Isotretinoin Overview

(eye soe TRET i noyn)

Accutane® [DSC]; Amnesteem™; Claravis™; Sotret®

Accutane®; Clarus™; Isotrex®

Isoface; Isotrex; Neotrex; Roaccutan; Sotrexe

Acne Products; Retinoic Acid Derivative

• Do not take this medicine if you are pregnant. Your healthcare provider will talk about the risk before starting you on this medicine. Use two effective forms of birth control 1 month before starting this medicine and for 1 month after treatment ends. Pregnancy tests will be done to show that you are NOT pregnant before starting and while taking this medicine. If you become pregnant while taking this medicine, call healthcare provider right away. If you understand all the information and can follow the directions you must sign a patient information/consent form. Do not sign the form and do not take the medicine if you do not understand everything on the form.

• This medicine is only for patients enrolled in the iPLEDGE program.

• This medicine does not mix well with many medicines. Serious reactions may occur. Check all medicines with healthcare provider.

• Please read the medication guide.

• If you have an allergy to isotretinoin, vitamin A, or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you are of childbearing age, but are not using two forms of birth control or if you are planning to become pregnant during your treatment or within 6 months after treatment has ended.

• If you are pregnant or may be pregnant.

• If you are breast-feeding.

• Isotretinoin decreases gland size in the skin.

• It injures cancer cells causing their death.

• You will get a month's supply of this medicine at a time.

• Take this medicine with food.

• Swallow capsule whole. Do not chew, break, or crush.

• Take this medicine with a full glass of water.

• Follow diet plan and exercise program as recommended by healthcare provider.

• Take a missed dose as soon as possible.

• If it is almost time for the next dose, skip the missed dose and return to your regular schedule.

• Do not take a double dose or extra doses.

• Do not change dose or stop medicine. Talk with healthcare provider.

• Change in condition being treated. Is it better, worse, or about the same?

• Check blood work regularly. Talk with healthcare provider.

• If you are a female of childbearing age, take two pregnancy tests before starting this medicine and monthly while using this medicine.

• Bone density test.

• Dry mouth may cause an increase in cavities. Take good care of your teeth. See a dentist regularly.

• Follow up with healthcare provider.

• Store at room temperature.

• Protect from light.

• Protect from moisture. Do not store in a bathroom or kitchen.

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

• Read the package insert for more details.

Created: 2006-10-13 13:23:24.0

Modified: 2010-03-17 13:57:12.0

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