isotretinoin - oral, Accutane, Amnesteem, Claravis,
GENERIC NAME: ISOTRETINOIN - ORAL (EYE-soeTRET-i-noyn)
BRAND NAME(S): Accutane, Amnesteem, Claravis, Sotret
WARNING: Women who are pregnant must not use isotretinoin. Women must avoid becoming pregnant while taking this medication. Serious (sometimes fatal) birth defects, miscarriages, and premature births have occurred when this drug has been used during pregnancy.
For female patients, two effective forms of birth control (or complete avoidance of sexual intercourse) must be used for 1 month before starting isotretinoin, during use, and for 1 month after stopping this drug. You must also have monthly pregnancy-avoidance counseling from your doctor. Do not use "minipills" for birth control (non-estrogen-containing pills) since they may not work as well with isotretinoin. If you are late in having your period, or if you have sexual intercourse at any time without using two effective forms of birth control, stop taking this medication and contact your doctor immediately. (See also the Precautions section.)
After December 31, 2005, only patients enrolled in the iPLEDGE program may obtain and use isotretinoin. You will need to register with iPLEDGE and view a video at your doctor's office before receiving your prescription. Only physicians enrolled in iPLEDGE may prescribe isotretinoin, and only pharmacies enrolled in the program may dispense it. Consult your doctor or pharmacist for more details about the iPLEDGE program and for more information about the risks and benefits of using this medication.
For female patients who are able to become pregnant (even if not sexually active), you will need to contact iPLEDGE every month, either through the internet or by telephone, and answer required questions every time you fill your prescription and 1 month after your last dose.
These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your specific regulations.
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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