isotretinoin (oral)

What is the most important information I should know about isotretinoin?

You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.

What is isotretinoin?

Isotretinoin is a form of vitamin A that is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

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

Isotretinoin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking isotretinoin?

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 isotretinoin, before each prescription is refilled, right after you take your last dose of isotretinoin, 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 isotretinoin 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.

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

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.

How should I take isotretinoin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Each prescription of isotretinoin 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 isotretinoin at one time.

You may need frequent blood tests.

What happens if I miss a dose?

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

What happens if I overdose?

What should I avoid while taking isotretinoin?

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

While you are taking isotretinoin 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.

What are the possible side effects of isotretinoin?

• 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 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.

What other drugs will affect isotretinoin?

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 affect isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor pharmacist can provide more information about isotretinoin.