Isotretinoin/Accutane is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
Isotretinoin/Accutane is a form of vitamin A. It decreases the amount of sebum (oil) that is released by the sebaceous (oil) glands, and it increases that rate at which the skin renews itself.
Isotretinoin/Accutane may also be used for purposes other than those listed in this medication guide.
WHAT HAPPENS IF I OVERDOSE?
Seek emergency medical attention.
Symptoms of an
isotretinoin/Accutane overdose include vomiting, abdominal pain, flushing of the face, inflammation of the lips, headache, dizziness, and clumsiness.
WHAT SHOULD I DISCUSS WITH MY DOCTOR BEFORE TAKING Accutane/Isotretinoin?
It is not known whether
isotretinoin/Accutane passes into breast milk. Do not take
isotretinoin/Accutane without first talking to your doctor if you are breast-feeding a baby.
Before taking
isotretinoin/Accutane , tell your doctor if you have
anorexia nervosa;
liver disease.
a personal or family history of mental problems including depression, suicidal behavior, or psychosis (loss of contact with reality, hearing voices, or seeing things that are not there);
diabetes;
asthma;
high cholesterol or triglyceride levels (types of fat) in the blood; or
heart disease;
osteoporosis (bone loss) or weak bones;
You may not be able to take
isotretinoin/Accutane , or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Do not take
isotretinoin/Accutane if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking
isotretinoin/Accutane .
Isotretinoin/Accutane is in the FDA pregnancy category X. This means that
isotretinoin/Accutane is known to cause severe birth defects in an unborn baby. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking
isotretinoin/Accutane and notify your doctor.
WHAT SHOULD I AVOID WHILE TAKING Accutane/Isotretinoin?
Do not donate blood while taking
isotretinoin/Accutane and for at least 1 month following the end of treatment. Blood donated while taking
isotretinoin/Accutane may be given to a pregnant woman and be harmful to her baby.
Use caution when driving a vehicle at night.
Isotretinoin/Accutane can cause decreased night vision. The onset of decreased night vision may be sudden.
Do not take vitamin supplements containing vitamin A during treatment with
isotretinoin/Accutane . This could cause increased side effects.
Avoid exposure to sunlight or UV rays while taking
isotretinoin/Accutane .
Isotretinoin/Accutane may increase the sensitivity of the skin to sunlight and a severe sunburn could result.
Do not use wax hair removal systems or have any skin resurfacing procedures (such as dermabrasion or laser treatment) performed while taking
isotretinoin/Accutane and for six months following treatment due to the possibility of scarring.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF Accutane/Isotretinoin?
Stop taking
isotretinoin/Accutane and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
leg swelling;
trouble breathing;
new or worsening heartburn;
depression including feelings of sadness, crying spells, irritability, changes in sleep patterns, unusual tiredness, trouble concentrating, loss of appetite, and/ or suicidal thoughts or other mental problems;
hearing problems or hearing loss;
increased thirst or urination;
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
severe headache or dizziness;
slurred speech or problems moving;
fainting;
changes in vision, blurred vision, or decreased vision (especially at night);
difficulty or pain when swallowing;
increased levels of cholesterol or triglyceride (types of fat) in your blood (detected by blood tests).
seizures;
nausea and vomiting;
painful or constant dryness of the eyes;
rectal bleeding, or severe or bloody diarrhea;
joint or muscle pain or bone problems;
yellowing of the skin or eyes or persistently dark urine;
stomach, chest, or bowel pain;
Other, less serious side effects are more likely to occur. Continue to take
isotretinoin/Accutane and talk to your doctor if you experience
increased sensitivity of the skin to the sun.
itching; or
inflammation, dryness, or cracking of the lips;
dry skin, dry mouth, dry or bleeding nose, dryness of the eyes and/ or difficulty wearing contact lenses;
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
WHAT HAPPENS IF I MISS A DOSE?
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.
HOW SHOULD I TAKE Accutane/Isotretinoin?
Due to the serious side effects that may occur with the use of this medication, do not share it with anyone else.
Take
isotretinoin/Accutane exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take
isotretinoin/Accutane twice a day with food or milk to get the best results from this medication, unless otherwise directed by your doctor.
Store
isotretinoin/Accutane at room temperature away from moisture and heat.
Take all of the
isotretinoin/Accutane that has been prescribed for you even if your symptoms start to improve. The acne may seem to get worse at the start of therapy, but should then begin to improve. For the best results, finish all of the medication that has been prescribed. You may require more than one course of therapy with
isotretinoin/Accutane .
Take each dose of
isotretinoin/Accutane with a full glass of water. This will help prevent the medication inside the capsule from irritating the lining of the esophagus. For the same reason, do not chew or suck on the capsule.
Your doctor may perform blood tests during treatment with
isotretinoin/Accutane to monitor side effects from this medication.
Isotretinoin/Accutane is a medication taken to treat severe nodular acne that has not been helped by other treatments, including antibiotics. However,
isotretinoin/Accutane can cause serious side effects. Before starting treatment with
isotretinoin/Accutane , discuss with your doctor how bad the acne is, the possible benefits of
isotretinoin/Accutane and the possible side effects. Your doctor will ask you to read and sign a form indicating that you understand the serious risks associated with
isotretinoin/Accutane therapy.
You will get no more than a 30-day supply of
isotretinoin/Accutane at a time. Your prescription should have a special yellow self-adhesive sticker attached to it. If your prescription does not have this yellow sticker, call your doctor. The pharmacy should not fill the prescription without this sticker.
WHAT DRUG(S) MAY INTERACT WITH Accutane/Isotretinoin?
other drugs that make you more sensitive to the sun such as sulfa drugs
What is the shelf life of the pills?
The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.
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