|(eye soe TRET i
|Foreign Brand Names|
Retinoic Acid Derivative|
|What key warnings should I know about before taking this
- Do not use if you are pregnant or could become pregnant. There is
an extremely high risk that your baby will be deformed or will die if you are
pregnant while taking this medicine. Your healthcare provider will talk about
the risk before starting you on the medicine. You must use 2 forms of birth
control. There are only two reasons why you would not need to use 2 separate
methods of effective birth control (you had your uterus removed by surgery or
you commit to complete abstinence). Effective birth control must be started 1
month before the medicine and continue for 1 month after the medicine is
stopped. Do not forget your birth control. You will need a pregnancy test each
month. If you have sex without using effective birth control or miss your
period, stop using this medicine and call your healthcare provider right
|Reasons not to take this medicine|
- If you have an allergy to parabens, vitamin A, another retinoid,
isotretinoin, or any other part of the medicine.
- If you are pregnant or plan on getting pregnant.
- If you are female and you do not understand the possible risks, are
unwilling to follow all the instructions and sign the patient consent
|What is this medicine used for?|
- This medicine is used to treat the most severe form of acne. Your acne
has not improved with other medicines including antibiotics.
- Other uses include treatment of some cancers in children. These
cancers have not responded to other
|How does it work?|
- Isotretinoin decreases gland size in the skin.
- It also affects cell growth and
|How is it best taken?|
- You will get a month's supply at a time.
- Take with food.
- Swallow capsule whole. Do not chew, break, or
|What do I do if I miss a dose?|
- If you miss a dose, skip that one. Return to your regular schedule.
- Do not take a double dose or extra
|What are the precautions when taking this
- Tell healthcare provider if you or anyone in your family has had
mental illness. This includes depression, suicidal thoughts or attempts, or loss
of contact with reality (psychosis).
- May have trouble wearing contact lenses. Your eyes may be dry.
- Limit alcohol intake (includes wine, beer, and liquor).
- Do not take extra vitamin A, beta-carotene, or a multivitamin
containing vitamin A while taking this medicine.
- Do not donate blood while using this medicine and for 1 month after
- Do not take antibiotics like tetracycline or minocycline with this
medicine. Increased pressure in the brain can occur.
- You can get sunburned more easily. Avoid sun, sunlamps and tanning
machines. Use sunscreen; wear protective clothing and eyewear.
- Avoid cosmetic procedures to smooth skin including waxing,
dermabrasion, or laser procedures for at least 6 months after stopping medicine.
- Tell healthcare provider if you are allergic to any medicine. Make
sure to tell about the allergy and how it affected you. This includes telling
about rash; hives; itching; shortness of breath; wheezing; cough; swelling of
face, lips, tongue, throat; or any other symptoms involved.
- There is a high risk of birth defects in babies whose mothers took
this medicine while pregnant.
- As a woman who is able to have children you must talk with healthcare
provider about the risks of this medicine to the baby if you were to get
pregnant. You will also get a written paper talking about the risks.
- You must have two pregnancy tests that say you are not pregnant. You
need a pregnancy test every month in order to get more medicine.
- Do not use in pregnancy and do not get pregnant. Use 2 forms of birth
control that you can trust. Use 1 month before starting this medicine, during,
and for at least 1 month after stopping this medicine.
- Do not use birth control pills that have a low dose of progesterone
(minipills). They may not work well.
- Do not use if you are breast-feeding. Do not breast-feed for 1 month
after stopping medicine.
|What are the common side effects of this
- Dry skin, itching, nose bleeds, dry mouth and nose, dry eyes.
- Inflamed lips and irritated eyes.
- Muscle aches and pains.
- Nausea, vomiting, belly pain.
- If you are pregnant this medicine can cause birth defects, premature
births, and death in babies.
- Serious mental problems such as
|What should I monitor?|
- If female, make sure that you take both forms of birth control. Do not
- If you have missed doses of your birth control then call healthcare
provider right away.
- Check blood work. Talk with healthcare provider.
- You will need 2 negative pregnancy tests before starting this
medicine. It must be repeated every month.
- Follow up with healthcare provider. If you are female, follow up must
be on a monthly basis.
|Reasons to call healthcare provider
- Signs of a life-threatening reaction. These include wheezing;
tightness in the chest; fever; itching; bad cough; blue skin color; fits;
swelling of face, lips, tongue, or throat.
- Feeling depressed, feeling blue, feeling sad, irritable, tired, having
trouble concentrating, or loss of appetite.
- Any thoughts of hurting yourself or of suicide.
- Severe muscle aches and pains.
- Severe belly pain, diarrhea, rectal bleeding, yellowing of skin or
eyes, dark urine.
- Pain with physical activity.
- Any rash.
- If you are pregnant or think you may be
|How should I store this medicine?|
- Store in a tight, light-resistant container at room
- Do not share your medicine with others and do not take anyone else's
- Keep all medicine out of the reach of children and pets.
- Keep a list of all your medicines (prescription, herbal/supplements,
vitamins, over-the-counter) with you. Give this list to healthcare provider
(doctor, nurse, pharmacist, physician assistant).
- Talk with healthcare provider before starting any new medicine,
including over-the-counter or natural products (herbs, vitamins).
- Read medication guide provided by pharmaceutical
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