The following information is a summary about Accutane. It is not intended to replace a doctor's instructions.
Pronounced:
ACC-u-tane
Generic name:
Isotretinoin
Other brand name:
Amnesteem
Why is Accutane prescribed?
Accutane, a chemical cousin of vitamin A, is prescribed for the
treatment of severe, disfiguring cystic acne that has not cleared up
in response to milder medications such as antibiotics. It works on
the oil glands within the skin, shrinking them and diminishing their
output. You take Accutane by mouth every day for several months,
then stop. The antiacne effect can last even after you have finished
your course of medication.
Most important fact about Accutane
Because Accutane can cause severe birth defects, including mental
retardation and physical malformations, a woman must not
become pregnant while taking it. Before starting Accutane therapy,
women of childbearing age will be asked to read a pamphlet, watch a
video, and sign a detailed consent form regarding the danger of
birth defects. You must have two negative pregnancy tests before
beginning Accutane therapy, and must take monthly pregnancy tests
while using Accutane.
In addition, you must use 2 forms of birth control during
Accutane therapy, and for 1 month before and after. Each
prescription for Accutane must bear a yellow qualification sticker
signifying that you meet these requirements. Scientists have not
ruled out the possibility that hormone-based contraceptives (birth
control pills and implants) may be less reliable when taken with
Accutane, so a second form of birth control should always be used
while taking Accutane. If you accidentally become pregnant while
taking Accutane, you should immediately consult your doctor.
How should you take Accutane?
Take Accutane two times a day with a meal, unless your doctor
tells you otherwise. Swallow the capsule. Don't suck or chew it.
Take it with a full glass of water, milk, or other nonalcoholic
liquid. Follow your doctor's instructions carefully.
Depending on your reaction to Accutane, your doctor may need to
adjust the dosage upward or downward. If you respond quickly and
very well, your doctor may take you off Accutane even before the 15
or 20 weeks are up.
After you finish taking Accutane, there should be at least a
2-month "rest period" during which you are off the drug. This is
because your acne may continue to get better even though you are no
longer taking Accutane. Once the 2 months are up, if your acne
is still severe, your doctor may want to give you a second course of
Accutane. If you are still growing, your doctor may recommend a
longer "rest period."
Avoid consumption of alcoholic beverages.
Read the patient information leaflet available with the product.
Do not crush the capsules.
Do not share Accutane with anyone because of the risk of birth
defects and other serious side effects.
--If you miss a dose...
Take the forgotten dose as soon as you remember. If it is almost
time for your next dose, skip the one you missed and go back to your
regular schedule. Do not take 2 doses at the same time.
--Storage instructions...
Store at room temperature, away from light.
Accutane side effects
Side effects cannot be anticipated. If any develop or change in
intensity, inform your doctor as soon as possible. Only your doctor
can determine if it is safe for you to continue taking Accutane.
- Side effects may include:
Abnormal hair growth or loss,
allergic reaction,
bleeding gums,
blood in urine,
bowel inflammation and pain,
bruising,
changes in blood sugar or cholesterol levels,
changes in skin pigmentation,
chest pain,
decreased night vision,
decreased tolerance to contact lenses,
delay in wound healing,
depression,
difficulty sleeping,
dizziness,
drowsiness,
dry or fragile skin,
dry or cracked lips,
dry mouth,
dry nose,
fatigue,
flushing,
headache,
hearing problems,
heartbeat irregularities,
herpes,
inflammation or sores in the esophagus,
itching,
joint pain,
liver disorders,
menstrual changes,
muscle wasting,
nail disorders,
nausea,
nervousness,
nosebleeds,
peeling palms or soles,
pinkeye,
rash,
skin infections,
stomach and intestinal discomfort,
stroke,
sudden drop in blood pressure (causing unconsciousness),
sunburn-sensitive skin,
suppression of growth,
sweating,
swelling due to fluid retention,
tendon and ligament problems,
urinary discomfort,
vision problems,
vomiting,
weakness,
weight loss
Why should Accutane not be prescribed?
If Accutane gives you an allergic reaction, you will not be able
to use it.
If you are a woman of childbearing age, you should not take
Accutane if you are pregnant, if you think there is a possibility
you might get pregnant during the treatment, or if you are unable to
keep coming back to the doctor for monthly checkups, including
pregnancy testing.
Special warnings about Accutane
Stop taking Accutane and notify your doctor immediately at the
first sign of a skin rash or any other allergic reaction. Although
they are rare, serious and even fatal allergic reactions have been
known to occur.
When you first start taking Accutane, it is possible that your
acne will get worse before it starts to get better.
Accutane may cause depression or other mental problems. In rare
cases, it has prompted thoughts of suicide. If you begin to feel
depressed or become troubled by suicidal thoughts, contact your
doctor immediately.
Before starting Accutane therapy, all patients must sign a
consent form noting that they are aware of the possibility of mental
side effects, the danger of birth defects, and the need for certain
other precautions.
If you are a woman of childbearing age and you are considering
taking Accutane, you will be given both spoken and written warnings
about the importance of avoiding pregnancy during the treatment. You
will also be asked to sign a second consent form noting that:
- You must not take Accutane if you are pregnant or may become
pregnant during treatment;
- If you get pregnant while taking Accutane, your baby will be at
high risk for birth defects;
- If you take Accutane, you must use 2 effective forms of birth
control from 1 month before the start of treatment through 1 month
after the end of treatment;
- You must have 2 negative pregnancy tests (one just before
starting Accutane therapy), and must be tested every month during
therapy;
- You may participate in a program that includes an initial free
pregnancy test and birth control counseling session;
- If you become pregnant, you must immediately stop taking
Accutane and see your doctor;
- You have read and understood the Accutane patient brochure and
asked your doctor any questions you had;
- You have been invited to participate in a survey of women being
treated with Accutane.
Some people taking Accutane, including some who simultaneously
took tetracycline, have experienced headache, nausea, and visual
disturbances caused by increased pressure within the skull. Avoid
taking tetracycline while using Accutane. See a doctor immediately
if you have these symptoms; if the doctor finds swelling of the
optic nerve at the back of your eye, you must stop taking Accutane
at once and see a neurologist for further care.
Be careful driving at night. Some people have experienced a
sudden decrease in night vision.
Accutane affects the body's processing of fats and sugars. It
should be used cautiously by people with diabetes, excess weight,
high triglyceride or cholesterol levels, or a tendency to drink too
much alcohol. If you have any of these conditions, your doctor will
monitor you closely during Accutane therapy.
You may not be able to tolerate your contact lenses during and
after your therapy with Accutane.
You should stop taking Accutane immediately if you have abdominal
pain, bleeding from the rectum, or severe diarrhea. You may have an
inflammatory disease of the bowel.
You should not donate blood during your therapy with Accutane and
for a month after you stop taking it.
You may become more sensitive to light while taking Accutane.
Try to stay out of the sun as much as possible.
You should not use wax hair removal treatments or skin
resurfacing procedures (dermabrasion, laser treatments) while taking
Accutane or for 6 months after completing therapy.
Some people taking Accutane develop vision or hearing problems.
If you notice changes in your vision or hearing, stop taking this
drug and contact your doctor.
Possible food and drug interactions when taking Accutane
While taking Accutane, do not take vitamin supplements containing
vitamin A. Accutane and vitamin A are chemically related; taking
them together is like taking an overdose of vitamin A.
Remember, too, that Accutane should not be combined with
tetracycline antibiotics such as Doryx, Minocin, and Vibramycin.
Special information if you are pregnant or breastfeeding
Accutane causes birth defects; do not use it while pregnant.
Nursing mothers should not take Accutane because of the possibility
of passing the drug on to the baby via breast milk.
Recommended dosage for Accutane
The recommended dosage range for Accutane is 0.5 to 1 milligram
per 2.2 pounds of body weight, divided into 2 doses daily, for 15 to
20 weeks. For very severe cases, the doctor may increase the daily
dose to as much as 2 milligrams per 2.2 pounds.
If after a period of 2 months or more off therapy, severe cystic
acne persists, your doctor may prescribe a second course of therapy.
Overdosage
Any medication taken in excess can have serious consequences. If
you suspect an overdose of Accutane, seek medical attention
immediately.
- Overdosage of Accutane, like overdosage of vitamin A,
can cause:
Abdominal pain,
dizziness,
dry or cracked lips,
facial flushing,
incoordination and clumsiness,
headache,
vomiting
