Accutane

Accutane treats severe acne. Your acne may get worse when you first start taking this medicine. In order to get your prescription, you must agree to the instructions of the iPLEDGE program.

Accutane Overview

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Accutane is a prescription medication used to treat the most severe form of acne called nodular acne. Accutane belongs to a group of drugs called retinoids. It is thought to work by preventing oil production in glands under the skin.

This medication comes in capsule form and is usually taken twice daily, with food. Accutane may be taken for four or five months. A longer period of use is not recommended.

Common side effects of Accutane include dry skin, chapped lips, dry eyes, or dry nose causing nosebleeds. Accutane can also cause birth defects, miscarriages, or premature births.

Because Accutane can cause birth defects, patients, doctors, and pharmacies must be registered with a special distribution program called the iPLEDGE program.

How was your experience with Accutane?

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What are you taking Accutane for?

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  • Other
  • Acne Vulgaris
  • Leukemia
  • Neuroblastoma

How long have you been taking it?

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  • Less than a week
  • A couple weeks
  • A month or so
  • A few months
  • A year or so
  • Two years or more

How well did Accutane work for you?

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Accutane Cautionary Labels

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Uses of Accutane

Accutane is a prescription medication used to treat severe from of acne (nodular acne) that has not responded to other treatments.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Accutane Drug Class

Accutane is part of the drug class:

Side Effects of Accutane

Serious side effects have been reported with Accutane. See “Accutane Precautions” section.

Common side effects of Accutane may include the following:

  • dry skin
  • chapped lips
  • dry eyes
  • 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.

Accutane Interactions

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 such as doxycycline, tetracycline, or minocycline (Minocin).
  • progestin-only birth control pills (mini-pills) such as Camilla, Norethindrone, and Orvette.
  • dilantin (phenytoin).
  • corticosteroids such as dexamethasone, hydrocortisone, or fludrocortisone (Florinef).
  • St. John’s wort.

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.

Accutane Precautions

  • 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:

  1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Accutane. Female patients must not get pregnant:

    If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

    • for 1 month before starting Accutane
    • while taking Accutane
    • for 1 month after stopping Accutane
    • FDA MedWatch at 1-800-FDA-1088, and
    • the iPLEDGE pregnancy registry at 1-866-495-0654
  2. Serious mental health problems. Accutane may cause:

    Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:

    • depression
    • psychosis (seeing or hearing things that are not real)
    • suicide. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives.
    • start to feel sad or have crying spells
    • lose interest in activities you once enjoyed
    • sleep too much or have trouble sleeping
    • become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
    • have a change in your appetite or body weight
    • have trouble concentrating
    • withdraw from your friends or family
    • feel like you have no energy
    • have feelings of worthlessness or guilt
    • start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
    • start acting on dangerous impulses
    • start seeing or hearing things that are not real

Other serious side effects:

  • Serious brain problemsAccutane 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
    • dizziness
    • nausea or vomiting
    • seizures (convulsions)
    • stroke
  • Skin problemsSkin rash can occur in patients taking Accutane. In some patients a rash can be serious. Stop using Accutane and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like “pink eye”), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
  • 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:
    • back pain.
    • joint 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.

  • 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.
  • Vision problemsAccutane 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.
  • 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 reactionsStop 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.
  • Blood sugar problems: Accutane may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
  • Decreased red and white blood cells: Call your doctor if you have trouble breathing, faint or feel weak.

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

  • Do not take Accutane if you are pregnant, plan to become pregnant or become pregnant during Accutane treatment. Accutane causes severe birth defects.
  • Do not take Accutane if you are allergic to anything in it.

Accutane Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Accutane there are no specific foods that you must exclude from your diet when receiving Accutane.

Inform MD

Tell your doctor if you have any of the following health conditions:

  • mental problems
  • asthma
  • liver disease
  • diabetes
  • heart disease
  • bone loss (osteoporosis) or weak bones
  • an eating problem called anorexia nervosa (where people eat too little)
  • 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.

Accutane and Pregnancy

Accutane must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that Accutane will cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby and early (premature) births. See "Drug Precautions" section.

A program called iPLEDGE has been set up to make sure that pregnant women do not take Accutane and that women do not become pregnant while taking Accutane. All patients, including women who cannot become pregnant and men, can get Accutane only if they are registered with iPLEDGE, have a prescription from a doctor who is registered with iPLEDGE and fill the prescription at a pharmacy that is registered with iPLEDGE. Before prescribing Accutane, your doctor will:

  • explain the iPLEDGE program to you
  • have you sign the Patient Information/Informed Consent form (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. Female patients must not get pregnant:

  • for 1 month before starting Accutane
  • while taking Accutane
  • for 1 month after stopping Accutane
 
If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:
  • FDA MedWatch at 1-800-FDA-1088, and
  • the iPLEDGE pregnancy registry at 1-866-495-0654

Accutane and Lactation

Accutane should not be used by women who are breastfeeding. It is not known if Accutane is excreted in human breast milk or if it will harm your nursing baby. Tell your doctor if you are breastfeeding before you receive Accutane.

Accutane Usage

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 form (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 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 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 two 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 two separate forms of effective birth control at the same time one month before, while taking and for one month after taking Accutane. You must access the iPLEDGE system to answer questions about the program requirements and to enter your two chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.

You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Accutane.

If you have sex at any time without using two forms of effective birth control, get pregnant or miss your expected period, stop using Accutane and call your doctor right away.

What you should avoid while taking Accutane:

  • Do not get pregnant while taking Accutane and for one month after stopping Accutane. See “Accutane Precautions" section.
  • Do not breastfeed while taking Accutane and for one month after stopping Accutane. It is not known if Accutane can pass through your milk and harm the baby.
  • Do not give blood while you take Accutane and for one 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. 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.

Accutane Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on your weight.

The recommended dosage range for Accutane (isotretinoin) is 0.5 to 2 mg/kg/day given in two divided doses.

The typical target dose is 1 mg/kg/day.

Accutane Overdose

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Other Requirements

  • Store at room temperature
  • Protect from light.
  • Keep Accutane and all medicines out of the reach of children.

Accutane FDA Warning

CONTRAINDICATIONS AND WARNINGS

Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases, death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements

Because of Accutane’s teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE.