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03196.txt
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1994-01-17
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$Unique_ID{BRK03196}
$Pretitle{}
$Title{isotretinoin}
$Subject{Accutane Roche Acne preparation isotretinoin severe cystic acne sebum
skin oil dries lesions}
$Volume{}
$Log{
Accutane*0319601.scf}
Copyright (C) 1993 Publications International, Ltd.
isotretinoin
------------------------------------------------------------------------------
BRAND NAME (Manufacturer)
Accutane (Roche)
TYPE OF DRUG
Acne preparation
INGREDIENT
isotretinoin
DOSAGE FORM
Capsules (10 mg, 20 mg, and 40 mg)
STORAGE
Isotretinoin should be stored at room temperature in a tightly closed,
light-resistant container.
USES
This medication is used to treat severe cystic acne. It is not clearly
understood how isotretinoin works, but it decreases the production of sebum (a
skin oil) and dries up the acne lesions.
TREATMENT
An information leaflet is packaged with this product. Be sure to read it
carefully.
Isotretinoin should be taken with meals to obtain maximum benefit.
It may take one to two months before the maximum effects of this
medication are observed.
If you miss a dose of this medication, take the missed dose as soon as
possible, and then return to your regular dosing schedule. However, if you do
not remember until it is time for your next dose, double the next dose, and
then return to your regular dosing schedule.
SIDE EFFECTS
Minor.
Changes in skin color, drowsiness, dry lips or mouth, fatigue, fluid
retention, headache, indigestion, inflammation of the eyelids, inflammation of
the lips, irritation of the eyes, or thinning of the hair. These side effects
may disappear as your body adjusts to the medication.
You may notice a worsening of your acne for the first few days of
treatment.
This medication can cause increased sensitivity to sunlight. Therefore,
avoid prolonged exposure to sunlight and sunlamps. You should wear protective
clothing and sunglasses, and also use an effective sunscreen.
To relieve mouth dryness, chew sugarless gum or suck on ice chips or a
piece of hard candy. If there is no relief within two weeks, consult your
doctor.
Major.
Tell your doctor about any side effects that are persistent or
particularly bothersome. IT IS ESPECIALLY IMPORTANT TO TELL YOUR DOCTOR about
black, tarry stools; bruising; burning or tingling sensation of the skin;
changes in the menstrual cycle; depression; dizziness; hives; muscle pain;
peeling of the palms and soles; rash; visual disturbances; or weight loss.
INTERACTIONS
This medication interacts with the following substances:
1. The concurrent use of alcohol and isotretinoin can lead to an increase
in blood lipid (fat) levels, which can be dangerous.
2. Vitamin A and isotretinoin together can result in additive toxic
effects.
BE SURE TO TELL YOUR DOCTOR about any medications you are currently
taking, especially vitamin A.
WARNINGS
* Tell your doctor about unusual or allergic reactions you have had to
any medications, especially to isotretinoin, vitamin A, or the preservative
parabens.
* Before starting to take this medication, tell your doctor if you now
have or if you have ever had diabetes mellitus (sugar diabetes) or
hyperlipidemia (high blood lipid levels).
* If this drug makes you drowsy, do not take part in any activity that
requires alertness, such as driving a car or operating potentially dangerous
machinery.
* Be sure to tell your doctor if you are pregnant. Isotretinoin has been
shown to cause birth defects in humans. An effective form of birth control
should be used by women of child-bearing age while they are taking this drug
and for at least one month before and after they stop taking it. Within two
weeks of starting this drug, women should have a blood pregnancy test. If the
test is negative, the drug will be started on the second or third day of the
next normal menstrual period. Women should have a pregnancy test each month
while they take this medication. All women must also sign an informed-consent
sheet. Also, tell your doctor if you are breast-feeding an infant. It is not
known whether this drug passes into breast milk.
----------------
The material contained here is "FOR INFORMATION ONLY" and should not replace
the counsel and advice of your personal physician. Promptly consulting your
doctor is the best path to a quick and successful resolution of any medical
problem.