Isotretinoin (By mouth)

Warnings While Using This Medicine

• Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of birth control together for 1 month before starting this medicine, during the entire time you are using this medicine, and for 1 month after your last dose. If you are using birth control pills, ask your doctor if your pills are a good kind of birth control to use. Some kinds of birth control pills may not work as well when you take this medicine. You will be required to have a pregnancy test every month during treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Do not breastfeed while you are using this medicine.
• Make sure your doctor knows if you have liver disease (including hepatitis), asthma, bowel or digestion problems (pain, bleeding, or diarrhea), diabetes, eye or vision problems, hearing problems, heart disease, pancreas problems (including pancreatitis), or if you have high cholesterol or triglycerides (fats in the blood). Tell your doctor if you or anyone in your family have had anorexia (an eating disorder), depression, aggressive behavior, or any kind of mental illness (schizophrenia), or a bone problem such as osteoporosis (thin bones). Tell your doctor if you drink large amounts of alcohol.
• This medicine is available only with a registered distribution program called the iPLEDGE? program. You or your child will be asked to sign a consent and agreement form before you take this medicine. This form tells you about the risks of using this medicine and the guidelines for safe use. Make sure you understand what is on the form before you sign it. You will also be asked to take part in a telephone survey and have your name placed on a patient registry list. Ask your doctor if you have any questions.
• Some people who have used this medicine have become very depressed or angry. Tell your doctor right away if you or your child think this medicine is causing changes in your mood or behavior. Some signs of this may be feeling very sad, getting upset easily, thinking about hurting yourself or someone else, feeling nervous, having trouble sleeping or sleeping too much, eating more or less than usual, gaining weight, losing weight, or having trouble thinking.
• This medicine may increase pressure in your head. This may increase your risk of vision loss or serious brain problems. Stop using this medicine and tell your doctor right away if you have a bad headache; blurred vision; dizziness; nausea or vomiting; or seizures.
• Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; diarrhea; itching; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.
• Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
• This medicine may cause problems with bones or muscles. You may get hurt more easily during rough sports. You may heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.
• Your skin problems may get worse for a short time before they start to improve. Your acne may continue to get better even after you stop using this medicine. Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Do not donate blood while using this medicine or for 1 month after your last dose.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• This medicine may cause some people to have hearing problems. Stop using this medicine and check with your doctor right away if you or your child have hearing loss, a continuing ringing or buzzing, or any other unexplained noise in the ears.
• This medicine may affect your vision, especially at night. Avoid driving, using machines, or doing anything else that may be dangerous if you are not able to see well.
• This medicine may cause dryness of the eyes. If you or your child wear contact lenses, your eyes may be more sensitive to them while you are taking isotretinoin and for a period of time after treatment. To help relieve dryness of the eyes, check with your doctor about using a lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor right away.
• This medicine may raise or lower your blood sugar, or it may cover up symptoms of very low blood sugar (hypoglycemia).
• Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.
• Stop using this medicine and tell your doctor right away if you or your child have abdominal or stomach pain, rectal bleeding, or severe diarrhea. These may be symptoms of a serious condition called inflammatory bowel disease.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• It is very important that you or your child not use wax epilation to remove hair or have any cosmetic procedures to smooth your skin (such as dermabrasion, laser) while you are taking this medicine and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from these procedures.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Blood in your urine or foamy urine.
• Blurred vision or changes in vision.
• Chest pain, or a fast or uneven heartbeat.
• Dark-colored urine or pale stools.
• Decreased vision after sunset and before sunrise.
• Feeling depressed or like you want to hurt yourself or others.
• Fever, chills, cough, sore throat, and body aches.
• Hearing problems or ringing in your ears.
• Muscle weakness.
• Seizures.
• Severe diarrhea, nausea, vomiting, stomach pain, or bleeding from your rectum.
• Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness.
• Sudden or severe headache, or problems with vision, speech, or walking.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Dizziness, drowsiness, or headache.
• Dry, itching, or peeling skin, dry eyes, or dry, cracked lips, mouth, or nose.
• Heartburn, new or worsening.
• Increase in thirst or how much you urinate.
• Muscle, back, or joint pain or aching (more likely in children).
• Skin rash.
• Trouble sleeping.
• Trouble swallowing or painful swallowing.
• Trouble wearing contact lenses.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using tetracycline (Sumycin®), St. John's wort, a vitamin A supplement, or a steroid medicine (such as cortisone, dexamethasone, hydrocortisone, prednisolone, prednisone, Medrol®, or Orapred®). Tell your doctor if you are also using a medicine to control seizures, such as carbamazepine (Tegretol®), phenobarbital, or phenytoin (Dilantin®).
• Some medicines may cause birth control pills to not work as well. To keep from getting pregnant while you are using isotretinoin (Accutane®), you must use another form of birth control together with the pill, such as a condom, diaphragm, vaginal sponge, or contraceptive foam or jelly.
• Do not drink alcohol while you are using this medicine.

How to Use This Medicine

Liquid Filled Capsule

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole with a full glass (8 ounces) of water or other liquid. Do not break, crush, or chew it.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Introduction

Isotretinoin (eye-soe-TRET-i-noin)

Treats certain types of severe acne.

Brand Name(s)

Amnesteem, Claravis, Myorisan