Accutane

The proper way to use

Isotretinoin comes with patient information. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Women of reproductive age are required to sign up for a pregnancy risk program called iPLEDGE in order to receive their isotretinoin prescription each month. You can sign up on the internet (www.ipledge.com) or by telephone (1-866-495-0654). Be sure to ask your doctor if you have any questions about this program. It is very important that you understand and follow all of its requirements.

Isotretinoin must not be taken by women of reproductive age unless two effective forms of contraception (birth control) have been used for at least 1 month before the beginning of treatment. Contraception must be continued during the period of treatment, which is up to 20 weeks, and for 1 month after isotretinoin is stopped. Be sure you have discussed this information with your doctor.

If you are a woman who is able to have children, you must have a pregnancy blood test within 1 week before beginning treatment with isotretinoin to make sure you are not pregnant. Treatment with isotretinoin will then be started within the week, on the second or third day of your next normal menstrual period. In addition, you must have a pregnancy blood test each month while you are taking this medicine and one month after treatment is completed.

Take isotretinoin with food and a full glass of liquid, like water. Taking with food is important for getting the right amount of medicine out of your stomach. Taking with a full glass of liquid will reduce chest or stomach discomfort that may occur from isotretinoin.

It is very important that you take isotretinoin only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Importance of not sharing medication with anyone else because of the risk of birth defects and other serious side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For acne:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 1 milligram (mg) per kilogram (kg) (0.23 to 0.45 mg per pound) of body weight a day. It is recommended that the dose per day be divided and not taken all at one time. For adult patients with severe acne, dosage adjustments may be needed and must be determined by your doctor.
    • Children—Use is usually not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.