GENERIC NAME: ISOTRETINOIN - ORAL (eye-so-tret-ih-NO-in)
BRAND NAME(S): Accutane, Amnesteem, Claravis, Sotret
Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage
WARNING: Women who are pregnant must not use isotretinoin. Women must avoid becoming pregnant while taking this medication. Birth defects (sometimes fatal), spontaneous miscarriages, and premature births have occurred while using this drug during pregnancy. Females - Two effective forms of birth control (or complete avoidance of sexual intercourse) must be used together for 1 month before starting this drug, during the use of this drug, and for 1 month after stopping isotretinoin use. You must also have monthly pregnancy avoidance counseling from your doctor. Do not use "minipills" for birth control (non-estrogen-containing pills), since they may not work as well with isotretinoin. If you are late in having your period, or if you have sexual intercourse at any time without using two forms of effective birth control, contact your doctor immediately (also see the Precautions section). Only carefully selected patients may use this medication. Consult your doctor or pharmacist for more information about the risks and benefits of using this medication.
USES: This medication is used to treat severe cystic acne.
HOW TO USE: Read and complete the material in the Pregnancy Prevention Program (PPP) booklet provided by your doctor, which includes the Informed Consent document and the "Be Smart Be Safe Be Sure" educational materials. Watch the video provided. Also be sure to get a Medication Guide from your pharmacist, and then read it carefully. Your prescription must have a yellow "Qualification Sticker" attached to it in order for the pharmacy to dispense a 30 day supply without refills. This sticker indicates you have been properly educated about isotretinoin. The preceding requirements apply in the United States. If you live in Canada or other countries, consult your doctor and pharmacist for your specific regulations. If you have any questions regarding isotretinoin, consult your doctor or pharmacist before taking the medication. Swallow capsules whole. Do not crush or chew them. Isotretinoin is generally taken twice daily with food, or as directed for 15-20 weeks. Food helps increase absorption of this medication into your bloodstream. Take this with a full glass of water, and do not lie down for 30 minutes after taking it. It may take a month or two before the full benefits of this medication are noticed, and acne may worsen during the first few days of therapy. A second course of treatment may be started after two months off the drug if severe acne reoccurs. The manufacturer does not recommend long-term use of isotretinoin. Do not exceed the recommended dose.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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