Abilify Tablet

GENERIC NAME: ARIPIPRAZOLE (AR-i-PIP-ra-zole)

COMMON USES: This medicine is an atypical antipsychotic used to treat schizophrenia, bipolar disorder, and irritability associated with autistic disorder. It is also used along with other medicines to treat depression. It may also be used to treat other conditions as determined by your doctor.

BEFORE USING THIS MEDICINE: WARNING: This medicine is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. This medicine is not approved to treat mental problems caused by dementia. Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using this medicine outweigh the risks. Family and caregivers must closely watch patients who take this medicine. It is important to keep m close contact with the patient's doctor. Tell the doctor right away, if the patient has symptoms like worsened depression suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you anticholinergics (such as methscopolamine, benztropine); benzodiazepines (such as lorazepam); clarithromycin; imidazole antifungals (such as ketoconazole); quinidine; selective serotonin reuptake inhibitors (SSRIs) (such as fluoxetine); voriconazole; carbamazepine; hydantoins (such as phenytoin); rifampin; alpha-blockers (such as terazosin); or medicine for high blood pressure. DO NO START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including, if you or a family, member has a history of diabetes, you are very overweight, a history of phenylketonuria, a history of heart problems (such as heart failure, irregular heartbeat, heart attack), low blood pressure, blood vessel problems, stroke, seizures, dementia, Alzheimer disease, neuroleptic malignant syndrome (NMS), depression or other mental/mood disorders, or suicidal thoughts or attempts. Inform your doctor of any other medical conditions including dehydration, low blood volume trouble swallowing allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history, of low white blood cell levels (including low white blood cell levels caused by any medicine). Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, is that you may have about this medicine. This medicine may be taken on an empty stomach or with food. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C) in a tightly-closed container, away from heat and light. Brief storage between 59 to 86 degrees F (15 to 30 degrees C) is permitted. Do not store in bathroom. Use this medicine regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. If your symptoms do not improve or if they become worse, check with your doctor. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. 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 USE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or use more often than prescribed without checking with your doctor. Lab and/or medical tests may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. THIS MEDICINE MAY CAUSE drowsiness, dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of these effects. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. DO NOT DRINK ALCOHOL while you are using this medicine. Check with your doctor before you use medicines that may cause drowsiness. DO NOT BECOME OVERHEATED in hot weather, during exercise, or during other activities since risk of heatstroke may be increased. THIS MEDICINE MAY LOWER THE ABILITYOF YOUR BODY TO FIGHT INFECTION. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection (e.g., fever chills sore throat). CHILDREN, TEENAGERS, AND YOUNG ADULTS WHO TAKE THIS MEDICINE may be at increased risk for suicidal thoughts or actions. Watch all patients who take this medicine closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any, unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. NEUROLEPTIC MALIGNANT SYNDROME (NMS) IS A POSSIBLY FATAL SYNDROME THAT CAN BE CAUSED BY THIS MEDICATION. Contact your doctor at once if you have fever; stiff muscles; confusion; abnormal thinking, fast or irregular heartbeat; and sweating. SOME PATIENTS WHO USE THIS MEDICINE MAY DEVELOP MUSCLE MOVEMENTS THAT THEY CANNOT CONTROL. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face; mouth; or jaw while taking this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED when using this medicine in the elderly; they may be more sensitive to its effects. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Using this medicine during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. DIABETICS: This medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include abnormal dreams; blurred vision; constipation; dizziness; drowsiness; headache; increased appetite (in children); increased saliva production; lightheadedness; nausea; sore throat (in children); stomach upset; tiredness; trouble sleeping; vomiting; or weight gain. THIS MEDICINE MAY INCREASE YOUR RISK OF DEVELOPING DIABETES or increase blood sugar levels. High blood sugar may make you feel confused, drowsy, or thirsty. It can also cause increased urination and make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thinking; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (e.g., puffing of cheeks, puckering of mouth, chewing movements); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (e.g., anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; trouble swallowing; trouble walking; unusual bruising; unusual tiredness or weakness; or vision or speech changes. AN ALLERGIC REACTION TO THIS MEDICINE IS UNLIKELY, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include aggression; confusion; fast, slow, or irregular heartbeat; loss of consciousness; seizures; severe drowsiness, dizziness, or vomiting; tremor; trouble breathing; or unusual mental changes.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.