ARIPIPRAZOLE ER INJ. (ABILIFY MAINTENA) BOXED WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. This medication is not approved for the treatment of patients with dementia-related psychosis. • Children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders are at increased risk of suicidal thinking and behavior. ******************************************************************************************************************************** * This medication is not for use in psychotic conditions related to dementia. * This medication may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. * You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment. * Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. ABILIFY MAINTENA may cause serious side effects, including: • Increased risk of death in elderly people with dementia-related psychosis. ABILIFY MAINTENA is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). • Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Tell your healthcare provider right away if you have some or all of the following symptoms of NMS: o high fever o stiff muscles o confusion o sweating o changes in pulse, heart rate, and blood pressure BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP DIABETES; LOW BLOOD PRESSURE; HEART CONDITION; SEIZURES. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * FOR INTRAMUSCULAR USE ONLY. * WASH hands before and after using medication. WARNINGS/PRECAUTIONS: TOP * This medicine may cause dizziness, lightheadedness or fainting. Avoid sudden changes in posture. BE CAREFUL and slowly sit up or stand up. * This medicine may impair judgement, thinking or motor skills; DO NOT drive or operate machinery until reasonably certain that you can do so safely. * AVOID concurrent use of alcohol or other CNS depressants as it may intensify the drowsiness, dizziness, or lightheadedness effect of this medicine. * The risk of suicide attempt is inherent in psychotic illnesses and in patients with substance abuse. Close supervision is necessary. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * You should exercise appropriate care in avoiding heat exposure, overheating, and dehydration. * It is important that you do not stop taking your medications without consulting your doctor. * Improvement may take 2-4 weeks or longer. * Notify your doctor if signs of HYPERGLYCEMIA develops [eg, excessive thirst or urination, positive test for glucose or ketones in urine]. * This medicine may affect BLOOD SUGAR levels in diabetics, dose adjustment of antidiabetic agents may be necessary. * DO NOT take this medication if you are pregnant or intend to become pregnant. * Nursing mothers should be advised not to breastfeed. * Inform your doctor if you have a history of SEIZURES or conditions that lower the seizure threshold e.g. Alzheimer dementia. * SPECIAL POPULATIONS: * Patients with Hepatic Impairment: No dosage adjustment is required. * Patients with Renal Impairment: No dosage adjustment is required. * GERIATRIC: No dose adjustment is needed based on age. * Gender: Bioavailability and pharmacokinetics are similar in men and women. No dosage adjustment is recommended based on gender. * Race: Pharmacokinetic difference due to race have not been determined. * Smoking: Pharmacokintic differences have not been identified. No dosage adjustment is recommended based on smoking status. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Blurred vision; Unusual movements of eye, face, limb; Yellowing of eyes or skin; Muscle cramps; Skin rash; Shakiness; Impairment of voluntary movement; Jerkings of face, trunk, or extremities; Difficulty swallowing; Irregular heartbeat; High blood sugar level. Other Common Side Effects: TOP Restlessness; Headache; Difficulty falling asleep; Anxiety; Nausea; Vomiting; Sleepiness; Lightheadedness; Constipation; Suicidal tendency; Dizziness upon standing; Weight gain; Fever; Cough; Nasal congestion; Muscle weakness. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved