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Special Alerts
Antipsychotics: Newborn Extrapyramidal and Withdrawal Symptoms with Third Trimester Exposure (Update)
June 2011
The U.S. Food and Drug Administration (FDA) and Health Canada have updated or are in the process of updating the pregnancy sections of their respective prescribing information for antipsychotics to contain detailed information about nonteratogenic effects following maternal use during pregnancy. Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms; EPS) and withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor. These effects vary in severity and may be self-limiting (subsiding within hours or days) or require hospitalization. In the cases reported to the FDA, concomitant use of other medications (known to precipitate withdrawal symptoms) may have contributed to the effects, although in some cases, antipsychotic medication use was the only contributing factor for the EPS and withdrawal symptoms.
Women who are taking antipsychotics should not stop them if they become pregnant (abrupt discontinuation is not recommended), but should notify their healthcare provider. Women taking antipsychotics who intend to become pregnant should discuss treatment concerns with their healthcare provider. Any adverse effects noted in newborns should be reported in the U.S. to the FDA's Medwatch program (1-800-332-1088 or https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm) or in Canada to Health Canada's Canada Vigilance Program (1-866-234-2345 or http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
For additional information, please refer to:
U.S.: http://www.fda.gov/Drugs/DrugSafety/ucm243903.htm#aihp
Canada: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_78-eng.php
ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(proe klor PER a zeen)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Management of nausea and vomiting; psychotic disorders, including schizophrenia and anxiety
Use: Unlabeled
Behavioral syndromes in dementia; psychosis/agitation related to Alzheimer's dementia
Pregnancy Considerations
Jaundice or hyper-/hyporeflexia have been reported in newborn infants following maternal use of phenothiazines. Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization.
Lactation
Excretion in breast milk unknown/use caution
Breast-Feeding Considerations
Other phenothiazines are excreted in human milk; excretion of prochlorperazine is not known.
Contraindications
Hypersensitivity to prochlorperazine or any component of the formulation (cross-reactivity between phenothiazines may occur); severe CNS depression; coma; pediatric surgery; Reye's syndrome; should not be used in children <2 years of age or <9 kg
Warnings/Precautions
Boxed warnings:
• Dementia: See “Disease-related concerns” below.
Concerns related to adverse effects:
• Altered cardiac conduction: May alter cardiac conduction (life-threatening arrhythmias have occurred with therapeutic doses of phenothiazines).
• Anticholinergic effects: May cause anticholinergic effects (constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, paralytic ileus, urinary retention, BPH, xerostomia, or visual problems.
• Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported in clinical trials and postmarketing reports with antipsychotic use; presence of risk factors (eg, pre-existing low WBC or history of drug-induced leuko-/neutropenia) should prompt periodic blood count assessment. Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil count <1000/mm3.
• Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk of pneumonia (ie, 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.
• Hyperprolactinemia: Use associated with increased prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.
• Hypotension: May occur following administration, particularly when parenteral form is used or in high dosages.
• Neuroleptic malignant syndrome (NMS): May be associated with NMS; monitor for mental status changes, fever, muscle rigidity, and/or autonomic instability.
• Ocular effects: May cause pigmentary retinopathy, and lenticular and corneal deposits, particularly with prolonged therapy.
• 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 cause sedation, which may impair physical or mental abilities; 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:
• Cardiovascular disease: Use with caution in patients with severe cardiovascular disease.
• Dementia: [U.S. Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Prochlorperazine is not approved for the treatment of dementia-related psychosis.
• Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; condition may be exacerbated by cholinergic blockade.
• Parkinson's disease: Use with caution in patients with Parkinson's disease; they may be more sensitive to adverse effects.
• Renal impairment: Use with caution in patients with renal impairment.
• Seizure disorder: 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.
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Elderly: Use with caution in the elderly; increased risk for developing tardive dyskinesia, particularly elderly women.
• Pediatrics: Children with acute illness or dehydration are more susceptible to neuromuscular reactions (eg, dystonias); use cautiously.
Dosage form specific issues:
• Benzyl alcohol: Injection contains benzyl alcohol which has been associated with “gasping syndrome” in neonates.
Adverse Reactions
Reported with prochlorperazine or other phenothiazines. Frequency not defined.
Cardiovascular: Cardiac arrest, hypotension, peripheral edema, Q-wave distortions, T-wave distortions
Central nervous system: Agitation, catatonia, cerebral edema, cough reflex suppressed, dizziness, drowsiness, fever (mild - I.M.), headache, hyperactivity, hyperpyrexia, impairment of temperature regulation, insomnia, neuroleptic malignant syndrome (NMS), paradoxical excitement, restlessness, seizure
Dermatologic: Angioedema, contact dermatitis, discoloration of skin (blue-gray), epithelial keratopathy, erythema, eczema, exfoliative dermatitis (injectable), itching, photosensitivity, rash, skin pigmentation, urticaria
Endocrine & metabolic: Amenorrhea, breast enlargement, galactorrhea, gynecomastia, glucosuria, hyper-/hypoglycemia, lactation, libido (changes in), menstrual irregularity, SIADH
Gastrointestinal: Appetite increased, atonic colon, constipation, ileus, nausea, weight gain, xerostomia
Genitourinary: Ejaculating dysfunction, ejaculatory disturbances, impotence, incontinence, polyuria, priapism, urinary retention, urination difficulty
Hematologic: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenic purpura
Hepatic: Biliary stasis, cholestatic jaundice, hepatotoxicity
Neuromuscular & skeletal: Dystonias (torticollis, opisthotonos, carpopedal spasm, trismus, oculogyric crisis, protrusion of tongue); extrapyramidal symptoms (pseudoparkinsonism, akathisia, dystonias, tardive dyskinesia); SLE-like syndrome, tremor
Ocular: Blurred vision, cornea and lens changes, lenticular/corneal deposits, miosis, mydriasis, pigmentary retinopathy
Respiratory: Asthma, laryngeal edema, nasal congestion
Miscellaneous: Allergic reactions, diaphoresis
Metabolism/Transport Effects
None known.
Drug Interactions
Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotics. Severe extrapyramidal symptoms have occurred in some patients. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Amphetamines: Antipsychotics may diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy
Analgesics (Opioid): Antipsychotic Agents (Phenothiazines) may enhance the hypotensive effect of Analgesics (Opioid). Risk C: Monitor therapy
Antacids: May decrease the absorption of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy
Antidepressants (Serotonin Reuptake Inhibitor/Antagonist): Antipsychotic Agents (Phenothiazines) may enhance the adverse/toxic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). Specifically, this may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Antidepressants (Serotonin Reuptake Inhibitor/Antagonist) may enhance the hypotensive effect of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Antimalarial Agents: May increase the serum concentration of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Anti-Parkinson's Agents (Dopamine Agonist): Antipsychotics (Typical) may enhance the therapeutic effect of Anti-Parkinson's Agents (Dopamine Agonist). Anti-Parkinson's Agents (Dopamine Agonist) may diminish the therapeutic effect of Antipsychotics (Typical). 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. Risk D: Consider therapy modification
Beta-Blockers: Antipsychotic Agents (Phenothiazines) may enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Exceptions: Atenolol; Levobunolol; Metipranolol; Nadolol. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy
Deferoxamine: May enhance the adverse/toxic effect of Prochlorperazine. Specifically, prolonged loss of consciousness has been reported. Risk D: Consider therapy modification
Dofetilide: Prochlorperazine may increase the serum concentration of Dofetilide. Risk X: Avoid combination
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. Risk D: Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Lithium formulations: May enhance the neurotoxic effect of Antipsychotics. Lithium formulations may decrease the serum concentration of Antipsychotics. Specifically noted with chlorpromazine. Risk C: Monitor therapy
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. Risk D: Consider therapy modification
Methylphenidate: Antipsychotics may enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotics. Risk C: Monitor therapy
Metoclopramide: May enhance the adverse/toxic effect of Antipsychotics. Risk X: Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
Quinagolide: Antipsychotics may diminish the therapeutic effect of Quinagolide. Risk C: Monitor therapy
Serotonin Modulators: Antipsychotics may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy
Tetrabenazine: May enhance the adverse/toxic effect of Antipsychotics. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: May increase CNS depression; monitor for increased effects with coadministration. Caution patients about effects.
Food: Limit caffeine.
Herb/Nutraceutical: Avoid dong quai, St John's wort (may also cause photosensitization). Avoid kava kava, gotu kola, valerian, St John's wort (may increase CNS depression).
Storage
Injection: Store at <30°C (<86°F); do not freeze. Protect from light. Clear or slightly yellow solutions may be used.
I.V. infusion: Injection may be diluted in 50-100 mL NS or D5W.
Suppository, tablet: Store at 15°C to 30°C (59°F to 86°F). Protect from light.
Compatibility
Stable in D5W, D10W, D5LR, D51/4NS, D51/2NS, D5NS, LR, 1/2NS, NS.
Y-site administration: Compatible: Amsacrine, cisatracurium, cisplatin, cladribine, cyclophosphamide, cytarabine, dexmedetomidine, docetaxel, doxorubicin, doxorubicin liposome, fluconazole, granisetron, heparin, hetastarch in lactate electrolyte injection (Hextend®), hydrocortisone sodium succinate, linezolid, melphalan, methotrexate, methylprednisolone sodium succinate, ondansetron, oxaliplatin, paclitaxel, potassium chloride, propofol, remifentanil, sargramostim, sufentanil, teniposide, thiotepa, topotecan, vinorelbine. Incompatible: Aldesleukin, allopurinol, amifostine, amphotericin B cholesteryl sulfate complex, aztreonam, bivalirudin, cefepime, etoposide phosphate, fenoldopam, filgrastim, fludarabine, foscarnet, gemcitabine, pantoprazole, pemetrexed, piperacillin/tazobactam, vitamin B complex with C. Variable (consult detailed reference): Calcium gluconate, gallium nitrate.
Compatibility in syringe: Compatible: Atropine, butorphanol, chlorpromazine, cimetidine, diphenhydramine, droperidol, fentanyl, glycopyrrolate, hydroxyzine, meperidine, metoclopramide, nalbuphine, pentazocine, promethazine, ranitidine, scopolamine, sufentanil. Incompatible: Dimenhydrinate, ketorolac, midazolam, pantoprazole, pentobarbital, thiopental. Variable (consult detailed reference): Hydromorphone, morphine sulfate.
Mechanism of Action
Prochlorperazine is a piperazine phenothiazine antipsychotic which blocks postsynaptic mesolimbic dopaminergic D1 and D2 receptors in the brain, including the chemoreceptor trigger zone; exhibits a strong alpha-adrenergic and anticholinergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones; believed to depress the reticular activating system, thus affecting basal metabolism, body temperature, wakefulness, vasomotor tone and emesis
Pharmacodynamics/Kinetics
Onset of action: Oral: 30-40 minutes; I.M.: 10-20 minutes; Rectal: ~60 minutes
Peak antiemetic effect: I.V.: 30-60 minutes
Duration: Rectal: 12 hours; Oral: 3-4 hours; I.M., I.V.: Adults: 4-6 hours; I.M.: Children: 12 hours
Distribution: Vd: 1400-1548 L; crosses placenta; enters breast milk
Metabolism: Primarily hepatic; N-desmethyl prochlorperazine (major active metabolite)
Bioavailability: Oral: 12.5%
Half-life elimination: Oral: 6-10 hours (single dose), 14-22 hours (repeated dosing); I.V.: 6-10 hours
Dosage
Antiemetic: Children (therapy >1 day usually not required): Note: Not recommended for use in children <9 kg or <2 years:
Oral, rectal: >9 kg: 0.4 mg/kg/24 hours in 3-4 divided doses; or
9-13 kg: 2.5 mg every 12-24 hours as needed; maximum: 7.5 mg/day
13.1-17 kg: 2.5 mg every 8-12 hours as needed; maximum: 10 mg/day
17.1-37 kg: 2.5 mg every 8 hours or 5 mg every 12 hours as needed; maximum: 15 mg/day
I.M.: 0.13 mg/kg/dose; change to oral as soon as possible
Antiemetic: Adults:
Oral (tablet): 5-10 mg 3-4 times/day; usual maximum: 40 mg/day; larger doses may rarely be required
I.M. (deep): 5-10 mg every 3-4 hours; usual maximum: 40 mg/day
I.V.: 2.5-10 mg; maximum: 10 mg/dose or 40 mg/day; may repeat dose every 3-4 hours as needed
Rectal: 25 mg twice daily
Surgical nausea/vomiting: Adults: Note: Should not exceed 40 mg/day
I.M.: 5-10 mg 1-2 hours before induction or to control symptoms during or after surgery; may repeat once if necessary
I.V. (administer slow IVP <5 mg/minute): 5-10 mg 15-30 minutes before induction or to control symptoms during or after surgery; may repeat once if necessary
Rectal (unlabeled use): 25 mg
Antipsychotic:
Children 2-12 years (not recommended in children <9 kg or <2 years):
Oral, rectal: 2.5 mg 2-3 times/day; do not give more than 10 mg the first day; increase dosage as needed to maximum daily dose of 20 mg for 2-5 years and 25 mg for 6-12 years
I.M.: 0.13 mg/kg/dose; change to oral as soon as possible
Adults:
Oral: 5-10 mg 3-4 times/day; titrate dose slowly every 2-3 days; doses up to 150 mg/day may be required in some patients for treatment of severe disturbances
I.M.: Initial: 10-20 mg; if necessary repeat initial dose every 1-4 hours to gain control; more than 3-4 doses are rarely needed. If parenteral administration is still required; give 10-20 mg every 4-6 hours; change to oral as soon as possible.
Nonpsychotic anxiety: Oral (tablet): Adults: Usual dose: 15-20 mg/day in divided doses; do not give doses >20 mg/day or for longer than 12 weeks
Elderly: Behavioral symptoms associated with dementia (unlabeled use): Initial: 2.5-5 mg 1-2 times/day; increase dose at 4- to 7-day intervals by 2.5-5 mg/day; increase dosing intervals (twice daily, 3 times/day, etc) as necessary to control response or side effects; maximum daily dose should probably not exceed 75 mg in elderly; gradual increases (titration) may prevent some side effects or decrease their severity
Administration: I.M.
Inject by deep IM into outer quadrant of buttocks.
Administration: I.V.
Administer slow I.V. at a rate not exceeding 5 mg/minute. To reduce the risk of hypotension, patients receiving I.V. prochlorperazine must remain lying down and be observed for at least 30 minutes following administration
Administration: I.V. Detail
Do not dilute with any diluent containing parabens as a preservative. Avoid skin contact with injection solution, contact dermatitis has occurred. I.V. may be administered IVP or IVPB.
pH: 4.2-6.2
Monitoring Parameters
Vital signs; lipid profile, fasting blood glucose/Hgb A1c; BMI; mental status, abnormal involuntary movement scale (AIMS); periodic ophthalmic exams (if chronically used); extrapyramidal symptoms (EPS)
Test Interactions
False-positives for phenylketonuria, pregnancy, urinary amylase, uroporphyrins, urobilinogen
Dietary Considerations
Increase dietary intake of riboflavin; should be administered with food or water. Rectal suppositories may contain coconut and palm oil.
Patient Education
Avoid alcohol. You may experience appetite changes. Maintain adequate hydration unless instructed to restrict fluid intake. May cause dizziness, tremors, or visual disturbance (especially during early therapy). Do not change position rapidly(rise slowly). May cause photosensitivity reaction. Report immediately any changes in gait or muscular tremors. Report unresolved changes in voiding or elimination (constipation or diarrhea), acute dizziness or unresolved sedation, vision changes, palpitations, yellowing of skin or eyes, or changes in color of urine or stool (pink or red brown urine is expected).
Geriatric Considerations
Due to side effect profile (dystonias, EPS) this is not a preferred drug in the elderly for antiemetic therapy.
Many elderly patients receive antipsychotic medications for inappropriate nonpsychotic behavior. Before initiating antipsychotic medication, the clinician should investigate any possible reversible cause; any stress or stress from any disease can cause acute “confusion” or worsening of baseline nonpsychotic behavior. Most commonly acute changes in behavior are due to increases in drug dose or addition of new drug to regimen, fluid electrolyte loss, infections, and changes in environment.
Any changes in disease status in any organ system can result in behavior changes.
In the treatment of agitated, demented, older adult patients, authors of meta-analysis of controlled trials of the response to the traditional antipsychotics (phenothiazines, butyrophenones) in controlling agitation have concluded that the use of neuroleptics results in a response rate of 18%. Clearly neuroleptic therapy for behavior control should be limited with frequent attempts to withdraw the agent given for behavior control.
Additional Information
Not recommended as an antipsychotic due to inferior efficacy compared to other phenothiazines.
Anesthesia and Critical Care Concerns/Other Considerations
Clinical Pearls/Comments: When compared with ondansetron (4 mg I.V.), prochlorperazine (10 mg I.M.) administered at the end of surgery more effectively reduced postoperative nausea and the need for rescue antiemetics in patients undergoing total hip or knee replacement. In patients undergoing tympanoplasty, prophylactic prochlorperazine (0.02 mg/kg I.M.) administered at the end of surgery was as effective as ondansetron (0.06 mg/kg I.V.) for reducing PONV.
Evidence-Based Information: Prochlorperazine has a faster onset of action and causes less sedation than promethazine.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation).
Significant hypotension may occur, especially when the drug is administered parenterally or following administration of local anesthetics containing vasoconstrictors (ie, epinephrine or levonordefrin); orthostatic hypotension is due to alpha-receptor blockade, the elderly are at greater risk for orthostatic hypotension.
Significant sedation can occur and may be increased in the elderly and in patients taking other CNS depressants (ie, opioid analgesics or benzodiazepines).
Extrapyramidal effects including akathisia (motor restlessness), acute dystonia (spasmodic contractures), pseudoparkinsonism, and tardive dyskinesia can occur with 1 dose. These effects are more likely in the elderly, patients taking other dopamine antagonists (including antipsychotic agents and some antiemetic agents), and patients with Parkinson's disease.
Due to increased risk of adverse effects and drug interactions especially with opioid analgesics, reserve use for patients with moderate-to-severe postoperative nausea and vomiting, who cannot afford ondansetron, and for whom promethazine did not provide adequate control.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
May lower seizure threshold; use caution when administering prochlorperazine in combination with other agents that reduce seizure threshold (ie, local anesthetics). Due to prochlorperazine induced alpha-adrenergic blockade, administration of local anesthetics containing vasoconstrictors (epinephrine or levonordefrin), causes unopposed stimulation of beta-adrenergic receptors in heart and peripheral blood vessels that may result in tachycardia, peripheral vasodilation, or hypotension. Effects on blood pressure are greater in combination with epinephrine than levonordefrin.
Mental Health: Comment
While structurally a phenothiazine, this agent has limited antipsychotic activity and should not be used as such.
In 2008, the FDA issued a warning regarding increased mortality risk with typical and atypical antipsychotic drugs when used in elderly patients with dementia-related psychosis.
Nursing: Physical Assessment/Monitoring
For I.V., continuously monitor blood pressure and heart rate during administration. Monitor blood pressure and heart rate, fluid balance, and for dehydration. Monitor for seizures, especially with known seizure disorder. Monitor for excessive sedation, neuromuscular malignant syndrome, autonomic instability (eg, anticholinergic effects), and extrapyramidal symptoms.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution, as edisylate [strength expressed as base]: 5 mg/mL (2 mL, 10 mL)
Suppository, rectal: 25 mg (12s)
Compro®: 25 mg (12s) [contains coconut oil, palm oil]
Tablet, oral, as maleate [strength expressed as base]: 5 mg, 10 mg
Pricing: U.S. (www.drugstore.com)
Suppository (Compro)
25 mg (12): $33.99
Tablets (Prochlorperazine Maleate)
5 mg (30): $13.99
References
Ernst AA, Weiss SJ, Park S, et al, “Prochlorperazine Versus Promethazine for Uncomplicated Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial,” Ann Emerg Med, 2000, 36(2):89-94.
Gan TJ, Meyer TA, Apfel CC, et al, “Society for Ambulatory Anesthesia Guidelines for the Management of Postoperative Nausea and Vomiting,” Anesth Analg, 2007, 105(6):1615-28.
Gill SS, Bronskill SE, Normand SL, et al, “Antipsychotic Drug Use and Mortality in Older Adults With Dementia,” Ann Intern Med, 2007, 146(11):775-86.
Goldstein D, Levi JA, Woods RL, et al, “Double-Blind Randomized Cross-Over Trial of Dexamethasone and Prochlorperazine as Antiemetics for Cancer Chemotherapy,” Oncology, 1989, 46(2):105-8.
Golembiewski J, Chernin E, and Chopra T, “Prevention and Treatment of Postoperative Nausea and Vomiting,” Am J Health-Syst Pharm, 2005, 62(12):1247-60.
Hesketh PJ, Gandara DR, Hesketh AM, et al, “Improved Control of High-Dose-Cisplatin-Induced Acute Emesis With the Addition of Prochlorperazine to Granisetron/Dexamethasone,” Cancer J Sci Am, 1997, 3(3):180-3.
Isah AO, Rawlins MD, and Bateman DN, “Clinical Pharmacology of Prochlorperazine in Healthy Young Males,” Br J Clin Pharmacol, 1991, 32(6):677-84.
Lapierre J, Amin M, and Hattangadi S, “Prochlorperazine - A Review of the Literature Since 1956,” Can Psychiatr Assoc J, 1969, 14(3):267-74.
National Institute for Health and Clinical Excellence (NICE), National Collaborating Centre for Mental Health , “Schizophrenia. Core Interventions in the Treatment and Management of Schizophrenia in Primary and Secondary Care (Updated),” National Clinical Practice Guideline Number 82, 2009:1-399. Available at www.nice.org.uk/cg082
Olver IN, Webster LK, Bishop JF, et al, “A Dose Finding Study of Prochlorperazine as an Antiemetic for Cancer Chemotherapy,” Eur J Cancer Clin Oncol, 1989, 25(10):1457-61.
Owens NH, Schauer AR, Nightingale CH, et al, “Antiemetic Efficacy of Prochlorperazine, Haloperidol, Droperidol in Cisplatin-Induced Emesis,” Clin Pharm, 1984, 3(2):167-70.
Peabody CA, Warner MD, Whiteford HA, et al, “Neuroleptics and the Elderly,” J Am Geriatr Soc, 1987, 35(3):233-8.
Rabins PV, Blacker D, Rovner BW, et al, “Practice Guideline for the Treatment of Patients With Alzheimer's Disease and Other Dementias,” October, 2007. Available at http://www.psych.org/psych_pract/treatg/pg/prac_guide.cfm
Schneeweiss S, Setoguchi S, Brookhart A, et al, “Risk of Death Associated With the Use of Conventional Versus Atypical Antipsychotic Drugs Among Elderly Patients,” CMAJ, 2007, 176(5): 627-32.
Taylor WB and Bateman DN, “Preliminary Studies of the Pharmacokinetics and Pharmacodynamics of Prochlorperazine in Healthy Volunteers,” Br J Clin Pharmacol, 1987, 23(2): 137-42.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
Content last modified March 2012
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