Droperidol

Mechanism of Action

Antiemesis: dopamine receptor blockade in brain, predominantly dopamine-2 receptor & when reuptake is prevented, a strong antidopaminergic, antiserotonic response occurs

Droperidol reduced motor activity, anxiety, and causes sedation; also possesses adrenergic-blocking, antifibrillatory, antihistaminic, & anticonvulsive properties

Pharmacotherapy

Half-Life elimination: 2 hr (parent drug), 8-12 hr (metabolites)

Onset: 3-10 min

Duration: 2-4 hr, may persist up to12 hr

Peak Response Time: 10-30 min

Peak Plasma Time: 60 min (IM)

Protein Bound: extensive

Metabolism: extensively in the liver

Metabolites: [Benzimidazolone, p-Fluorophenylacetic acid, p-Hydroxypiperidine] (inactive)

Vd: 2 L/kg (Adults); 0.58 L/kg (Children)

Excretion: Urine (75%); feces (22%)

INAPSINE (droperidol) is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• AZITHROMYCIN/DROPERIDOL
• BEDAQUILINE/DROPERIDOL
• CABERGOLINE/DROPERIDOL
• CITALOPRAM/DROPERIDOL
• CLARITHROMYCIN/DROPERIDOL
• CRIZOTINIB/DROPERIDOL
• DOFETILIDE/DROPERIDOL
• DROPERIDOL/ENTACAPONE
• DROPERIDOL/ERYTHROMYCIN
• DROPERIDOL/LEVODOPA
• DROPERIDOL/METHADONE
• DROPERIDOL/METOCLOPRAMIDE
• DROPERIDOL/PASIREOTIDE
• DROPERIDOL/PERGOLIDE
• DROPERIDOL/PRAMIPEXOLE
• DROPERIDOL/ROPINIROLE HYDROCHLORIDE
• DROPERIDOL/SAQUINAVIR
• DROPERIDOL/SODIUM OXYBATE
• DROPERIDOL/SORAFENIB
• DROPERIDOL/TOREMIFENE CITRATE
• DROPERIDOL/VEMURAFENIB
• DROPERIDOL/ZIPRASIDONE

This is not a complete list of Droperidoldrug interactions. Ask your doctor or pharmacist for more information.

Usual Adult Dose for Nausea/Vomiting:

Dosage: The dosage should be individualized. Factors to be considered in determining dose are age, body weight, physical status, underlying pathological condition, use of other drugs, the type of anesthesia to be used, and the surgical procedure involved. Vital signs and ECG should be monitored closely.

Maximum Dosage: The maximum recommended initial dose is 2.5 mg IM or slow IV. Additional 1.25 mg doses of droperidol may be administered to achieve the desired effect. The additional doses should be administered with caution and only if the potential benefit outweighs the potential risk.

Use: To reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures

Usual Adult Dose for Nausea/Vomiting -- Postoperative:

Dosage: The dosage should be individualized. Factors to be considered in determining dose are age, body weight, physical status, underlying pathological condition, use of other drugs, the type of anesthesia to be used, and the surgical procedure involved. Vital signs and ECG should be monitored closely.

Maximum Dosage: The maximum recommended initial dose is 2.5 mg IM or slow IV. Additional 1.25 mg doses of droperidol may be administered to achieve the desired effect. The additional doses should be administered with caution and only if the potential benefit outweighs the potential risk.

Use: To reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures

Usual Pediatric Dose for Nausea/Vomiting:

Dosage: The dosage should be individualized. Factors to be considered in determining dose are age, body weight, physical status, underlying pathological condition, use of other drugs, the type of anesthesia to be used, and the surgical procedure involved. Vital signs and ECG should be monitored closely.

Children 2 to 12 years:
Postoperative nausea and vomiting (PONV):
Prophylaxis, if high risk for PONV: 0.01 to 0.015 mg/kg/dose IM or IV given near the end of surgery Maximum dose: 1.25 mg
Administer additional doses after at least 6 hours with caution and only if potential benefit outweighs risks.
(Previous reports suggested a higher dose of 0.075 mg/kg as effective; however, due to side effects associated with the higher doses, doses greater than 0.05 mg/kg are considered excessive and no longer recommended.)

Treatment (not first line): IV:
Manufacturer recommendations: 0.1 mg/kg/dose. Administer additional doses with extreme caution and only if potential benefit outweighs risks.

Alternate dosing: Doses as low as 0.01 to 0.015 mg/kg/dose (up to 0.03 mg/kg) may be effective for breakthrough nausea and vomiting
Maximum initial dose: 0.1 mg/kg
Administer additional doses after at least 6 hours with caution and only if potential benefit outweighs risks.

Use: To reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures

Usual Pediatric Dose for Nausea/Vomiting -- Postoperative:

Dosage: The dosage should be individualized. Factors to be considered in determining dose are age, body weight, physical status, underlying pathological condition, use of other drugs, the type of anesthesia to be used, and the surgical procedure involved. Vital signs and ECG should be monitored closely.

Children 2 to 12 years:
Postoperative nausea and vomiting (PONV):
Prophylaxis, if high risk for PONV: 0.01 to 0.015 mg/kg/dose IM or IV given near the end of surgery Maximum dose: 1.25 mg
Administer additional doses after at least 6 hours with caution and only if potential benefit outweighs risks.
(Previous reports suggested a higher dose of 0.075 mg/kg as effective; however, due to side effects associated with the higher doses, doses greater than 0.05 mg/kg are considered excessive and no longer recommended.)

Treatment (not first line): IV:
Manufacturer recommendations: 0.1 mg/kg/dose. Administer additional doses with extreme caution and only if potential benefit outweighs risks.

Alternate dosing: Doses as low as 0.01 to 0.015 mg/kg/dose (up to 0.03 mg/kg) may be effective for breakthrough nausea and vomiting
Maximum initial dose: 0.1 mg/kg
Administer additional doses after at least 6 hours with caution and only if potential benefit outweighs risks.

Use: To reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures

• Exhibits strong sedative and tranquilizing effects.a Potentiates the actions of other CNS depressants but apparently has no analgesic activity.114 a

• Has antiemetic activity.114 a

• Acts principally at CNS subcortical levels;a may cause extrapyramidal reactions.114 a

• Exhibits some α-adrenergic blocking activity; attenuates the cardiovascular response to sympathomimetic amines (e.g., reduces pressor effect of epinephrine).114 a

• Direct peripheral vasodilatory effects, alone or in conjunction with α-adrenergic blockade, may cause hypotension and decreased peripheral vascular resistance.114 a

• May decrease pulmonary arterial pressure (particularly if abnormally high).114 a

• May reduce the incidence of epinephrine-induced arrhythmias but does not appear to prevent other arrhythmias.114 a

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Hallucinations (seeing or hearing things that are not there).
• Chest pain or pressure or a fast heartbeat.
• Change in how you act.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.

Droperidol should be administered with extreme caution in the presence of risk factors for development of prolonged QT syndrome, such as: 1) clinically significant bradycardia (less than 50 bpm), 2) any clinically significant cardiac disease, 3) treatment with Class I and Class III antiarrhythmics, 4) treatment with monoamine oxidase inhibitors (MAOI’s), 5) concomitant treatment with other drug products known to prolong the QT interval (see PRECAUTIONS, Drug Interactions), and 6) electrolyte imbalance, in particular hypokalemia and hypomagnesemia, or concomitant treatment with drugs (e.g., diuretics) that may cause electrolyte imbalance.

Effects on Cardiac Conduction:

A dose-dependent prolongation of the QT interval was observed within 10 minutes of Droperidol administration in a study of 40 patients without known cardiac disease who underwent extracranial head and neck surgery. Significant QT prolongation was observed at all three dose levels evaluated, with 0.1, 0.175, and 0.25 mg/kg associated with prolongation of median QTc by 37, 44, and 59 msec, respectively.

Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes, ventricular arrhythmias, cardiac arrest, and death) have been observed during post-marketing treatment with Droperidol. Some cases have occurred in patients with no known risk factors and at doses at or below recommended doses. There has been at least one case of nonfatal torsade de pointes confirmed by rechallenge.

Based on these reports, all patients should undergo a 12-lead ECG prior to administration of Droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, Droperidol should NOT be administered. For patients in whom the potential benefit of Droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias.

FLUIDS AND OTHER COUNTERMEASURES TO MANAGE HYPOTENSION SHOULD BE READILY AVAILABLE.

As with other CNS depressant drugs, patients who have received Droperidol should have appropriate surveillance.

It is recommended that opioids, when required, initially be used in reduced doses.

As with other neuroleptic agents, very rare reports of neuroleptic malignant syndrome (altered consciousness, muscle rigidity and autonomic instability) have occurred in patients who have received Droperidol.

Since it may be difficult to distinguish neuroleptic malignant syndrome from malignant hyperpyrexia in the perioperative period, prompt treatment with dantrolene should be considered if increases in temperature, heart rate or carbon dioxide production occur.

• Dehydrobenzperidol
• Inapsine

• Antiemetic
• First Generation (Typical) Antipsychotic

Postoperative nausea/vomiting (PONV): Prevention and/or treatment of nausea and vomiting from surgical and diagnostic procedures

Acute undifferentiated agitation

Data from randomized, placebo- and active-control studies supports the use of droperidol as monotherapy or with concomitant benzodiazepines for decreasing time to sedation and reducing the risk of needing additional medications in the treatment of acute undifferentiated agitation, including agitation caused by trauma, acute psychiatric or medical disorders, or intoxication from alcohol or illicit substances [Calver 2015], [Chan 2013], [Isbister 2010], [Knott 2006], [Martel 2005], [Taylor 2016], [Thomas 2016] Data from a meta-analysis supports the use of droperidol for decreasing time to tranquilization and reducing the risk of needing additional medications in the treatment of psychosis-induced aggression or agitation [Khokhar 2016].

Based on the American Academy of Emergency Medicine (AAEP) position statement on the safety of droperidol use in the emergency department, droperidol is safe and effective for the management of agitation. Despite a recommendation by the Food and Drug Administration for strict ECG monitoring to detect QTc prolongation with droperidol use, the AAEP position statement does not recommend monitoring ECG for doses less than 2.5 mg [Perkins 2015]. Based on a clinical policy by the American College of Emergency Physicians (ACEP), antipsychotics like droperidol are effective and recommended for the management of acute agitation in patients with known psychiatric illness for which antipsychotics are indicated. Guidelines from the Society of Critical Care Medicine (SCCM) on the management of agitation in the intensive care unit do not mention the use of droperidol.

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 US labeling): Not for use in children ≤2 years of age

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

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

Amifampridine: May diminish the anticholinergic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Amifampridine. 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. Monitor therapy

Anti-Parkinson 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 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 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

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

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

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic 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. Consider therapy modification

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

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

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

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

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

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

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: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

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

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. 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

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: May enhance the CNS depressant effect of CNS Depressants. CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. 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: May enhance the adverse/toxic effect of Antipsychotic Agents. Antipsychotic Agents may enhance the adverse/toxic effect of Methylphenidate. 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

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. 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

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

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. 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

Piribedil: May diminish the therapeutic effect of Antipsychotic Agents. Antipsychotic Agents may diminish the therapeutic effect of Piribedil. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended. Avoid combination

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

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination

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

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

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

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 concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of 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. Exceptions: Nicergoline. 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: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. 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

Thiopental: Droperidol may enhance the therapeutic effect of Thiopental. Management: Consider thiopental dose reduction when used concomitantly with droperidol. Monitor patient response to treatment closely if using this combination. Consider therapy modification

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

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

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

Xipamide: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

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

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Dosage: The dosage should be individualized. Factors to be considered in determining dose are age, body weight, physical status, underlying pathological condition, use of other drugs, the type of anesthesia to be used, and the surgical procedure involved. Vital signs and ECG should be monitored closely.

Children 2 to 12 years:
Postoperative nausea and vomiting (PONV):
Prophylaxis, if high risk for PONV: 0.01 to 0.015 mg/kg/dose IM or IV given near the end of surgery Maximum dose: 1.25 mg
Administer additional doses after at least 6 hours with caution and only if potential benefit outweighs risks.
(Previous reports suggested a higher dose of 0.075 mg/kg as effective; however, due to side effects associated with the higher doses, doses greater than 0.05 mg/kg are considered excessive and no longer recommended.)

Treatment (not first line): IV:
Manufacturer recommendations: 0.1 mg/kg/dose. Administer additional doses with extreme caution and only if potential benefit outweighs risks.

Alternate dosing: Doses as low as 0.01 to 0.015 mg/kg/dose (up to 0.03 mg/kg) may be effective for breakthrough nausea and vomiting
Maximum initial dose: 0.1 mg/kg
Administer additional doses after at least 6 hours with caution and only if potential benefit outweighs risks.

Use: To reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures

Single-dose or short-term use during breastfeeding (such as during surgery), is not likely to adversely affect the breastfed infant, especially if the infant is older than 2 months. If multiple doses are given to the mother, the infant should be monitored for drowsiness, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs. UK manufacturer information states that administration of droperidol during lactation should be limited to a single administration and repeat use is not recommended.

AU: Use of droperidol is contraindicated. UK: Treatment with droperidol should be limited to a single administration. US: Caution is recommended. Excreted into human milk: Unknown (droperidol); Yes (butyrophenones) Comments: The effects in the nursing infant are unknown.

Summary of Use during Lactation

Because little information is available on the long-term use of droperidol during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Single-dose or short-term use during breastfeeding, such as during surgery, is unlikely to adversely affect the breastfed infant, especially if the infant is older than 2 months.[1] When multiple doses are given to the mother, monitor the infant for drowsiness, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A randomized study compared the breastfed infants born by cesarean section whose mothers received either morphine or morphine plus droperidol by patient-controlled analgesia postoperatively. On days 1 and 2 of life, the infants whose mothers received droperidol had a lower neonatal neurologic and adaptive capacity score (NACS) than those who received morphine only.[2]

One breastfed (extent not stated) infant whose mother was taking droperidol had a somewhat decreased intellectual development on testing, but her mother had also taken olanzapine, clonazepam, sertraline, thioridazine and valproic acid while breastfeeding.[3]

Effects on Lactation and Breastmilk

Hyperprolactinemia has been reported in patients taking long-term droperidol[4][5] and after short-term use during surgical procedures.[6][7] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.

References

1. Spigset O. Anaesthetic agents and excretion in breast milk. Acta Anaesthesiol Scand. 1994;38:94-103. PMID: 8171959

2. Bonhomme V, Brichant JF, Wuilmart M et al. Droperidol reduces nausea after caesarean section but alters the neurological status of the breastfed infants. Anesthesiology. 2002;96:A1044. Abstract.

3. Gardiner SJ, Kristensen JH, Begg EJ et al. Transfer of olanzapine in to breast milk, calculation of infant drug dose, and effect on breast-fed infants. Am J Psychiatry. 2003;160:1428-31. PMID: 12900304

4. Langer G, Puhringer W. Haloperidol and droperidol treatment in schizophrenics. Clinical application of the "prolactin-model". Acta Psychiatr Belg. 1980;80:574-83. PMID: 7234451

5. Smith S, Wheeler MJ, Murray R, O'Keane V. The effects of antipsychotic-induced hyperprolactinaemia on the hypothalamic-pituitary-gonadal axis. J Clin Psychopharmacol. 2002;22:109-14. PMID: 11910254

6. Naito Y, Tamai S, Fukata J et al. Comparison of endocrinological stress response associated with transvaginal ultrasound-guided oocyte pick-up under halothane anaesthesia and neuroleptanaesthesia. Can J Anaesth. 1989;36:633-6. PMID: 2555076

7. Jullien Y, de Rodez M, Bonardet A et al. [Comparison of postoperative blood levels of prolactin and somatotropin after two methods of anesthesia]. Ann Anesthesiol Fr. 1980;21:459-66. PMID: 6110401