Accutane Information

Generic Name: E: ISOTRETINOIN (eye-soe-TRET-i-noyn)

Common Uses: This medicine is a retinoid used to treat severe acne that has not improved with other available treatment. It may also be used to treat other conditions as determined by your doctor.

How to use this Medicine: Follow the directions for using this medicine provided by your doctor. 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. THIS MEDICINE COMES WITH A MEDICATION GUIDE. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. If you live in the United States, your prescription must include a yellow "Qualification Sticker". This indicates that you have been properly educated about isotretinoin and will allow the pharmacy to provide you with a 30-day supply of medicine. If you live in Canada or in any other country, consult your doctor or pharmacist for specific regulations. SWALLOW WHOLE. Do not break, crush, chew, or suck on the capsule before swallowing. TAKE THIS MEDICINE with food or milk. TAKE THIS MEDICINE with a full glass of water or other liquid. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container, away from heat and light. For best results, take this medicine regularly. Taking your medicine at the same times each day will help you remember. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this medicine. DO NOT TAKE MORE OF THIS MEDICINE or take this medicine for longer than your doctor has told you to. Doing so will not improve your condition faster and may increase your risk for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while taking this medicine. Medical and/or laboratory tests such as pregnancy tests, cholesterol or lipid levels, liver function, blood sugar levels, and white blood cell counts may be performed to monitor your progress or check for side effects. DO NOT TAKE VITAMIN A, or vitamin supplements containing vitamin A, while you are taking this medicine. DO NOT DRINK ALCOHOL while you are using this medicine as it may worsen side effects or increase the risk for pancreatitis. IF YOU WEAR CONTACT LENSES, you may have difficulty wearing them during and after therapy. REPORT ANY CHANGES IN VISION to your doctor immediately. A SUDDEN DECREASE IN NIGHT VISION may occur while you are taking this medicine. Use caution when driving at night and avoid driving at night if you experience decreased night vision. THIS MEDICINE MAY CAUSE increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use sunscreen or protective clothing if you must be outside for a prolonged period. TO PREVENT CRACKING OF LIPS, use a lip lubricant. IT MAY TAKE SEVERAL WEEKS for this medicine to work, and acne may even worsen during the first few days of therapy. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. DO NOT DONATE BLOOD for transfusion during therapy or for 30 days after stopping therapy. DO NOT have cosmetic procedures to smooth your skin (e.g., waxing, laser, or dermabrasion) during and for six months after isotretinoin therapy. Skin scarring may occur. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. Limited information suggests isotretinoin may cause some bone loss. Therefore, playing impact sports may result in bone problems, including an increased risk of fractures. Limited information also suggests isotretinoin may stop normal growth in some children. Consult your doctor for more details. FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. You must have two negative pregnancy tests before starting this medicine. You must have a monthly pregnancy test during treatment with isotretinoin. If the test is positive, you must stop taking this medicine and consult your doctor immediately. Use two reliable forms of birth control together at least 1 month before starting therapy, during therapy, and for 1 month after this medicine is stopped. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. Due to the potential risks to an infant, DO NOT BREAST-FEED while taking this medicine.

Possible Side Effects: SIDE EFFECTS, that may go away during treatment, include temporary worsening of acne; dry and peeling skin; itching; thinning of hair; fatigue; or dry mouth, nose, or eyes. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience skin infections or sun sensitivity. CONTACT YOUR DOCTOR IMMEDIATELY if you experience mood or personality changes including depression, aggressive or violent behavior, or suicidal thoughts or tendencies; back, joint, or muscle pain; or fever or other signs of infection. STOP TAKING THIS MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY if you experience severe headache, vision changes, ringing in the ears or hearing loss, dark urine or yellowing eyes and skin, severe diarrhea, or rectal bleeding. Isotretinoin may infrequently cause pancreatic disease (pancreatitis), which rarely can be fatal. STOP TAKING THIS MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY if you experience severe stomach pain, severe or persistent nausea/vomiting. AN ALLERGIC REACTION to this medicine is unlikely but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include unusual itching, rash, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

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