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What is the most important information I should know about
isotretinoin?
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Isotretinoin is a medication taken to treat severe nodular
acne that has not been helped by other treatments, including antibiotics.
However, isotretinoin can cause serious side effects. Before starting
treatment with isotretinoin, discuss with your doctor how bad the acne
is, the possible benefits of isotretinoin, and the possible side effects.
Your doctor will ask you to read and sign a form indicating that you
understand the serious risks associated with isotretinoin therapy. |
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Do not take isotretinoin if you are pregnant or if you
could become pregnant during treatment or for one month after you stop
taking isotretinoin. Isotretinoin is in the FDA pregnancy category X.
This means that isotretinoin is known to cause severe birth defects in
an unborn baby. It can also cause miscarriage, premature birth, or death
of the baby. You must take a pregnancy test and have negative results
when you and your doctor decide that isotretinoin may be beneficial for
your condition. You must have a second pregnancy test with negative
results during the first 5 days of the menstrual period right before you
start taking isotretinoin. Two reliable forms of birth control must be
used at the same time (unless abstinence is the chosen method of birth
control or if you have undergone a hysterectomy) for one month before
starting treatment with isotretinoin, during treatment with isotretinoin,
and for at least 1 month following the end of treatment. You will also
be asked to take a pregnancy test on a monthly basis. Your doctor will
discuss with you and provide for you a video and written information
regarding choices for birth control, possible causes for birth control
failure, and the importance of using birth control while taking
isotretinoin. If you become pregnant, stop using birth control, or miss
your menstrual period, immediately stop taking isotretinoin and notify
your doctor. |
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Some patients have experienced depression (including feelings
of sadness, irritability, unusual tiredness, trouble concentrating, and
loss of appetite) and suicidal thoughts and/ or behavior during, and
soon after stopping, treatment with isotretinoin. Notify your doctor
immediately if you begin to experience signs of depression or if you
begin to have thoughts about taking your own life during or shortly
following treatment with isotretinoin. |
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Do not take vitamin supplements containing vitamin A during
treatment with isotretinoin. This could cause increased side effects. |
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Do not donate blood while taking isotretinoin and for at
least 1 month following the end of treatment. Blood donated while taking
isotretinoin may be given to a pregnant woman and be harmful to her
baby. |
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Do not use wax hair removal systems or have any skin
resurfacing procedures (such as dermabrasion or laser treatment)
performed while taking isotretinoin and for six months following
treatment due to the possibility of scarring. |
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Avoid exposure to sunlight or UV rays while taking isotretinoin.
Isotretinoin may increase the sensitivity of the skin to sunlight and a
severe sunburn could result. |
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Use caution when driving a vehicle at night. Isotretinoin can cause
decreased night vision. The onset of decreased night vision may be
sudden. |
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Take all of the isotretinoin that has been prescribed for you even
if your symptoms start to improve. The acne may seem to get worse at the
start of therapy, but should then begin to improve. For the best results,
finish all of the medication that has been prescribed. You may require
more than one course of therapy with isotretinoin. |
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Isotretinoin is a form of vitamin A. It decreases the amount of
sebum (oil) that is released by the sebaceous (oil) glands, and it
increases that rate at which the skin renews itself. |
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Isotretinoin is used to treat severe nodular acne that has not
responded to other treatments, including antibiotics. |
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Isotretinoin may also be used for purposes other than those listed
in this medication guide. |
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What should I discuss with my healthcare provider before taking
isotretinoin?
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Before taking isotretinoin, tell your doctor if you have |
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a personal or family history of mental problems including depression,
suicidal behavior, or psychosis (loss of contact with reality, hearing
voices, or seeing things that are not there); |
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osteoporosis (bone loss) or weak bones; |
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high cholesterol or triglyceride levels (types of fat) in the blood;
or |
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You may not be able to take isotretinoin, or you may require a
dosage adjustment or special monitoring during treatment if you have any
of the conditions listed above. |
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Do not take isotretinoin if you are pregnant or if you could
become pregnant during treatment or for one month after you stop taking
isotretinoin. Isotretinoin is in the FDA pregnancy category X. This
means that isotretinoin is known to cause severe birth defects in an
unborn baby. It can also cause miscarriage, premature birth, or death of
the baby. You must take a pregnancy test and have negative results when
you and your doctor decide that isotretinoin may be beneficial for your
condition. You must have a second pregnancy test with negative results
during the first 5 days of the menstrual period right before you start
taking isotretinoin. Two reliable forms of birth control must be used at
the same time (unless abstinence is the chosen method of birth control
or if you have undergone a hysterectomy) for one month before starting
treatment with isotretinoin, during treatment with isotretinoin, and for
at least 1 month following the end of treatment. You will also be asked
to take a pregnancy test on a monthly basis. Your doctor will discuss
with you and provide for you a video and written information regarding
choices for birth control, possible causes for birth control failure,
and the importance of using birth control while taking isotretinoin. If
you become pregnant, stop using birth control, or miss your menstrual
period, immediately stop taking isotretinoin and notify your doctor.
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It is not known whether isotretinoin passes into breast milk. Do not
take isotretinoin without first talking to your doctor if you are
breast-feeding a baby. |
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How should I take isotretinoin?
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Take isotretinoin exactly as directed by your doctor. If you do not
understand these instructions, ask your pharmacist, nurse, or doctor to
explain them to you. |
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• |
Isotretinoin is a medication taken to treat severe nodular acne that
has not been helped by other treatments, including antibiotics. However,
isotretinoin can cause serious side effects. Before starting treatment
with isotretinoin, discuss with your doctor how bad the acne is, the
possible benefits of isotretinoin and the possible side effects. Your
doctor will ask you to read and sign a form indicating that you
understand the serious risks associated with isotretinoin therapy. |
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You will get no more than a 30-day supply of isotretinoin at a time.
Your prescription should have a special yellow self-adhesive sticker
attached to it. If your prescription does not have this yellow sticker,
call your doctor. The pharmacy should not fill the prescription without
this sticker. |
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Take each dose of isotretinoin with a full glass of water. This will
help prevent the medication inside the capsule from irritating the
lining of the esophagus. For the same reason, do not chew or suck on the
capsule. |
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Take isotretinoin twice a day with food or milk to get the best
results from this medication, unless otherwise directed by your doctor. |
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Take all of the isotretinoin that has been prescribed for you even
if your symptoms start to improve. The acne may seem to get worse at the
start of therapy, but should then begin to improve. For the best results,
finish all of the medication that has been prescribed. You may require
more than one course of therapy with isotretinoin. |
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Your doctor may perform blood tests during treatment with
isotretinoin to monitor side effects from this medication. |
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Due to the serious side effects that may occur with the use of this
medication, do not share it with anyone else. |
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Store isotretinoin at room temperature away from moisture and heat. |
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What happens if I miss a dose?
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Take the missed dose as soon as you remember. However, if it is
almost time for the next dose, skip the missed dose and only take the
next regularly scheduled dose. Do not take a double dose of this
medication. |
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What happens if I overdose?
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Seek emergency medical attention. |
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Symptoms of an isotretinoin overdose include vomiting, abdominal
pain, flushing of the face, inflammation of the lips, headache,
dizziness, and clumsiness. |
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What should I avoid while taking isotretinoin?
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Do not take vitamin supplements containing vitamin A during
treatment with isotretinoin. This could cause increased side effects. |
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Do not donate blood while taking isotretinoin and for at least 1
month following the end of treatment. Blood donated while taking
isotretinoin may be given to a pregnant woman and be harmful to her
baby. |
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• |
Do not use wax hair removal systems or have any skin resurfacing
procedures (such as dermabrasion or laser treatment) performed while
taking isotretinoin and for six months following treatment due to the
possibility of scarring. |
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• |
Avoid exposure to sunlight or UV rays while taking isotretinoin.
Isotretinoin may increase the sensitivity of the skin to sunlight and a
severe sunburn could result. |
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• |
Use caution when driving a vehicle at night. Isotretinoin can cause
decreased night vision. The onset of decreased night vision may be
sudden. |
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What are the possible side effects of isotretinoin?
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Stop taking isotretinoin and seek emergency medical attention or
contact your doctor immediately if you experience any of the following
serious side effects: |
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an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives); |
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changes in vision, blurred vision, or decreased vision (especially
at night); |
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painful or constant dryness of the eyes; |
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depression including feelings of sadness, crying spells,
irritability, changes in sleep patterns, unusual tiredness, trouble
concentrating, loss of appetite, and/ or suicidal thoughts or other
mental problems; |
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stomach, chest, or bowel pain; |
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rectal bleeding, or severe or bloody diarrhea; |
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difficulty or pain when swallowing; |
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new or worsening heartburn; |
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yellowing of the skin or eyes or persistently dark urine; |
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severe headache or dizziness; |
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joint or muscle pain or bone problems; |
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hearing problems or hearing loss; |
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increased thirst or urination; |
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slurred speech or problems moving; |
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increased levels of cholesterol or triglyceride (types of fat) in
your blood (detected by blood tests). |
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Other, less serious side effects are more likely to occur. Continue
to take isotretinoin and talk to your doctor if you experience |
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inflammation, dryness, or cracking of the lips; |
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dry skin, dry mouth, dry or bleeding nose, dryness of the eyes and/
or difficulty wearing contact lenses; |
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increased sensitivity of the skin to the sun. |
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Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome. |
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What other drugs will affect isotretinoin?
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Do not take any of the following medicines while taking isotretinoin: |
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vitamin supplements containing vitamin A; or |
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a tetracycline antibiotic such as tetracycline (Sumycin, Achromycin,
Panmycin, Robitet, others), minocycline (Minocin, Dynacin, Vectrin),
doxycycline (Doryx, Monodox, Vibramycin, Vibra-Tabs), demeclocycline (Declomycin),
or troleandomycin (TAO). |
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Taking any of the drugs listed above during treatment with
isotretinoin may be dangerous. |
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Before taking isotretinoin, tell your doctor if you are taking
carbamazepine (Tegretol, Carbatrol, Epitol). You may require a dosage
adjustment or special monitoring during treatment. |
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Do not use other acne medications unless otherwise directed by your
doctor. They may interfere with the treatment or increase irritation of
the skin. |
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Do not take birth control pills that do not contain estrogen ("minipills")
during treatment with isotretinoin. They may not work while taking
isotretinoin. |
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Drugs other than those listed here may also interact with
isotretinoin. Talk to your doctor or pharmacist before taking any
prescription or over-the-counter medicines, including herbal products. |
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Where can I get more information?
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Your pharmacist has additional information about isotretinoin
written for health professionals that you may read. |
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Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed |
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Every effort has been made to ensure that the information provided
by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
but no guarantee is made to that effect. Drug information contained
herein may be time sensitive. Multum information has been compiled for
use by healthcare practitioners and consumers in the United States and
therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug
information does not endorse drugs, diagnose patients or recommend
therapy. Multum's drug information is an informational resource designed
to assist licensed healthcare practitioners in caring for their patients
and/ or to serve consumers viewing this service as a supplement to, and
not a substitute for, the expertise, skill, knowledge and judgment of
healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug
or drug combination is safe, effective or appropriate for any given
patient. Multum does not assume any responsibility for any aspect of
healthcare administered with the aid of information Multum provides. The
information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist. |
Copyright 1996-2004 Cerner Multum, Inc. Version: 5.05. Revision date: 8/
23/ 04. |