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Precautions and Warnings With Zenatane

Potentially dangerous complications may occur while using Zenatane, such as hearing problems, high pressure within the cranium, or suicidal behavior. To minimize your risk for these problems, let your healthcare provider know if you have liver disease or other existing medical conditions. Other warnings to be aware of with Zenatane include safety precautions for those who have certain allergies and potential risks for psychological problems.

What Should I Tell My Healthcare Provider?

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

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • Zenatane is a generic version of Accutane®. All the risks and side effects you may have heard about with Accutane also apply to Zenatane.
  • This medication is likely to cause severe birth defects if it is taken during pregnancy. It is absolutely essential that you do not take Zenatane while pregnant, and you should not get pregnant while taking the drug or for one month after stopping treatment. Zenatane may also increase the risk for miscarriages and premature birth (see Accutane and Pregnancy).
  • Zenatane can cause depression, psychosis, or suicidal behavior. Make sure to let your healthcare provider know if you have had such problems in the past, or even if any of your family members have had such problems. It is important for you, as well as 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.
  • There are strict rules for Zenatane 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 Zenatane 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 Zenatane is combined with tetracycline antibiotics. Let your healthcare provider know if you develop signs of this condition, such as:
  • In some cases, Zenatane 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 for pancreatitis, a dangerous condition of the pancreas. Your healthcare provider should test your triglycerides before you start taking Zenatane 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 Zenatane. 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.
  • Zenatane can cause hepatitis. High liver enzymes (found using a simple blood test) can be a sign of this problem. As many as 15 percent of people who take Zenatane will develop high liver enzymes, which often go away during treatment; however, high liver enzymes do not necessarily indicate a problem.
  • In rare cases, potentially life-threatening problems known as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) have been reported with Zenatane. Let your healthcare provider know right away if you have signs or symptoms of such problems, such as a rash with blisters or with sores in the mouth or throat, especially if skin peeling occurs.
  • In certain clinical trials, Zenatane seemed to cause skeletal hyperostosis, a type of degenerative arthritis. If you develop back or joint pain during treatment, let your healthcare provider know.
  • Zenatane 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 Zenatane.
  • If you experience vision changes while taking Zenatane, you should stop taking the medication, get an eye exam, and let your healthcare provider know. Zenatane 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 Zenatane, or for one month after stopping the medication.
  • It is unknown if Zenatane 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).

Zenatane Acne Medication

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