fda registry for accutane
isotretinoin (oral)(eye so TREH tih noyn)
What is the most important information I should know about Accutane?
• Accutane is a medication taken to treat severe nodular acne that hasnot been helped by other treatments, including antibiotics fda registry for accutane. However, Accutanecan cause serious side effects fda registry for accutane. Before starting treatment with Accutane, discusswith your doctor how bad the acne is, the possible benefits of Accutane, andthe possible side effects fda registry for accutane. Your doctor will ask you to read and sign a formindicating that you understand the serious risks associated with Accutane therapy fda registry for accutane.
• Do not take Accutane if you are pregnant or if you could become pregnantduring treatment or for one month after you stop taking Accutane fda registry for accutane. Accutane isin the FDA pregnancy category X fda registry for accutane. This means that Accutane is known to causesevere birth defects in an unborn baby fda registry for accutane. It can also cause miscarriage, prematurebirth, or death of the baby fda registry for accutane. You must take a pregnancy test and have negativeresults when you and your doctor decide that Accutane may be beneficial foryour condition fda registry for accutane. You must have a second pregnancy test with negative resultsduring the first 5 days of the menstrual period right before you start takingAccutane fda registry for accutane. Two reliable forms of birth control must be used at the same time(unless abstinence is the chosen method of birth control or if you have undergonea hysterectomy) for one month before starting treatment with Accutane, duringtreatment with Accutane, and for at least 1 month following the end of treatment fda registry for accutane. You will also be asked to take a pregnancy test on a monthly basis fda registry for accutane. Your doctorwill discuss with you and provide for you a video and written information regardingchoices for birth control, possible causes for birth control failure, and theimportance of using birth control while taking Accutane fda registry for accutane. If you become pregnant,stop using birth control, or miss your menstrual period, immediately stop takingAccutane and notify your doctor fda registry for accutane.
• Some patients have experienced depression (including feelings of sadness,irritability, unusual tiredness, trouble concentrating, and loss of appetite)and suicidal thoughts and/or behavior during, and soon after stopping, treatmentwith Accutane fda registry for accutane. Notify your doctor immediately if you begin to experience signsof depression or if you begin to have thoughts about taking your own life duringor shortly following treatment with Accutane fda registry for accutane.
• Do not take vitamin supplements containing vitamin A during treatmentwith Accutane fda registry for accutane. This could cause increased side effects fda registry for accutane.
• Do not donate blood while taking Accutane and for at least 1 month followingthe end of treatment fda registry for accutane. Blood donated while taking Accutane may be given to apregnant woman and be harmful to her baby fda registry for accutane.
• Do not use wax hair removal systems or have any skin resurfacing procedures(such as dermabrasion or laser treatment) performed while taking Accutane andfor six months following treatment due to the possibility of scarring fda registry for accutane.
• Avoid exposure to sunlight or UV rays while taking Accutane fda registry for accutane. Accutanemay increase the sensitivity of the skin to sunlight and a severe sunburn couldresult fda registry for accutane.
• Use caution when driving a vehicle at night fda registry for accutane. Accutane can cause decreasednight vision fda registry for accutane. The onset of decreased night vision may be sudden fda registry for accutane.
• Take all of the Accutane that has been prescribed for you even if yoursymptoms start to improve fda registry for accutane. The acne may seem to get worse at the start of therapy,but should then begin to improve fda registry for accutane. For the best results, finish all of the medicationthat has been prescribed fda registry for accutane. You may require more than one course of therapy withAccutane fda registry for accutane.
What is Accutane?
• Accutane is a form of vitamin A fda registry for accutane. It decreases the amount of sebum (oil)that is released by the sebaceous (oil) glands, and it increases that rate atwhich the skin renews itself fda registry for accutane.
• Accutane is used to treat severe nodular acne that has not respondedto other treatments, including antibiotics fda registry for accutane.
• Accutane may also be used for purposes other than those listed in thismedication guide fda registry for accutane.
What should I discuss with my healthcare provider before taking Accutane?
• Before taking Accutane, tell your doctor if you have
· a personal or family history of mental problems including depression,suicidal behavior, or psychosis (loss of contact with reality, hearing voices,or seeing things that are not there);
· diabetes;
· asthma;
· heart disease;
· osteoporosis (bone loss) or weak bones;
· anorexia nervosa;
· high cholesterol or triglyceride levels (types of fat) in the blood;or
· liver disease fda registry for accutane.
• You may not be able to take Accutane, or you may require a dosage adjustmentor special monitoring during treatment if you have any of the conditions listedabove fda registry for accutane.
• Do not take Accutane if you are pregnant or if you could become pregnantduring treatment or for one month after you stop taking Accutane fda registry for accutane. Accutane isin the FDA pregnancy category X fda registry for accutane. This means that Accutane is known to causesevere birth defects in an unborn baby fda registry for accutane. It can also cause miscarriage, prematurebirth, or death of the baby fda registry for accutane. You must take a pregnancy test and have negativeresults when you and your doctor decide that Accutane may be beneficial foryour condition fda registry for accutane. You must have a second pregnancy test with negative resultsduring the first 5 days of the menstrual period right before you start takingAccutane fda registry for accutane. Two reliable forms of birth control must be used at the same time(unless abstinence is the chosen method of birth control or if you have undergonea hysterectomy) for one month before starting treatment with Accutane, duringtreatment with Accutane, and for at least 1 month following the end of treatment fda registry for accutane. You will also be asked to take a pregnancy test on a monthly basis fda registry for accutane. Your doctorwill discuss with you and provide for you a video and written information regardingchoices for birth control, possible causes for birth control failure, and theimportance of using birth control while taking Accutane fda registry for accutane. If you become pregnant,stop using birth control, or miss your menstrual period, immediately stop takingAccutane and notify your doctor fda registry for accutane.
• It is not known whether Accutane passes into breast milk fda registry for accutane. Do not takeAccutane without first talking to your doctor if you are breast-feeding a baby fda registry for accutane.
How should I take Accutane?
• Take Accutane exactly as directed by your doctor fda registry for accutane. If you do not understandthese instructions, ask your pharmacist, nurse, or doctor to explain them toyou fda registry for accutane.
• Accutane is a medication taken to treat severe nodular acne that hasnot been helped by other treatments, including antibiotics fda registry for accutane. However, Accutanecan cause serious side effects fda registry for accutane. Before starting treatment with Accutane, discusswith your doctor how bad the acne is, the possible benefits of Accutane andthe possible side effects fda registry for accutane. Your doctor will ask you to read and sign a formindicating that you understand the serious risks associated with Accutane therapy fda registry for accutane.
• You will get no more than a 30-day supply of Accutane at a time fda registry for accutane. Yourprescription should have a special yellow self-adhesive sticker attached toit fda registry for accutane. If your prescription does not have this yellow sticker, call your doctor fda registry for accutane. The pharmacy should not fill the prescription without this sticker fda registry for accutane.
• Take each dose of Accutane with a full glass of water fda registry for accutane. This will helpprevent the medication inside the capsule from irritating the lining of theesophagus fda registry for accutane. For the same reason, do not chew or suck on the capsule fda registry for accutane.
• Take Accutane twice a day with food or milk to get the best results fromthis medication, unless otherwise directed by your doctor fda registry for accutane.
• Take all of the Accutane that has been prescribed for you even if yoursymptoms start to improve fda registry for accutane. The acne may seem to get worse at the start of therapy,but should then begin to improve fda registry for accutane. For the best results, finish all of the medicationthat has been prescribed fda registry for accutane. You may require more than one course of therapy withAccutane fda registry for accutane.
• Your doctor may perform blood tests during treatment with Accutane tomonitor side effects from this medication fda registry for accutane.
• Due to the serious side effects that may occur with the use of this medication,do not share it with anyone else fda registry for accutane.
• Store Accutane at room temperature away from moisture and heat fda registry for accutane.
What happens if I miss a dose?
• Take the missed dose as soon as you remember fda registry for accutane. However, if it is almosttime for the next dose, skip the missed dose and only take the next regularlyscheduled dose fda registry for accutane. Do not take a double dose of this medication fda registry for accutane.
What happens if I overdose?
• Seek emergency medical attention fda registry for accutane.
• Symptoms of an Accutane overdose include vomiting, abdominal pain, flushingof the face, inflammation of the lips, headache, dizziness, and clumsiness fda registry for accutane.
What should I avoid while taking Accutane?
• Do not take vitamin supplements containing vitamin A during treatmentwith Accutane fda registry for accutane. This could cause increased side effects fda registry for accutane.
• Do not donate blood while taking Accutane and for at least 1 month followingthe end of treatment fda registry for accutane. Blood donated while taking Accutane may be given to apregnant woman and be harmful to her baby fda registry for accutane.
• Do not use wax hair removal systems or have any skin resurfacing procedures(such as dermabrasion or laser treatment) performed while taking Accutane andfor six months following treatment due to the possibility of scarring fda registry for accutane.
• Avoid exposure to sunlight or UV rays while taking Accutane fda registry for accutane. Accutanemay increase the sensitivity of the skin to sunlight and a severe sunburn couldresult fda registry for accutane.
• Use caution when driving a vehicle at night fda registry for accutane. Accutane can cause decreasednight vision fda registry for accutane. The onset of decreased night vision may be sudden fda registry for accutane.
What are the possible side effects of Accutane?
• Stop taking Accutane and seek emergency medical attention or contactyour doctor immediately if you experience any of the following serious sideeffects:
· an allergic reaction (difficulty breathing; closing of the throat;swelling of the lips, tongue, or face; or hives);
· changes in vision, blurred vision, or decreased vision (especiallyat night);
· painful or constant dryness of the eyes;
· depression including feelings of sadness, crying spells, irritability,changes in sleep patterns, unusual tiredness, trouble concentrating, loss ofappetite, and/or suicidal thoughts or other mental problems;
· stomach, chest, or bowel pain;
· rectal bleeding, or severe or bloody diarrhea;
· difficulty or pain when swallowing;
· new or worsening heartburn;
· yellowing of the skin or eyes or persistently dark urine;
· severe headache or dizziness;
· seizures;
· nausea and vomiting;
· joint or muscle pain or bone problems;
· hearing problems or hearing loss;
· trouble breathing;
· fainting;
· increased thirst or urination;
· slurred speech or problems moving;
· leg swelling;
· increased levels of cholesterol or triglyceride (types of fat) in yourblood (detected by blood tests) fda registry for accutane.
• Other, less serious side effects are more likely to occur fda registry for accutane. Continue totake Accutane and talk to your doctor if you experience
· inflammation, dryness, or cracking of the lips;
· dry skin, dry mouth, dry or bleeding nose, dryness of the eyes and/ordifficulty wearing contact lenses;
· itching; or
· increased sensitivity of the skin to the sun fda registry for accutane.
• Side effects other than those listed here may also occur fda registry for accutane. Talk to yourdoctor about any side effect that seems unusual or that is especially bothersome fda registry for accutane.
What other drugs will affect Accutane?
• Do not take any of the following medicines while taking Accutane:
· vitamin supplements containing vitamin A; or
· a tetracycline antibiotic such as tetracycline (Sumycin, Achromycin,Panmycin, Robitet, others), minocycline (Minocin, Dynacin, Vectrin), doxycycline(Doryx, Monodox, Vibramycin, Vibra-Tabs), demeclocycline (Declomycin), or troleandomycin(TAO) fda registry for accutane.
• Taking any of the drugs listed above during treatment with Accutane maybe dangerous fda registry for accutane.
• Before taking Accutane, tell your doctor if you are taking carbamazepine(Tegretol, Carbatrol, Epitol) fda registry for accutane. You may require a dosage adjustment or specialmonitoring during treatment fda registry for accutane.
• Do not use other acne medications unless otherwise directed by your doctor fda registry for accutane. They may interfere with the treatment or increase irritation of the skin fda registry for accutane.
• Do not take birth control pills that do not contain estrogen ("minipills")during treatment with Accutane fda registry for accutane. They may not work while taking Accutane fda registry for accutane.
• Drugs other than those listed here may also interact with Accutane fda registry for accutane. Talkto your doctor or pharmacist before taking any prescription or over-the-countermedicines, including herbal products fda registry for accutane.
Where can I get more information?
• Your pharmacist has additional information about Accutane written forhealth professionals that you may read fda registry for accutane.
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