Isotretinoin). Therefore, it is critically important for female patients of childbearing potential to select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form.
    - Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum 7/7/7 Tablets as an oral contraceptive agent, Roaccutane (Isotretinoin) at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Prescribers are advised to consult the package insert of medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
-  Phenytoin: Roaccutane (Isotretinoin) has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Roaccutane (Isotretinoin). Therefore, caution should be exercised when using these drugs together.
-  Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between systemic corticosteroids and Roaccutane (Isotretinoin). Therefore, caution should be exercised when using these drugs together.