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ACCUTANE (ISOTRETINOIN) CAPSULES: MEDICATION GUIDE

Read the Medication Guide that comes with Isotretinoin (Accutane) pills before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Accutane?

Accutane medication guide: most important information


What is Accutane?

Isotretinoin (Accutane) pills are taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Accutane can cause serious side effects. this medication can only be:

  • prescribed by doctors that are registered in the iPLEDGE program
  • dispensed by a pharmacy that is registered with the iPLEDGE program
  • given to patients who are registered in the iPLEDGE program and agree to do everything required in the program


    What is severe nodular acne?

    Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.


    Who should not take Accutane?

  • Do not take this drug if you are pregnant, plan to become pregnant, or become pregnant during Accutane (Isotretinoin) treatment. This medicine causes severe birth defects.
  • Do not take Accutane if you are allergic to anything in it. This medication contains parabens as the preservative. See the end of this Medication Guide for a complete list of ingredients in Isotretinoin (Accutane).


    What should I tell my doctor before taking Accutane?

    Accutane medication guide: before taking


    How should I take Accutane (Isotretinoin) pills?

    Accutane medication guide: how to take


    What should I avoid while taking Isotretinoin (Accutane) capsules?

  • Do not get pregnant while taking Accutane and for 1 month after stopping this medication.
  • Do not breast feed while taking Accutane (Isotretinoin) pills and for 1 month after stopping this drug. We do not know if Accutane can pass through your milk and harm the baby.
  • Do not give blood while you take Isotretinoin (Accutane) pills and for 1 month after stopping Accutane. If someone who is pregnant gets your donated blood, her baby may be exposed to Accutane and may be born with birth defects.
  • Do not take other medicines or herbal products with this medicine unless you talk to your doctor.
  • Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
  • Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane (Isotretinoin) and for at least 6 months after you stop. This medication can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
  • Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.
  • Do not share Accutane with other people. It can cause birth defects and other serious health problems.


    What are the possible side effects of Isotretinoin (Accutane)?

    Accutane medication guide: side effects


    How should I store Isotretinoin (Accutane) pills?

  • Store Accutane at room temperature, between 59° and 86°F. Protect from light.
  • Keep Accutane and all medicines out of the reach of children.


    General Information about Accutane (Isotretinoin)

    Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Accutane for a condition for which it was not prescribed. Do not give Accutane to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about Accutane. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Isotretinoin (Accutane) that is written for health care professionals.


    What are the ingredients in Accutane?

    Active Ingredient: Isotretinoin

    Inactive Ingredients: beeswax, edetate disodium, butylated hydroxyanisole, hydrogenated soybean oil flakes, soybean oil, hydrogenated vegetable oil.

    Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20 mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

    Manufactured and distributed by Roche pharmaceutical company and its divisions.

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