Generic Name: Isotretinoin

  • What is Amnesteem?

    Amnesteem is a medication taken by mouth to clear up the most severe form of acne, nodular acne. Amnesteem should only be used if other forms of treatment have not worked, including antibiotics. Amnesteem can only be prescribed by doctors who are registered in the iPLEDGE program, dispensed by a pharmacy that is registered with the iPLEDGE program, and given to patients who are registered in the iPLEDGE program, and who understand and agree to do everything required in the program.

  • What is the most important information I should know about Amnesteem?

    Amnesteem may cause birth defects, miscarriage, death of a baby, and early births; therefore, it can only be used by patients enrolled in the iPLEDGE program. Females should not become pregnant if they or their partners are taking Amnesteem. Pregnancy should be avoided 1 month before taking this drug, while taking it, and for 1 month after therapy has ended.

    If you get pregnant while taking Amnesteem, stop taking it immediately and call your doctor right away. Doctors and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088, and the iPLEDGE pregnancy registry at 1-866-495-0654.

    This drug may also cause serious mental health problems such as depression, psychosis, and suicidal thoughts. If you or a family member notices signs and symptoms of depression or psychosis, stop Amnesteem and call your doctor right away. You may also need follow-up mental healthcare if you had any symptoms of depression or psychosis after stopping Amnesteem.

  • Who should not take Amnesteem?

    Do not take Amnesteem if you are pregnant, plan to become pregnant, or become pregnant during therapy. Also, talk to your doctor about the ingredients of this drug to make sure you are not allergic to anything in it.

  • What should I tell my doctor before I take the first dose of Amnesteem?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Amnesteem. Also, talk to your doctor about your complete medical history, especially if you have asthma, bone loss/weak bones (osteoporosis), diabetes, an eating disorder (anorexia), heart problems, liver disease, mental problems, or allergies to foods or medications.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Adults and children ≥12 years: The usual dosage of Amnesteem is 0.5-1 milligram (mg) per 2.2 pounds of body weight per day, taken in two divided doses for 15-20 weeks.

  • How should I take Amnesteem?

    Amnesteem should be taken two times a day with a meal, unless told otherwise by your doctor. Swallow Amnesteem capsules whole with a full glass of water; do not chew or suck on the capsules.

  • What should I avoid while taking Amnesteem?

    While being treated with Amnesteem, do not breastfeed, drive at night, get pregnant, give blood, have waxing, dermabrasion, or laser procedures performed on your face, stay in sunlight and under ultraviolet light (tanning beds), take other medicines or herbal products, or share Amnesteem with other people.

  • What are possible food and drug interactions associated with Amnesteem?

    Consult with your doctor before taking antibiotics, corticosteroids, Dilantin (phenytoin), progestin-only birth control pills (mini pills), St. John's wort, and vitamin A supplements.

  • What are the possible side effects of Amnesteem?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: back pain, birth defects in babies, blood sugar changes, blurred vision, broken bones, chapped lips, dark urine, decreased red and white blood cells, diarrhea, dizziness, dry eyes, dry nose leading to nosebleeds, dry skin, headache, hearing problems, heartburn, joint pain, lipid (fats and cholesterol in blood) problems, muscle weakness/damage, nausea/vomiting, painful swallowing, rectal bleeding, seizures, serious allergic reactions, serious mental health problems, severe stomach/chest/bowel pain, stroke, vision problems, yellowing of skin/eyes

  • Can I receive Amnesteem if I am pregnant or breastfeeding?

    Do not take Amnesteem if you are pregnant. Do not become pregnant if you are receiving treatment with Amnesteem. This drug causes severe developmental problems during pregnancy, and may result in loss of the child. Also, do not nurse while on Amnesteem, as the drug may pass into breast milk.

  • What should I do if I miss a dose of Amnesteem?

    If you miss a dose of Amnesteem, skip it and continue on your regular schedule. Do not take two doses at the same time.

  • How should I store Amnesteem?

    Store at room temperature, away from light.

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