Generic Name: isotretinoin, dosage Form: capsule, liquid filled, medically reviewed on February 1, 2018, show On This generic forms of accutane Page. View All, causes birth, defects, dO NOT GET, pregnant. Contraindications AND warnings, accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals eye abnormalities (including microphthalmia facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements, because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called ipledge. Accutane must only be prescribed by prescribers who are registered and activated with the ipledge program. Accutane must only be dispensed by a pharmacy registered and activated with ipledge, and must only be dispensed to patients who are registered and meet all the requirements of ipledge (see. Table 1 Monthly Required ipledge Interactions. Female Patients of Childbearing Potential, male Patients, And Female Patients Not of Childbearing Potential. Prescriber, confirms patient counseling, x generic forms of accutane X, enters the 2 contraception methods chosen by the patient. X, enters pregnancy test results X patient, answers educational questions before every prescription. X, enters 2 forms of contraception X pharmacist, contacts generic forms of accutane system to get an authorization. X X, the Accutane brand name has been discontinued in the.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available. Accutane Description, isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg soft gelatin generic forms of accutane 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. 3, FD C Blue. 1, and titanium dioxide; 40 mg FD C Yellow. 6, D C Yellow.
Generic Name: isotretinoin (oral) (EYE so tret i noyn). Brand Names: Accutane, Amnesteem, Claravis, Sotret, medically reviewed on accutane depression treatment March 21, 2018. The, accutane brand name has been discontinued in the.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available. Accutane is a form of vitamin. It reduces the amount of oil released by oil glands in your accutane depression treatment skin, and helps your skin renew itself more quickly. Accutane is used to treat severe nodular accutane depression treatment acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms. Accutane may also be used for other purposes not listed in this medication guide. Accutane can cause severe, life-threatening birth defects. Accutane if you are pregnant. Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking isotretinoin. Accutane is available only under a special program called ipledge. It is dangerous to try and purchase. Accutane on the Internet or from vendors outside accutane depression treatment of the United States. Do not take vitamin supplements containing vitamin A while you are taking isotretinoin. Do not donate blood while taking. Accutane and for at least 30 days after you stop taking. What should I discuss with my healthcare provider before taking. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Ask your doctor or call the drug maker if you have questions about the program or the written requirements. The sale and distribution. Accutane outside of the ipledge program violates the regulations of the.S. Food and Drug Administration for the safe use of this medication. Do not use this medication if you are allergic to isotretinoin or to parabens, or if you are pregnant or may become pregnant. To make sure you can safely take. Accutane, tell your doctor if you have any of these other conditions: a personal or family history of depression or mental illness; heart disease, high cholesterol or triglycerides; osteoporosis or other bone disorders; an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's. Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant. For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. Even women who have had their tubes tied are required to use birth control while taking Accutane. You must have a negative pregnancy test 30 days before you start taking Accutane. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Accutane, and again 30 days later. All pregnancy testing is required by the ipledge program.