 |
Accutane
® (Isotretinoin) |
 |
Accutane
pricing |
| Brand
Accutane manufactured by: HOFFMANN-LA ROCHE |
| Chemical
name: Isotretinoin (Generic not available) |
Accutane (Isotretinoin)
capsules cannot be split.
10mg and 40mg Accutane is available, however 20mg Accutane
not available in Canada.
Accutane
Information | Accutane
Side Effects | How
To Take Accutane | What
to Expect
Accutane Common
Use: Nodular/Inflammatory and Conglobate Acne Therapy.
IMPORTANT NOTE: The following information is
intended to heighten awareness of health information
and does not suggest diagnosis or treatment. This information
is not a substitute for individual medical attention
and should not be construed to indicate that use of
the drug is safe, appropriate, or effective for you.
See your health care professional for medical advice
and treatment.
Read the following information carefully every time
you get a prescription or a refill for Accutane. There
may be new information. This information does not take
the place of talking with your doctor.
If you need any explanations, or further information,
ask your physician or pharmacist.
What
is the most important information you should know about
Accutane? Accutane is a medicine used to
treat severe acne (nodular and or inflammatory acne)
that cannot be cleared up by other acne treatments,
including antibiotics. However, Accutane can cause serious
side effects. Before starting Accutane, discuss with
your doctor how bad your acne is, the possible benefits
of Accutane, and its possible side effects, to decide
if Accutane is right for you. Your doctor will ask you
to read and sign a form indicating you understand some
of the serious risks of Accutane.
Possible
serious side effects of taking Accutane include
birth defects and mental health problems.
All Females: Birth defects:
Accutane can cause birth defects (deformed
babies) if taken by a pregnant woman. It can
also cause miscarriage, premature birth, or death
of the baby. Do not take Accutane if you are pregnant
or plan to become pregnant while being treated,
and for at least 1 month after therapy. Also,
if you get pregnant while taking Accutane, stop
taking it right away and call your doctor.
All females should read the section in this
Information for the Consumer:
“What are the important warnings for
females taking Accutane?”
All Patients: Mental health problems and suicide:
Some patients, while taking Accutane or soon
after stopping Accutane, have become depressed
or developed other serious mental health problems.
Signs of these problems include feelings of sadness,
irritability, unusual tiredness, trouble concentrating,
and loss of appetite. Some patients taking Accutane
have had thoughts about putting an end to their
own lives (suicidal thoughts), 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.
No one knows if Accutane caused these behaviors
or if they would have happened even if the person
did not take Accutane.
All patients should read the section in this
Information for the Consumer:
“What special symptoms you must immediately
tell your doctor about--Signs of mental health
problems:”
For other possible serious side effects of
Accutane, see:
“What special symptoms you must immediately
tell your doctor about:”
What are the important warnings for females
taking Accutane?
Accutane can cause deformed babies. There
is an extremely high risk that your baby will
be deformed if you are pregnant while taking Accutane.
This risk exists even if Accutane is taken for
a short time. If you are a female of childbearing
potential, your physician should have discussed
this risk with you, and explained how to avoid
becoming pregnant while taking Accutane.
• Do not take Accutane if you are or
may become pregnant during your Accutane treatment.
• You must avoid becoming pregnant while
you are taking Accutane and for at least 1 month
after you stop taking Accutane.
• You must discuss effective birth control
with your doctor before beginning Accutane treatment,
and you must use effective birth control:•
For at least 1 month before you start Accutane;•
While you are taking Accutane; and• For
at least 1 month after you stop taking Accutane;bearing
in mind that any method of birth control can fail.
• It is recommended that you either
abstain from sexual intercourse or use 2 reliable
methods of birth control at the same time.
• Do not take Accutane until you are
sure that you are not pregnant.
• You must have 2 negative pregnancy
tests before you start Accutane, be assessed on
a monthly basis while on the drug and 1 month
after the termination of Accutane. If your menstrual
period is abnormal in length and intensity, first
contact your doctor. (See the Accutane Pregnancy
Prevention Plan.)
• You must wait until the second or
third day of your next normal menstrual period
before you start Accutane.
• Stop taking Accutane and contact your
doctor immediately if you do become pregnant while
taking Accutane or during the first month after
treatment has stopped, if you miss your period,
or if you have sexual intercourse without using
effective birth control. You should discuss with
your doctor the serious risk of your baby having
severe birth deformities because you are taking
or have taken Accutane. You should also discuss
the desirability of continuing with your pregnancy.
• Do not breast-feed while taking Accutane. |
You should have been counseled
using the manufacturer's Pregnancy Prevention Program
which includes:
• Comprehensive information about the risks of
this drug
• A line drawing of a deformed baby
• A checklist of criteria you had to meet before
receiving this drug
• Detailed information on birth control options
• A chart: “Accutane Pregnancy Prevention
Plan”
• An informed consent for you to review and sign.
Please note that the manufacturer of Accutane provides
confidential contraception counseling (from a health
care professional). For more information, please contact
Hoffmann-La Roche Limited. If you were not counseled
using the “Pregnancy Prevention Program”,
please contact your doctor for more information.
All patients should read the rest of this Information
for the Consumer.
Do not take Accutane unless you completely understand
its possible risks and are willing to follow all of
the instructions in this Information for the Consumer.
What should you tell your
doctor before starting Accutane?
• Tell your doctor if you or someone in your
family has ever had any mental illness, including depression,
suicidal behavior, or psychosis. Psychosis means a loss
of contact with reality, such as hearing voices or seeing
things that are not there. Also, you should tell your
doctor if you are taking medicines for any of these
problems.
• Tell your doctor if you or any member of your
family have liver disease, kidney disease, heart disease
or high cholesterol, diabetes or asthma.
• Tell your doctor if you plan vigorous physical
activity during treatment with Accutane.
• Tell your doctor if you are sensitive to parabens
or any of the other nonmedicinal ingredients in Accutane
listed at the end of this document or if you have any
food or drug allergies.
• Tell your doctor if you are taking any vitamin
preparations or health food supplements that contain
Vitamin A.
• Tell your doctor the brand of contraceptives
you are taking. There are certain types of contraceptives
that should not be taken while on Accutane.
• Tell your doctor if you are taking an antibiotic
(particularly tetracyclines).
What should you avoid while
taking Accutane?
Females:
• Do not get pregnant while taking Accutane.
See “What is the most important information you
should know about Accutane?” and “What are
the important warnings for females taking 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 use low dose birth control pills. They
may not work while you take Accutane.
All Patients:
• 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 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.
• Do not have cosmetic procedures to smooth your
skin, such as 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 or inflammation of the skin from these procedures.
Check with your doctor for advice about when you can
have cosmetic procedures.
• Avoid the use of artificial ultraviolet lights
such as the ones used in tanning machines and protect
yourself from excessive sunlight. Accutane may make
your skin more sensitive to ultraviolet light.
• Do not share Accutane with other people. It
can cause birth defects and other serious health problems.
• Do not take antibiotics with Accutane unless
you talk to your doctor. For some antibiotics, you may
have to stop taking Accutane until the antibiotic treatment
is finished. Use of both drugs together can increase
the chances of getting increased pressure in the brain.
Certain antibiotics interfere with the effectiveness
of birth control pills.
What special symptoms you
must immediately tell your doctor about:
Serious side effects have been reported with Accutane.
It is important to watch for the symptoms listed below
as they may be signs of serious side effects. If you
get these symptoms, you must tell your doctor immediately
because it may be necessary to stop Accutane. These
symptoms could lead to serious health problems requiring
treatment even if Accutane is stopped.
Signs of mental health problems:
• changes in your mood such as becoming depressed,
feeling sad, or having crying spells,
• losing interest in your usual activities,
• changes in your normal sleep patterns,
• becoming more irritable than usual,
• losing your appetite,
• becoming unusually tired,
• having trouble concentrating,
• withdrawing from family and friends,
• having thoughts about taking your own life
(suicidal thoughts).
Your doctor may recommend a consultation with a
specialist if you become depressed or experience these
changes in mood.
• Signs of hypertension in your head: bad headaches,
blurred vision, dizziness, nausea, vomiting.
• Signs of inflammation of the liver, pancreas,
or intestines (bowel): severe stomach pain, diarrhea,
rectal bleeding; yellowing of the skin or eyes and/or
dark urine.
• Changes in your hearing or ringing in your
ears.
• Changes in your vision especially at night.
• Persistent feelings of dry eyes.
• Signs of bone changes: aches or pains in bones
or joints, or difficulty in moving. If a bone breaks
tell your doctor.
• Signs of allergy to Accutane: hives, swollen
face or mouth, trouble breathing, fever, rash, red patches,
bruises.
• Signs of changes in your blood sugar levels:
fainting, becoming very thirsty, urinating a lot, feeling
weak.
• Leg swelling, seizures (convulsions), slurred
speech, problems moving or any other serious unusual
problems.
Accutane may affect blood fat, cholesterol, or sugar
levels. Therefore it is important for you to see your
doctor at regularly scheduled visits.
What are the other possible
side effects of Accutane? It is important
to watch for the special symptoms listed above as these
may be signs of serious side effects.
The side effects listed below are generally temporary
and disappear when Accutane treatment is stopped; however,
you must tell your doctor if any of your side effects
do not clear up in a few weeks after you stop taking
Accutane. You must also check with your doctor if these
effects become bothersome to see if any change in your
medication is needed.
• Some of the most common side effects are:
dryness of the skin, lips, mouth, and lining of the
nose. Some other side effects that may occur include:
facial or body rash, flaking of the skin, itching, peeling
of the palms and soles, increased sensitivity to the
sun, inflammation of the lips, mild nose bleed, bleeding
and inflammation of the gums, easily injured skin and
increased fatigue. You may experience some redness,
dryness, or irritation of the eyes.
• If you wear contact lenses, you may find them
uncomfortable during treatment because Accutane may
cause dry eyes. This may continue after treatment has
stopped.
• In some patients variable amounts of hair loss
have occurred. In rare cases, this hair loss persisted
after treatment was completed.
These are not all of Accutane's possible side effects.
Your doctor or pharmacist can give you more detailed
information that is written for health care professionals.
How
should you take Accutane?
• Keep Accutane out of the reach of children.
• Read your prescription label carefully and
be sure to take the exact amount of medicine prescribed
by your doctor. Your doctor may change your prescribed
dose from time to time, therefore, it is important that
you check the label each time you fill your Accutane
prescription. If you have any questions, call your doctor.
• Take Accutane with food or just after a meal.
If you forget to take a dose of Accutane, it may be
taken later the same day, but do not take more Accutane
in one day than your doctor has prescribed.
• Be sure to return to your doctor as scheduled.
It is important for your doctor to see you regularly,
every month, when you are taking Accutane. Blood tests
and other tests allow your doctor to check your response
to Accutane. Discuss your progress and any concerns
with your doctor.
• Protect Accutane capsules from sunlight and
heat. Accutane does not need to be refrigerated.
What
should you expect while taking Accutane?
During the first few weeks of treatment, your acne may
seem to get worse. Redness and itching of the affected
skin are common initial effects. These should disappear
as you continue to take Accutane. Most often, the first
signs of healing occur after 2 to 3 weeks of treatment.
It may take 1 to 2 months before beneficial effects
are seen. Most patients with severe acne notice a marked
improvement after 1 or 2 courses of treatment with Accutane.
Active Ingredient:
Isotretinoin.
Inactive Ingredients:
Accutane ‘Roche' 10: beeswax, canthaxanthin, gelatin,
glycerin, hydrogenated hydrolysed starch, mannitol,
soybean and hydrogenated soybean oil, sorbitol, titanium
dioxide.
Accutane ‘Roche' 40: beeswax, gelatin, glycerin,
methylparaben, propylparaben, quinoline yellow WS, soybean
and hydrogenated soybean oil, sunset yellow FCF, titanium
dioxide.
This Information for the Consumer is only a summary
of some important information about Accutane. Medicines
are sometimes prescribed for purposes other than those
listed in an Information for the Consumer. If you have
any concerns or questions about Accutane, ask your doctor.
Do not use Accutane for a condition for which it
was not prescribed.
Figure 1--Accutane
Accutane Pregnancy Prevention Plan
* To ensure that you are using two reliable methods
of birth control at the same time.
** Duration of therapy is typically 3-4 months.
*** To ensure that you are using two reliable methods
of birth control the same time, and to detect any side
effect that you may have from the treatment.
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to heighten awareness of health information and does
not suggest diagnosis or treatment. This information
is not a substitute for individual medical attention.
See your health care professional for medical advice
and treatment. You should carefully read all product
packaging. iCanRx disclaims all representations and
warranties, including for example warranties of merchantability
and fitness for a particular purpose. In addition, iCanRx
does not represent or warrant that the information accessible
via this site is accurate, complete or current. Accutane
is used for nodular/inflammatory and conglobate acne
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