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Precautions and Warnings With Amnesteem

Although many people with severe acne may benefit from Amnesteem, this prescription medication may not be suitable for people who have a mental illness, those with weak bones, or other conditions. Other precautions for using Amnesteem safely include warnings to women who are of childbearing potential, as this drug must not be taken during pregnancy due to the risks of fetal death or birth defects.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Amnesteem® (isotretinoin) if you have:
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Amnesteem Precautions and Warnings

Some warnings and precautions to be aware of prior to taking Amnesteem include the following:
  • Amnesteem is a generic version of Accutane®. All of the risks you may have heard about with Accutane also apply to Amnesteem.
  • Amnesteem can cause depression, psychosis, or suicidal behavior. Make sure to let your healthcare provider know if you have had these types of problems in the past, or even if any of your family members have had these problems. It is important for you and those around you to watch for any mood or mental changes that could indicate a problem, such as:
    • A sad mood
    • Hopelessness
    • Feelings of guilt, worthlessness, or helplessness
    • Loss of pleasure or interest in activities
    • Fatigue
    • Difficulty concentrating
    • Changes in sleep pattern
    • Changes in weight or appetite
    • Suicidal thoughts or attempts
    • Restlessness or irritability
    • Acting on dangerous impulses
    • Hallucinations or delusions.
  • This medication is likely to cause severe birth defects if it is taken during pregnancy. It is absolutely essential that you not take Amnesteem while pregnant, and you should not get pregnant while taking the drug or for one month after stopping treatment. Amnesteem may also increase the risk of miscarriages and premature birth (see Accutane and Pregnancy for more information).
  • There are strict rules for Amnesteem prescriptions, especially for women of childbearing potential. These women must use two reliable forms of birth control and must have a negative pregnancy test (done at a lab) every month.
No one (male or female) can get more than 30 days' worth of Amnesteem at a time, and you must sign consent forms. Each prescription must be authorized using the iPLEDGE program (your healthcare provider will do this for you) before your pharmacy can fill it, and you must get your prescription within seven days of the authorization.
  • This medication can cause pseudotumor cerebri, a condition involving high pressure inside the cranium. This seems to occur mostly when Amnesteem is combined with tetracycline antibiotics. Let your healthcare provider know if you develop signs of this condition, such as:
  • Sometimes, Amnesteem causes high triglycerides, which could possibly increase your risk of heart disease, although this is not known for sure. Also, high triglycerides can increase your risk of pancreatitis, a dangerous condition of the pancreas. Your healthcare provider should test your triglycerides before you start taking Amnesteem, and periodically during the first month of treatment. If you cannot get your triglycerides under control, you will need to stop taking this drug.
  • Some people have experienced hearing problems possibly due to Amnesteem. In some cases, these problems did not go away when the medication was stopped. Let your healthcare provider know right away if you develop any hearing changes.
  • Amnesteem can cause hepatitis. High liver enzymes (found using a simple blood test) can be a sign of this problem. However, as many as 15 percent of people who take this drug will develop high liver enzymes, which will often go away during treatment; high liver enzymes do not necessarily indicate a problem.
  • This medication may cause inflammatory bowel disease (ulcerative colitis or Crohn's disease). Let your healthcare provider know if you develop signs of these problems, such as:
  • In rare cases, potentially life-threatening problems known as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in people taking Amnesteem. Let your healthcare provider know right away if you have signs or symptoms of these problems, such as a rash with blisters or with sores in the mouth or throat, especially if skin peeling occurs.
  • In certain clinical trials, Amnesteem seemed to cause skeletal hyperostosis, a type of degenerative arthritis. If you develop back or joint pain during treatment, let your healthcare provider know.
  • Amnesteem has been shown to decrease bone mineral density. This may increase the risk of osteoporosis, broken bones, and slow bone healing. This seems more common in people who take more than one course of the drug.
  • If you experience vision changes while taking this medicine, you should stop taking it, get an eye exam, and let your healthcare provider know. Amnesteem can cause poor night vision. While you don't need to stop taking the drug for this problem, you may need to limit night driving.
  • You cannot donate blood or blood products while taking Amnesteem, or for one month after stopping the medication.
  • It is unknown if Amnesteem passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Accutane and Breastfeeding).

Amnesteem Acne Medication

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