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Precautions and Warnings With Claravis

If you are about to start acne treatment with Claravis, make sure your healthcare provider knows if you have any type of mental illness, weak bones, or any liver problems. Updating your healthcare provider on any medical issues you have and any medications you are taking can help ensure safe treatment with Claravis. There are also specific safety precautions and warnings for women of childbearing potential.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Claravis™ (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 Claravis Precautions and Warnings

Some warnings and precautions to be aware of prior to taking Claravis include the following:
  • Claravis is a generic version of Accutane®. All of the risks you may have heard about with Accutane also apply to Claravis.
  • This medication is likely to cause severe birth defects if it is taken during pregnancy. It is absolutely essential that you not take Claravis while pregnant, and you should not get pregnant while taking the drug or for one month after stopping treatment. Claravis may also increase the risk of miscarriages and premature birth (see Accutane and Pregnancy for more information).
  • There are strict rules for Claravis 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 Claravis 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.
  • Claravis 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:
    • Feelings of guilt, worthlessness, or helplessness
    • Loss of pleasure or interest in activities
    • A sad mood
    • Hopelessness
    • 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 can cause pseudotumor cerebri, a condition involving high pressure inside the cranium. This seems to occur mostly when Claravis is combined with tetracycline antibiotics. Let your healthcare provider know if you develop signs of this condition, such as:
  • Sometimes, Claravis 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 Claravis, 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 Claravis. 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.
  • This medication can cause hepatitis. High liver enzymes (found using a simple blood test) can be a sign of this. 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 Claravis. 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, Claravis seemed to cause skeletal hyperostosis, a type of degenerative arthritis. If you develop back or joint pain during treatment, let your healthcare provider know.
  • Claravis 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. Claravis 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 Claravis, or for one month after stopping the medication.
  • It is unknown if Claravis 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).

Claravis Acne Medication

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