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(isotretinoin) Capsule, Gelatin Coated
(isotretinoin) Capsule, Liquid Filled
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT
CONTRAINDICATIONS AND WARNINGS
Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin capsules 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 isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin 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 isotretinoin capsules, isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin capsules 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 isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin's teratogenicity and to minimize fetal exposure, Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) capsules 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 PRECAUTIONS).
Table 1: Monthly Required iPLEDGE Interactions
|Female Patients of Childbearing Potential||Male Patients, And Female Patients Not of Childbearing Potential|
|Confirms patient counseling||X||X|
|Enters the 2 contraception methods chosen by the patient||X|
|Enters pregnancy test results||X|
|Answers educational questions before every prescription||X|
|Enters 2 forms of contraception||X|
|Calls system to get an authorization||X||X|
Isotret (isotret (isotretinoin capsules) inoin capsules) inoin, a retinoid, is available as Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) in 10 mg, 20 mg, 30 mg, and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil, hydrogenated vegetable oil, iron oxide black, soybean oil and white wax. 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; 30 mg - FD&C Yellow No. 6, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide. Chemically, isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:
What are the possible side effects of isotretinoin (Amnesteem, Claravis, Sotret)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:
- depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
- sudden numbness or weakness, especially on one side of the body;
- blurred vision, sudden and severe...
What are the precautions when taking isotretinoin capsules (Sotret)?
Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as tretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders (including depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss...
Last reviewed on RxList: 3/30/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Sotret Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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