Accutane 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.

Accutane is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Accutane is available only from a certified pharmacy under a special program called iPLEDGE.

Accutane in just a single dose can cause severe birth defects or death of a baby. Never use this medicine if you are pregnant or able to become pregnant.

You must have a negative pregnancy test before taking Accutane. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine.

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 Accutane. Stop using Accutane and call your doctor at once if you think you might be pregnant.

Accutane is available only under a special program called iPLEDGE. It is dangerous to try and purchase this medicine on the Internet or from vendors outside of the United States.

Do not take vitamin supplements containing vitamin A while you are taking Accutane. Do not donate blood while taking Accutane and for at least 30 days after you stop taking it.

Take Accutane exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Each prescription of Accutane must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of Accutane at one time.

Always take Accutane with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Follow all directions about taking Accutane with or without food.

Use this medicine for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.

You may need frequent blood tests.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Acne:

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
Maximum dose: Up to 2 mg/kg/day
Duration of therapy: Up to 20 weeks.

Usual Pediatric Dose for Acne:

12 years or older:
-Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
-Maximum dose: 2 mg/kg/day
-Duration of therapy: Up to 20 weeks

Comments:
-Patients should take some formulations of this drug with food.
-Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).
-Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.
-Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.
-The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.

Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Accutane can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or 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 Accutane if you are pregnant or able to become 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 able to get pregnant. You must have 2 negative pregnancy tests before you start taking Accutane, before each prescription is refilled, right after you take your last dose, 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 Accutane and ending 30 days after your last dose. 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 with or without spermicide;

• a diaphragm plus a spermicide;

• a cervical cap plus a spermicide; and

• a vaginal sponge containing a spermicide.

Stop using Accutane 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.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

You should not use Accutane if you are allergic to isotretinoin.

To make sure Accutane is safe for you, tell your doctor if you have ever had:

• depression or mental illness;

• asthma;

• liver disease;

• diabetes;

• heart disease or high cholesterol;

• osteoporosis or low bone mineral density;

• an eating disorder such as anorexia;

• a food or drug allergy; or

• an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.

Do not breastfeed.

Not approved for use by anyone younger than 12 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.

Do not take a vitamin or mineral supplement that contains vitamin A, unless your doctor tells you to.

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 a pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

While you are taking Accutane and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.

Isotretinoin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid driving or hazardous activity until you know how this medicine will affect you. Isotretinoin may impair your vision, especially at night.

Get emergency medical help if you have signs of an allergic reaction to Accutane (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Accutane and call your doctor at once if you have:

• problems with your vision or hearing;

• muscle or joint pain, bone pain, back pain;

• increased thirst, increased urination;

• hallucinations, (see or hearing things that are not real);

• symptoms of depression - unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;

• signs of liver or pancreas problems - loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);

• severe stomach problems - severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or

• increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common Accutane side effects may include:

• dryness of your skin, lips, eyes, or nose (you may have nosebleeds);

• vision problems;

• headache, back pain, joint pain, muscle problems;

• skin reactions; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Tell your doctor about all your other medicines, especially:

• phenytoin;

• St. John's wort (may make birth control pills less effective);

• vitamin or mineral supplements;

• progestin-only birth control pills (mini-pills, may not work as well when taken with isotretinoin);

• steroid medicine; or

• a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may interact with isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.