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ACCUTANE
IMPORTANT NOTE:
THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE
FOR, THE EXPERTISE AND JUDGMENT OF YOUR PHYSICIAN, PHARMACIST OR
OTHER HEALTHCARE PROFESSIONAL. IT SHOULD NOT BE CONSTRUED TO
INDICATE THAT USE OF THE DRUG IS SAFE, APPROPRIATE, OR EFFECTIVE FOR
YOU. CONSULT YOUR HEALTHCARE PROFESSIONAL BEFORE USING ACCUTANE.
ISOTRETINOIN - ORAL (eye-so-tret-ih-NO-in)
COMMON BRAND NAME(S):
Accutane
WARNING:
Women who are pregnant must not use isotretinoin. Women must avoid
becoming pregnant while taking ACCUTANE. Birth defects, spontaneous
abortion and premature births have occurred while using ACCUTANE
during pregnancy. Two effective forms of birth control must be used
for 1 month before starting ACCUTANE, during the use of ACCUTANE,
and for 1 month after stopping isotretinoin use. If you are late in
having your period, contact your doctor immediately. Only carefully
selected patients may use ACCUTANE. Consult your doctor or
pharmacist for more information about the risks and benefits of
using ACCUTANE.
USES:
ACCUTANE is used to treat severe cystic acne.
HOW TO TAKE ACCUTANE:
Read and complete the Informed Consent form with your doctor. Also
be sure to get a Medication Guide from your pharmacist, and then
read it carefully. If you have any questions regarding isotretinoin,
consult your doctor or pharmacist before taking the medication.
Swallow capsules whole. Do not crush or chew them. It may take a
month or two before the full benefits of this medication are
noticed.
SIDE EFFECTS:
May cause dry lips and mouth, minor swelling of the eyelids or lips,
crusty skin, nosebleeds, indigestion, headache, or thinning of hair.
If these effects persist or worsen, notify your doctor promptly.
Tell your doctor immediately if you have any of these unlikely but
serious side effects:
mental/mood changes (e.g., depression, and in rare cases, thoughts
of suicide); changes in vision; stomach pain; rectal bleeding;
severe diarrhea; tingling sensation of the skin; sun sensitivity
("sunburn" effect). Acne may worsen during the first few
days of therapy. In the unlikely event you have an allergic reaction
to this drug, seek medical attention immediately. Symptoms of an
allergic reaction include:
rash, itching, swelling, dizziness, trouble breathing. If you notice
other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS:
Before using ACCUTANE, tell your doctor your medical history,
including:
diabetes, family history of high blood fats (triglycerides),
psychiatric disorders, any allergies. Do not donate blood while you
take isotretinoin and for at least one month after you stop taking
it. Avoid exposure to the sun and sunlamps. Use a sunscreen and wear
protective clothing when you are exposed to direct sunlight.
Isotretinoin can affect your night vision. Be cautious when driving
or operating any machinery after dark. If you wear contact lenses,
you may not tolerate them as well as usual while using ACCUTANE.
Avoid the use of alcohol while taking ACCUTANE. ACCUTANE should not
be used during pregnancy. If you become pregnant or think you may be
pregnant, inform your doctor immediately. ACCUTANE should not be
used by those who may become pregnant during treatment. Consult your
doctor. It is not known if ACCUTANE is excreted into breast milk.
Breast-feeding is not recommended while using ACCUTANE. Use two
reliable forms of birth control together, starting one month before
treatment, during and at least one month after stopping the drug.
Semen may pose a risk to a pregnant woman if the male is using
ACCUTANE. Consult your doctor. This statement is based on
information for a similar drug, acitretin.
DRUG INTERACTIONS:
Tell your doctor of all prescription and nonprescription drugs
you may use, especially of:
vitamin A-type drugs (including etretinate and vitamin A itself),
minocycline, tetracycline. Do not start or stop any medicine without
doctor or pharmacist approval.
OVERDOSE:
If overdose is suspected, contact your local poison control center
or emergency room immediately. Symptoms of overdose may include
vomiting, stomach pain, facial flushing, headache, dizziness, and
loss of balance.
NOTES:
Do not allow anyone else to take ACCUTANE.
MISSED DOSE:
If you miss a dose, take as soon as remembered; do not take if it is
almost time for the next dose, instead, skip the missed dose and
resume your usual dosing schedule. Do not "double-up" the
dose to catch up.
STORAGE:
Store at room temperature between 59 and 86 degrees F (between 15
and 30 degrees C) away from moisture and sunlight. Do not store in
the bathroom.
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