Accutane

• • as prescribed by doctors registered in the iPLEDGE program
• • dispensed at a pharmacy registered in the iPLEDGE program
• issued to patients who are enrolled in the iPLEDGE program and agree to do whatever is necessary for the program

What is severe nodular acne?

Severe nodular acne is when many red, swollen, tender lumps form on the skin. These can be pencil-sized erasers or larger ones. Left untreated, nodular acne can lead to persistent scarring.

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

• Accutane is used to treat severe acne (nodular pimples) that has not been helped by other treatments, including antibiotics.
• Because Accutane can cause birth defects, Accutane is only for use by patients who can understand and agree to follow all instructions in the iPLEDGE program.
• Accutane can cause serious mental health problems.

Accutane can cause serious side effects. These serious side effects include:

• Accutane can cause birth defects (malformed babies), loss of a baby before birth (miscarriage), death of a baby, and early (premature) birth.
• Accutane can cause serious mental health problems
• Serious brain problems. Accutane can increase pressure in your brain. This can lead to permanent vision loss and, in rare cases, death. Stop taking Accutane and call your doctor right away if you have any of these signs of increased brain pressure:
• Strong headache
• vague vision
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• dizziness
• nausea or vomiting
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• convulsions (convulsions)
• Problems in the stomach (abdomen). Certain symptoms may mean that your internal organs are damaged. These organs include the liver, pancreas, intestines (intestine), and esophagus (the connection between the mouth and stomach). If your organs are damaged, they may not recover even after you stop taking Accutane. Stop taking Accutane and call your doctor if you have:
• severe pain in the stomach, chest, or intestines
• trouble swallowing or painful swallowing
• new or worsening heartburn
• pride
• rectal bleeding
• yellowing of the skin or eyes
• dark urine
• Problems with bones and muscles. Accutane can affect bones, muscles, and ligaments and cause joint or muscle pain. Tell your doctor if you plan to do strenuous physical activity while taking Accutane. Tell your doctor if you develop:
• joint pain
• back pain
• broken bone. Tell all healthcare providers that you are taking Accutane if you break a bone.
• Stop taking Accutane and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage...
• Accutane may stop the growth of long bones in teenagers who are still growing.
• vision problems. Accutane may affect your ability to see in the dark. This condition usually resolves after Accutane is stopped, but may be permanent. Other serious eye effects may occur. Stop taking Accutane and call your doctor at once if you have vision problems or dry eyes that are painful or persistent. If you wear contact lenses, you may have trouble wearing them while taking Accutane and after treatment.
• Hearing problems. Stop using Accutane and call your doctor if your hearing gets worse or you get ringing in your ears. Your hearing loss may be permanent.
• Problems with lipids (fats and cholesterol in the blood). Accutane may increase blood fat and cholesterol levels. This can be a serious problem. Go back to your doctor for a blood test to check your lipid levels and get the treatment you need. These problems usually go away after Accutane treatment is completed.
• Serious allergic reactions. Stop taking Accutane and seek emergency care immediately if you develop hives, swelling of your face or mouth, or trouble breathing. Stop taking Accutane and call your doctor if you develop a fever, rash, red spots, or bruising on your legs.
• Decreased red and white blood cells. Call your doctor if you have trouble breathing, pass out, or feel weak.
• Common, less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose, which can lead to nosebleeds. Call your doctor if you have any side effects that bother you or that don't go away.

These are not all the possible side effects of Accutane. Your doctor or pharmacist can provide you with more information.

How should I take Accutane?

• You must take Accutane exactly as prescribed. You must also follow all iPLEDGE program instructions. Before prescribing Accutane, your doctor:
• explain the iPLEDGE program to you
• whether you signed the Patient Information/Informed Consent (for all patients). Female patients who may become pregnant must also sign another consent form.
• You will not be given Accutane unless you agree to or follow all instructions in the iPLEDGE program.
• You will receive no more than a 30-day supply of Accutane at a time. This is to ensure that you are following the Accutane iPLEDGE program. You should talk to your doctor every month about side effects.
• The amount of Accutane you take has been chosen especially for you. It depends on your body weight and may change during treatment.
• Take Accutane 2 times a day with meals unless otherwise directed by your doctor. Swallow Accutane capsules whole with a full glass of liquid. Do not chew or dissolve the capsule. Accutane can damage the tube that connects your mouth to your stomach (esophagus) if not swallowed whole.
• If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
• If you have taken too much Accutane or have an overdose, call your doctor or poison control center right away.
• Acne may get worse when you first start taking Accutane. This should not last long. Talk to your doctor if this is a problem for you.
• You should return to your doctor as instructed to make sure you do not have any signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Accutane. Female patients who can become pregnant will have a pregnancy test every month.
• Female patients who may become pregnant must agree to use 2 separate forms of effective contraceptives at the same time 1 month before taking and 1 month after taking Accutane.

Important safety information

What should I avoid while taking Accutane?

• Do not become pregnant while taking Accutane and within 1 month of stopping Accutane.
• Do not breastfeed while taking Accutane and for 1 month after stopping Accutane. We don't know if Accutane can pass through your milk and harm your baby.
• Do not donate blood while taking Accutane and for 1 month after you stop taking Accutane. If a pregnant woman receives your blood donation, her baby may be exposed to Accutane and may be born with birth defects.
• Do not take other medicines or herbal products with Accutane unless you have spoken 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 skin-tightening cosmetic procedures, including waxing, dermabrasion, or laser treatments, while you are using Accutane and for at least 6 months after you stop taking it. Accutane may increase the chance of scarring from these procedures.
• Avoid sunlight and ultraviolet light whenever possible. Tanning machines use ultraviolet radiation. Accutane can make your skin more sensitive to light.
• Do not share Accutane with other people. This can cause birth defects and other serious health problems.

If you don't know, ask your doctor.

What should I tell my doctor before taking Accutane?

• Tell your doctor if you or a family member have any of the following conditions:
• mental problems
• asthma
• liver disease
• diabetes
• bone loss (osteoporosis) or bone weakness
• an eating problem called anorexia nervosa (when people eat too little)
• heart disease
• food or drug allergies
• Tell your doctor if you are pregnant or breastfeeding. Accutane should not be used by pregnant or breastfeeding women.
• Tell your doctor about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Accutane and some other medicines can interact with each other, sometimes causing serious side effects. Tell your doctor especially if you are taking:
• Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chances of getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane may increase the chance of high blood pressure in the brain.
• Progestin-only birth control pills (mini-pills). They may not work while you are taking Accutane. If you are not sure which drug you are using, ask your doctor or pharmacist.
• Dilantin (phenytoin). This medicine, taken with Accutane, can weaken your bones.
• Corticosteroid drugs. These medicines taken with Accutane can weaken your bones.
• St. John's wort. This herbal supplement may reduce the effectiveness of birth control pills.

These medicines should not be used with Accutane unless your doctor tells you that this is normal.

Know the medicines you are taking. Make a list of them to show your doctor and pharmacist. Do not take new medicines without talking to your doctor.

General information about Accutane

Sometimes medications are prescribed for conditions not listed 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 as you. This could harm them.

What are the ingredients in Accutane?

Active Ingredient:  Isotretinoin

Other Ingredient:  Beeswax, butylated hydroxyanisole, disodium edetate, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl) with the following color 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.