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What is the most importantinformation I should know about isotretinoin? * Isotretinoin is in a class of drugs called retinoids. It isused to treat severe acne that has not responded to oral or topicalanti-infectives.
* This medication should not be prescribed for other usesask your doctor or pharmacist for more information.
* Because Accutane can cause severe birth defects, includingmental retardation and physical malformations, a woman must not becomepregnant while taking it. Before starting Accutane therapy, women ofchildbearing age will be asked to read a pamphlet, watch a video, andsign a detailed consent form regarding the danger of birth defects. Youmust have two negative pregnancy tests before beginning Accutanetherapy, and must take monthly pregnancy tests while using this drug.
* In addition, you must use 2 forms of birth control duringAccutane therapy, and for 1 month before and after. Each prescriptionfor Accutane must bear a yellow qualification sticker signifying thatyou meet these requirements. Scientists have not ruled out thepossibility that hormone-based contraceptives (birth control pills andimplants) may be less reliable when taken with Accutane, so a secondform of birth control should always be used while taking this drug. Ifyou accidentally become pregnant while taking Accutane, you shouldimmediately consult your doctor.
What is isotretinoin? * Isotretinoin is a form of vitamin A. It decreasesthe amount of sebum (oil) that is released by the sebaceous (oil)glands, and it increases that rate at which the skin renews itself.
* Isotretinoin is used to treat severe nodular acnethat has not responded to other treatments, including antibiotics.
* Isotretinoin may also be used for purposes otherthan those listed in this medication guide.
What should I discuss with myhealthcare provider before taking isotretinoin? * Before taking isotretinoin, tell your doctor ifyou have
- a personal orfamily history of mental problems including depression, suicidalbehavior, or psychosis (loss of contact with reality, hearing voices,or seeing things that are not there)
- diabetes
- asthma
- heart disease
- osteoporosis (boneloss) or weak bones
- anorexia nervosa
- high cholesterolor triglyceride levels (types of fat) in the blood or
- liver disease.
* You may not be able to take isotretinoin, or youmay require a dosage adjustment or special monitoring during treatmentif you have any of the conditions listed above.
* Do not take isotretinoin if you are pregnant orif you could become pregnant during treatment or for one month afteryou stop taking isotretinoin. Isotretinoin is in the FDA pregnancycategory X. This means that isotretinoin is known to cause severe birthdefects in an unborn baby. It can also cause miscarriage, prematurebirth, or death of the baby. You must take a pregnancy test and havenegative results when you and your doctor decide that isotretinoin maybe beneficial for your condition. You must have a second pregnancy testwith negative results during the first 5 days of the menstrual periodright before you start taking isotretinoin. Two reliable forms of birthcontrol must be used at the same time (unless abstinence is the chosenmethod of birth control or if you have undergone a hysterectomy) forone month before starting treatment with isotretinoin, during treatmentwith isotretinoin, and for at least 1 month following the end oftreatment. You will also be asked to take a pregnancy test on a monthlybasis. Your doctor will discuss with you and provide for you a videoand written information regarding choices for birth control, possiblecauses for birth control failure, and the importance of using birthcontrol while taking isotretinoin. If you become pregnant, stop usingbirth control, or miss your menstrual period, immediately stop takingisotretinoin and notify your doctor. * It is not known whether isotretinoin passes intobreast milk. Do not take isotretinoin without first talking to yourdoctor if you are breast-feeding a baby.
How should I takeisotretinoin? * Isotretinoin comes as a capsule to take by mouth.Isotretinoin usually is taken twice a day. Take isotretinoin with foodor milk. Follow the directions on your prescription label carefully,and ask your doctor or pharmacist to explain any part you do notunderstand. Take isotretinoin exactly as directed. Do not take more orless of it or take it more often than prescribed by your doctor.
* You may not notice any improvement in your condition untilafter 4-6 weeks of treatment, and your acne may actually get worseduring the first few weeks. Your acne should improve within 15-20weeks. If it does not improve, your doctor will probably stop givingyou isotretinoin for 8 weeks and then restart your treatment.
What happens if I miss a dose? * Take the missed dose as soon as you remember.However, if it is almost time for the next dose, skip the missed doseand only take the next regularly scheduled dose. Do not take a doubledose of this medication.
What happens if I overdose? * Seek emergency medical attention.
* Symptoms of an isotretinoin overdose includevomiting, abdominal pain, flushing of the face, inflammation of thelips, headache, dizziness, and clumsiness.
What should I avoid whiletaking isotretinoin? * Do not take vitamin supplements containingvitamin A during treatment with isotretinoin. This could causeincreased side effects.
* Do not donate blood while taking isotretinoin andfor at least 1 month following the end of treatment. Blood donatedwhile taking isotretinoin may be given to a pregnant woman and beharmful to her baby.
* Do not use wax hair removal systems or have anyskin resurfacing procedures (such as dermabrasion or laser treatment)performed while taking isotretinoin and for six months followingtreatment due to the possibility of scarring.
* Avoid exposure to sunlight or UV rays whiletaking isotretinoin. Isotretinoin may increase the sensitivity of theskin to sunlight and a severe sunburn could result.
* Use caution when driving a vehicle at night.Isotretinoin can cause decreased night vision. The onset of decreasednight vision may be sudden.
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