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summary of accutane labeling

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summary of accutane labeling
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 summary of accutane labeling. However, Accutanecan cause serious side effects summary of accutane labeling. Before starting treatment with Accutane, discusswith your doctor how bad the acne is, the possible benefits of Accutane, andthe possible side effects summary of accutane labeling. Your doctor will ask you to read and sign a formindicating that you understand the serious risks associated with Accutane therapy summary of accutane labeling.
• Do not take Accutane if you are pregnant or if you could become pregnantduring treatment or for one month after you stop taking Accutane summary of accutane labeling. Accutane isin the FDA pregnancy category X summary of accutane labeling. This means that Accutane is known to causesevere birth defects in an unborn baby summary of accutane labeling. It can also cause miscarriage, prematurebirth, or death of the baby summary of accutane labeling. You must take a pregnancy test and have negativeresults when you and your doctor decide that Accutane may be beneficial foryour condition summary of accutane labeling. You must have a second pregnancy test with negative resultsduring the first 5 days of the menstrual period right before you start takingAccutane summary of accutane labeling. 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 summary of accutane labeling. You will also be asked to take a pregnancy test on a monthly basis summary of accutane labeling. 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 summary of accutane labeling. If you become pregnant,stop using birth control, or miss your menstrual period, immediately stop takingAccutane and notify your doctor summary of accutane labeling.
• 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 summary of accutane labeling. 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 summary of accutane labeling.
• Do not take vitamin supplements containing vitamin A during treatmentwith Accutane summary of accutane labeling. This could cause increased side effects summary of accutane labeling.
• Do not donate blood while taking Accutane and for at least 1 month followingthe end of treatment summary of accutane labeling. Blood donated while taking Accutane may be given to apregnant woman and be harmful to her baby summary of accutane labeling.
• 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 summary of accutane labeling.
• Avoid exposure to sunlight or UV rays while taking Accutane summary of accutane labeling. Accutanemay increase the sensitivity of the skin to sunlight and a severe sunburn couldresult summary of accutane labeling.
• Use caution when driving a vehicle at night summary of accutane labeling. Accutane can cause decreasednight vision summary of accutane labeling. The onset of decreased night vision may be sudden summary of accutane labeling.
• Take all of the Accutane that has been prescribed for you even if yoursymptoms start to improve summary of accutane labeling. The acne may seem to get worse at the start of therapy,but should then begin to improve summary of accutane labeling. For the best results, finish all of the medicationthat has been prescribed summary of accutane labeling. You may require more than one course of therapy withAccutane summary of accutane labeling.

What is Accutane?
• Accutane is a form of vitamin A summary of accutane labeling. 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 summary of accutane labeling.
• Accutane is used to treat severe nodular acne that has not respondedto other treatments, including antibiotics summary of accutane labeling.
• Accutane may also be used for purposes other than those listed in thismedication guide summary of accutane labeling.

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 summary of accutane labeling.
• 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 summary of accutane labeling.
• Do not take Accutane if you are pregnant or if you could become pregnantduring treatment or for one month after you stop taking Accutane summary of accutane labeling. Accutane isin the FDA pregnancy category X summary of accutane labeling. This means that Accutane is known to causesevere birth defects in an unborn baby summary of accutane labeling. It can also cause miscarriage, prematurebirth, or death of the baby summary of accutane labeling. You must take a pregnancy test and have negativeresults when you and your doctor decide that Accutane may be beneficial foryour condition summary of accutane labeling. You must have a second pregnancy test with negative resultsduring the first 5 days of the menstrual period right before you start takingAccutane summary of accutane labeling. 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 summary of accutane labeling. You will also be asked to take a pregnancy test on a monthly basis summary of accutane labeling. 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 summary of accutane labeling. If you become pregnant,stop using birth control, or miss your menstrual period, immediately stop takingAccutane and notify your doctor summary of accutane labeling.
• It is not known whether Accutane passes into breast milk summary of accutane labeling. Do not takeAccutane without first talking to your doctor if you are breast-feeding a baby summary of accutane labeling.

How should I take Accutane?
• Take Accutane exactly as directed by your doctor summary of accutane labeling. If you do not understandthese instructions, ask your pharmacist, nurse, or doctor to explain them toyou summary of accutane labeling.
• Accutane is a medication taken to treat severe nodular acne that hasnot been helped by other treatments, including antibiotics summary of accutane labeling. However, Accutanecan cause serious side effects summary of accutane labeling. Before starting treatment with Accutane, discusswith your doctor how bad the acne is, the possible benefits of Accutane andthe possible side effects summary of accutane labeling. Your doctor will ask you to read and sign a formindicating that you understand the serious risks associated with Accutane therapy summary of accutane labeling.
• You will get no more than a 30-day supply of Accutane at a time summary of accutane labeling. Yourprescription should have a special yellow self-adhesive sticker attached toit summary of accutane labeling. If your prescription does not have this yellow sticker, call your doctor summary of accutane labeling. The pharmacy should not fill the prescription without this sticker summary of accutane labeling.
• Take each dose of Accutane with a full glass of water summary of accutane labeling. This will helpprevent the medication inside the capsule from irritating the lining of theesophagus summary of accutane labeling. For the same reason, do not chew or suck on the capsule summary of accutane labeling.
• Take Accutane twice a day with food or milk to get the best results fromthis medication, unless otherwise directed by your doctor summary of accutane labeling.
• Take all of the Accutane that has been prescribed for you even if yoursymptoms start to improve summary of accutane labeling. The acne may seem to get worse at the start of therapy,but should then begin to improve summary of accutane labeling. For the best results, finish all of the medicationthat has been prescribed summary of accutane labeling. You may require more than one course of therapy withAccutane summary of accutane labeling.
• Your doctor may perform blood tests during treatment with Accutane tomonitor side effects from this medication summary of accutane labeling.
• Due to the serious side effects that may occur with the use of this medication,do not share it with anyone else summary of accutane labeling.
• Store Accutane at room temperature away from moisture and heat summary of accutane labeling.

What happens if I miss a dose?
• Take the missed dose as soon as you remember summary of accutane labeling. However, if it is almosttime for the next dose, skip the missed dose and only take the next regularlyscheduled dose summary of accutane labeling. Do not take a double dose of this medication summary of accutane labeling.

What happens if I overdose?
• Seek emergency medical attention summary of accutane labeling.
• Symptoms of an Accutane overdose include vomiting, abdominal pain, flushingof the face, inflammation of the lips, headache, dizziness, and clumsiness summary of accutane labeling.

What should I avoid while taking Accutane?
• Do not take vitamin supplements containing vitamin A during treatmentwith Accutane summary of accutane labeling. This could cause increased side effects summary of accutane labeling.
• Do not donate blood while taking Accutane and for at least 1 month followingthe end of treatment summary of accutane labeling. Blood donated while taking Accutane may be given to apregnant woman and be harmful to her baby summary of accutane labeling.
• 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 summary of accutane labeling.
• Avoid exposure to sunlight or UV rays while taking Accutane summary of accutane labeling. Accutanemay increase the sensitivity of the skin to sunlight and a severe sunburn couldresult summary of accutane labeling.
• Use caution when driving a vehicle at night summary of accutane labeling. Accutane can cause decreasednight vision summary of accutane labeling. The onset of decreased night vision may be sudden summary of accutane labeling.

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) summary of accutane labeling.
• Other, less serious side effects are more likely to occur summary of accutane labeling. 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 summary of accutane labeling.
• Side effects other than those listed here may also occur summary of accutane labeling. Talk to yourdoctor about any side effect that seems unusual or that is especially bothersome summary of accutane labeling.

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) summary of accutane labeling.
• Taking any of the drugs listed above during treatment with Accutane maybe dangerous summary of accutane labeling.
• Before taking Accutane, tell your doctor if you are taking carbamazepine(Tegretol, Carbatrol, Epitol) summary of accutane labeling. You may require a dosage adjustment or specialmonitoring during treatment summary of accutane labeling.
• Do not use other acne medications unless otherwise directed by your doctor summary of accutane labeling. They may interfere with the treatment or increase irritation of the skin summary of accutane labeling.
• Do not take birth control pills that do not contain estrogen ("minipills")during treatment with Accutane summary of accutane labeling. They may not work while taking Accutane summary of accutane labeling.
• Drugs other than those listed here may also interact with Accutane summary of accutane labeling. Talkto your doctor or pharmacist before taking any prescription or over-the-countermedicines, including herbal products summary of accutane labeling.

Where can I get more information?
• Your pharmacist has additional information about Accutane written forhealth professionals that you may read summary of accutane labeling.

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