Haloperidol Decanoate (2 brand names, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- HALDOL
- HALOPERIDOL DECANOATE
Boxed Warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol decanoate injection is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
Indications and Usage
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.
Contraindications
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)].
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Sudden Death, Torsades de Pointes, and QTc Interval Prolongation [see Warnings and Precautions (5.2)] Tachycardia and Hypotension [see Warnings and Precautions (5.3)] Tardive Dyskinesia [see Warnings and Precautions (5.5)] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.6)] Seizures [see Warnings and Precautions (5.8)] Hypersensitivity Reactions [see Warnings and Precautions (5.9)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.13)] Hyperprolactinemia [see Warnings and Precautions (5.14)] Risk of Severe Neurotoxicity in Patients with Thyrotoxicosis [see Warnings and Precautions (5.15)]
Overdosage
Reported overdose signs and symptoms are those resulting from an exaggeration of the drug’s known pharmacologic effects (e.g., drowsiness and sedation, tachycardia and hypotension) and adverse reactions, the most prominent of which would be: 1) severe extrapyramidal symptoms, 2) hypotension, or 3) sedation. Patients may appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. Extrapyramidal reactions may be manifested by muscular weakness or rigidity and a generalized or localized tremor, as demonstrated by the akinetic or agitans types, respectively. The risk of QTc interval prolongation and torsade de pointes should be considered [see Adverse Reactions (6.2)]. Management of Overdose There is no specific antidote for a haloperidol overdose. Should hypotension occur and a vasopressor be required, epinephrine must not be used since haloperidol decanoate may block its vasopressor activity, and paradoxical further lowering of the blood pressure may occur. Instead, metaraminol, phenylephrine or norepinephrine should be used. In case of severe extrapyramidal reactions, antiparkinson drugs should be administered, and should be continued for several weeks, and then withdrawn gradually as extrapyramidal symptoms may emerge if discontinued abruptly. Monitor ECG and vital signs for signs of QTc interval prolongation or dysrhythmias and continue monitoring until the dysrhythmias resolve and the haloperidol-induced QTc interval prolongation resolves. Dialysis is not recommended in the treatment of overdose because it removes only very small amounts of haloperidol. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.