accutane labeling requirements
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 accutane labeling requirements. However, Accutanecan cause serious side effects accutane labeling requirements. Before starting treatment with Accutane, discusswith your doctor how bad the acne is, the possible benefits of Accutane, andthe possible side effects accutane labeling requirements. Your doctor will ask you to read and sign a formindicating that you understand the serious risks associated with Accutane therapy accutane labeling requirements.
• Do not take Accutane if you are pregnant or if you could become pregnantduring treatment or for one month after you stop taking Accutane accutane labeling requirements. Accutane isin the FDA pregnancy category X accutane labeling requirements. This means that Accutane is known to causesevere birth defects in an unborn baby accutane labeling requirements. It can also cause miscarriage, prematurebirth, or death of the baby accutane labeling requirements. You must take a pregnancy test and have negativeresults when you and your doctor decide that Accutane may be beneficial foryour condition accutane labeling requirements. You must have a second pregnancy test with negative resultsduring the first 5 days of the menstrual period right before you start takingAccutane accutane labeling requirements. 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 accutane labeling requirements. You will also be asked to take a pregnancy test on a monthly basis accutane labeling requirements. 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 accutane labeling requirements. If you become pregnant,stop using birth control, or miss your menstrual period, immediately stop takingAccutane and notify your doctor accutane labeling requirements.
• 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 accutane labeling requirements. 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 accutane labeling requirements.
• Do not take vitamin supplements containing vitamin A during treatmentwith Accutane accutane labeling requirements. This could cause increased side effects accutane labeling requirements.
• Do not donate blood while taking Accutane and for at least 1 month followingthe end of treatment accutane labeling requirements. Blood donated while taking Accutane may be given to apregnant woman and be harmful to her baby accutane labeling requirements.
• 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 accutane labeling requirements.
• Avoid exposure to sunlight or UV rays while taking Accutane accutane labeling requirements. Accutanemay increase the sensitivity of the skin to sunlight and a severe sunburn couldresult accutane labeling requirements.
• Use caution when driving a vehicle at night accutane labeling requirements. Accutane can cause decreasednight vision accutane labeling requirements. The onset of decreased night vision may be sudden accutane labeling requirements.
• Take all of the Accutane that has been prescribed for you even if yoursymptoms start to improve accutane labeling requirements. The acne may seem to get worse at the start of therapy,but should then begin to improve accutane labeling requirements. For the best results, finish all of the medicationthat has been prescribed accutane labeling requirements. You may require more than one course of therapy withAccutane accutane labeling requirements.
What is Accutane?
• Accutane is a form of vitamin A accutane labeling requirements. 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 accutane labeling requirements.
• Accutane is used to treat severe nodular acne that has not respondedto other treatments, including antibiotics accutane labeling requirements.
• Accutane may also be used for purposes other than those listed in thismedication guide accutane labeling requirements.
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 accutane labeling requirements.
• 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 accutane labeling requirements.
• Do not take Accutane if you are pregnant or if you could become pregnantduring treatment or for one month after you stop taking Accutane accutane labeling requirements. Accutane isin the FDA pregnancy category X accutane labeling requirements. This means that Accutane is known to causesevere birth defects in an unborn baby accutane labeling requirements. It can also cause miscarriage, prematurebirth, or death of the baby accutane labeling requirements. You must take a pregnancy test and have negativeresults when you and your doctor decide that Accutane may be beneficial foryour condition accutane labeling requirements. You must have a second pregnancy test with negative resultsduring the first 5 days of the menstrual period right before you start takingAccutane accutane labeling requirements. 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 accutane labeling requirements. You will also be asked to take a pregnancy test on a monthly basis accutane labeling requirements. 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 accutane labeling requirements. If you become pregnant,stop using birth control, or miss your menstrual period, immediately stop takingAccutane and notify your doctor accutane labeling requirements.
• It is not known whether Accutane passes into breast milk accutane labeling requirements. Do not takeAccutane without first talking to your doctor if you are breast-feeding a baby accutane labeling requirements.
How should I take Accutane?
• Take Accutane exactly as directed by your doctor accutane labeling requirements. If you do not understandthese instructions, ask your pharmacist, nurse, or doctor to explain them toyou accutane labeling requirements.
• Accutane is a medication taken to treat severe nodular acne that hasnot been helped by other treatments, including antibiotics accutane labeling requirements. However, Accutanecan cause serious side effects accutane labeling requirements. Before starting treatment with Accutane, discusswith your doctor how bad the acne is, the possible benefits of Accutane andthe possible side effects accutane labeling requirements. Your doctor will ask you to read and sign a formindicating that you understand the serious risks associated with Accutane therapy accutane labeling requirements.
• You will get no more than a 30-day supply of Accutane at a time accutane labeling requirements. Yourprescription should have a special yellow self-adhesive sticker attached toit accutane labeling requirements. If your prescription does not have this yellow sticker, call your doctor accutane labeling requirements. The pharmacy should not fill the prescription without this sticker accutane labeling requirements.
• Take each dose of Accutane with a full glass of water accutane labeling requirements. This will helpprevent the medication inside the capsule from irritating the lining of theesophagus accutane labeling requirements. For the same reason, do not chew or suck on the capsule accutane labeling requirements.
• Take Accutane twice a day with food or milk to get the best results fromthis medication, unless otherwise directed by your doctor accutane labeling requirements.
• Take all of the Accutane that has been prescribed for you even if yoursymptoms start to improve accutane labeling requirements. The acne may seem to get worse at the start of therapy,but should then begin to improve accutane labeling requirements. For the best results, finish all of the medicationthat has been prescribed accutane labeling requirements. You may require more than one course of therapy withAccutane accutane labeling requirements.
• Your doctor may perform blood tests during treatment with Accutane tomonitor side effects from this medication accutane labeling requirements.
• Due to the serious side effects that may occur with the use of this medication,do not share it with anyone else accutane labeling requirements.
• Store Accutane at room temperature away from moisture and heat accutane labeling requirements.
What happens if I miss a dose?
• Take the missed dose as soon as you remember accutane labeling requirements. However, if it is almosttime for the next dose, skip the missed dose and only take the next regularlyscheduled dose accutane labeling requirements. Do not take a double dose of this medication accutane labeling requirements.
What happens if I overdose?
• Seek emergency medical attention accutane labeling requirements.
• Symptoms of an Accutane overdose include vomiting, abdominal pain, flushingof the face, inflammation of the lips, headache, dizziness, and clumsiness accutane labeling requirements.
What should I avoid while taking Accutane?
• Do not take vitamin supplements containing vitamin A during treatmentwith Accutane accutane labeling requirements. This could cause increased side effects accutane labeling requirements.
• Do not donate blood while taking Accutane and for at least 1 month followingthe end of treatment accutane labeling requirements. Blood donated while taking Accutane may be given to apregnant woman and be harmful to her baby accutane labeling requirements.
• 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 accutane labeling requirements.
• Avoid exposure to sunlight or UV rays while taking Accutane accutane labeling requirements. Accutanemay increase the sensitivity of the skin to sunlight and a severe sunburn couldresult accutane labeling requirements.
• Use caution when driving a vehicle at night accutane labeling requirements. Accutane can cause decreasednight vision accutane labeling requirements. The onset of decreased night vision may be sudden accutane labeling requirements.
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) accutane labeling requirements.
• Other, less serious side effects are more likely to occur accutane labeling requirements. 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 accutane labeling requirements.
• Side effects other than those listed here may also occur accutane labeling requirements. Talk to yourdoctor about any side effect that seems unusual or that is especially bothersome accutane labeling requirements.
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) accutane labeling requirements.
• Taking any of the drugs listed above during treatment with Accutane maybe dangerous accutane labeling requirements.
• Before taking Accutane, tell your doctor if you are taking carbamazepine(Tegretol, Carbatrol, Epitol) accutane labeling requirements. You may require a dosage adjustment or specialmonitoring during treatment accutane labeling requirements.
• Do not use other acne medications unless otherwise directed by your doctor accutane labeling requirements. They may interfere with the treatment or increase irritation of the skin accutane labeling requirements.
• Do not take birth control pills that do not contain estrogen ("minipills")during treatment with Accutane accutane labeling requirements. They may not work while taking Accutane accutane labeling requirements.
• Drugs other than those listed here may also interact with Accutane accutane labeling requirements. Talkto your doctor or pharmacist before taking any prescription or over-the-countermedicines, including herbal products accutane labeling requirements.
Where can I get more information?
• Your pharmacist has additional information about Accutane written forhealth professionals that you may read accutane labeling requirements.
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