Accutane
Generic Name: isotretinoin (oral) (eye so TRET i noyn)
Brand Names: Accutane
What is isotretinoin?
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.
Isotretinoin is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms.
Isotretinoin may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about isotretinoin?
Isotretinoin can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby"s ears, eyes, face, skull, heart, and brain. Never use isotretinoin 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. Unless you have had a total hysterectomy or have been in menopause for at least a year, you are considered to be of child-bearing potential.
Isotretinoin is available only under a special program called iPLEDGE. You must be registered in the program and sign agreements to use birth control and undergo pregnancy testing as required by the program. Read all program brochures and agreements carefully.
It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
What should I discuss with my healthcare provider before taking isotretinoin?
Isotretinoin is available only under a special program called iPLEDGE. 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. Read all of the iPLEDGE program brochures and agreements carefully. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.
It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.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.Before taking isotretinoin, tell your doctor if you are allergic to any foods or drugs, or if you have:
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a personal or family history of depression or mental illness;
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heart diease, high cholesterol or triglycerides;
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osteoporosis or other bone disorders;
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diabetes;
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asthma;
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an eating disroder (anorexia nervosa); or
- liver disease.
If you have any of these conditions, you may not be able to use isotretinoin, or you may need a dosage adjustment or special tests during treatment.
Isotretinoin can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby"s ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) 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 isotretinoin.
You must have a negative pregnancy test 30 days before you start taking isotretinoin. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.
You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control must be used together.
Primary forms of birth control include:
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tubal ligation (tubes tied);
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vasectomy of the male sexual partner;
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an IUD (intrauterine device);
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estrogen-containing birth control pills (not mini-pills); and
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hormonal birth control patches, implants, injections, or vaginal ring.
Secondary forms of birth control include:
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a male latex condom plus spermicidal foam or gel;
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a diaphragm plus spermicidal foam or gel;
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a cervical cap plus spermicidal foam or gel; and
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a vaginal sponge containing spermicide.
Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant.
It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without first talking to your doctor if you are breast-feeding a baby.
