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2005-07-20T22:48:00.000-07:00

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Accutane :

Active Ingredients: Isotretinoin
Representative Names: Accutane, Amnesteem, Claravis, Sotret

What are isotretinoin capsules? (Back to top)
ISOTRETINOIN (Accutane®, Claravis™) treats severe cystic acne (also called nodular acne) that has not responded to other therapy such as antibiotics. It can produce complete and prolonged remission of the disease. Isotretinoin may also be used to treat other skin conditions besides acne. To receive isotretinoin, your prescriber must give you a special prescription, including a new prescription for each refill. Prior to prescribing this drug, your prescriber will give you information on the drug and forms to sign that indicate you understand this information. The prescription you receive from your prescriber should have a special yellow sticker on it. If your prescription does not have this yellow sticker, call your prescriber. The pharmacy will not fill prescriptions for this drug unless they have the yellow sticker. Make sure you receive and read the Medication Guide every time you get a prescription or refill for isotretinoin. Get a new Medication Guide with every refill. It is important that you read all of the information. Generic isotretinoin capsules are available.
What should my health care professional know before I take isotretinoin?
They need to know if you have any of these conditions:
• anorexia nervosa or an eating disorder
• back pain
• diabetes
• high blood cholesterol or triglycerides
• hearing problems
• if you frequently drink alcohol-containing beverages
• inflammatory bowel disease
• liver disease
• low white blood cell count
• mental problems, such as depression, psychosis, attempted suicide, or a family history of mental problems
• osteoporosis, osteomalacia, or other bone disorders
• pancreatitis
• participate in sports or activities where you are more likely to break a bone, such as football or rugby
• weight problem
• an unusual or allergic reaction to isotretinoin, vitamin A or related drugs, parabens, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding
How should I take this medicine?
Take isotretinoin capsules by mouth. Follow the directions on the prescription label. This medicine is usually taken 2 times a day with a meal, unless your prescriber tells you otherwise. Swallow the capsules with a full glass of water to help prevent throat irritation. Do not chew or suck on the capsules. Do not take your medicine more often than directed.
Make sure you receive and read the isotretinoin Medication Guide every time you get a prescription or refill for isotretinoin. Get a new Medication Guide with every refill. It is important that you read and understand all of this information.
Do not share this medicine with anyone else due to the risk of birth defects and other serious side effects.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose? (Back to top)
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What drug(s) may interact with isotretinoin? (Back to top)
• alcohol
• benzoyl peroxide, salicylic acid, or other drying medicines used for acne
• corticosteroids (example: prednisone)
• medicines for seizures
• orlistat
• other drugs that make you more sensitive to the sun such as sulfa drugs
• progestin-only birth control hormones (examples: 'Minipills' like Aygestin®, Micronor®, Nor-QD® or injectable/implantable products such as Depo-Provera® or Norplant®)
• tetracycline antibiotics (examples: doxycycline, tetracycline)
• vitamins and other supplements containing vitamin A
• warfarin
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What side effects may I notice from taking isotretinoin?
Stop taking isotretinoin and notify your prescriber at once if you have any of these symptoms:
• difficulty concentrating
• feel like you have no energy
• feel unusually sad or have crying spells
• feelings of worthlessness or inappropriate guilt
• increased irritability, anger, aggression or thoughts of violence
• loss of interest in usual activities
• sleep too much or have trouble sleeping
• start to have thoughts about hurting yourself
• withdraw from family or friends
Side effects that you should report to your prescriber or health care professional as soon as possible:
• chest pain
• changes in menstrual cycle
• changes in vision, like blurred or double vision or decreased night vision
• difficulty breathing or shortness of breath
• dizziness
• fainting
• hearing loss or ringing in the ears
• hives, skin rash
• increased urination and/or thirst or dark urine
• irregular heartbeat
• muscle or joint pain
• muscle weakness with or without pain
• nausea and vomiting
• severe headache
• slurred speech
• stomach pain
• swelling of face or mouth
• trouble swallowing
• unusual bruising or bleeding
• yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• chapped lips
• dry eyes
• dry mouth
• dry nose that may lead to nosebleeds
• dry skin
• flushing
• hair loss, increased fragility of hair
• headache (mild)
• increased sensitivity of skin to the sun
What should I watch for while taking isotretinoin?
You may experience a flare of acne during the initial treatment period. You will need to see your prescriber or health care professional monthly to get a new prescription and to check on your progress and for side effects. Your pharmacist cannot fill a prescription for isotretinoin without a written prescription that has a qualification sticker. Phoned-in prescriptions or refills will not be filled. If your prescription for isotretinoin does not have a yellow sticker on it, contact your prescriber.
Isotretinoin can cause birth defects; do not get pregnant while taking this drug.
• All females who may be able to have children: You will receive information concerning the risks of isotretinoin therapy. It is very important for you to read and understand all of the information provided to you. You must complete 2 consent forms and review materials that describe the precautions you must take. If you do not understand any part of the consent forms, do not sign them, and do not take any isotretinoin until all of your questions have been answered. If you do not have the Medications Guide, a video, and a booklet about pregnancy prevention, do not start taking isotretinoin. Call your prescriber. You will need to have 2 negative pregnancy tests before starting isotretinoin and then monthly pregnancy tests during treatment, even if you are not sexually active. You cannot get monthly refills for isotretinoin unless there is proof of the negative pregnancy test. Use 2 reliable forms of birth control together for 1 month prior to, during, and for 1 month after stopping isotretinoin therapy. Avoid using birth control pills that do not contain estrogen; they may not work while you are taking isotretinoin. If you become pregnant, miss a menstrual cycle, or stop using birth control, you must immediately stop taking isotretinoin. Severe birth defects may occur even if just one dose of isotretinoin is taken. Do not breast-feed your infant while taking isotretinoin or for 1 month after stopping treatment.
• All Males: You will also receive information concerning the risks of isotretinoin therapy. In addition, you should read the Medication guide and review all other information supplied. You will need to sign a consent form that indicates you understand the information and instructions.
Do not donate blood while taking isotretinoin and for 30 days after completion of treatment to avoid exposing pregnant women to isotretinoin through the donated blood.
Do not share your isotretinoin prescription with anyone else due to the risk of birth defects and other serious adverse effects.
Some patients have become depressed or developed serious mental problems while taking isotretinoin or soon after stopping isotretinoin. Some patients have had thoughts about ending their life, have tried to end their life (attempted suicide), or have ended their own life (committed suicide). There have been reports of patients receiving isotretinoin becoming aggressive or violent. No one knows if isotretinoin caused people to act this way or if it would have happened even if the person did not take isotretinoin. Stop taking isotretinoin if you start feeling depressed or have thoughts of violence or suicide.
Isotretinoin can increase cholesterol and triglyceride levels and decrease HDL (the 'good' cholesterol) levels. Your health care provider will monitor these levels and recommend appropriate therapy, including dietary changes or prescription drugs, if necessary. Alcohol can increase the risk of developing high cholesterol or high blood lipids. Avoid alcoholic drinks while you are taking isotretinoin.
If you wear contact lenses, they may feel uncomfortable. If your eyes get dry, check with your eye doctor. Isotretinoin may decrease your night vision; this effect may occur suddenly. Be careful driving or operating machinery especially at night. Isotretinoin may cause other vision changes. If you experience any change in vision, stop taking isotretinoin and see an eye doctor.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.
Avoid multivitamins or nutritional supplements that contain vitamin A.
Isotretinoin can increase sensitivity of the skin to sun or UV light. Keep out of the sun, or wear protective clothing outdoors and use a sunscreen (SPF 15 or higher). Do not use sun lamps or sun tanning beds or booths.
Cosmetic procedures to smooth your skin including waxing, dermabrasion, or laser therapy should be avoided during isotretinoin therapy and for at least 6 months after you stop due to the possibility of scarring. Check with your health care provider for advice about when you can have cosmetic procedures.
Isotretinoin may affect your blood sugar levels. If you are diabetic check with your prescriber or health care professional if you notice any change in your blood sugar tests.
Isotretinoin may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your prescriber if you plan vigorous physical activity during your treatment with isotretinoin. Tell your health care provider if you develop pain, particularly back pain or joint pain. It is not known if taking isotretinoin for acne will affect your bones. Muscle weakness with or without pain can be a sign of a serious problem. If this happens, stop taking isotretinoin and call your prescriber right away.
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15—30 degrees C (59—86 degrees F). Throw away any unused medicine after the expiration date.
Program For Preventing Accutane Birth Defects Changed advertisement.
Accutane is very effective, but its use carries significant potential risks, including birth defects and even fetal death.
The Food and Drug Administration (FDA) today is advising consumers and health care providers about significant changes to the Accutane risk management program for pregnancy prevention. The new program is called S.M.A.R.T. (System to Manage Accutane Related Teratogenicity). S.M.A.R.T. was developed in consultation with FDA by Accutane's manufacturer, Roche Laboratories. The program is designed to enhance the safe and appropriate use of Accutane by strengthening the existing Accutane Pregnancy Prevention Program (PPP), a comprehensive patient education program.
Accutane is approved to treat the most serious form of acne. This form of acne is painful, permanently disfiguring, and does not respond to other acne treatments. Accutane is very effective, but its use carries significant potential risks, including birth defects and even fetal death.
In recent years, as more women have been receiving prescriptions for Accutane, the risk that pregnant women may be inappropriately using the drug has increased. On September 18, 2000, the FDA held a meeting of its Dermatologic and Ophthalmic Drugs Advisory Committee to discuss what additional measures might help prevent exposure of unborn babies to Accutane.
The S.M.A.R.T. program was developed to address the two main goals identified at this meeting:
1) no woman should begin Accutane therapy if she is pregnant; and 2) no pregnancies should occur while a woman is taking Accutane. S.M.A.R.T. involves Accutane prescribers, patients, and pharmacists in a partnership to prevent fetal exposure. The risk management components are described fully within the boxed Contraindications and Warnings (Black Box) and the Precautions sections of the Accutane package insert, which provides prescribing information for healthcare professionals.
The S.M.A.R.T. program requires the following::
* Prescribers must study the S.M.A.R.T. "Guide to Best Practices"provided by Roche, and then sign and return to Roche the Letter of Understanding certifying their knowledge of the measures to minimize fetal exposures to Accutane. The manufacturer has also developed a Continuing Medical Education (CME) course for prescribers that includes specific, practical information about pregnancy prevention. FDA strongly encourages participation in this half-day course. Prescribers will then receive from Roche special self-adhesive Accutane Qualification Stickers. All prescriptions for Accutane should have the special yellow sticker attached to the prescriber's regular prescription form. This sticker will indicate to the pharmacist that the patient is "qualified"according to the new package insert, which means that the female patient has had negative pregnancy tests as described below, as well as education and counseling about pregnancy prevention. The pregnancy test will be repeated every month throughout the Accutane treatment course, and no prescriptions should be given for more than a one month supply of Accutane at a time.
* ALL female patients must have two negative urine or serum pregnancy tests before the initial Accutane prescription is written, and for each month of therapy they must have a negative pregnancy test result before receiving their next prescription, regardless of whether they are sexually active. Patients who are, or might become, sexually active with a male partner must also select and use two forms of effective contraception simultaneously for at least one month prior to initiation of Accutane therapy, during therapy, and for one month following discontinuation of therapy. They must sign a Patient Information/Consent form about Accutane and birth defects, in addition to the Consent Form that all patients should receive about other potentially serious risks. Finally, female patients must be given the opportunity to enroll in the Accutane Survey. This confidential Survey will collect data to help Roche and FDA decide if S.M.A.R.T. is helping to prevent exposure of unborn babies to Accutane. Patients who agree to participate in the Survey will be making a major contribution to the public health by helping identify aspects of S.M.A.R.T. that could be improved as experience with it grows.
* Pharmacists will dispense Accutane only upon presentation of a prescription with the special Accutane Qualification Sticker. Pharmacists will dispense a maximum one-month supply of Accutane, fill prescriptions within seven days from the date of "qualification,"and provide a Medication Guide for patients with each Accutane prescription. Requests for refills (i.e. more Accutane without a new prescription) and phoned-in prescriptions will not be filled.
To measure the effectiveness of the S.M.A.R.T. program, Roche will use several independent outcome assessment approaches. These include the Accutane Survey, conducted by the Slone Epidemiology Unit of Boston University School of Public Health, and an independent audit of pharmacies to assess the use of Accutane Qualification Stickers by prescribers. Prescribers, patients, and pharmacists all must participate fully in these critically important measures to ensure that fetal exposure to this potent teratogen does not occur.
Exposure of an unborn baby to Accutane is a serious adverse event and should be reported to Roche, or directly to the FDA MedWatch Program. The contacts are as follows: Roche Medical Services 1-800-526-6367, FDA MedWatch program 1-800-FDA-1088. MedWatch can also be accessed via the Internet at www.fda.gov/medwatch/index.html.

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