What is isotretinoin (oral)?
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 may also be used for other purposes not listed in this medication guide.
What does Amnesteem look like?
Amnesteem 40 mg
Amnesteem 10 mg
Amnesteem 20 mg
What should I discuss with my healthcare provider before taking isotretinoin (oral)?
Isotretinoin is available only under a special program called iPLEDGE. You must be registered
in the program and sign documents stating that you understand the dangers of this medication and that
you agree to use birth control as required by the program. Ask your doctor or call the drug maker if
you have questions about the program or the written requirements.
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.
Do not use this medication if you are allergic to isotretinoin or to parabens, or if you are
pregnant or may become pregnant.
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely take isotretinoin:
-
a personal or family history of depression or mental illness;
-
heart disease, high cholesterol or triglycerides;
-
osteoporosis or other bone disorders;
-
diabetes;
-
asthma;
-
an eating disorder (anorexia nervosa); or
-
liver disease.
Isotretinoin can cause severe, life-threatening birth
defects if the mother takes the medication 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.
Even women who have had their tubes tied are required to use birth control while taking
isotretinoin.
You must have a negative pregnancy test 30 days before you start taking isotretinoin. A
pregnancy test is also required 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 you stop taking it.
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 plus spermicidal foam or gel;
-
a diaphragm plus spermicidal foam or gel;
-
a cervical cap plus spermicidal foam or gel; and
-
a vaginal sponge containing spermicide.
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.
It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without
first talking to your doctor if you are breast-feeding a baby.
How should I take isotretinoin (oral)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger
amounts, or take it for longer than recommended by your doctor. Follow the directions on your
prescription label.
Each prescription of isotretinoin must be filled within 7 days of the date it was prescribed 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 to prevent the capsule from melting in
your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as
quickly as possible.
Take isotretinoin with food or milk.
Take this medication for the entire length of time prescribed by your doctor. Your acne
may seem to get worse at first, but should then begin to improve.
To be sure this medication is not causing harmful effects, your blood may need to be tested on a
regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your
doctor.
Never share this medicine with another person, even if they have the same
symptoms you have.
Store isotretinoin at room temperature away from moisture, heat, and light.
What happens if I miss a dose of isotretinoin (oral)?
Skip the missed dose and take the medicine at your next regularly scheduled time.
Do
not
take extra medicine to make up the missed dose.
Where can I get more information about isotretinoin (oral)?
Your pharmacist has information about isotretinoin (oral) written for health professionals that you may read.
What are the possible side effects of isotretinoin (oral)?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side
effects:
-
depressed mood, trouble concentrating, sleep problems, crying
spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or
hurting yourself;
-
sudden numbness or weakness, especially on one side of the
body;
-
blurred vision, sudden and severe headache or pain behind
your eyes, sometimes with vomiting;
-
hearing problems, hearing loss, or ringing in your ears;
-
seizure (convulsions);
-
severe pain in your upper stomach spreading to your back,
nausea and vomiting, fast heart rate;
-
loss of appetite, dark urine, clay-colored stools, jaundice
(yellowing of the skin or eyes);
-
severe diarrhea, rectal bleeding, black, bloody, or tarry
stools;
-
fever, chills, body aches, flu symptoms, purple spots under
your skin, easy bruising or bleeding; or
-
joint stiffness, bone pain or fracture.
Less serious side effects may include:
-
joint pain, back pain;
-
feeling dizzy, drowsy, or nervous;
-
dryness of the lips, mouth, nose, or skin; or
-
cracking or peeling skin, itching, rash, changes in your
fingernails or toenails.
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 (oral)?
Isotretinoin can cause severe, life-threatening birth defects. Never use
isotretinoin if you are pregnant.
Women of child-bearing potential must agree in writing to use two specific forms of birth control
and have regular pregnancy tests before, during, and after taking isotretinoin.
Isotretinoin is available only under a special program called iPLEDGE. It is dangerous to try
and purchase isotretinoin on the Internet or from vendors outside of the United States.
Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.
Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking
it.
What should I avoid while taking isotretinoin (oral)?
Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.
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 pregnant woman could lead to birth defects in her baby if the
blood contains any level of isotretinoin.
Do not use wax hair removers or have dermabrasion or laser skin treatments while you are
taking isotretinoin and for at least 6 months after you stop taking it. Scarring may result.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Isotretinoin
can make your skin more sensitive to sunlight and sunburn may result.
Isotretinoin can cause side effects that may impair your vision, especially at night. Be
careful if you drive or do anything that requires you to see clearly.
What other drugs will affect isotretinoin (oral)?
Before taking isotretinoin, tell your doctor if you are also taking:
-
steroids (prednisone and others);
-
seizure medication such phenytoin (Dilantin); or
-
a tetracycline antibiotic such as demeclocycline
(Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline
(Brodspec, Sumycin, Tetracap).
This list is not complete and there may be other drugs that can interact with
isotretinoin. Tell your doctor about all the prescription and over-the-counter medications you use. This
includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using
a new medication without telling your doctor.
What happens if I have an overdose of isotretinoin (oral)?
