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Droperidol

Pronunciation

Pronunciation

(droe PER i dole)

Index Terms

  • Dehydrobenzperidol
  • Inapsine

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Generic: 2.5 mg/mL (2 mL)

Pharmacologic Category

  • Antiemetic
  • First Generation (Typical) Antipsychotic

Pharmacology

Droperidol is a butyrophenone antipsychotic; antiemetic effect is a result of blockade of dopamine stimulation of the chemoreceptor trigger zone. Other effects include alpha-adrenergic blockade, peripheral vascular dilation, and reduction of the pressor effect of epinephrine resulting in hypotension and decreased peripheral vascular resistance; may also reduce pulmonary artery pressure

Absorption

IM: Rapid

Distribution

Crosses blood-brain barrier and placenta; Vd: Children: ~0.6 L/kg, Adults: ~1.5 L/kg

Metabolism

Hepatic, to p-fluorophenylacetic acid, benzimidazolone, p-hydroxypiperidine

Excretion

Urine (75%, <1% as unchanged drug); feces (22%, 11% as unchanged drug)

Onset of Action

3-10 minutes; Peak effect: Within 30 minutes

Duration of Action

2-4 hours, may extend to 12 hours

Half-Life Elimination

~2.3 hours

Protein Binding

85% to 90%

Use: Labeled Indications

Prevention and/or treatment of nausea and vomiting from surgical and diagnostic procedures

Contraindications

Hypersensitivity to droperidol or any component of the formulation; known or suspected QT prolongation, including congenital long QT syndrome (prolonged QTc is defined as >440 msec in males or >450 msec in females)

Canadian labeling: Additional contraindications (not in U.S. labeling): Not for use in children ≤2 years of age

Dosing: Adult

Note: Titrate carefully to desired effect

Prevention of PONV: IM, IV:

Manufacturer labeling: Maximum initial dose: 2.5 mg; additional doses of 1.25 mg may be administered with caution to achieve desired effect

Consensus guideline recommendations: 0.625-1.25 mg IV administered at the end of surgery (Gan, 2007)

Canadian labeling:

Prevention and treatment of PONV: IV: 0.625-1.25 mg 30 minutes prior to anticipated end of surgery, and then every 6 hours as needed for breakthrough PONV

Dosing: Geriatric

Refer to adult dosing.

Canadian labeling: PONV: IV: 0.625 mg 30 minutes prior to anticipated end of surgery and then every 6 hours as needed for breakthrough PONV; additional dosing should be administered with caution.

Dosing: Pediatric

Note: Titrate carefully to desired effect

Prevention of postoperative nausea and vomiting (PONV): IM, IV: Children 2-12 years:

Manufacturer labeling: Maximum dose: 0.1 mg/kg; additional doses may be repeated with caution to achieve desired effect

Consensus guideline recommendations: 0.01-0.015 mg/kg (maximum: 1.25 mg) IV administered at the end of surgery (Gan, 2007)

Canadian labeling:

Prevention and treatment of PONV: IV: Children >2 years and Adolescents: 0.02-0.05 mg/kg (maximum dose: 1.25 mg) 30 minutes prior to anticipated end of surgery, and then every 6 hours as needed for breakthrough PONV

Dosing: Renal Impairment

U.S. labeling: Specific dosing recommendations are not provided; use with caution.

Canadian labeling: IV: 0.625 mg; additional dosing should be administered with caution.

Dosing: Hepatic Impairment

U.S. labeling: Specific dosing recommendations are not provided; use with caution.

Canadian labeling: IV: 0.625 mg; additional dosing should be administered with caution.

Reconstitution

IV infusion: Dilute in 50-100 mL NS or D5W.

Administration

Administer IM or IV; according to the manufacturer, IV push administration should be slow. For IV infusion, further dilute.

Compatibility

Stable in D5W, LR, NS.

Y-site administration: Incompatible with allopurinol, amphotericin B cholesteryl sulfate complex, cefepime, cefotetan, fluorouracil, foscarnet, furosemide, leucovorin calcium, nafcillin, pemetrexed, piperacillin/tazobactam.

Compatibility in syringe: Incompatible with fluorouracil, furosemide, heparin, leucovorin calcium, methotrexate, pentobarbital.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Solutions diluted in NS or D5W are stable at room temperature for up to 7 days in PVC bags or glass bottles. Solutions diluted in LR are stable at room temperature for 24 hours in PVC bags and up to 7 days in glass bottles.

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy

Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotic Agents. Severe extrapyramidal symptoms have occurred in some patients. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Amisulpride: Antipsychotic Agents may enhance the adverse/toxic effect of Amisulpride. Avoid combination

Amphetamines: Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Exceptions: Levocabastine (Nasal). Monitor therapy

Anti-Parkinson's Agents (Dopamine Agonist): May diminish the therapeutic effect of Antipsychotic Agents (First Generation [Typical]). Antipsychotic Agents (First Generation [Typical]) may diminish the therapeutic effect of Anti-Parkinson's Agents (Dopamine Agonist). Management: Avoid concomitant therapy if possible and monitor for decreased effects of both agents when these combinations cannot be avoided. Atypical antipsychotics such as clozapine and quetiapine may be less likely to reduce the effects of anti-Parkinson's agents. Consider therapy modification

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

CNS Depressants: Droperidol may enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Exceptions: Levocabastine (Nasal). Consider therapy modification

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate: Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Hydrocodone: CNS Depressants may enhance the CNS depressant effect of Hydrocodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Ivabradine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Lithium: May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mequitazine: Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Consider therapy modification

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

Methylphenidate: Antipsychotic Agents may enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy

Metoclopramide: Droperidol may enhance the adverse/toxic effect of Metoclopramide. Avoid combination

Metyrosine: May enhance the adverse/toxic effect of Droperidol. Monitor therapy

Mifepristone: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Moderate Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Quinagolide: Antipsychotic Agents may diminish the therapeutic effect of Quinagolide. Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Serotonin Modulators: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

Sulpiride: Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride. Avoid combination

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Adverse Reactions

Frequency not defined.

Cardiovascular: Cardiac arrest, hypertension, hypotension (especially orthostatic), QTc prolongation (dose dependent), tachycardia, torsade de pointes, ventricular tachycardia

Central nervous system: Anxiety, chills, depression (postoperative, transient), dizziness, drowsiness (postoperative) increased, dysphoria, extrapyramidal symptoms (akathisia, dystonia, oculogyric crisis), hallucinations (postoperative), hyperactivity, neuroleptic malignant syndrome (NMS) (rare), restlessness

Respiratory: Bronchospasm, laryngospasm

Miscellaneous: Anaphylaxis, shivering

ALERT: U.S. Boxed Warning

Arrhythmias:

Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation, and some cases have been fatal.

Due to its potential for serious proarrhythmic effects and death, reserve droperidol for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs.

Cases of QT prolongation and serious arrhythmias (eg, torsade de pointes) have been reported in patients treated with droperidol. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (ie, QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, do not administer droperidol. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, perform ECG monitoring prior to treatment and continue for 2 to 3 hours after completing treatment to monitor for arrhythmias.

Droperidol is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.

Administer droperidol with extreme caution to patients who may be at risk for development of prolonged QT syndrome (eg, congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age greater than 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Initiate droperidol at a low dose and adjust upward, with caution, as needed to achieve the desired effect.

Warnings/Precautions

Concerns related to adverse effects:

• Arrhythmias: [U.S. Boxed Warning]: Cases of QT prolongation and torsade de pointes, including some fatal cases, have been reported. Use extreme caution in patients with bradycardia (<50 bpm), cardiac disease, concurrent MAO inhibitor therapy, Class I and Class III antiarrhythmics or other drugs known to prolong QT interval, and electrolyte disturbances (hypokalemia or hypomagnesemia), including concomitant drugs which may alter electrolytes (diuretics).

• Anticholinergic effects: May cause anticholinergic effects (constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, urinary retention, BPH, xerostomia, or visual problems. Relative to other neuroleptics, droperidol has a low potency of cholinergic blockade.

• Esophageal dysmotility/aspiration: Has been associated with antipsychotic use; use with caution in patients at risk of pneumonia (eg, Alzheimer’s disease).

• Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia. Risk of dystonia (and possibly other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients. Risk of tardive dyskinesia and potential for irreversibility may be increased in elderly patients (particularly women), prolonged therapy, and higher total cumulative dose; antipsychotics may also mask signs/symptoms of tardive dyskinesia. Consider therapy discontinuation with signs/symptoms of tardive dyskinesia.

• Neuroleptic malignant syndrome (NMS): Use may be associated with neuroleptic malignant syndrome (NMS); monitor for mental status changes, fever, muscle rigidity and/or autonomic instability.

• Orthostatic hypotension: May cause orthostatic hypotension; use with caution in patients at risk of this effect or in those who would not tolerate transient hypotensive episodes (cerebrovascular disease, cardiovascular disease, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia).

• Sedation: May be sedating, use with caution in disorders where CNS depression is a feature; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Temperature regulation: Impaired core body temperature regulation may occur; caution with strenuous exercise, heat exposure, dehydration, and concomitant medication possessing anticholinergic effects.

Disease-related concerns:

• Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade. Screening is recommended. Relative to other neuroleptics, droperidol has a low potency of cholinergic blockade.

• Hepatic impairment: Use with caution in patients with severe hepatic impairment.

• Pheochromocytoma: Use with caution in patients with pheochromocytoma; severe hypertension and/or tachycardia may occur.

• Prolactin-dependent tumors: Use with caution in breast cancer or other prolactin-dependent tumors; may elevate prolactin levels.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizures: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold.

Concurrent drug therapy issues:

• Antiemetic effects: May mask toxicity of other drugs or conditions (eg, intestinal obstruction, Reye's syndrome, brain tumor) due to antiemetic effects.

Special populations:

• Elderly: Use with caution in the elderly; reduce initial dose.

Monitoring Parameters

To identify QT prolongation, a 12-lead ECG prior to use is recommended; continued ECG monitoring for 2-3 hours following administration is recommended. Vital signs; serum magnesium and potassium; mental status, abnormal involuntary movement scale (AIMS); observe for dystonias, extrapyramidal side effects, and temperature changes

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Although use in pregnancy has been reported, due to cases of QT prolongation and torsade de pointes (some fatal), use of other agents in pregnant women is preferred (ACOG, 2004).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience anxiety, fatigue, or agitation. Have patient report immediately to prescriber abnormal movements, twitching, change in balance, dysphagia, difficulty speaking, tachycardia, arrhythmia, severe dizziness, passing out, hallucinations, angina, behavioral changes, or signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, abnormal heartbeat, or sweating a lot) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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