Black Box Warnings Patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk for death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature This drug is not approved for treatment of patients with dementia-related psychosis

Contraindications

Hypersensitivity to phenothiazines

Coma, severe hypotension, severe central nervous system (CNS) depression, concurrent administration of large amounts of CNS depressants, subcortical brain damage, poorly controlled seizure disorder

Severe cardiovascular disease

Lactation

Cautions

Avoid using in children with suspected Reye syndrome

Use caution in glaucoma, prostatic hypertrophy, stenosing peptic ulcer disease (PUD), history of NMS, Parkinson disease, hypocalcemia, renal or hepatic impairment, history of severe reaction to insulin or electroconvulsive therapy (ECT), history of seizures, asthma, respiratory tract infection, cardiovascular disease, myelosuppression

Risk of extrapyramidal symptoms (EPS), NMS, hypotension

Significant hypotension may occur, especially with parenteral administration; hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency; in case of severe hypotension, treat with norepinephrine or phenylepinephrine, and do not use epinephrine or dopamine

May alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of phenothiazines; may cause QT prolongation and subsequent torsade de pointes; avoid use in patients diagnosed or suspected congenital long QT syndrome

May cause anticholinergic effects; use caution in patients with paralytic ileus, gastrointestinal motility, urinary retention, xerostomia, or visual problems

Agranulocytosis, leukopenia, and neutropenia reported with antipsychotic use; periodic blood count assessment recommended in patients with history of risk factors, including history of drug-induced leuko/neutropenia or preexisting low WBC

Esophageal dysmotility and aspiration reported with antipsychotic use; use caution in patients at risk of pneumonia

May cause extrapyramidal symptoms, including akathisia, acute dystonic reactions, and pseudoparkinsonism, and tardive dyskinesia; risk of dystonia greater with increased doses

Therapy is associated with increased prolactin levels; significance unknown

May cause pigmentary retinopathy, and lenticular and corneal deposits with prolonged therapy

May cause orthostatic hypotension; use caution in patients with risk factors, including patients who do not tolerate transient hypotensive episodes such as hypovolemia, cerebrovascular disease, cardiovascular disease, or medicatioin predisposing to hypotension/bradycardia

May impair physical or mental abilities due to sedating properties; use caution when operating heavy machinery

Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia

Antiemetic effect may obscure toxicity of chemotherapeutic drugs

Anticholinergic antiparkinsonian agent may be needed to counter EPS

Strong anticholinergic agent and alpha blocker

Potential for priapism

US Food and Drug Administration (FDA) warning regarding off-label use for dementia in elderly (see Black Box Warnings)