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Uses, Side Effects, Dosage, Interactions, Warnings

PATIENT INFORMATION

Patient Information/Informed Consent About Birth Defects
(for female patients who can get pregnant)

To be completed by the patient (and her parent or guardian*
if patient is under age 18) and signed by her doctor.

Read each item below and initial in the space provided to
show that you understand each item and agree to follow your doctor’s
instructions. Do not sign this consent and do not take isotretinoin if there
is anything that you do not understand.

*A parent or guardian of a minor patient (under age 18) must
also read and initial each item before signing the consent.

______________________________________________________________

(Patient’s Name)

1. I understand that there is a very high chance that my
unborn baby could have severe birth defects if I am pregnant or become pregnant
while taking isotretinoin. This can happen with any amount and even if taken
for short periods of time. This is why I must not be pregnant while taking
isotretinoin.

Initial: ______

2. I understand that I must not get pregnant 1 month before,
during the entire time of my treatment, and for 1 month after the end of my
treatment with isotretinoin.

Initial: ______

3. I understand that I must avoid sexual intercourse
completely, o r I must use 2 separate, effective forms of birth control
(contraception) at the same time. The only exceptions are if I have had surgery
to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal.

Initial: ______

4. I understand that hormonal birth control products are
among the most effective forms of birth control. Combination birth control
pills and other hormonal products include skin patches, shots, under-the-skin
implants, vaginal rings, and intrauterine devices (IUDs). Any form of birth
control can fail. That is why I must use 2 different birth control methods at
the same time, starting 1 month before, during, and for 1 month after stopping
therapy every time I have sexual intercourse, even if 1 of the methods I choose
is hormonal birth control.

Initial: ______

5. I understand that the following are effective forms of
birth control:


Primary forms

  • tying my tubes (tubal sterilization)
  • partner’s vasectomy
  • intrauterine device
  • hormonal (combination birth control pills, skin patches, shots,
    under-the-skin implants, or vaginal ring)
Secondary forms
Barrier:

  • male latex condom with or without spermicide
  • diaphragm with spermicide
  • cervical cap with spermicide

Other:

  • vaginal sponge (contains spermicide)

A diaphragm and cervical cap must each be used with
spermicide, a special cream that kills sperm

I understand that at least 1 of my 2 forms of birth control
must be a primary method.

Initial: ______

6. I will talk with my doctor about any medicines including
herbal products I plan to take during my isotretinoin treatment because
hormonal birth control methods may not work if I am taking certain medicines or
herbal products.

Initial: ______

7. I may receive a free birth control counseling session
from a doctor or other family planning expert. My isotretinoin doctor can give
me an isotretinoin Patient Referral Form for this free consultation.

Initial: ______

8. I must begin using the birth control methods I have
chosen as described above at least 1 month before I start taking isotretinoin.

Initial: ______

9. I cannot get my first prescription for isotretinoin
unless my doctor has told me that I have 2 negative pregnancy test results. The
first pregnancy test should be done when my doctor decides to prescribe
isotretinoin. The second pregnancy test must be done in a lab during the first
5 days of my menstrual period right before starting isotretinoin therapy
treatment, or as instructed by my doctor. I will then have 1 pregnancy test; in
a lab.

  • every month during treatment
  • at the end of treatment
  • and 1 month after stopping treatment

I must not start taking isotretinoin until I am sure that I
am not pregnant, have negative results from 2 pregnancy tests, and the second
test has been done in a lab.

Initial: ______

10. I have read and understand the materials my doctor has
given to me, including The iPLEDGE Program Guide for Isotretinoin for Female
Patients Who Can Get Pregnant, The iPLEDGE Birth Control Workbook and The Ipledge
Program Patient Introductory Brochure.

My doctor gave me and asked me to watch the DVD containing a
video about birth control and a video about birth defects and isotretinoin.

I was told about a private counseling line that I may call
for more information about birth control. I have received information on
emergency birth control.

Initial: ______

11. I must stop taking isotretinoin right away and call my
doctor if I get pregnant, miss my expected menstrual period, stop using birth
control, or have sexual intercourse without using my 2 birth control methods at
any time.

Initial: ______

12. My doctor gave me information about the purpose and
importance of providing information to the iPLEDGE program should I become
pregnant while taking isotretinoin or within 1 month of the last dose. If I
become pregnant, I agree to be contacted by the iPLEDGE program and be asked questions
about my pregnancy. I also understand that if I become pregnant, information
about my pregnancy, my health, and my baby’s health may be given to the maker
of isotretinoin and government health regulatory authorities.

Initial: ______

13. I understand that being qualified to receive
isotretinoin in the iPLEDGE program means that I:

  • have had 2 negative urine or blood pregnancy tests before receiving the
    first isotretinoin prescription. The second test must be done in a lab. I
    must have a negative result from a urine or blood pregnancy test done in a
    lab repeated each month before I receive another isotretinoin prescription.
  • have chosen and agreed to use 2 forms of effective birth control at the
    same time. At least 1 method must be a primary form of birth control, unless
    I have chosen never to have sexual contact with a male (abstinence),
    or
    I have undergone a hysterectomy. I must use 2 forms of birth control for at
    least 1 month before I start isotretinoin therapy, during
  • therapy, and for 1 month after stopping therapy. I must receive counseling,
    repeated on a monthly basis, about birth control and behaviors associated
    with an increased risk of pregnancy.
  • have signed a Patient Information/Informed Consent About Birth Defects (for
    female patients who can get pregnant) that contains warnings about the chance
    of possible birth defects if I am pregnant or become pregnant and my unborn
    baby is exposed to isotretinoin.
  • have been informed of and understand the purpose and importance of providing
    information to the iPLEDGE program should I become pregnant while taking isotretinoin
    or within 1 month of the last dose. I agree to be contacted by the iPLEDGE
    program and be asked questions about my pregnancy.
  • have interacted with the iPLEDGE program before starting isotretinoin and
    on a monthly basis to answer questions on the program requirements and to
    enter my two chosen forms of birth control.

Initial: ______

My doctor has answered all my questions about
isotretinoin and I understand that it is my responsibility not to get pregnant
1 month before, during isotretinoin treatment, or for 1 month after I stop taking
isotretinoin.

Initial: ______

I now authorize my doctor ________________ to begin my treatment with isotretinoin.


Patient Signature:_____________________________________ Date: ______

Parent/Guardian Signature (if under age 18):________________ Date:______

Please print: Patient Name and Address_______________________________ ______________________________
Telephone _______________________ have fully explained to the patient, __________________,
the nature and purpose of the treatment described above and the risks to female
patients of childbearing potential. I have asked the patient if she has any
questions regarding her treatment with isotretinoin and have answered those
questions to the best of my ability.

Doctor Signature: __________________________________ Date:
______

PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT’S MEDICAL
RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.

Patient Information/Informed Consent (for all patients):

To be completed by patient (and parent or guardian if
patient is under age 18) and signed by the doctor.

Read each item below and initial in the space provided if
you understand each item and agree to follow your doctor’s instructions. A
parent or guardian of a patient under age 18 must also read and understand each
item before signing the agreement.

Do not sign this agreement and do not take isotretinoin
if there is anything that you do not understand about all the information you
have received about using isotretinoin.

1. I, ______________________________________________________,

(Patient’s Name)

understand that isotretinoin is a medicine used to treat
severe nodular acne that cannot be cleared up by any other acne treatments,
including antibiotics. In severe nodular acne, many red, swollen, tender lumps
form in the skin. If untreated, severe nodular acne can lead to permanent
scars.

Initials: ______

2. My doctor has told me about my choices for treating my
acne.

Initials: ______

3. I understand that there are serious side effects that may
happen while I am taking isotretinoin. These have been explained to me. These
side effects include serious birth defects in babies of pregnant patients.
[Note: There is a second Patient Information/Informed Consent About Birth
Defects (for female patients who can get pregnant)].

Initials: ______

4. I understand that some patients, while taking
isotretinoin or soon after stopping isotretinoin, have become depressed or
developed other serious mental problems. Symptoms of depression include sad,
“anxious” or empty mood, irritability, acting on dangerous impulses, anger,
loss of pleasure or interest in social or sports activities, sleeping too much
or too little, changes in weight or appetite, school or work performance going
down, or trouble concentrating. Some patients taking isotretinoin 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. There were reports that some of these people did not appear depressed.
There have been reports of patients on isotretinoin becoming aggressive or
violent. No one knows if isotretinoin caused these behaviors or if they would
have happened even if the person did not take isotretinoin. Some people have
had other signs of depression while taking isotretinoin (see #7 below).

Initials: ______

5. Before I start taking isotretinoin, I agree to tell my
doctor if I have ever had symptoms of depression (see #7 below), been
psychotic, attempted suicide, had any other mental problems, or take medicine
for any of these problems. Being psychotic means having a loss of contact with
reality, such as hearing voices or seeing things that are not there.

Initials: ______

6. Before I start taking isotretinoin, I agree to tell my
doctor if, to the best of my knowledge, anyone in my family has ever had
symptoms of depression, been psychotic, attempted suicide, or had any other
serious mental problems.

Initials: ______

7. Once I start taking isotretinoin, I agree to stop using
isotretinoin and tell my doctor right away if any of the following signs and
symptoms of depression or psychosis happen. I:

  • Start to feel sad or have crying spells
  • Lose interest in activities I 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 my appetite or body weight
  • Have trouble concentrating
  • Withdraw from my friends or family
  • Feel like I have no energy
  • Have feelings of worthlessness or guilt
  • Start having thoughts about hurting myself or taking my own life (suicidal
    thoughts)
  • Start acting on dangerous impulses
  • Start seeing or hearing things that are not real

Initials: ______

8. I agree to return to see my doctor every month I take
isotretinoin to get a new prescription for isotretinoin, to check my progress,
and to check for signs of side effects.

Initials: ______

9. Isotretinoin will be prescribed just for me — I will not
share isotretinoin with other people because it may cause serious side effects,
including birth defects.

Initials: ______

10. I will not give blood while taking isotretinoin or for 1
month after I stop taking isotretinoin. I understand that if someone who is
pregnant gets my donated blood, her baby may be exposed to isotretinoin and may
be born with serious birth defects.

Initials: ______

11. I have read The iPLEDGE Program Patient Introductory
Brochure,
and other materials my provider gave me containing important
safety information about isotretinoin. I understand all the information I received.

Initials: ______

12. My doctor and I have decided I should take isotretinoin.
I understand that I must be qualified in the iPLEDGE program to have my
prescription filled each month. I understand that I can stop taking
isotretinoin at any time. I agree to tell my doctor if I stop taking
isotretinoin.

Initials: ______

I now allow my doctor ___________________________ to begin
my treatment with isotretinoin.

Patient Signature: ____________________________________ Date: ______

Parent/Guardian Signature (if under age 18): _______________ Date: ______

Patient Name (print) ___________________________________ Patient Address ___________________________
Telephone (___.___.___) ____________________________________

I have:

  • fully explained to the patient, __________________, the nature and purpose
    of isotretinoin treatment, including its benefits and risks
  • given the patient the appropriate educational materials, The iPLEDGE
    Program Patient Introductory Brochure
    and asked the patient if he/she
    has any questions regarding his/her treatment with isotretinoin
  • answered those questions to the best of my ability

Doctor Signature: _________________________________ Date:
______

PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT’S MEDICAL
RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.

MEDICATION GUIDE

ACCUTANE (ACK-U-TANE)

(isotretinoin capsules)

Read the Medication Guide that comes with Accutane (isotretinoin) before
you start taking it and each time you get a prescription. There may be new
information. This information does not take the place of talking with your
doctor about your medical condition or your treatment.

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

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

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 (isotretinoin) . Female patients must not get pregnant:

  • for 1 month before starting Accutane (isotretinoin)
  • while taking Accutane (isotretinoin)
  • for 1 month after stopping Accutane (isotretinoin) .

If you get pregnant while taking Accutane (isotretinoin) , 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

2. Serious mental health problems. Accutane (isotretinoin) may
cause:

  • depression
  • psychosis (seeing or hearing things that are not real)
  • suicide. Some patients taking Accutane (isotretinoin) 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.

Stop Accutane (isotretinoin) 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:

  • 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

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

What is Accutane (isotretinoin) ?

Accutane (isotretinoin) 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 (isotretinoin) can cause serious side effects (see
“What is the most important information I should know about Accutane (isotretinoin) ?”
).
Accutane (isotretinoin) 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.

Who should not take Accutane (isotretinoin) ?

  • Do not take Accutane (isotretinoin) if you are pregnant, plan to become pregnant, or
    become pregnant during Accutane (isotretinoin) treatment
    . Accutane (isotretinoin) causes severe birth
    defects. See “What is the most important information I should know
    about Accutane (isotretinoin) ?”
  • Do not take Accutane (isotretinoin) if you are allergic to anything in it. Accutane (isotretinoin)
    contains parabens as the preservative. See the end of this Medication Guide
    for a complete list of ingredients in Accutane (isotretinoin) .

What should I tell my doctor before taking Accutane (isotretinoin) ?

Tell your doctor if you or a family member has any of the
following health conditions:

Tell your doctor if you are pregnant or breastfeeding.
Accutane (isotretinoin) 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 (isotretinoin) 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 (isotretinoin) . Taking both together may increase your chance of
    getting side effects.
  • Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane (isotretinoin)
    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 (isotretinoin) . Ask your doctor or pharmacist if you are not sure
    what type you are using.
  • Dilantin (phenytoin). This medicine taken with Accutane (isotretinoin) may weaken
    your bones.
  • Corticosteroid medicines. These medicines taken with Accutane (isotretinoin) 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 (isotretinoin) 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.

How should I take Accutane (isotretinoin) ?

  • You must take Accutane (isotretinoin) exactly as prescribed. You must also follow all the
    instructions of the iPLEDGE program. Before prescribing Accutane (isotretinoin) , 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 (isotretinoin) 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 (isotretinoin) at a time. This is
    to make sure you are following the Accutane (isotretinoin) iPLEDGE program. You should talk
    with your doctor each month about side effects.
  • The amount of Accutane (isotretinoin) you take has been specially chosen for you. It is
    based on your body weight, and may change during treatment.
  • Take Accutane (isotretinoin) 2 times a day with a meal, unless your doctor tells you otherwise.
    Swallow your Accutane (isotretinoin) capsules whole with a full glass of liquid. Do not
    chew or suck on the capsule.
    Accutane (isotretinoin) 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 (isotretinoin) or overdose, call your doctor or poison control
    center right away.
  • Your acne may get worse when you first start taking Accutane (isotretinoin) . 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 (isotretinoin) . 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 (isotretinoin) . You must access the iPLEDGE system
    to answer questions about the program requirements and to enter your 2 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 (isotretinoin) .
    If you have sex at any time without using 2 forms of effective birth control,
    get pregnant, or miss your expected period, stop using Accutane (isotretinoin) and call your
    doctor right away.

What should I avoid while taking Accutane (isotretinoin) ?

  • Do not get pregnant while taking Accutane (isotretinoin) and for 1 month after stopping
    Accutane (isotretinoin) . See “What is the most important information I should know
    about Accutane (isotretinoin) ?”
  • Do not breast feed while taking Accutane (isotretinoin) and for 1 month after stopping
    Accutane (isotretinoin) . We do not know if Accutane (isotretinoin) can pass through your milk and harm the
    baby.
  • Do not give blood while you take Accutane (isotretinoin) and for 1 month after stopping
    Accutane (isotretinoin) . If someone who is pregnant gets your donated blood, her baby may
    be exposed to Accutane (isotretinoin) and may be born with birth defects.
  • Do not take other medicines or herbal products with Accutane (isotretinoin) unless
    you talk to your doctor. See “What should I tell my doctor before
    taking Accutane (isotretinoin) ?”
  • Do not drive at night until you know if Accutane (isotretinoin) has affected your vision.
    Accutane (isotretinoin) 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 (isotretinoin) and for at
    least 6 months after you stop.
    Accutane (isotretinoin) 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 (isotretinoin) may make your skin more sensitive
    to light.
  • Do not share Accutane (isotretinoin) with other people. It can cause birth defects
    and other serious health problems.

What are the possible side effects of Accutane (isotretinoin) ?

  • Accutane (isotretinoin) can cause birth defects (deformed babies), loss of a baby before
    birth (miscarriage), death of the baby, and early (premature) births. See
    “What is the most important information I should know about Accutane (isotretinoin) ?”
  • Accutane (isotretinoin) may cause serious mental health problems. See “What is
    the most important information I should know about Accutane (isotretinoin) ?”
  • serious brain problems. Accutane (isotretinoin) can increase t he pressure in your
    brain. This can lead to permanent loss of eyesight and, in rare cases, death.
    Stop taking Accutane (isotretinoin) and call your doctor right away if you get any of these
    signs of increased brain pressure:
  • 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 (isotretinoin) . Stop taking Accutane (isotretinoin) 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 (isotretinoin) 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 (isotretinoin) . Tell your doctor
    if you get:

    • back pain
    • joint pain
    • broken bone. Tell all healthcare providers that you take Accutane (isotretinoin) if
      you break a bone.
      Stop Accutane (isotretinoin) 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 (isotretinoin) may stop long bone growth in teenagers who are still growing.
  • hearing problems. Stop using Accutane (isotretinoin) and call your doctor if your
    hearing gets worse or if you have ringing in your ears. Your hearing loss
    may be permanent.
  • vision problems. Accutane (isotretinoin) may affect your ability to see in the dark.
    This condition usually clears up after you stop taking Accutane (isotretinoin) , but it may
    be permanent. Other serious eye effects can occur. Stop taking Accutane (isotretinoin) 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 (isotretinoin) and after treatment.
  • lipid (fats and cholesterol in blood) problems. Accutane (isotretinoin) 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 (isotretinoin) treatment is
    finished.
  • serious allergic reactions. Stop taking Accutane (isotretinoin) and get emergency
    care right away if you develop hives, a swollen face or mouth, or have trouble
    breathing. Stop taking Accutane (isotretinoin) and call your doctor if you get a fever, rash,
    or red patches or bruises on your legs.
  • blood sugar problems. Accutane (isotretinoin) 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.
  • The common, less serious side effects of Accutane (isotretinoin) 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 (isotretinoin) . Your doctor or pharmacist can give you more detailed information.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088 or Roche at 1-800-526-6367.

How should I store Accutane (isotretinoin) ?

  • Store Accutane (isotretinoin) at room temperature, between 59° and 86°F. Protect
    from light.
  • Keep Accutane (isotretinoin) and all medicines out of the reach of children.

General Information about Accutane (isotretinoin)

Medicines are sometimes prescribed for conditions that are
not mentioned in Medication Guides. Do not use Accutane (isotretinoin) for a condition for
which it was not prescribed. Do not give Accutane (isotretinoin) to other people, even if they
have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important
information about Accutane (isotretinoin) . If you would like more information, talk with your
doctor. You can ask your doctor or pharmacist for information about Accutane (isotretinoin)
that is written for health care professionals. You can also call iPLEDGE
program at 1-866-495-0654 or visit www.ipledgeprogram.com.

What are the ingredients in Accutane?

Active Ingredient: Isotretinoin

Inactive Ingredients: 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.

This Medication Guide has been approved by the U.S. Food and
Drug Administration.

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