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Haloperidol Lactate

Brand names Haldol, generic

Medication error Look-alike, sound-alike drug names. Haloperidol has been confused with hydrALAZINE, potential hydromorphone, and . Haldol has been confused with Halcion, Hytrin, and nadolol. Confusion with Stadol has resulted in patient harm.(1) Only haloperidol lactate should be administered IV. Do not infuse the decanoate product intravenously.

Contraindications U.S. : None related to the pediatric population.(2) and warnings Contraindications: Hypersensitivity to haloperidol or any components of the formulation. Patients with significant CNS depression or who are comatose from any cause should not be given haloperidol.(2) Because of risk for , and should not be given to those with bone marrow suppression.(2) (See the Comments section.) Other warnings: Both QT prolongation and were reported with IV administration in adults(2,3) and were more likely to occur with larger doses.(3) (See the Comments section.) May cause dose-dependent irreversible (e.g., pseudoparkinson- ism, acute dystonic reactions, , hyperpyrexia, and tardive ).(2) (See the Comments section.) Neuroleptic malignant syndrome (NMS) has been reported.(2,14) (See the Comments section.)

Infusion-related IV administration is associated with a higher incidence of cardiovascular toxicity. An ECG cautions should be continuously monitored for QT prolongation and arrhythmias.(2) (See the Com- ments section.)

Dosage Injectable haloperidol is only approved by the FDA for IM ; however, IV adminis- tration is used off-label in clinical practice. If atypical have failed and an IV agent is needed, then haloperidol should be given. When administered IV, an ECG should be continuously monitored for QT prolongation, and the dosage should be reduced or the drug discontinued if changes are noted.(2,4) Use lowest effective dose over the shortest duration possible. Do not infuse the decano- ate product intravenously. Agitation and in critically ill children: IV/IM doses ranging from 0.013 to 0.28 mg/kg(4-8) up to a maximum single dose of 5 mg have been given.(16) May be repeated hourly as needed.

Dosage adjustment Not reported(2) in organ dysfunction

Maximum dosage Although 0.28 mg/kg has been given, the usual upper limits of dosing is 0.15 mg/kg not to exceed 5 mg as a single dose.(16) The maximum daily dose in an adult is 20 mg.(2)

Additives Contains 1.8 mg of methylparaben and 0.2 mg of propylparaben per mL.(2) Although there is a preservative-free product, some dosage forms may contain benzyl . (See Appendix C for specific information about potential adverse effects.)

Suitable diluents D5W.(11) NS products should not be used.

Maximum Should be given IM undiluted (5 mg/mL),(11) or further dilute to concentrations <5 mg/mL. concentration  452 Haloperidol Lactate

Preparation and Parenteral products should be visually inspected for particulate matter and discoloration delivery before use. Refer to appropriate references for more information on compatibility with other drugs and solutions; compatibility following Y-site delivery, and suggested storage and extended stability.(11) Stability: Store at room temperature.(11) Compatibility: See Appendix D for PN compatibility information. Photosensitivity: Protect from light during storage.(11)

IV push Given slowly with concurrent ECG monitoring(2,7)

Intermittent An ECG should be monitored when infused IV.(2) infusion

Continuous infusion Has been infused continuously in adults.(12)

Other routes of IM(2) administration

Comments Adverse effects Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported.(2) Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil count <1000/mm.(3) Cardiovascular: May cause hypotension and arrhythmias.(2,8) Prolongation of the QT interval may result in ventricular dysrhythmias, torsades de points, and sudden cardiac death.(2,3,13) Extrapyramidal symptoms: May cause dose-dependent irreversible extrapyramidal symptoms (e.g., pseudoparkinsonism, acute dystonic reactions, akathisia, hyperpy- rexia, and ).(2) Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of drugs increases. However, the syndrome can develop after relatively brief treatment periods at small doses. These symptoms have been reported in children with burns who received IV therapy.(5) Use lowest dose and shortest duration possible. Neuroleptic malignant syndrome (NMS): Presents as hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs), and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhyth- mias).(2) Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. A 16-year-old, developed NMS following (10 mg/day), repeated injections of (37.5 mg/day), and a single injection of haloperidol (2.5 mg). Genetic testing revealed that the patient was homozygous for a nonfunctional CYP2D6*4 allele. Because the metabolism of haloperidol is catalyzed by CYP2D6, a patient who lacks activity of this enzyme might be more likely to experience adverse effects on standard doses.(14) Seizures: Haloperidol may lower the seizure threshold and should be used cautiously in patients with a history of epilepsy or in those receiving antiepileptic medications.(2) Monitoring: Blood pressure (), heart rate (tachycardia), and ECG monitoring (if used IV) for prolongation of the QT interval. The patient should also be monitored for abnormal involuntary movements, and extrapyramidal symptoms.(15) Laboratory testing: and potassium concentrations should be monitored. , with elevated bilirubin and alkaline phosphatase, may occur, but generally resolves upon discontinuation. Increased hepatic enzymes in patients who are asymp- tomatic are usually not clinically significant.(15)  453