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Drug Information For: ACCUTANE 10MG CAPSULES

Ingredient Name: ISOTRETINOIN (eye-soe-TRET-i-noyn)

Drug Manufacturer: ROCHE

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.

Before Using This Medicine: WARNING: Women who are pregnant must not take this medicine. Women must avoid becoming pregnant while taking this medicine. Birth defects, spontaneous miscarriages, and premature births have occurred while using this medicine 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 medicine, during the use of this medicine, and for 1 month after stopping this medicine. You must also be registered with the iPLEDGE program and have monthly pregnancy avoidance counseling from your doctor. Do not use "minipills" or non-estrogen-containing pills for birth control since they may not work as well with this medicine. If you are late in having your period, or if you have sexual intercourse at any time without using 2 forms of effective birth control at the same time, contact your doctor immediately. Only carefully selected patients may use this medicine. Consult your doctor or pharmacist for more information about the risks and benefits of using this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking tetracycline antibiotics, or vitamin A-type medicines (including etretinate and vitamin A itself). Avoid the use of St. John's Wort or any other product that may decrease the effectiveness of birth control pills. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking medicines that cause bone loss (such as phenytoin, or corticosteroids like prednisone). Consult your doctor or pharmacist for details. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including diabetes, family or personal history of high blood cholesterol or triglycerides, family or personal history of mood or mental problems (such as depression or psychiatric problems), liver problems, pancreas problems, bowel problems (such as severe stomach pain, rectal bleeding, or persistent or severe diarrhea), bone density problems (such as osteoporosis or osteomalacia), eating disorders (such as anorexia), irregular menstrual periods, asthma, heart disease, hearing problems (such as ringing in the ear or hearing loss), allergies, pregnancy, or breast-feeding.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. THIS MEDICINE COMES WITH A MEDICATION GUIDE. Read it carefully. The dispensing of this medicine is managed by the iPLEDGE program. This program is a computer-based system designed to eliminate exposure of an unborn child to this medicine. Read all the information provided by your doctor. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine, the medication guide, or the iPLEDGE program. 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. Take this medicine regularly to receive the most benefit from it. Taking this 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 EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Doing so will not improve your condition faster and may increase your risk for side effects. Medical and/or laboratory tests such as pregnancy tests, cholesterol or lipid level tests, liver function tests, blood sugar tests, blood tests for muscle problems (creatine phosphokinase), and white blood cell counts may be performed to monitor your progress or check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. SOME PATIENTS BECOME depressed or suicidal while taking this medicine. If you begin to be depressed or have thoughts of harming yourself, contact your doctor immediately. DO NOT DRINK ALCOHOL while you are taking 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. THIS MEDICINE MAY CAUSE A SUDDEN DECREASE IN NIGHT VISION. 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. IT MAY TAKE SEVERAL WEEKS for this medicine to work, and acne may even worsen during the first few days of therapy. DO NOT DONATE BLOOD for transfusion during therapy or for 30 days after stopping therapy. DO NOT have cosmetic procedures to smooth your skin (such as 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 that this medicine may cause some bone loss. Therefore, playing impact sports may result in bone problems, including an increased risk of fractures. Limited information also suggests this medicine may stop normal growth in some children. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of this medicine. 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. Due to the potential risks to an infant, DO NOT BREAST-FEED while taking this medicine.

Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include temporary worsening of acne; dry and peeling skin; itching; thinning of hair; fatigue; chapped lips; 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 increased urination, increased thirst, or signs of infection (such as fever, chills, or sore throat). CONTACT YOUR DOCTOR IMMEDIATELY if you experience mood or mental changes (such as depression, aggressive or violent behavior, suicidal thoughts or tendencies, or seeing things that are not really there); back or joint pain; muscle pain; muscle weakness; or fractures or broken bones. STOP TAKING THIS MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY if you experience severe headache, vision changes, seizures, 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, or severe or persistent nausea, vomiting, or indigestion. 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.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include vomiting, stomach pain, facial flushing, headache, dizziness, and loss of balance.
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