HALOPERIDOL LACTATE INJ. (HALDOL INJ.) * 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. BOXED WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. HALDOL Injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * The drug should not be administered intravenously. WARNINGS/PRECAUTIONS: TOP * This medicine may cause changes in the electrocardiogram (QTc interval prolongation). * Use with caution in patients receiving drugs that affect the QTc interval e.g. Cisapride, Erythromycins, Antipsychotics and Tricyclic Antidepressants. * 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. * This medicine may cause increased sensitivity to the sun. You should AVOID prolonged or excessive exposure to direct and/or artificial sunlight. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * The results of some MEDICAL or LAB tests may be affected by this medicine. Inform the doctor in charge that you are taking this medicine. 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; Slowing of cardiac contraction; Fever; Sore throat. Other Common Side Effects: TOP Increased sensitivity to sunlight; Low blood pressure; Rapid heart rate; High blood pressure; Irregular heartbeat. 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. Taking this medication may cause the following mineral depletion: TOP UBIQUINONE ORAL (COENZYME Q10). 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