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IMPORTANT WARNING:


Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking isotretinoin, stop taking isotretinoin and call your doctor immediately. Isotretinoin can harm the fetus. You will need to have two negative pregnancy tests before starting to take isotretinoin, and you will need to take a pregnancy test once a month while taking isotretinoin. Use two reliable methods of birth control for 1 month before taking, while taking, and for 1 month after stopping to take this drug. It is important to use two reliable methods of birth control to be sure that you do not accidentally become pregnant. Your doctor should show you a videotape and give you written information about birth control. Carefully read the consent form before signing it. Ask your doctor any questions you have about this information.Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to isotretinoin.


Why is this medication prescribed?
Isotretinoin Drug
Isotretinoin is in a class of drugs called retinoids. It is used to treat severe acne that has not responded to oral or topical anti-infectives.

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?
Isotretinoin comes as a capsule to take by mouth. Isotretinoin usually is taken twice a day. Take isotretinoin with food or milk. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take isotretinoin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You may not notice any improvement in your condition until after 4-6 weeks of treatment, and your acne may actually get worse during the first few weeks. Your acne should improve within 15-20 weeks. If it does not improve, your doctor will probably stop giving you isotretinoin for 8 weeks and then restart your treatment.

Other uses for this medicine
Isotretinoin has been used to treat other skin disorders, including keratosis follicularis, pityriasis rubra pilaris, lamellar ichthyosis, keratosis palmaris et plantaris, rosacea, and leukoplakia. Talk to your doctor about the possible risks of using this drug for your condition.

What special precautions should I follow?
Before taking isotretinoin,

tell your doctor and pharmacist if you are allergic to isotretinoin, parabens, or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially carbamazepine (Tegretol), demeclocycline (Declomycin), doxycyline (Monodox, Vibramycin, and others), minocycline (Minocin), oxytetracycline (Uri-Tet), tetracycline (Achromycin V), vitamin A, and other vitamins and herbal products. Do not take any vitamin supplements that contain vitamin A to avoid possible harmful reactions.
tell your doctor if you have or have ever had diabetes, liver disease, pancreatitis, a high amount of triglycerides (fats) in your blood, a family history of high triglycerides in the blood, or depression.
plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Isotretinoin may make your skin sensitive to sunlight.
isotretinoin may cause intracranial hypertension, especially when it is taken with tetracycline. Intracranial hypertension is a condition caused when the pressure in the blood vessels of the brain increases or when the brain swells. Symptoms of intracranial hypertenstion include severe headache, upset stomach and vomiting, and changes in vision. If you have any of these symptoms, call your doctor immediately.
be aware that this medicine may affect your night vision. Be cautious when driving or operating any machinery after dark.
hair removal by waxing and laser procedures to the skin should be avoided while taking isotretinoin and for 6 months after stopping isotretinoin. These procedures may cause scarring.
What special dietary instructions should I follow?
Isotretinoin increases the amount of triglycerides (fats) in your blood. Limit your intake of dietary fat and alcoholic beverages (alcohol also increases the amount of triglycerides in your blood) while taking isotretinoin.

What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?
Side effects from isotretinoin are common.Tell your doctor if any of these symptoms are severe or do not go away:

red, cracked, and sore lips
red, itchy, dry, and inflamed eyes
dry mouth and nose
dry skin
thinning of the hair
fatigue
If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

bone or joint pain
chest pain
dizziness
stomach pain
headache
upset stomach
vomiting
difficulty with vision
difficulty breathing or swallowing
difficulty hearing
ringing in your ears
difficulty walking
rectal bleeding
severe diarrhea
bruising or red patches of the skin
muscle aches
difficulty walking
skin peeling
skin infections
depression
seeing visions or hearing voices that do not exist
thoughts of suicide
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?
When you begin taking isotretinoin, your acne may become worse before it starts to improve.

Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it.

If you wear contact lenses, you may not tolerate them as well as usual while you take isotretinoin.

Do not let anyone else take your medication, especially a woman who may become pregnant. Ask your pharmacist any questions you have about refilling your prescription.

Brand names
Accutane

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