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ACCUTANE® – Oncopod- Chemotherapy Drugs Information, Acronyms, Side effects
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ACCUTANE®
Isotretinoin
(ACK-U-TANE)

Chemotherapy 

Have a Question ?

ACCUTANE®
Isotretinoin
(ACK-U-TANE)

Chemotherapy

Have a Question ?

What is ACCUTANE ?

Accutane is a medicine 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 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.

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

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

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

  • Accutane can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.
  • Accutane may cause serious mental health problems
  • Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your doctor right away if you get any of these signs of increased brain pressure:
  • bad headache
  • blurred vision
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  • dizziness
  • nausea or vomiting
  • stroke
  • seizures (convulsions)
  • Stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your doctor if you get:
  • severe stomach, chest or bowel pain
  • trouble swallowing or painful swallowing
  • new or worsening heartburn
  • diarrhea
  • rectal bleeding
  • yellowing of your skin or eyes
  • dark urine
  • Bone and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan hard physical activity during treatment with Accutane. Tell your doctor if you get:
  • joint pain
  • back pain
  • broken bone. Tell all healthcare providers that you take Accutane if you break a bone.
    Stop 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 long bone growth in teenagers who are still growing.
  • vision problems. Accutane may affect your ability to see in the dark. This condition usually clears up after you stop taking Accutane, but it may be permanent. Other serious eye effects can occur. Stop taking Accutane and call your doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. 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 if you have ringing in your ears. Your hearing loss may be permanent.
  • Lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Accutane treatment is finished.
  • Serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
  • Decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
  • The common, less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.

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

How should I take Accutane?

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

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Nucleic Acid Diagnostic kit

Important Safety Information

What should I avoid while taking Accutane?

  • Do not get pregnant while taking Accutane and for 1 month after stopping Accutane
  • Do not breast feed while taking Accutane and for 1 month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
  • Do not give blood while you take Accutane 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 Accutane 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 and for at least 6 months after you stop. Accutane can increase your chance of scarring from these 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

Ask your healthcare provider if you do not know.

What should I tell my healthcare provider before taking Accutane?

  • Tell your doctor if you or a family member has any of the following health conditions:
  • mental problems
  • asthma
  • liver disease
  • diabetes
  • bone loss (osteoporosis) or weak bones
  • an eating problem called anorexia nervosa (where people eat too little)
  • heart disease
  • food or medicine allergies
  • Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding
  • Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:
  • Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects
  • Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.
  • Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
  • Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
  • Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
  • St. John’s Wort. This herbal supplement may make birth control pills work less effectively.

These medicines should not be used with Accutane unless your doctor tells you it is okay.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

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General information about Accutane

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.

What are the ingredients in Accutane?

Active ingredient: Isotretinoin

Other ingredient: beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean 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.

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