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ISOTRETINOIN (Accutane®, Claravis™) treats severe cystic acne (also called nodular acne) that has not responded to other therapy such as antibiotics. It can produce complete and prolonged remission of the disease. Isotretinoin may also be used to treat other skin conditions besides acne. You may experience a flare of acne during the initial treatment period. You will need to see your prescriber or health care professional monthly to get a new prescription and to check on your progress and for side effects.

Stop taking isotretinoin and notify your prescriber at once if you have any of these symptoms: Difficulty concentrating, feel like you have no energy, feel unusually sad or have crying spells, feelings of worthlessness or inappropriate guilt, increased irritability, anger, aggression or thoughts of violence, loss of interest in usual activities, sleep too much or have trouble sleeping, start to have thoughts about hurting yourself, withdraw from family or friends. Side effects that you should report to your prescriber or health care professional as soon as possible: Chest pain, changes in menstrual cycle, changes in vision, like blurred or double vision or decreased night vision, difficulty breathing or shortness of breath, dizziness, fainting, hearing loss or ringing in the ears, hives, skin rash, increased urination and/or thirst or dark urine, irregular heartbeat, muscle or joint pain, muscle weakness with or without pain, nausea and vomiting, severe headache, slurred speech, stomach pain, swelling of face or mouth, trouble swallowing, unusual bruising or bleeding, yellowing of the eyes or skin. Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):Chapped lips, dry eyes, dry mouth, dry nose that may lead to nosebleeds, dry skin, flushing, hair loss, increased fragility of hair, headache (mild), increased sensitivity of skin to the sun.

Take isotretinoin capsules by mouth. Follow the directions on the prescription label. This medicine is usually taken 2 times a day with a meal, unless your prescriber tells you otherwise. Swallow the capsules with a full glass of water to help prevent throat irritation. Do not chew or suck on the capsules. Do not take your medicine more often than directed. Do not share this medicine with anyone else due to the risk of birth defects and other serious side effects. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

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