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Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product. Haloperidol decanoate injection is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.

Haloperidol decanoate injection is contraindicated in patients with: Severe toxic central nervous system depression or comatose states from any cause. Known hypersensitivity to haloperidol or any components of haloperidol decanoate. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with haloperidol [see Warnings and Precautions (5.9) and Adverse Reactions (6.2)]. Parkinson's disease [see Warnings and Precautions (5.7)]. Dementia with Lewy bodies [see Warnings and Precautions (5.7)]. Severe toxic central nervous system depression or comatose states from any cause (4). Known hypersensitivity to haloperidol or any components of haloperidol decanoate (4). Parkinson's disease (4, 5.7, 6.1). Dementia with Lewy bodies (4, 5.7).

Sudden Death, Torsades de Pointes (TdP), and QTc Interval Prolongation: Avoid use of haloperidol decanoate in patients who are at risk of developing TdP. Avoid concomitant use of haloperidol decanoate with drugs that may increase risk of QTc interval prolongation or increase haloperidol exposure. Obtain ECG and serum electrolytes at baseline and during treatment as clinically indicated (5.2). Tachycardia and Hypotension: Monitor orthostatic vital signs (5.3). Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis: Use with caution in patients with schizophrenia who have risk factors for cerebrovascular adverse reactions (5.4). Tardive Dyskinesia: Discontinue treatment if clinically appropriate (5.5). Neuroleptic Malignant Syndrome (NMS): Immediately discontinue and monitor closely (5.6). Seizures: Haloperidol decanoate injection is generally not recommended in patients receiving antiseizure drugs or who have a history of seizures or EEG abnormalities. If clinically, indicated, maintain patients taking haloperidol decanoate on adequate antiseizure therapy (5.8). Potential for Cognitive and Motor Impairment: Advise patients to not drive a motor vehicle or operate hazardous machinery until they are reasonably certain haloperidol decanoate does not impair their cognitive and motor functions (5.11). Risk of Encephalopathic Syndrome with Concomitant Use of Lithium: Monitor closely for early signs of neurological toxicity and …

Pregnancy: Neonates exposed to haloperidol decanoate during the third trimester of pregnancy may develop extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and decreased feeding) (8.1). Lactation: Monitor breastfed infants for excessive sedation, irritability, poor feeding, abnormal muscle movements, and tremors (8.2). 8.1 Pregnancy Risk Summary Available data from published epidemiologic studies of pregnant patients exposed to haloperidol have not established a drug-associated risk of major birth defects or miscarriage. Case reports of limb malformations in neonates have been reported in haloperidol-treated mothers; …