* Generic Name: isotretinoin
* Brand Name: Accutane
* What is isotretinoin?
* What are the possible side effects of isotretinoin?
* What is the most important information I should know about
isotretinoin?
* What should I discuss with my healthcare provider before taking
isotretinoin?
* How should I take isotretinoin?
* What happens if I miss a dose?
* What happens if I overdose?
* What should I avoid while taking isotretinoin?
* What other drugs will affect isotretinoin?
* Where can I get more information?
What is isotretinoin?
Isotretinoin is a form of vitamin A. It reduces the amount of
oil released by oil glands in your skin, and helps your skin renew
itself more quickly.
Isotretinoin is used to treat severe nodular acne that has not
responded to other treatments, including antibiotics.
Isotretinoin is available only from a certified pharmacy under a
special program called iPLEDGE.
Isotretinoin may also be used for purposes not listed in this
medication guide.
What are the possible side effects of isotretinoin?
Get emergency medical help if you have signs of an allergic reaction
(hives, difficult breathing, swelling in your face or throat) or a
severe skin reaction (fever, sore throat, burning eyes, skin pain,
red or purple skin rash with blistering and peeling).
Stop using isotretinoin and call your doctor at once if you have:
* problems with your vision or hearing;
* hallucinations, (see or hearing things that are not real),
thoughts about suicide or hurting yourself;
* depressed mood, crying spells, changes in behavior, feeling angry
or irritable;
* loss of interest in things you enjoyed before, feeling hopeless or
guilty;
* sleep problems, extreme tiredness, trouble concentrating;
* changes in weight or appetite;
* a seizure (convulsions), sudden numbness or weakness;
* muscle weakness, pain in your bones or joints or in your back;
* severe diarrhea, rectal bleeding, bloody or tarry stools;
* pale skin, feeling light-headed or short of breath;
* severe stomach or chest pain, pain when swallowing; or
* dark urine, or jaundice (yellowing of your skin or eyes).
Common side effects may include:
* dryness of your skin, lips, eyes, or nose (you may have
nosebleeds).
This is not a complete list of side effects and others may occur. Call
your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about isotretinoin?
Isotretinoin in just a single dose can cause severe birth defects or
death of a baby. Never use this medicine if you are pregnant or may
become pregnant.
You must have a negative pregnancy test before taking isotretinoin.
You will also be required to use two forms of birth control to prevent
pregnancy while taking this medicine. Stop using isotretinoin and call
your doctor at once if you think you might be pregnant.
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What should I discuss with my healthcare provider before taking isotretinoin?
Isotretinoin can cause miscarriage, premature birth, severe birth
defects, or death of a baby if the mother takes this medicine at the
time of conception or during pregnancy. Even one dose of isotretinoin
can cause major birth defects of the baby's ears, eyes, face,
skull, heart, and brain. Never use isotretinoin if you are pregnant.
For Women: Unless you have had your uterus and ovaries removed
(total hysterectomy) or have been in menopause for at least 12
months in a row, you are considered to be of child-bearing potential.
You must have a negative pregnancy test before you start taking
isotretinoin, before each prescription is refilled, right after you
take your last dose of isotretinoin, and again 30 days later. All
pregnancy testing is required by the iPLEDGE program.
You must agree in writing to use two specific forms of birth control
beginning 30 days before you start taking isotretinoin and ending 30
days after your last dose. Both a primary and a secondary form of birth
control must be used together.
Primary forms of birth control include:
* tubal ligation (tubes tied);
* vasectomy of the male sexual partner;
* an IUD (intrauterine device);
* estrogen-containing birth control pills (not mini-pills); and
* hormonal birth control patches, implants, injections, or vaginal
ring.
Secondary forms of birth control include:
* a male latex condom with or without spermicide;
* a diaphragm plus a spermicide;
* a cervical cap plus a spermicide; and
* a vaginal sponge containing a spermicide.
Not having sexual intercourse (abstinence) is the most effective method
of preventing pregnancy.
Stop using isotretinoin and call your doctor at once if you have
unprotected sex, if you quit using birth control, if your period is
late, or if you think you might be pregnant. If you get pregnant while
taking isotretinoin, call the iPLEDGE pregnancy registry at
1-866-495-0654.
You should not use isotretinoin if you are allergic to it.
Tell your doctor if you have ever had:
* depression or mental illness;
* asthma;
* liver disease;
* diabetes;
* heart disease or high cholesterol;
* osteoporosis or low bone mineral density;
* an eating disorder such as anorexia;
* a food or drug allergy; or
* an intestinal disorder such as inflammatory bowel disease or
ulcerative colitis.
It is dangerous to try and purchase isotretinoin on the Internet or
from vendors outside of the United States. The sale and distribution of
isotretinoin outside of the iPLEDGE program violates the regulations of
the U.S. Food and Drug Administration for the safe use of this
medication.
You should not breast-feed while using this medicine.
Isotretinoin is not approved for use by anyone younger than 12 years
old.
How should I take isotretinoin?
Follow all directions on your prescription label and read all
medication guides or instruction sheets. Use the medicine exactly as
directed.
Each prescription of isotretinoin must be filled within 7 days of the
date it was written by your doctor. You will receive no more than a
30-day supply of isotretinoin at one time.
Always take isotretinoin with a full glass of water. Do not chew or
suck on the capsule. Swallow it whole.
Follow all directions about taking isotretinoin with or without food.
Use this medicine for the full prescribed length of time. Your acne may
seem to get worse at first, but should then begin to improve.
You may need frequent blood tests.
Never share this medicine with another person, even if they have the
same symptoms you have.
Store at room temperature away from moisture, heat, and light.
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What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not
use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at
1-800-222-1222. Overdose symptoms may include headache, dizziness,
vomiting, stomach pain, warmth or tingling in your face, swollen or
cracked lips, and loss of balance or coordination.
What should I avoid while taking isotretinoin?
Do not take a vitamin or mineral supplement that contains vitamin A.
Do not donate blood while taking isotretinoin and for at least 30 days
after you stop taking it. Donated blood that is later given to a
pregnant woman could lead to birth defects in her baby if the blood
contains any level of isotretinoin.
While you are taking isotretinoin and for at least 6 months after your
last dose: Do not use wax hair removers or have dermabrasion or
laser skin treatments. Scarring may result.
Isotretinoin could make you sunburn more easily. Avoid sunlight or
tanning beds. Wear protective clothing and use sunscreen (SPF 30 or
higher) when you are outdoors.
Avoid driving or hazardous activity until you know how this medicine
will affect you. Isotretinoin may impair your vision, especially at
night.
What other drugs will affect isotretinoin?
Tell your doctor about all your other medicines, especially:
* phenytoin;
* St. John's wort;
* vitamin or mineral supplements;
* progestin-only birth control pills (mini-pills);
* steroid medicine; or
* a tetracycline antibiotic, including doxycycline or
minocycline.
This list is not complete. Other drugs may affect isotretinoin,
including prescription and over-the-counter medicines, vitamins, and
herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your pharmacist can provide more information about isotretinoin.
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